Showing posts with label Investment News HCV Drugs. Show all posts
Showing posts with label Investment News HCV Drugs. Show all posts

Friday, September 30, 2011

T.G.I.F Hepatitis News Ticker; Hep C Drugs:Bristol-Myers, Merck and Vertex

New On The Blog

AASLD- Abstracts To Be Presented At The Nov Meeting;

AASLD-Vertex presentation of New Data; INCIVEK™and VX-222
AASLD-New Data On BMS-790052 and BMS-650032 to be presented by Bristol-Myers Squibb
AASLD-Acceptance of Four TMC435 Abstracts by Medivir
AASLD-New Data Analyses for VICTRELIS™ (boceprevir) will be Presented By Merck

Hepatitis C patients likely to falter in adherence to treatment regimen over time
Galectin-inhibiting therapeutics to treat fibrosis, liver disease and cancer
Consider Hepatitis C Infection in Some Arthritis Patients
Liver Health and Wellness

Four Ways to Beat Hepatitis Fatigue
Fatigue is a problem frequently experienced by those with chronic hepatitis. Fortunately, there are several different kinds of approaches that can help mitigate fatigue.
by Nicole Cutler, L.Ac.
As the most common symptom of chronic hepatitis, fatigue is also one of the hardest ones to address. Likely because of the complex combination of cellular and chemical processes involved in producing energy, battling fatigue is best accomplished through a variety of different approaches....

Local towns among hot spots for high rates of HIV, Hep C
NEW GLASGOW – Local groups are claiming that the incidence of AIDS, HIV and Hepatitis C is increasing rapidly in Pictou County, primarily due to a rising number of intravenous drug users in the region.

Rayann Toner, executive director of the Pictou County Centre for Sexual Health, says that a study done by Caroline Ploems for Health Canada Population and Public Health Branch shows that there are six “hot spots” in mainland Nova Scotia where injection drug use has been identified as a problem.


The Next Big Thing In Biotech: Hep C Drugs

Adam Feuerstein, senior columnist for TheStreet, explains why hepatitis C
drugmakers will be the biotech stocks to watch in the coming week.

ANALYSIS-Vertex takes early rounds of hep C bout with Merck

29 Sep 2011 17:48 Source: reuters // Reuters

New prescriptions for Vertex drug outpacing Merck entry

* Incivek could be one of fastest drugs to reach $1 bln

* VA contract could give boost to Merck

By Bill Berkrot
Sept 29 (Reuters) - In the bout between a pair of breakthrough hepatitis C treatments, Incivek from upstart biotech Vertex Pharmaceuticals appears to have taken the first round from pharmaceutical heavyweight Merck & Co and its Victrelis by a wide margin.

The companies next month will report sales from the first full quarter on the U.S. market for their new medicines, and weekly prescription data indicates that Merck has some serious catching up to do.

About 1,100 new patients are likely to begin Incivek treatment each week in the fourth quarter compared with about 300 new patients for Victrelis, according to Wolters Kluwer, a provider of analytical data to the healthcare industry.

It estimates U.S. Incivek sales reaching $752 million in 2011 -- a trajectory that would see the drug surpass $1 billion in its first year on the market -- making for one of the most successful drug launches in history.

Genentech's blockbuster cancer drug Avastin, which was approved in February 2004, racked up its first billion dollars in sales in about a year and a half.

In contrast, Wolters Kluwer inThought unit is forecasting $146 million in 2011 U.S. Victrelis sales.

"It's absolutely impressive," Julie Hoggatt, an analyst for inThought, said of Incivek performance out of the gate. "It does seem that Vertex, being that this was its first launch, did a very good job."

The two drugs, which promise far higher cure rates for the serious liver disease than prior standard treatments, as well as the potential for shorter treatment durations, were approved within days of each other in May.

Analysts said that Merck has made some savvy moves, including a co-promotion deal with rival Roche - the biggest seller of one of the older drugs that must be used in combination with the new medicines.

But it has so far been unable to alter the perception that Vertex has the better drug, even though the two have never been tested against each other.

In the final round of clinical trials Incivek, known chemically as telaprevir, cured between 75 percent and 80 percent of patients. Victrelis, known chemically as boceprevir, cured 66 percent. Both results easily topped the cure rate of only about 40 percent for the previous standard treatments that had to be taken for nearly a year and which often caused miserable flu-like symptoms.


While many industry observers believed the Roche co-promotion would help bring the market share split much closer to 50-50, Incivek has so far been dominating.

"There was a feeling that maybe Merck could do a little bit better because they've done some unique things in the marketplace," said Deutsche Bank analyst Barbara Ryan.

"The reality is that the Vertex drug is more potent, has a more straightforward, simple dosing regimen, and for that reason they got the lion share of the market," she added.

"We still think that in some markets, like the Asian markets, that Merck will do better than its share here just because the company's presence in those markets is so strong," Ryan said.

Both drugs were recently approved in Europe, where Johnson & Johnson will sell the Vertex drug.

Hoggatt agreed that simplicity and a larger percentage of patients who qualify for shorter treatment time with Incivek were working in Vertex favor.

"One negative for boceprevir is how confusing its label is," Hoggatt said. "I think maybe seeing some hesitation from physicians because of the complexity."

Under the Victrelis regimen the two older drugs -- interferon and ribavirin -- are taken for four weeks before the Merck drug is added to the mix. There are several treatment duration variables depending on a patient response to the drugs at certain points along the way.

With Incivek, all three drugs are taken from the beginning and there are fewer pills and fewer duration variables.

"Patients are asking for telaprevir," confirmed Dr. Douglas Dieterich, a liver disease specialist and professor of medicine at Mt. Sinai School of Medicine in New York.

"It's probably going to become less telaprevir-dominated as the side effects roll in," Dieterich predicted. Incivek has been associated with serious rash in clinical trials.

But asked if patients have also been asking for the new Merck drug, Dieterich said, "No. Not at all."

Both companies have so far limited consumer marketing to campaigns aimed at raising awareness of hepatitis C, a disease that someone can have for many years without symptoms. If untreated, it can lead to cirrhosis, liver cancer and death.

"While it's still early, we are off to a good start with the launch of Victrelis and are encouraged by the positive responses we received on our product from physicians, patients and payers," Merck spokeswoman Pamela Eisele said.

Merck has won a contract for Victrelis to be the preferred treatment option by the U.S. Department of Veterans Affairs that serves thousands of patients, which should provide a boost for its drug.

But Merck may need to alter course and begin to promote its brand with consumers to get patients to start asking doctors for Victrelis if it is to close the gap.

"We thought it would be little better on the Merck side as a percent, less than 50 but certainly better than 25 percent," said Barclays Capital analyst Tony Butler.

But Butler said it was too early to declare a winner.

"In the past I've been surprised at how things have changed over time," he said. (Reporting by Bill Berkrot in New York, editing by Matthew Lewis)

Bristol-Myers Is Close To Completing A Groundbreaking Hepatitis C Treatment (BMY)
AP) — The drugmaker Bristol-Myers Squibb Co. is building a hepatitis C virus treatment franchise that could be launched by 2015 and produce as much as $2.9 billion in global sales five years later, according to a Citi analyst.

The New York company is close to starting a late-stage clinical development program for the franchise in Japan, where its opportunity is underappreciated, Citi analyst John T. Boris said in a research note late Thursday. He said it is estimated that there are as many as 2 million hepatitis C virus carriers in Japan, with 20 percent diagnosed and 30 percent treated.

Another late-stage trial was started this month and is expected to be completed in 2013

Hepatitis C is the primary cause of liver transplants in the United States and is expected to become a much larger public health problem as aging baby boomers succumb to the disease. It’s an infectious disease that can be spread by sharing needles or having sex with an infected person.

Boris said in the note he is maintaining a “buy” rating on Bristol-Myers shares, which have risen more than 17 percent in value so far this year.

The stock closed at $31.12 on Thursday after hitting a 52-week high of $31.78 earlier this month.

Combined Effects of HBV, HCV on Hepatoma Vary With Age, Gender
By Dave Levitan NEW YORK (Reuters Health)
Coinfection with hepatitis B virus (HBV) and hepatitis C virus (HCV) is associated with substantially higher risk of hepatocellular carcinoma than single infections, but the complex interactions of the viruses vary depending on gender and age, a study from Taiwan shows. The researchers report that in general, coinfection produced weaker effects than previously reported.

"By the age of 75 years, one quarter of patients or more affected by chronic viral hepatitis will be affected by hepatocellular carcinoma," or HCC, the research team noted in an August 22nd online paper in the Journal of Clinical Oncology. Led by Dr. Yen-Tsung Huang of Harvard University, the study tracked 23,820 residents of Taiwan aged 30 to 65 years at enrollment in 1991-1992. Overall, 17.44% were seropositive for HBV surface antigen and 5.52% were seropositive for antibodies against HCV. Altogether, 477 subjects developed HCC. The cumulative lifetime incidence of HCC for was 38.35% for men with both viruses and 27.40% for women with both viruses. Men and women who were seropositive only for HBsAg had cumulative lifetime HCC rates of 27.38% and 7.99%, respectively.

These rates in men and women with only HCV were 23.73% and 16.71%, respectively. In contrast, the cumulative lifetime incidence rates for subjects with neither virus were 1.55% in men and 1.03% in women. On multivariate analysis, the hazard ratio for HCC was 19.5 for those positive for both infections. The interactive effects of the two viruses varied based on age, however. The HCC risk with dual infection was "sub-additive" before the age of 65 years, especially in men. But after age 65, the risk with dual infection was "consistently higher than that for single infection." Specifically, in older patients, the HR in men was 22.38 for dual infection vs. 8.94 and 12.34 for single infections with HBV and HCV, respectively. In women after age 65, HRs for HCC were 27.29 with dual infection, 6.58 with HBV and 15.01 with HCV. "With the increase in age, the HCC risk decreased in HBsAg-seropositive men but increased in anti-HCV-seropositive women," said study senior author Dr. Chien-Jen Chen, of the National Taiwan University in Taipei, in an email to Reuters Health.

The authors advise more intensive clinical management of patients with dual infection. "The therapy of chronic HBV/HCV infection using antivirals and/or interferon may reduce the risk of newly developed HCC," Dr. Chen said. "Frequent liver surveillance using various imaging methods (ultrasonography, CT scan, angiogram, etc.) may help early detection of small HCC, which may be treated more effectively and efficiently by surgery or embolization. The HCC case fatality may thus be lowered."

J Clin Oncol 2011. Analysis of the sustained virological response in patients with chronic hepatitis C and liver steatosis.
Piccoli LD, Mattos AA, Coral GP, Mattos AZ, Santos DE.
Chronic hepatitis C as well as non-alcoholic fatty liver disease are recognized as the main cause of liver disease in Western countries. It is common to see the concomitance of the diseases and the influence of steatosis in the sustained virological response of patients with hepatitis C virus.
Assess the sustained virological response in chronic hepatitis C patients according to the presence of liver steatosis.
One hundred sixty patients with chronic hepatitis C were retrospectively evaluated. Demographic data such as gender, age, body mass index, presence of diabetes mellitus and systemic arterial hypertension, virus genotype and use of pegylated interferon were analyzed, as was the staging of fibrosis and the presence of steatosis at histology.
Most patients were male (57.5%), with a mean age of 48 ± 9.7 years. The most frequent genotype observed was 3 (56.9%) and, in the histological evaluation, steatosis was observed in 65% of the patients (104/160). Sustained virological response in patients with steatosis occurred in 38.5%, and in 32.1% in patients without steatosis (P = 0.54). When we analyzed possible factors associated with the presence of steatosis, only body mass index and systemic arterial hypertension revealed a significant association. When the factors that influenced sustained virological response were evaluated in a logistic regression, genotype and use of pegylated interferon proved to be independent factors associated to the response.
In the evaluated patients the presence of liver steatosis did not influence the sustained virological response of patients with chronic hepatitis C treated with interferon and ribavirin.
[PubMed - as supplied by publisher]


ICAAC: ICAAC 2011: Medically Important Highlights - David H Shepp, MD, Hofstra NSLIJ Medical School Division of Infectious Diseases North Shore University Hospital - Manhasset-
Novel Treatments for HIV
Adoptive Transfer of CCR5-Modified T-cells. Combination antiretroviral therapy (ART) can suppress the growth of HIV and restore immunity to opportunistic illnesses. However, latent virus is not eliminated, requiring lifelong treatment to maintain benefit. An important thrust of current HIV research is directed to finding therapies that will allow ART to be discontinued. The apparent cure of HIV infection in a patient with leukemia who received allogeneic hematopoietic stem cell transplantation (HSCT) from a CCR5 delta 32 homozygous donor has triggered renewed interest in gene therapy for treatment of HIV

Liver Cancer

‘Micro’-chemo and Cancer Pill Combo Tested in Liver Cancer Patients
A combination of an oral drug, called sorafenib, and a method for injecting microbeads of chemotherapy directly into tumors has been proven safe for liver cancer patients and may improve outcomes for those who have these fast-growing, deadly tumors whose numbers are on the rise in the U.S.

Reporting in the Sept. 12 online version of the Journal of Clinical Oncology, Johns Hopkins investigators tested the combination in 35 patients with advanced, inoperable liver cancer. Both sorafenib and the chemotherapy drug used in this study, doxorubicin, have independently – but not in combination — been approved to treat liver cancer.

Combining the right therapies at the right time is an intense focus of study among cancer experts, and Johns Hopkins interventional radiologist Jean-Francois Geschwind, M.D., saw promise in the two therapies tested in the current study.“Both therapies have increased survival rates in advanced liver cancer, and combining them may push those survival rates further,” says Geschwind, professor of radiology, surgery and oncology at Johns Hopkins.

For the study, Geschwind employed a method called chemoembolization that uses catheters the size of a single hair to deliver microbeads filled with high concentrations of the chemotherapy drug, doxorubicin, directly to the tumor. The chemotherapy seeps out of the microbead for at least three weeks.

Sorafenib, approved for its ability to block a key pathway, depriving tumors of blood vessels, was given twice daily to patients one week before their chemoembolization procedure. “The idea is to block blood vessel formation in these cancers, which typically peaks 24 to 36 hours after chemoembolization. This may help prolong the chemotherapy’s impact.” says Geschwind.

Patients treated with the combination had no more side effects than reported for sorafenib or chemoembolization alone, according to Geschwind. Common side effects included fatigue, skin reactions in hands and feet, and body rash.

Patients in the study were admitted to the hospital overnight for their chemoembolization treatment. The patients continued oral sorafenib twice daily until their disease progressed. For the study, Geschwind says that patients received up to four chemoembolization treatments within a six-month period.Primary liver cancer incidence is rising in the U.S., says Geschwind, because of increasing rates of hepatitis C infections, which cause liver inflammation and are major risk factors for liver cancer.

Liver cancer tends to grow rapidly and without specific symptoms. Measures of a liver cancer marker called alpha-fetoprotein are elevated in only half of patients, adds Geschwind, making it difficult to find the disease early.

When the cancer is confined to the liver, doctors can transplant or remove the liver, but three-quarters of patients are not eligible for surgery. Without treatment, median survival of these inoperable patients is typically less than nine months. Chemoembolization procedures add 10 to 15 months of survival.

A phase III trial comparing chemoembolization with or without sorafenib is under way at Johns Hopkins and 100 other sites in the U.S. “We’re on the path to improving the standard of care for liver cancer,” says Geschwind.

The study was funded by Bayer Health-Care and Onyx Pharmaceuticals, manufacturer of sorafenib, and Biocompatibles, makers of the microbeads.

Researchers involved in the study include Timothy Pawlik, Diane Reyes, David Cosgrove, and Ihab Kamel, Nikhil Bhagat of Johns Hopkins.

Pawlik and Geschwind are consultants to Bayer HealthCare Pharmaceuticals, and Geschwind is a consultant to Biocompatibles. The terms of these arrangements are being managed by the Johns Hopkins University in accordance to its conflict-of-interest policies.

Liver Cancer Drug Provectus Receives Orphan Drug Designation From FDA
The U.S. Food and Drug Administration (FDA) has given orphan drug designation to Provectus Pharmaceuticals, Inc., for Rose Bengal, the active component in their new oncology medication PV-10. The drug is designed for the treatment of hepatocellular carcinoma (HCC), the most prevalent form of liver cancer. At present Provectus is designing a Phase II investigation, following the January 2011 completion of their Phase I study, which involved patient accrual and treatment of PV-10 for liver cancer in all participants...


Listeriosis Deaths Climb to 13 in 'Deadliest' Outbreak
By Todd Neale, Senior Staff Writer, MedPage Today Published: September 28, 2011 The listeriosis outbreak stemming from tainted cantaloupes has sickened at least 72 individuals, killing 13 of them, according to the CDC. "This is the deadliest outbreak of a foodborne disease that we've identified in more than a decade," said CDC director Thomas Frieden, MD, MPH, on a conference call with reporters Wednesday. Overall, 18 states have been affected as of Monday, with four different strains of Listeria monocytogenes implicated. State and federal health officials are continuing to investigate other listeriosis cases across the country that might be related to the outbreak. Most of the infected individuals are older than 60 or have conditions that weaken the immune system, the CDC said in its most recent update. All but one of the patients with information on hospitalization have required admission.

The 13 confirmed deaths have occurred in New Mexico (four), Colorado and Texas (two each), and Kansas, Maryland, Missouri, Nebraska, and Oklahoma (one each). That figure is more than triple the four deaths reported last week. Early on in the investigation, the Colorado Department of Public Health and Environment identified cantaloupes grown in the Rocky Ford region of the state as the likely source of the outbreak, which is unusual because Listeria has not previously been seen in cantaloupe. Within days, the department pinpointed the exact source as whole cantaloupes grown at Jensen Farms' production fields in Granada, Colo., which was later confirmed by the FDA.

The FDA said it is working with other agencies to determine how the contamination of the facility occurred, with consideration given to all environmental factors on the farm, including possible animal intrusions, water quality, and growing practices. On Sept. 14, Jensen Farms recalled its Rocky Ford brand whole cantaloupes, reporting distribution to 17 states. In its update, the CDC said that the cantaloupes were shipped to at least 25 states, with the possibility of further distribution. Even though the cantaloupes have been recalled, the CDC said that it expects to receive reports of more cases related to the outbreak through October because individuals can develop listeriosis up to two months after coming into contact with the bacteria. The shelf life of cantaloupe is about two weeks, and all of the affected product was shipped from July 29 to Sept. 10.

The FDA said that it is collaborating with state health officials to check retail stores, wholesalers, and distributors to make sure they know about the recall and that they have taken steps to inform customers and remove affected product from shelves. The agency said that consumers should throw away any of the recalled cantaloupes from Jensen Farms and should not try to wash the bacteria off of the fruit. The CDC recommended that people at high risk for listeriosis -- including older adults, immunocompromised individuals, and pregnant women -- should not eat Rocky Ford cantaloupes from Jensen Farms, and that other individuals should not eat those cantaloupes if they want to reduce their risk of Listeria infection. The agency noted that the bacteria can grow both at room temperature and in the refrigerator.
"For the public, it's important to know that if you know the cantaloupe that you have is not [from] Jensen Farms, then it's okay to eat," Frieden said, "but if you're in doubt, then throw it out." According to the CDC, there are about 800 reported cases of Listeria infection each year in the U.S., with three or four outbreaks. Typical sources include deli meats, hot dogs, and Mexican-style soft cheeses made with unpasteurized milk, although produce -- including sprouts in 2009 and celery in 2010 -- has been implicated as well.

Frieden said over the past decade there have been about 10 outbreaks of foodborne illness in which cantaloupes were the definite vehicle for infection, seven involving Salmonella and three involving norovirus. He added that the number of multistate outbreaks of foodborne illness in general have increased substantially in recent years. "This is a reflection at least of better quality monitoring and perhaps also of the increasing complexity and centralization of the food supply," he said. "It's not that food is getting riskier, but we're getting better at identifying problems that have probably been there for a long, long time."
FDA commissioner Margaret Hamburg, MD, added that "these kinds of outbreaks are a powerful reminder that, despite the fact that we have one of the safest food supplies in the world, it does remain vulnerable to contamination, and the American people remain vulnerable to foodborne illness."

Off The Cuff

September 29, 2011, 12:01 am
Why Doctors Order So Many Tests
One afternoon when I was running later than usual, I recognized a familiar face among the patients waiting to see me. A voluble newspaper fanatic, the gentleman, in his 70s, was usually eager to discuss the latest headlines with me. That day, however, he was remarkably quiet. He was suffering from the flu. “I’m really feeling no good,” he rasped.

Australia: Poor Hospital Supply Lines Endanger Patients
Julie Robotham (The Sydney Morning Herald, September 29, 2011) "Hospitals operate with less than a month's supply of many essential medicines, leaving patients vulnerable if local distributors are unable to import them through fragile international supply chains. The issue was emphasized [recently when]…the sole supplier [revealed that it]…would be unable to import intravenous penicillin until December…Yvonne Allinson, the head of the Society of Hospital Pharmacists of Australia, said state and federal governments should co-operate to ensure viable supplies of essential drugs were maintained…Current purchasing policies discouraged companies from manufacturing in Australia, and incentives to encourage local research had been eroded. A spokeswoman for the Department of Health and Ageing said there were already 'well-developed processes to ensure an adequate supply of essential medicines in the Australian market,' but temporary shortages were not uncommon."

Medical marijuana as a treatment for cancer
FERNDALE -- When his cancer came back for a fifth time, Michael McShane was desperate for treatment outside of traditional medicine.
The last time squamous cell carcinoma left lumpy tumors around his mouth, doctors cut it away and reconstructed his bottom lip by turning out a portion of its inner layer.
In all, the state act defines 14 chronic or debilitating diseases, medical conditions, and side effects from treatments that qualify, including glaucoma, HIV/AIDS, hepatitis C, amyotrophic lateral sclerosis, Chrohn’s disease, agitation of Alzheimer’s disease, nail patella, Cachexia or wasting syndrome, and seizures.

Tuesday, September 6, 2011

Dramatic Changes in Hepatitis C Treatment Expected to Continue

Dramatic Changes in Hepatitis C Treatment Expected to Continue
From Anadys Pharmaceuticals President and CEO Steve Worland
Steve Worland 9/6/11

Earlier this year the FDA approved telaprevir (Incivek) from Vertex Pharmaceuticals and boceprevir (Victrelis) from Merck for the treatment of hepatitis C. Both agents are protease inhibitors and represent the first approvals of direct acting antivirals for hepatitis C. Direct acting antivirals are a broad class of agents that act to block the growth of viruses by directly disrupting essential viral functions. The benefit of these drugs for hepatitis C follows the dramatic success of this class over the last 15 years in HIV. Now the future advances of direct acting antiviral therapy for hepatitis C is expected to follow a central theme of their use in HIV: that combination of multiple antivirals in a single treatment regimen will provide greater benefit than use of any one antiviral drug alone.

The new protease inhibitors were approved for use only in combination with two previously approved agents, pegylated interferon and ribavirin. The addition of either protease inhibitor increased clinical cure rates, known formally as sustained viral response (SVR) rates, by 30 to 40 percentage points over control groups receiving the standard pegylated interferon and ribavirin alone. As dramatic as these improvements are, there is a good chance for even more dramatic improvements if all-oral regimens, assembled by combining multiple direct acting antivirals, are able to maintain high cure rates while eliminating injectable interferon and its associated flu-like side effects that patients have long sought to avoid.

Next in the development queue are three agents that entered Phase III development this year, including two additional protease inhibitors (TMC435 from Johnson & Johnson’s Tibotec unit and BI201335 from Boehringer Ingelheim) and a cyclophilin inhibitor that disrupts a host function required for viral replication (alisporivir from Novartis). All three Phase III programs are exploring a modality similar to the approved agents, i.e. addition of a single new agent to the standard pegylated interferon/ribavirin. The ongoing Phase III programs will hope to demonstrate one or more advantage over the recently approved agents, potentially including better tolerability, further increases in cure rates, shorter duration of therapy and/or an increased proportion of patients successfully treated with shortened therapy. While such improvements may well be achieved, they may become less important or even irrelevant if the rapidly expanding number of direct acting antiviral combination trials leads to identification of new regimens that surpass all regimens that are based on a single antiviral drug added to the old standard regimen.

Investigation of direct acting antiviral combination regimens has exploded in the last 12 months. This advance has become possible because of the diversity of antiviral mechanisms distinct from protease inhibitors that are now represented in the pipeline of hepatitis C drugs in Phase II development across the industry. Diverse mechanisms are important because they typically provide distinct resistance profiles, and antiviral combinations are being assembled using new compounds with non-overlapping resistance profiles to provide a greater barrier to the development of antiviral resistance. Additional factors that are considered important in assembling optimal combinations include the safety and tolerability profile of each agent, compatible pharmacokinetic profiles and a low potential for unfavorable drug-drug interactions. The more extensively characterized each individual antiviral drug is, the lower the risk of an unanticipated negative interaction between the drugs once combined.

New mechanisms other than protease inhibitors that have entered large Phase IIb studies include non-nucleoside polymerase inhibitors (setrobuvir from my company, Anadys Pharmaceuticals, as well as tegobuvir from Gilead Sciences and filibuvir from Pfizer). Another class is composed of nucleoside/tide polymerase inhibitors (mericitabine from Roche and PSI-7997 from Pharmasset). There’s also an NS5a inhibitor in Phase IIb development (BMS-790052 from Bristol-Myers Squibb).

At Anadys, we chose to focus on the non-nucleoside class of polymerase inhibitors for several reasons. We recognized an inherent potential for an excellent safety profile, given the absence of structurally related host targets and the ability to generate inhibitors without relying on close analogs of host metabolites. The excellent safety record to date for setrobuvir is consistent with our initial expectations regarding safety. The diversity of applicable chemotypes also led us to expect a clear path to patent-protected intellectual property, exemplified by our recently issued U.S. patent covering setrobuvir. In other antiviral drug classes, especially nucleosides/tides and NS5a inhibitors, the range of useful chemical space discovered to date is considerably more narrow, leading to the potential for more interference on the IP side. Lastly, we recognized that a potential liability of the non-nucleoside class, a lower genetic barrier to resistance, could likely be addressed if we were able to engineer a high pharmacological barrier to resistance into candidate molecules. This recognition was based on the lessons learned about non-nucleosides in the 1990s in HIV. Specifically, there were two disappointing product introductions of non-nucleoside products for HIV that were plagued with rapid emergence of resistance—nevirapine (Viramune) from Boehinger Ingelheim and delavirdine (Rescriptor), now marketed by Pfizer. After that came efavirenz (Sustiva) from Bristol-Myers Squibb, so named for its ability to last longer in the bloodstream, which demonstrated that a non-nucleoside with good potency and a prolonged plasma half-life could demonstrate a dramatically improved resistance profile. While we reasoned that a similar solution would be applicable in hepatitis C, we also understood the significant medicinal chemistry challenge to accomplish this objective and furthermore understood that the technology platform at Anadys was exquisitely well matched to the molecular engineering challenge of simultaneously optimizing potency and pharmacokinetics. The excellent resistance profile of setrobuvir observed to date demonstrates the high pharmacological resistance barrier achieved with setrobuvir, and data to date is consistent with our idea that a high pharmacological barrier to resistance could serve in place of a high genetic barrier to resistance.

As the hepatitis C development landscape continues to advance, we expect to see an increasing number of direct acting antiviral combination trials and subsequent approval of new agents based on data derived from such trials. The FDA as well as patient advocacy groups have been strong proponents of investigating antiviral drug combinations prior to approval of individual components, and I expect an ongoing favorable regulatory environment towards combination trials provided that each individual agent is sufficiently well-characterized.

Companies that believe in the importance of antiviral combinations for future commercial relevance in hepatitis C are likely to have opinions as to how many drugs they believe will be needed in antiviral combination regimens, and are likely to pursue strategies directed at accessing at least that number of compounds if not a greater number as insurance against attrition. Mathematical modeling from Perelson and colleagues suggests that interferon-free regimens will need to contain three or four distinct antiviral mechanisms to result in viral eradication (SVR) prior to emergence of resistance. To access the required number of drugs, companies have several business alternatives available. They can rely on maturation of their internal pipelines, although few if any companies appear today to have sufficiently robust internal pipelines to rely exclusively on this approach. Companies can rely on cross-company clinical collaboration agreements to gain initial data on particular antiviral combinations, although this approach doesn’t directly answer the question of how to seek approval and launch effective marketing efforts for the individual components studied in a cross-company antiviral drug combination trial. Companies with antiviral drugs other than protease inhibitors can look to utilize one of the approved protease inhibitors as one other mechanism, analogous to the use of interferon and ribavirin in the development of the protease inhibitors to date, but this will only be a partial solution if three or more DAAs are required. Lastly, companies can gain exclusive access to antiviral drugs outside their current pipelines through a variety of business deals, allowing them to quickly assemble a pipeline with sufficient depth to increase the chances of being early to market with a successful combination regimen. To date, examples of all these strategies except combination with one of the approved protease inhibitors have been pursued by one or more companies. Going forward, these efforts across the industry are likely to culminate in approval of direct acting antiviral combination regimens, with the ultimate goal of assembling combinations powerful enough to eliminate interferon and perhaps ribavirin from hepatitis C therapy. These advancements may occur within the next few years, and if realized, would represent yet another dramatic improvement in hepatitis C therapy, at least as dramatic as the advances recently realized with the approval of the first protease inhibitors.

Read More;

Related Posts @ Xconomy
Combination Drugs Are The Future for Hepatitis C
Using HIV as Model, Anadys Develops Drug Cocktail Ingredient for Hepatitis C
Hepatitis C Drug From Anadys Shows Quick Virus-Killing Punch
Anadys Keeps Surging, as Hepatitis C Drug Data Trickles In
Anadys Drug Found Safe in Small Study, Aims to Contend in New Class of Hepatitis C Meds

Monday, May 2, 2011

Analyst; Telaprevir – the Mightiest in the Land

Off The Cuff

Thought this might be interesting, below is a bit of info from the investment site  istockanalyst........

Telaprevir – the Mightiest in the Land

Part two, click here for boceprevir part one.

Recall from yesterday, that SVR is what we consider a "cure rate."  So how did Telaprevir do in its trials?
Treatment naive patients – SVR cure rates of 79 percent compared with 46 percent in the standard of care group (Advance trial). 
Null responders – A 31 percent  SVR cure rate was found for null responders, compared with a 3percent SVR cure rate in patients who were retreated with the current standard of care, PEG-IFN + Rib (Realize Trial).  All treatments were administered for 48 weeks.  This is important because Boceprevir has not been given to null responders, which represents a sizable (~30%) treatment population.
Partial responders – a 61 percent SVR cure rate in the Telaprevir group versus a 15 percent cure rate found in the standard of care group.  All treatments were administered for 48 weeks.
Relapsers – an 84 percent SVR cure rate in the Telaprevir group versus a 22 percent cure rate found in the standard of care group.  All treatments were administered for 48 weeks.
Overall, very impressive results as compared with the current standard of care.

Additionally, two-thirds of patients are eligible to receive shortened 24-week treatment duration, in contrast to the current 48 week regimen.   This plays into a term called, response guided therapy (RGT), or doctor mediated control of dosing, where early response or decrease in HCV RNA is rewarded by early cessation of treatments.  Patients like this, as it means they do not have to experience a lot of the side effects concurrent with all three treatments - PEG-IFN, Rib or Telaprevir/Boceprevir.  Patients on RGT had SVR cure rates from 87 percent to -92 percent at 24 weeks of treatment (Illuminate trial).  Keep all of this in mind, as this is a strong positive for Vertex, as all other treatment types might have to live up to RGT's standards.
Here are some additional points to consider. Telaprevir, like Boceprevir, is a three times daily pill, although Vertex already has data showing that a two pill per day dose .   Also, in African-American populations, Telaprevir cured 62 percent  of patients versus 29 percent of patients in the standard of care control.   
What is clear from the data is that Vertex was better prepared and more elegant in their trial design than Merck.  They both have better efficacy and lots of data.  However, and this is a very important issue, both drugs have not been compared side by side.  Additionally, both drugs have different side effect profiles that might lead physicians to prescribe them differently.

Telaprevir – is this rash contagious and "Fire in the hole"?

In total, Telaprevir has been given to over 3,000 patients.  Of these patients, rash has been an issue with 56 percent of Telaprevir patients versus 34 percent of standard of care patients.  However, Vertex was aware of the issue and had in place a rash management plan that allowed doctor's to switch Telaprevir patients to standard of care therapy.  This kept the discontinuation rate in the trials low.
In over 90 percent of the patients, the rash was treatable with topical steroids.  However, there were three cases of Stevens Johnson Syndrome (SJS), a severe skin disease that recently claimed the life of former NBA star Manute Bol.  Fortunately, all the cases resolved.  Unfortunately, SJS is not something the FDA takes lightly and it has derailed drugs in the past.  Additionally, there were 11 cases of DRESS or drug rash with eosinophilia and systemic symptoms that mostly resolved, with one patient not returning for follow up.
So then, what is, "fire in the hole"?  Some patients complain of anorectal symptoms (29 percent for Telaprevir vs. 7 percent for standard care group). Vertex made clear that some patients experience a burning or itching at the onset of Telaprevir treatment.  However, symptoms resolve quickly and they did not record any patient discontinuations in their trials due to anorectal problems.
In conclusion, the FDA panel really spent time hammering away at the rash issue, but then concluded that Vertex had done a good job characterizing the problem and dealing with it.  Then they voted 18-0.  Overall, a lot of a drama for an expected result.

What about Vertex? Everything Sounds Great, Should I Buy?

Vertex (VRTX), closed today's trading at $55.05 per share.  Its current market cap is at $11.41 billion - not an insignificant amount for a company without a marketed product.  Net losses last year amounted to $754 million, with their only revenue coming from royalties and collaborations.  However, Vertex is a compelling company, even considered by many to be a Wall Street darling.   Both Telaprevir and its other phase-III drug, VX-770, are poised to achieve blockbuster status upon approval.  Now investors need to decide if the stock is overheated.  Perhaps this question is best answered by what type of sales and ultimate retained earnings deserves such a staggering valuation.  For this, investors need to decide for themselves what percent of the HCV market will be using Telaprevir versus Boceprevir.

In Case You Missed It....

Also, Over at the AIDS Beacon is a two part series on telaprevir and boceprevir;
This article is first in a two-part series that will discuss the benefits and drawbacks of two drugs, boceprevir and telaprevir, which are being developed for hepatitis C. Part 1 discusses the efficacy of the two drugs in clinical trials. Part 2 will discuss the complications and side effects for each 
Video Melissa Palmer, M.D. discusses in a two part series both new drugs Telaprevir & Boceprevir .

Thursday, February 3, 2011

Vertex reports a loss:Spent more money to develop its hepatitis C drug candidate telaprevir along with other drugs

Vertex books bigger 4Q loss on research costs
Feb 3, 2011 6:13 PM ET By The Associated Press

CAMBRIDGE, Mass. (AP) — Vertex Pharmaceuticals Inc. reported a larger fourth-quarter loss on Thursday as it spent more money to develop its hepatitis C drug candidate telaprevir, along with a potential cystic fibrosis treatment and other drugs.

With its research and development costs up 25 percent, Vertex said it lost $180.4 million, or 90 cents per share, in the last three months of 2010. A year ago it booked a smaller loss of $158.6 million, or 86 cents per share. Revenue nearly doubled to $65.5 million from $33.9 million.

Analysts had expected a loss of 92 cents per share and $38.8 million in revenue, according to FactSet.

Vertex has applied for marketing approval of telaprevir in the U.S., Europe, and Canada. The Food and Drug Administration is expected to make a decision by May 23. Vertex is also waiting for data from a late-stage clinical trial of VX-770, its cystic fibrosis drug, and running a mid-stage clinical trial of a regimen that combines telaprevir with another one of its hepatitis C drug candidates, VX-222. The company expects results from that study later in the first quarter.

Vertex said it plans to file for approval of VX-770 in the U.S. and Europe in the second half of 2011.

The company said its research and development costs climbed to $168.9 million from $135.2 million a year ago. However revenue from partnerships more than doubled to $57.1 million from $25.5 million. Royalty revenue was unchanged at $8.4 million.

For the full year, Vertex lost $754.6 million, or $3.77 per share, compared with a loss of $642.2 million, or $3.71 per share, in 2009. Revenue grew 41 percent, to $143.4 million from $101.9 million.

"We believe that our financial position will support our key business objectives through 2012, at which time we expect to begin generating earnings as a cashflow positive company," said Matthew Emmens, chairman, president and CEO, in a statement.

Shares of Vertex fell 17 cents to close at $38.80 on Thursday.

Tuesday, January 18, 2011

Medical Technology: U.S. consumers “could eventually be last in line”

18 Jan 2011 09:00

Noted From The WSJ: The U.S. is losing ground to emerging-market countries such as China, India and Brazil as a center of medical innovation, according to a new report from PricewaterhouseCoopers.
"The report says that med tech innovators are increasingly going outside the U.S. “to seek clinical data, new-product registration and first revenue,” and that U.S. consumers “could eventually be last in line” to benefit from med tech advances. And, it says developing nations are becoming “the leading markets for smaller, faster, more affordable devices that enable delivery of care anywhere and help bend the healthcare cost curve downward.”

Emerging markets are gaining ground in medical technology innovation, finds PwC’s Medical Technology Innovation Scorecard

Emerging markets, led by China, India and Brazil, are gaining ground in their capacity to produce the latest in medical technology innovation and may surpass developed countries in innovative healthcare delivery over the next decade, according to a new PwC report published today titled Medical Technology Innovation Scorecard: The race for global leadership.

Growth in these emerging market economies is attracting the focus of the world’s innovation resources and activity, and they are taking the lead in developing a new generation of small, faster, more affordable medical devices.

The report is based on the findings of the PwC Medical Technology Innovation Scorecard, a new, multifaceted assessment of the capacity of nine countries to adapt to the changing nature of innovation: Brazil, China, France, Germany, India, Israel, Japan, the United Kingdom and the United States.

While there has been much anecdotal evidence that the centre of innovation is moving away from the U.S. the incumbent global leader, PwC is the first to analyse the specific factors that contribute to medical technology innovation. PwC quantified five factors, using 86 different metrics, to evaluate how well each nation promotes the advance of innovation, looking at the past five years and projecting change over the next decade to 2020.

The Innovation Scorecard ranks the overall capacity of each country on a scale of 1 to 9 with 9 being the highest score. A top-line view of the report finding reveals:

The U.S. currently holds its position as the global leader in medical technology innovation, and because of decades of innovation dominance, it continues to show the greatest capacity for medical technology innovation. The U.S. currently has a total score of 7.1.
The scores of the other developed nations (the UK, Germany, Japan and France) fall within a tight band of 4.8 to 5.4. Among the developed countries included in this study, Germany and the U.K. demonstrate the strongest support for innovation and Japan the weakest.
Israel, despite its small size, ranks near the level of the European nations, a reflection of its strong capacity to foster innovation.
The emerging markets lag behind developed ones. China, with its powerful economic growth engine, scores 3.4, ranking it higher than India and Brazil, each of which scored 2.7.

Looking to the future, the U.S. is expected to continue to lead in medical technology innovation, but also will lose ground to other countries during the next decade. The Innovation Scorecard also projects relative declines for Japan, Israel, France, the UK and Germany. By contrast, China, India and Brazil are likely to see gains during the coming decade. China, which has shown the largest improvement in its medical technology innovation capacity during the past five years, is expected to continue to outpace other countries and reach near parity with the developed nations of Europe by 2020.

Mike Swanick U.S. pharmaceuticals, medical device and life sciences industry leader, PwC, said:

“A confluence of social, demographic, economic and technology changes is altering the dynamics of the medical technology field. As a result, ecosystems that promote medical technology innovation – with supportive elements such as access to financing, scientific knowledge and patient interaction – are being established around the world, These changes are creating opportunities for companies – and entire nations – that are able to adapt to a rapidly evolving environment.”

Simon Friend, global pharmaceuticals, medical device and life sciences industry leader, PwC, added:

“If developed counties do not step up levels of investment in innovation, over the next decade new markets will surpass developed countries in innovative healthcare delivery; stimuli for new technologies is being built through the education system and we will see businesses focussing on new markets for new ideas and expanding sales bases.”

The Innovation Scorecard examined where each of the nine countries evaluated stands in relation to five broad “pillars” that helped to make the U.S. a leader in medical technology innovation for the past several decades: Powerful financial incentives such as reimbursements for adoption of new technologies; resources for innovation, such as academic medical centers; a supportive regulatory system; demanding and price-insensitive patients; and a supportive investment community of venture capitalists and other investors.

The Innovation Scorecard indicated that the ideal innovation ecosystem itself is changing as the nature of medical technology innovation evolves. Some of this transformation is being driven by changes in the U.S., such as more expensive, less-predictable regulatory approvals, an increased focus on value and cost-effective solutions in healthcare and increasingly international investments in R&D. Other dynamics are the result of changes abroad, including increasing investment in local academic medical centers; investment in research programmes; the return of foreign-educated scientists and doctors to their homelands; advancement of mobile health technologies that expand access to care; and a focus on the lean, frugal and reverse innovation necessary to deliver faster, better, cheaper and more effective healthcare solutions in these markets.

As a result of these many factors, medical technology companies increasingly are seeking clinical data, new-product registration and first revenue in non-U.S. markets that are becoming more attractive and supportive of new innovation. Medical technology innovators already are going first to market in Europe and, by 2020, likely will move into emerging countries before entering the U.S.

Despite the size of the markets in China, India and Brazil, their global leadership in medical technology innovation is not necessarily preordained. Factors related to intellectual property protection, difficulty of doing business in some emerging countries and weak local supplier networks could make these markets less attractive, despite their size, and could hinder these nations’ effort to assume innovation leadership.

Christopher L. Wasden, PwC managing director and co-author of the report said:

“We created the Innovation Scorecard because we wanted to better understand how medical technology innovation is changing and which nations have the strongest capacity and capability for innovation. The findings will be helpful to government officials and regulators seeking to advance policies that foster innovation as well as medical technology companies working to develop their own commercialisation strategies.”

Notes to Editors:

The complete report is available for download at .

The PwC Medical Technology Innovation Scorecard incorporates 86 qualitative and quantitative data and analysis to identify and provide support for industry best practices. The overall scores and rankings in each of 10 dimensions, as well as in aggregate, should be regarded as a general guide to help support the advancement of regulatory and advocacy work within the medical device industry.

About PwC’s Pharmaceuticals, Medical Device and Life Sciences Industry Group
PwC’s Pharmaceuticals, Medical Device and Life Sciences Industry Group ( and ) is dedicated to delivering effective solutions to the complex strategic, operational and financial challenges facing pharmaceutical,
, biotechnology and medical device companies. We provide industry-focused assurance, tax

For more information contact:
Rebecca Laird
Consumer and Industrial Products & Services, PR Manager, PwC Tel:020 7213 5829 Mobile:07793 680 467

PwC Global
PwC firms provide industry-focused assurance, tax and advisory services to enhance value for their clients. More than 161,000 people in 154 countries in firms across the PwC network share their thinking, experience and solutions to develop fresh perspectives and practical advice. See for more information.

Thursday, December 30, 2010

2011 Hepatitis C And Wall Street/ Part Two

2010 Archives Part One Hepatitis C Drugs and Wall Street
For Future Updates Please See ; HCV In The News
Part Two : 2011 HCV and Wall Street
Jan 20th/Telaprevir
Updated: Jan 6th/Boceprevir
Week Of Feb 7th
If a lot of chemistry work has to be done later and what we put in development is not the original compound, then we take the IP in case the same molecule can be used in a commercial environment. For example, some compounds for dengue might also work for Hepatitis C, which is a blockbuster. We could give that IP to Novartis’ pharmaceutical department, which is a commercial organization.
Idenix Pharmaceuticals to Present at Two Upcoming Investor Conferences
Written by TradersHuddle Staff Monday, 07 February 2011 16:08
CAMBRIDGE, Mass.-( Business Wire )-
Idenix Pharmaceuticals, Inc. (NASDAQ: IDIX), announced today that Idenix management will present a corporate overview at the 13th Annual BIO CEO & Investor Conference on February 14, 2011 at 10:30 a.m. ET at the Waldorf Astoria, New York City and at the Leerink Swann Hot Topics Roundtable Conference on February 16, 2011 at 2:20 p.m. ET at the Roosevelt Hotel, New York City. The live and archived webcasts of the company presentations can be accessed under “Calendar of Events” in the Idenix Investor Center at Please log in approximately 5-10 minutes before each event to ensure a timely connection. The archived replay will be available on the Idenix website for two weeks following the conferences.
Week Of Feb 1st
The fourth quarter net loss was $531 million, or 17 cents a share, the Whitehouse Station, New Jersey-based company said. The company withdrew its long-term profit forecast of high single-digit growth through 2013.
In the past quarter, Merck's hepatitis C drug, boceprevir, won expedited reviews by regulators in the U.S. and European Union. A decision by the U.S. Food and Drug Administration is also expected this year on an extended version of the Janumet diabetes pill, which combines Merck's Januvia with a generic drug called metformin.
Vertex Loses $180M in Q4Vertex Pharmaceuticals Inc. reported a larger fourth-quarter loss as it spent more money to develop its hepatitis C drug candidate telaprevir, along with a potential cystic fibrosis treatment and other drugs. ...continue
If Vertex Pharmaceuticals gets its way in talks with U.S. public health officials, most people over 50 could soon get blood tests to screen for hepatitis C infections at the doctor’s office. If the U.S. Centers for Disease Control and Prevention (CDC) agrees this is a good idea, it could prompt another 1 million patients who don’t realize they are infected to come out of the woodwork and start clamoring for Vertex’s new hepatitis C drug over the next few years.

Idenix Pharmaceuticals to Present at the 29th Annual J.P. Morgan Healthcare Conference
Vertex Pharmaceuticals Incorporated (Vertex) is engaged in the business of discovering, developing and commercializing small molecule drugs for the treatment of serious diseases. Telaprevir, the Company’s lead drug candidate, is an oral hepatitis C protease inhibitor and a new class of antiviral treatments in clinical development that target hepatitis C virus (HCV), infection. Telaprevir is being evaluated in a registration program focused on treatment-naïve and treatment-failure patients with genotype 1 HCV infection. VX-770, the lead drug candidate in its cystic fibrosis (CF), program is being evaluated in a registration program that focuses on patients with CF who have the G551D mutation in the gene responsible for CF. Vertex is conducting a number of Phase IIa clinical trials of its earlier-stage drug candidates. On March 12, 2009, Vertex acquired ViroChem Pharma Inc. (ViroChem)
Bayer teams up in India
German pharma and chemical group Bayer and Indian company Zydus Cadila have agreed to create a new company in India called Bayer Zydus Pharma. Each company will have a 50 per cent stake in the joint venture and equal representation on the management board. Bayer says it is looking to strengthen its position in the Indian pharma market. About 600 employees will transfer to the new company from the parent companies.
Teva buys Peruvian generics firm
Israeli generics firm Teva has said it will buy Corporacion Infarmasa, a pharmaceutical company based in Peru, from the two investment companies that own it. Teva already owns a company based in Peru: Corporacion Medco. Infarmasa makes generics, including corticosteroids, antihistamines, analgesics and antibiotics, at two sites in Lima. Financial details were not disclosed.
Arena Pharmaceuticals: Should The CEO Go?
By Ed Silverman // January 31st, 2011 // 10:37 am
For the past few months, Arena Pharmaceuticals ceo Jack Lief has been at the center of controversy over the extent to which the drugmaker’s Lorqess diet pill may have links to tumors in rats and, more specifically, whether data about this possibility was disclosed correctly. Last September, he was chastised for not conveying any info prior to disclosure that was made publicly by FDA staffers, who discussed the data in documents submitted for an FDA advisory panel
For example, consider just a few companies with new breakthrough drugs that are expected to become blockbusters (among nearly a dozen others): Dendreon’s (Nasdaq: DNDN ) prostate cancer drug, Provenge. Vertex Pharmaceuticals’ (Nasdaq: VRTX ) hepatitis therapy, Telaprevir. The drug is expected to receive FDA approval in May and could generate as much as $4 billion in annual sales. Human Genome Sciences’ (Nasdaq: HGSI ) treatment for lupus.
But these “hotshot” analysts are also overlooking what I think will be the biggest growth area for biotech in the coming months…
Week Of Jan 24
J&J Disappoints, 2011 Outlook Weak
Johnson & Johnson's
(JNJ - Analyst Report) fourth-quarter 2010 earnings (excluding special items) of $1.03 per share was in-line with the Zacks Consensus Estimate and a penny above the year-ago earnings of $1.02. Full year earnings came in at $4.76 per share, a penny above the Zacks Consensus Estimate and 2.8% above the year-ago earnings.
Drugmaker Vertex moving to Fan Pier
Cambridge-based Vertex Pharmaceuticals has signed a non-binding letter of intent for two buildings on Fan Pier, the company said.Under the terms of the deal, developer Joseph Fallon would build 1 million square feet of office and research and development space on the waterfront. Signing the lease would be contingent on Food and Drug Administration approval of Vertex’s drug to treat hepatitis C, according to Vertex spokesman Zachry more
PRINCETON, N.J., Jan. 24, 2011 /PRNewswire/ -- Pharmasset, Inc. (Nasdaq: VRUS) announced today the underwriters of its recent underwritten public offering have exercised their option to purchase from Pharmasset an additional 495,000 shares of common stock.
Week Of Jan 17th
Mark Your Calendar, Drug Investors
Mark your calendars, Fools:
May is going to be a solid month for drug approvals.The multiyear marathon between Schering-Plough and Vertex Pharmaceuticals (Nasdaq: VRTX) to develop the next-generation hepatitis C drug is finally coming to a close. Vertex announced yesterday that the Food and Drug Administration has accepted its New Drug Application to market telaprevir. Not surprisingly, given the unmet need, the agency will give telaprevir a priority review, so Vertex should hear back on or before May 23.Merck (NYSE: MRK), which took over development of boceprevir when it bought Schering-Plough, announced a few weeks ago that the FDA had accepted its application with a priority review, as well. Since one drug isn't all that material to Merck's business, the company didn't feel compelled to give an exact date of the submission, so we don't know exactly when the FDA will come back with a decision.
Bristol-Myers Squibb touted the five drugs in its pipeline that could reach the market by 2012; Pfizer highlighted its four most advanced oncology drugs; Merck & Co. emphasized its deep investment in cardiovascular drugs and the speedy filing of a New Drug Application for the hepatitis C drug boceprevir
have teamed up in a clinical partnership that marks the first cross-company collaboration to study two investigational oral drugs for the treatment of hepatitis C. The firms announced plans to study Bristol's NS5A replication complex inhibitor BMS-790052 and Pharmasset's nucleotide polymerase inhibitor on Jan. 10.
Drug makers do not generally collaborate on clinical trials for investigative drugs for competitive reasons and tend instead to study combinations within their own pipelines or with at least one already marketed drug. Regulatory uncertainties and, perhaps, just as important, cultural resistance, also present hurdles. But novel-novel combinations increasingly are viewed as the best way to treat certain serious diseases, like cancer and hepatitis C, and have become more common.
In hepatitis C specifically, the primary drug development focus is on combinations that could replace or reduce the use of the current standard of care, ribavirin and pegylated interferon (Roche's Pegasys or Merck's Pegintron), a regimen with a hasty side effect profile and limited efficacy. Bristol's decision to sign a clinical trial collaboration rather than in-licensing a polymerase inhibitor is intersting since the company recently acquired its hepatitsi C partner ZymoGenetics to gain more control over the program.
Deals Of the Week: Merck-Parexel; Biotie-Synosia And More...
The setback in Merck & Co.'s Phase III program for its anti-platelet drug vorapaxar and the annual J.P. Morgan health care conference dominated this week's biopharma news, but they weren't the only news of note
After the recalls of tens of millions of bottles and packages of numerous over-the-counter meds and surgical devices; months of negative publicity about corporate behavior; various government investigations and highly publicized congressional hearings, consumers may be turning away from Johnson & Johnson (JNJ) OTC products (back stories here, here, here and here).
In the last quarter of 2010, Johnson & Johnson’s share of the $4.2 billion cough and cold market sank to about 5 percent from about 17 percent in early 2009, according to Nielsen data cited by Wells Fargo analyst Larry Biegelsen in an investor note. The J&J share of the $2.4 billion pain and arthritis market fell to just below 10 percent from just under 20 percent during the same period, while its share of the $1.4 billion gastrointestinal market slid to less than 5 percent from more than 10 percent.
Sunday, January 16, 2011
Merck/Parexel International: Merck was one of the first companies to announce a strategy for bringing low-cost biologic copies to market after U.S. healthcare reform provided a clearer regulatory path for biosimilars. It announced the formation of a BioVentures unit in December 2008, with plans to put at least six biosimilars in development by 2012. It has kept close to the vest details of its target priorities, however, noting publicly only its interest in Amgen's granulocyte colony-stimulating factors Neupogen (filgrastim) and Neulasta (pegfilgrastim).
Now, the Big Pharma has struck a partnership with clinical research organization Parexel International Corp. in which the CRO will conduct clinical trials for some of Merck's biosimilar programs. True to form, the companies won't say which therapeutic areas are covered by their collaboration, however. "One of the things that was exciting for us is that we were able to build a deal structure with Parexel in which they are rewarded for performance," Merck BioVentures President Michael Kamarck told "The Pink Sheet" DAILY. "In the biosimilars arena, time is everything, so...they will rpovide us with timeliness, and efficiency in execution of trials." -- Lisa LaMotta.
Week Of Jan 10th
India Rising
Published by kshaw on January 14, 2011 03:49 pm under Biotech
India is moving toward an innovative culture that will drive biotechnology’s continued growth. We are moving in the right direction – the Indian biotechnology sector’s prospects have never looked brighter. But there is more work that needs to be done. We need to increase collaborations and deal making across the biotech industry in India and globally, while promoting our assets and capabilities to global biotechnology and pharmaceutical companies as well as to investors and other financial stakeholders. Many biopharmaceutical companies want to diversify into generic drugs and biosimilars and are looking to India for partners based on our leadership in those segments.
Biosimilars: Empty Threats?
The Jan. 10 announcement by Novartis' Sandoz division of the start of Phase II trials of a biosimilar version of Roche's rituximab (Rituxan) is beginning to look a bit like posturing. After all, when was the last time a biosimilars firm gave away anything about its pipeline, let alone details of a specific compound?
By Deena Beasley
SAN FRANCISCO Thu Jan 13, 2011 3:57pm EST
SAN FRANCISCO (Reuters) - More drugmakers are seeing potential in the business of producing copycat versions of expensive biotechnology drugs as U.S. guidelines take shape.
The topic was at the forefront of plans discussed by several executives at this week's JP Morgan healthcare conference in San Francisco.
Kevin Sharer, chief executive officer at Amgen Inc, said the world's largest maker of branded biotechnology drugs would consider entering the "biosimilars" space, particularly in emerging markets like Asia and South America.
Should Merck Have Bought Schering-Plough?
The merger has always been about much more than any one product. This merger was about taking two strong companies and making an even stronger one. As a result of the merger, the combined company is much better positioned to address the evolving needs of today’s healthcare environment:
-Strong late-stage pipeline with boceprevir, odanacatib and anacetrapib, among others. [Matt adds: those are for hepatitis C, osteoporosis, and heart disease]
South Korean Pharma Market Grows at 7.1% CAGR
Business Monitor International’s forecasts Korea's pharma market to reach almost $19.3 billion at in 2014, with a compound annual growth rate (CAGR) of 7.1% South Korean pharmaceuticals market set to expand at 7.1% CAGR - Pharma Letter.
NEW YORK (Dow Jones)--Vertex Pharmaceuticals Inc. (VRTX) Chief Executive Matthew Emmens is ready to go toe-to-toe with one of the world's biggest pharmaceutical companies, Merck & Co. (MRK).
Cambridge, Mass., based Vertex has filed for Food and Drug Administration approval of telaprevir, which has shown a sharp increase in cure rates of hepatitis C in multiple studies when added to current treatments. Merck also has shown success with its similar drug, boceprevir, and has filed for approval with expedited review granted in both the U.S. and Europe.
The drugs are expected to come to the market at similar times and create a market share battle, but Emmens isn't concerned about the size mismatch.
Ligand pushes into China with liver drugs deal
By Keith Darcé
Originally published January 6, 2011 at 10:30 a.m., updated January 6, 2011 at 3:38 p.m.
In its first move into the potentially lucrative Chinese market, Ligand Pharmaceuticals said Thursday that it partnered with the U.S. affiliate of a Hong Kong drug company to develop and market two experimental liver disease drugs in China.
Bristol-Myers and Pharmasset enter into clinical collaboration agreement
Posted on: Tue, 11 Jan 2011 09:24:36 EST
Symbols: BMY
Jan 11, 2011 (Datamonitor via COMTEX) --
Bristol-Myers Squibb Company and Pharmasset have entered into a clinical collaboration agreement to evaluate the utility of BMS-790052, Bristol-Myers Squibb's NS5A replication complex inhibitor, in combination with PSI-7977, Pharmasset's nucleotide polymerase inhibitor, for the treatment of chronic hepatitis C virus, or HCV.
This proof of concept study will evaluate the potential to achieve sustained viral response 24 weeks post treatment with an oral, once-daily treatment regimen in patients
across HCV genotypes.
(NASDAQ:VRTX) percentage change grew 0.36%, to close at $36.29 and its overall traded volume was 2.16M shares on Monday, the stock had average daily volume of 1.72M shares. VRTX opened at $35.95 and is trading within the range of $35.71-$36.54. The 52-week range of the stock is $31.25 – $43.94. The market capitalization of the company stands at $7.37B and it has 203.19M outstanding shares.Vertex Pharmaceuticals Incorporated (Vertex) is engaged in the business of discovering, developing and commercializing small molecule drugs for the treatment of serious diseases. Telaprevir, the Company’s lead drug candidate, is an oral hepatitis C protease inhibitor and a new class of antiviral treatments in clinical development that target hepatitis C virus (HCV), infection. Telaprevir is being evaluated in a registration program focused on treatment-naïve and treatment-failure patients with genotype 1 HCV infection. VX-770, the lead drug candidate in its cystic fibrosis (CF), program is being evaluated in a registration program that focuses on patients with CF who have the G551D mutation in the gene responsible for CF. Vertex is conducting a number of Phase IIa clinical trials of its earlier-stage drug candidates. On March 12, 2009, Vertex acquired ViroChem Pharma Inc. (ViroChem).,
On November 22, 2010, Vertex completed the submission of its New Drug Application (NDA) for telaprevir to the United States Food and Drug Administration (FDA). A response from the FDA regarding the company’s request for Priority Review of the telaprevir NDA is expected this month. The FDA’s goal for completion of its review for NDA submissions granted Priority Review status is six months from the NDA submission date
Vertex Announces Key Business Objectives To Support Planned Launch of Telaprevir in Hepatitis C and Continued Progress in Other Serious Diseases -Hepatitis C: Submission of New Drug Application complete for telaprevir-
Published: Sunday, 9 Jan 2011 9:34 PM ET
SAN FRANCISCO, Jan 09, 2011
(BUSINESS WIRE) -- ---Cystic Fibrosis: First Phase 3 data for VX-770 expected in first quarter 2011- ---Additional ongoing trials in HCV, CF, epilepsy and rheumatoid arthritis- ---Vertex enters 2011 with cash and cash equivalents position of more than $1 billion- Vertex Pharmaceuticals Incorporated (NASDAQ: VRTX) today announced its 2011 business objectives in conjunction with the 29th Annual J.P. Morgan Healthcare Conference in San Francisco. Matthew Emmens, Chairman, President and Chief Executive Officer of Vertex, will discuss these objectives as part of a live webcast presentation, which will be available on Vertex's website, , on Monday, January 10 at 9:30 a.m. PT (12:30 p.m. ET).
"2011 will be a landmark year for Vertex as we prepare for the expected launch of telaprevir in hepatitis C and advance other new therapies in development," said Mr. Emmens.
Chiva Pharmaceuticals in-licensed China rights for two clinical-stage liver drugs from Ligand Pharma (NSDQ: LGND) (see story). It also will receive non-exclusive rights to Ligand’s HepDirect technology to discover and develop new molecules for hepatitis B, hepatitis C and hepatocellular carcinoma. Chiva, which is headquartered in California, is an affiliate of Hainan Kaihua Pharma.
January 2011 00:20
Inhibitex, Inc. today reported positive preliminary interim safety and antiviral data from the first two monotherapy cohorts of its ongoing Phase 1b clinical trial of INX-189, an oral NS5b nucleotide inhibitor being developed to treat chronic infections caused by hepatitis C virus (HCV).
Week Of Jan 3rd
The U.S. Food and Drug Administration accepted Merck's approval filing for its hepatitis C drug boceprevir, the company said Thursday. The news from Merck is a bit of a surprise since the company hadn't previously announced or confirmed that boceprevir had been filed with U.S. regulators. It's also a tad embarrassing for Vertex, which is still waiting to hear back from FDA about the acceptance of the approval filing for telaprevir, its competing hepatitis C drug. That news should come by Jan. 24, based on Vertex's previous announcement that it filed the drug's application on Nov. 23. Still, it seems as if Merck beat Vertex to the FDA by at least two weeks.
Continue Reading....
Pharmasset Reports Positive Results from its HCV Clinical Programs - PSI-7977 400mg QD with pegylated interferon and ribavirin was generally safe and well tolerated while demonstrating potent viral suppression in patients with HCV genotype 2 or 3 over 12 weeks of dosing- PSI-938 300mg QD monotherapy was generally safe and well tolerated over 14 days of dosing and demonstrated potent antiviral activity and no viral breakthrough
BASi (Bioanalytical Systems Inc.), a life sciences company in the Purdue Research Park, has entered into a Preferred Provider Agreement (PPA) with Princeton, New Jersey-based Pharmasset Inc., a clinical-stage pharmaceutical company committed to discovering, developing and commercializing novel drugs to treat viral infections, to provide preclinical services for pre-IND and post-IND activities. The agreement includes provisions to provide exclusive toxicology services as well as pharmaceutical analysis and bioanalytical services as needed.
Chiva Pharmaceuticals negotiated Chinese development rights to Ligand Pharmaceuticals’ clinical-stage HepDirect candidates, Pradefovir for hepatitis B (hepB) and MB01733 for hepatocellular carcinoma (HCC). The deal also gives Chiva a nonexclusive license to use Ligand’s HepDirect technology for the discovery, development, and worldwide commercialization of new candidates against hep B, hep C, and HCC.
Pradefovir is a HepDirect prodrug of PMEA, the active metabolite in the FDA-approved HepB drug adefovir dipivoxil (Hepsera®). The drug is currently in Phase II development in the U.S. MB07133 is a HepDirect prodrug of the intermediate form of cytarabine (araC) 5’-monophosphate. Currently in Phase I/II development treatment of hepatocellular carcinoma, the drug has already demonstrated strong response rates in terms of intrahepatic tumor regression in a U.S. trial, Ligand states.
Piper Jaffray Overweight On Vertex Pharmaceuticals (VRTX)
By Jonathan Chen Benzinga Staff WriterJanuary 06, 2011 8:01 AM
The supply of the Hepatitis C drug to Vertex by Shasun Chemicals is set to take off earlier than anticipated. The product is set to launch in June-July next year. "Commercial supplies have already started and we are preparing for the launch this year," says Vimal Kumar, Managing Director of Shasun Chemicals, in an exclusive interview with CNBC-TV18's Udayan Mukherjee and Mitali Mukherjee.
Pharmasset to Present at the 29th Annual J.P. Morgan Healthcare Conference
PRINCETON, N.J., Jan. 4, 2011 /PRNewswire/ -- Pharmasset, Inc. (Nasdaq: VRUS) announces that management will present at the 29th Annual J.P. Morgan Healthcare Conference to be held January 10-13, 2011 at the Westin St. Francis Hotel, San Francisco, CA. Schaefer Price, President and Chief Executive Officer, will provide an overview of the company on Wednesday, January 12, 2011 at 9:00 AM (PT).
To access a simultaneous webcast of Mr. Price's overview via the internet, log on to the "Events & Presentations" section of the Investor Center on Pharmasset's website at Please connect to the website at least ten minutes prior to the start of the presentation to ensure adequate time for a reliable connection and any software download that may be necessary for the webcast.
A replay of the webcast will be available on Pharmasset's website for thirty days following the conference. The investor presentation will be available for download in PDF format immediately following the presentation in the "Events & Presentations" section of the Investor Center on Pharmasset's website at
XOMA soars on deal with French drug company. CPEX Pharma climbs on takeover offer. Positive ID surges on deal with Siemens
(BioMed Reports Via Acquire Media NewsEdge) Below is a look at some of the headlines for companies that made news in the healthcare sector on January 4, 2011.
After the bell Tuesday, Anadys Pharmaceuticals, Inc. (Nasdaq:ANDS) announced that it has initiated the planned Phase IIb study of ANA598 in combination with pegylated interferon and ribavirin. The protocol for the study has been cleared by the United States Food and Drug Administration and Health Canada. Patient screening has begun and patient dosing is expected to commence within the next several weeks. In the study ANA598 will be tested in both treatment-naive patients and treatment-experienced patients who failed a prior course of therapy with interferon and ribavirin. ANA598 is the Company's direct-acting antiviral, or DAA, being developed for the treatment of hepatitis C.Earlier Tuesday: Shares of XOMA Ltd. (Nasdaq:XOMA) have caught fire once again. Today the company announced a partnership with Les Laboratoires Servier (Servier), France's largest privately-held pharmaceutical company, to develop and commercialize XOMA 052, XOMA's anti-inflammatory drug candidate, in multiple indications. The drug is designed to inhibit the pro-inflammatory cytokine interleukin-1 beta that is believed to be a primary trigger of pathologic inflammation in multiple diseases.
From Tape Beat
InterMune, Inc. (NASDAQ:ITMN) decreased -0.34%, currently trading at $37.78 and its overall traded volume was 1.04M shares while reporting, against its average volume of 2.44M. ITMN opened the day at $37.64, it made an intraday low of $36.98 and an intraday high of $38.58. The stock has a 52 week low of $8.34 and 52 week high of $49.46. ITMN's market capitalization is 2.12B and it has 56.03M outstanding shares. InterMune, Inc. (InterMune) is a biotech company focused on developing and commercializing therapies in pulmonology and hepatology. In November 2008, InterMune together with Roche and Pharmasset, Inc. (Pharmasset) announced the initiation of INFORM-1, a dual combination clinical trial investigating the combination of two oral antiviral molecules in the absence of interferon. In August 2009, the Company together with Hoffmann-LaRoche Inc. and F. Hoffmann-LaRoche Ltd. (collectively Roche) began a Phase IIb study testing RG7227 in combination with PEGASYS (peginterferon alfa-2a) and COPEGUS (ribavirin), the standard of care (SOC) in hepatitis C virus (HCV).
Vertex Pharmaceuticals Incorporated (Vertex) is engaged in the business of discovering, developing and commercializing small molecule drugs for the treatment of serious diseases. Telaprevir, the Company’s lead drug candidate, is an oral hepatitis C protease inhibitor and a new class of antiviral treatments in clinical development that target hepatitis C virus (HCV), infection. Telaprevir is being evaluated in a registration program focused on treatment-naïve and treatment-failure patients with genotype 1 HCV infection. VX-770, the lead drug candidate in its cystic fibrosis (CF), program is being evaluated in a registration program that focuses on patients with CF who have the G551D mutation in the gene responsible for CF. Vertex is conducting a number of Phase IIa clinical trials of its earlier-stage drug candidates. On March 12, 2009, Vertex acquired ViroChem Pharma Inc. (ViroChem).
Shares of Vertex Pharmaceuticals (NASDAQ: VRTX) traded down 0.79% during mid-day trading on Friday, hitting $35.06. Vertex Pharmaceuticals has a 52 week low of $31.25 and a 52 week high of $44.24. The stock’s 50-day moving average is $34.28 and its 200-day moving average is $34.94. On average, analysts predict that Vertex Pharmaceuticals will post $-0.90 EPS next quarter. The company has a market cap of $7.124 billion and a price-to-earnings ratio of N/A.
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Zacks Investment Research research analysts reiterated a “neutral” rating for shares of Achillion Pharmaceuticals Inc (NASDAQ: ACHN) in a research note issued to investors on Thursday.
Achillion Pharmaceuticals Inc (NASDAQ: ACHN)’s stock traded down 1.20% on Monday, hitting $4.10. Achillion Pharmaceuticals Inc has a 52 week range of $1.99 to $4.20. The stock’s 50-day moving average is $3.1 and its 200-day moving average is $2.77. Analysts predict on average that Achillion Pharmaceuticals Inc will post $-0.13 earnings per share next quarter. The company has a market cap of $239.2 million and a P/E (price-to-earnings ratio) of N/A.
About Achillion Pharmaceuticals Inc (NASDAQ: ACHN)Achillion Pharmaceuticals, Inc. (Achillion) is a biopharmaceutical company focused on the discovery, development and commercialization of treatments for infectious diseases. Within the anti-infective market, the Company focuses on the development of antivirals for the treatment of chronic hepatitis C and the development of antibacterials for the treatment of resistant bacterial infections. As of December 31, 2009, Achillion focused on developing three Hepatitis C virus (HCV) drug candidates: ACH-1625, a protease inhibitor for the treatment of chronic hepatitis C in phase Ib clinical testing; ACH-1095, a NS4A antagonist also for the treatment of chronic hepatitis C, in late stage preclinical testing, and ACH-2684, a high-potency protease inhibitor in preclinical testing. In addition, it has established other product candidates, which include ACH-702 for the treatment of serious bacterial infections and elvucitabine for the treatment of human immunodeficiency virus (HIV) infection.
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“There has been no systemic change in how the FDA is approaching drug approvals” Walsh said in an e-mail. “The primary factor driving first-cycle approval is the quality of the application.”No drugmaker had more than one new medicine approved in 2010, according to data Bloomberg compiled. The figures, derived from an agency database of “new molecular entities,” exclude blood products and vaccines such as Seattle-based Dendreon Corp.’s Provenge for prostate cancer, approved April 29 after a three-year wait, because the FDA doesn’t consider them drugs.
Merck, of Whitehouse Station, N.J., made progress in 2010 launching new products and advancing its drug pipeline, said Ron Rogers, a spokesman. Products to be evaluated this year include boceprevir, a hepatitis C treatment that five analysts project, on average, will have sales of $524.4 million in 2014.
Dynavax Technologies Corporation (Dynavax) is a biopharmaceutical company that discovers and develops products to prevent and treat infectious diseases, asthma and inflammatory and autoimmune diseases. The Company’s principal product candidate is HEPLISAV, a Phase III investigational adult hepatitis B vaccine. Its pipeline of product candidate includes HEPLISAV; its Universal Flu vaccine; clinical-stage programs for hepatitis C and hepatitis B therapies, and preclinical programs partnered with AstraZeneca and GlaxoSmithKline (GSK). In January 2010, the Company announced the completion of the acquisition of Symphony Dynamo, Inc.
Dynavax Technologies Co. (NASDAQ: DVAX) traded down 3.44% during mid-day trading on Monday. The stock has a 52 week low of $1.19 and a 52 week high of $3.24. Its 50-day moving average is $2.38 and its 200-day moving average is $2.01. The company has a market cap of $357.1 million and a price-to-earnings ratio of N/A.
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Dec 2010
Vertex gears up for its big year
Boston Business Journal - by Julie M. Donnelly Date: Friday, December 31, 2010, 6:00am EST
This is supposed to be Cambridge-based Vertex Pharmaceuticals’ big year. The company has been steadily adding staff over the past year and a half, as the company gears up for its anticipated transformation to a profitable, commercial biopharmaceutical company, joining the elite ranks of its neighbors Biogen Idec and Genzyme Corp.
Vertex submitted its much-anticipated drug candidate Telaprevir, for the treatment of hepatitis C to the U.S. Food and Drug Administration in November. Vertex has asked for a priority review, meaning that a decision could come as soon as May.
“This submission is a milestone in our more than 15-year effort to change the way hepatitis C is treated,” said Matthew Emmens, chairman, president and CEO of Vertex, at the time. But the company has recently halted two other, earlier stage clinical trials testing Telaprevir in conjunction with its other potential hepatitis C therapy called VX-222, because the combination wasn’t working. Three other trials, using Telaprevir in combination with other, non-Vertex drugs, are ongoing.
The stakes are high. Howard Liang, an analyst at Boston-based investment bank Leerink Swann has estimated that telaprevir may generate $2.6 billion annually by 2013, if approved. While its partners, Belgium-based Tibotec Pharmaceuticals and Japan-based Mitsubishi Tanabe Pharma hold the rights to commercialize the drug outside the United States, it is the American market that is expected to be the biggest revenue driver for Telapre ...
This is supposed to be Cambridge-based Vertex Pharmaceuticals’ big year. The company has been steadily adding staff over the past year and a half, as the company gears up for its anticipated transformation to a profitable, commercial biopharmaceutical company, joining the elite ranks of its neighbors Biogen Idec and Genzyme Corp.
Vertex submitted its much-anticipated drug candidate Telaprevir, for the treatment of hepatitis C to the U.S. Food and Drug Administration in November. Vertex has asked for a priority review, meaning that a decision could come as soon as May.
“This submission is a milestone in our more than 15-year effort to change the way hepatitis C is treated,” said Matthew Emmens, chairman, president and CEO of Vertex, at the time. But the company has recently halted two other, earlier stage clinical trials testing Telaprevir in conjunction with its other potential hepatitis C therapy called VX-222, because the combination wasn’t working. Three other trials, using Telaprevir in combination with other, non-Vertex drugs, are ongoing.
The stakes are high. Howard Liang, an analyst at Boston-based investment bank Leerink Swann has estimated that telaprevir may generate $2.6 billion annually by 2013, if approved. While its partners, Belgium-based Tibotec Pharmaceuticals and Japan-based Mitsubishi Tanabe Pharma hold the rights to commercialize the drug outside the United States, it is the American market that is expected to be the biggest revenue driver for Telaprevir.
A blockbuster drug approval in 2011 would also raise the profile of Vertex as an attractive acquisition target, analysts say, as big pharma companies seek to boost their supplies of new approved drugs to replace those that are going off patent.
Julie M. Donnelly can be reached at
Read Full Article
Dec 31
At the other extreme, Vertex Pharmaceuticals' (Nasdaq: VRTX) hepatitis C treatment, telaprevir, seems like a shoo-in. Given the extensive data and unmet need -- current treatments only cure about half of patients -- an approval seems all but certain.
Keeping in mind that you still have to expect the unexpected, of course.
Keep up with the drugs facing FDA decisions using The Fool's My Watchlist feature or subscribe to Brian Orelli's RSS feed here.
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Vertex Pharmaceuticals (NASDAQ: VRTX) Given “Neutral” Rating by Zacks Investment Research Analysts
December 31st, 2010 • Equities research analysts at Zacks Investment Research reiterated a “neutral” rating on shares of Vertex Pharmaceuticals (NASDAQ: VRTX) in a research note to clients and investors on Monday.
Separately, analysts at Canaccord Genuity raised their price target on shares of Vertex Pharmaceuticals to $35.00 in a research note to investors on Tuesday, December 21st. They now have a “hold” rating on the stock.
Vertex Pharmaceuticals Incorporated (Vertex) is engaged in the business of discovering, developing and commercializing small molecule drugs for the treatment of serious diseases. Telaprevir, the Company’s lead drug candidate, is an oral hepatitis C protease inhibitor and a new class of antiviral treatments in clinical development that target hepatitis C virus (HCV), infection. Telaprevir is being evaluated in a registration program focused on treatment-naïve and treatment-failure patients with genotype 1 HCV infection. VX-770, the lead drug candidate in its cystic fibrosis (CF), program is being evaluated in a registration program that focuses on patients with CF who have the G551D mutation in the gene responsible for CF. Vertex is conducting a number of Phase IIa clinical trials of its earlier-stage drug candidates. On March 12, 2009, Vertex acquired ViroChem Pharma Inc. (ViroChem).
Shares of Vertex Pharmaceuticals (NASDAQ: VRTX) traded down 0.79% during mid-day trading on Friday, hitting $35.06. Vertex Pharmaceuticals has a 52 week low of $31.25 and a 52 week high of $44.24. The stock’s 50-day moving average is $34.28 and its 200-day moving average is $34.94. On average, analysts predict that Vertex Pharmaceuticals will post $-0.90
Written by Matthew Tindall
Friday, 31 December 2010 08:22
Anadys Pharmaceuticals, Inc.
(Public,NASDAQ:ANDS) increased 2.07%, to close at $1.48 and its overall traded volume was 702,093.00 shares during the last session against its average volume of 882,279.00. ANDS opened the day at $1.55, it made an intraday low of $1.46 and an intraday high of $1.55. The stock has a 52 week low of $0.90 and 52 week high of $3.24. ANDS's market capitalization is 84.51M and it has 57.10M outstanding shares.
About Anadys Pharmaceuticals, Inc. (Public,NASDAQ:ANDS)
Anadys Pharmaceuticals, Inc. is a biopharmaceutical company engaged in developing medicines for the treatment of hepatitis C. The Company is developing ANA598, a small-molecule, non-nucleoside inhibitor of the NS5B polymerase for the treatment of hepatitis C. It has also investigated ANA773, an oral, small-molecule inducer of endogenous interferons that acts via the Toll-like receptor 7 (TLR7), pathway in a Phase I trial in hepatitis C. In June 2009, the Company initiated a strategic restructuring to focus its operations on the development of ANA598, in particular the Phase II study of ANA598 in combination with pegylated interferon and ribavirin. As part of the restructuring, it suspended further development of ANA773 Continue reading.....
Vertex Pharmaceuticals Incorporated
(Public,NASDAQ:VRTX) decreased -0.37%, to close at $35.34 and its overall traded volume was 630,062.00 shares during the last session against its average volume of 1.78M. VRTX opened the day at $35.39, it made an intraday low of $35.22 and an intraday high of $35.49. The stock has a 52 week low of $31.25 and 52 week high of $44.24. VRTX's market capitalization is 7.18B and it has 203.19M outstanding shares.
About Vertex Pharmaceuticals Incorporated (Public,NASDAQ:VRTX)
Vertex Pharmaceuticals Incorporated (Vertex) is engaged in the business of discovering, developing and commercializing small molecule drugs for the treatment of serious diseases. Telaprevir, the Company’s lead drug candidate, is an oral hepatitis C protease inhibitor and a new class of antiviral treatments in clinical development that target hepatitis C virus (HCV), infection. Telaprevir is being evaluated in a registration program focused on treatment-naïve and treatment-failure patients with genotype 1 HCV infection. VX-770, the lead drug candidate in its cystic fibrosis (CF), program is being evaluated in a registration program that focuses on patients with CF who have the G551D mutation in the gene responsible for CF. Vertex is conducting a number of Phase IIa clinical trials of its earlier-stage drug candidates. On March 12, 2009, Vertex acquired ViroChem Pharma Inc. (ViroChem).

December 30, 2010 about: ACHN / BMY / GILD

ACH-1625 has already been shown to significantly reduce viral loads in patients by 3 to 4.25 log10 and maintain a sustained viral response even after therapy has stopped. It has also been shown to be safe up to 2000mg/day, a level far above the highest dose tested in this Phase IIa.
Pre-clinical studies show ACH-1625 to be additive-synergistic to ribavirin and peg-interferon alpha; this study will be a first look at how well those studies translate in the clinic. Although 28 days is still short, the multiple active drug doses as well as a placebo control will allow investigators to gauge in detail the effectiveness of ACH-1625 in this combination. In any case, a full profile of the compound and its potential as part of this three-drug regimen will be in known by the end of 2011. There’s a lot riding on this study.
Aside from its lead compound, Achillion also has a lineup of several other HCV antivirals in development. The once promising ACH-1095, an inhibitor of the NS4A protease is in Phase I. It was originally developed in collaboration with Gilead (GILD), but its rights have since been handed back to the company- though Gilead still retains the ability to opt in at a later stage in the compound’s development.

Debrianna Obara, VP, media, Razorfish Health
In the digital world of health, more and more brands will focus on distribution of content as opposed to straight display media or search buys. This shift will allow brands who have invested in educational and branded content to amortize that investment by

getting more health seekers to interact with that content. The user benefits, as they can interact with valuable information without leaving their trusted 3rd party website of choice (such as AOL/Yahoo!/WebMD).

By contrast, growth of just 1% to 3% is forecast for the major European markets and Canada, with 3% to 5% growth predicted in the United States, which is still the world's largest drug consumer with 2011 sales expected to hit $320-$330 billion, up from $310 billion this year.
A tougher regulatory environment in the developed countries. The U.S. Food & Drug Administration and many foreign regulatory bodies are becoming more reluctant to grant initial approval for new drugs in the face of numerous recalls and growing safety concerns among the public.
Pressure from governments and private insurers to reduce medical and drug costs. Governments in virtually all of the developed countries are pushing cost-cutting measures, including increased use of generic medications, mandatory price cuts for brand-name drugs and elimination of rebates. Private insurers are increasing requirements for pre-authorization of treatments and higher cost-sharing percentages for patients.

Three Upcoming Make-or-Break Biotech Approvals

Vertex's Telaprevir Aims to Revolutionize HCV Treatment
Vertex (VRTX) is close to commercializing its hepatitis C drug telaprevir, part of a new class of therapies that have the potential to revolutionize the way the disease is treated. HCV's current standard of care requires 48 weeks of treatment, causes terrible side effects, and is still only able to cure patients 50% of the time. In contrast, telaprevir has the potential to cut treatment time in half and double cure rates. The drug is widely regarded as a major advancement, and we think telaprevir could hit the market in the first half of next year.

Vertex's chief rival, Merck (MRK), is developing a protease inhibitor of its own. We think telaprevir's slightly superior efficacy and convenience profile should give it an advantage with prescribers. However, Vertex has no commercialization experience, and Merck's established salesforce and ability to package the drug with the current standard of care should help even the commercialization playing field. Vertex ranked number 1 on our 2010 biotech takeout list, and we continue to believe the firm would benefit from the sales know-how of a larger pharma player like current partner Johnson & Johnson (JNJ). The stock currently trades at a 25% discount to our fair value estimate, providing an attractive entry point for investors with a stomach for risk.

Predictions for 2011
Biotech and the Capital Markets: The biotech industry did benefit from the return of investor confidence in the second half of the year...with the Burrill Biotech Select Index outperforming the Dow Jones Industrial Average on an annual basis. Expect to see the biotech industry continue to outperform the general markets as the financing environment continues to improve in 2011.

Biotech IPOs: The biotech IPO window will remain open despite the fact that the 17 new biotech issues that debuted on the U.S. market in 2010 were plagued by lackluster receptions (selling fewer shares well below the pricing range) and their average annual market performance was down by 13 percent. By the end of 2011, I predict that at least 25 biotech IPOs, possibly more, in the US will be completed.
Capital: The industry has achieved a "steady state" in terms of financing...raising about $15 billion annually. This situation will continue in 2011. The industry's collective market cap will also remain at its present $360 billion level as market value growth will be offset by acquisitions.
Partnering: There will be no major slow down in big Pharma's appetite for biotech partnering. Both big pharma and big biotech will again compete for companies with advanced product pipelines. The deal structures will embrace "shared risk". The days when biotech enjoyed major upfront payments for pharma companies to access their technologies are over. Collaborations with emerging market players in China, India and Latin America will also increase.
Mergers & Acquisitions: The predicted surge in big Pharma acquisitions of biotech companies did not happen in 2010. It will in 2011. Sanofi will finally seal the deal and acquire Genzyme and this will usher in several other marquee acquisitions of blue chip biotech companies.
Pharma Restructuring: Pharma companies will continue to make job cuts and restructuring their businesses ahead of loss of patents protection on major blockbusters.
Increased government involvement on healthcare: The federal government, through Medicare and Medicaid, will continue to play a greater role in the delivery and reimbursement of healthcare. This trend will create an array of new regulatory and compensatory rules, issues, and challenges for healthcare providers.
Biosimilars: Healthcare reform carries provision instructing the FDA to create a pathway for biosimilars and expect to see both biotech and pharma companies take a keen interest in the discussions on the drafting of new regulations governing the development of biosimilars.
Converging technologies impact healthcare: Expect to see a greater emphasis on prevention and wellness. A greater understanding of human genomics and the advent of molecular diagnostics, and the convergence of information, wireless, and medical technology promises to make personalized medicine an ever present reality in the way doctors and patients approach healthcare.
Regulatory environment: The industry will continue to adjust to a regulatory environment that includes comparative effectiveness research (CER). Payors will be looking at CER as a way to gather the necessary data on whether to reimburse for genomically guided medicines. With PDUFA expiring in 2012 there will be a major battleground over drug safety and review issues in Congress in 2011.
Science and Technology: The evolving legal battle over the patentability of genes will heat up; uncertainty will continue to swirl around stem cells but regenerative medicine will be hot.
Clean tech will boom: The clean tech boom in non-food crops will continue as major investments in solar power, wind power, and next generation biofuels gets attention. The market will not only embrace green, but technologies that improve energy efficiency and environmental "friendliness"—less polluting and less consuming.
Global markets: Expect emerging markets to continue to be a dominant factor. Increasing affluence, a growing middle class, and government policies will make healthcare big business in these countries.
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Pharmasset (Nasdaq: VRUS). Hepatitis C nuc polymerase inhibitors will be key components of future therapy, in our view. We expect key events in 2011, including: Phase 2b data and a Phase 3 start for Roche-partnered RG7128, Phase2b data for wholly owned PSI-7977, and data from Pharmasset’s proprietary all oral, two-nuc combination study of PSI-938 and PSI-7977. Continue Reading.......
Wednesday, December 22, 2010
Vertex halts part of HCV trial
Vertex Pharmaceuticals Inc. is discontinuing part of a Phase 2 clinical trial of its hepatitis C virus (HCV) drug candidate. The Cambridge biotech halted the second two-drug treatment, which consisted of telaprevir and VX-222, though it continues with three-drug and four-drug regimen trials.