Hepatitis C News; Achillion Phase 1 Trial of ACH-2684 and More

In The News ; May 25, 2011 8:55 AM EDT

Achillion Announces Initiation of Phase 1 Trial of ACH-2684 for the Treatment of Hepatitis C

Human Trial Will Evaluate Safety of Pan-Genotypic Protease Inhibitor in Both Healthy Subjects and Genotype 1 or 3 HCV-Infected Patients

NEW HAVEN, First-in-Conn., May 25, 2011 (GLOBE NEWSWIRE) -- Achillion Pharmaceuticals, Inc. (Nasdaq: ACHN), a leader in the discovery and development of small molecule drugs to combat the most challenging infectious diseases, today announced that the Company has begun dosing in a Phase 1 clinical trial of ACH-2684, a novel pan-genotypic protease inhibitor being developed for the treatment of chronic hepatitis C virus (HCV) infection.

The Phase 1 clinical study is a randomized, double-blind, placebo-controlled trial to investigate the safety, tolerability, pharmacokinetic profile and antiviral activity of ACH-2684. The trial consists of three segments including assessment of single ascending oral doses in healthy volunteers, a 14 day multiple ascending doses segment in healthy volunteers, and evaluation of 3 days of oral ascending repeat doses in subjects with either genotype 1 or genotype 3 hepatitis C infection. The trial will take place in the United States and is designed to enroll up to 78 healthy volunteers and up to 40 HCV-infected patients.

"This first-in-human clinical trial will be instrumental in establishing the safety profile of ACH-2684 in humans," stated Elizabeth A. Olek, D.O., Vice President and Chief Medical Officer of Achillion. "It will also provide Achillion with important preliminary efficacy data against HCV genotypes 1 and 3, and help us to select doses for subsequent clinical development."

"We are very excited to take ACH-2684 into the clinic and advance what we hope will be a unique pan-genotypic, once-daily protease inhibitor," said Michael D. Kishbauch, President and Chief Executive Officer of Achillion. "Furthermore, we expect to shortly launch the 12-week segment of the Phase 2 trial of our lead ACH-1625 protease inhibitor, as well as a Phase 1 trial of our ACH-2928 NS5A inhibitor. We believe we remain poised to deliver a trio of important HCV clinical milestones near the end of this year, namely, 12-week EVR results on ACH-1625 and human proof-of-concept data on both ACH-2684 and ACH-2928. These are all important components in our ultimate strategy of becoming a leader in the development of HCV combination therapies involving our protease and NS5A inhibitors."

About ACH-2684

ACH-2684 is a pan-genotypic HCV protease inhibitor designed and synthesized based on crystal structures of enzyme/inhibitor complex. ACH-2684 is a macro-cyclic, non-covalent, reversible inhibitor of NS3 protease. In preclinical studies, ACH-2684 demonstrated pico-molar potency, excellent pharmacokinetic properties and safety profile at high drug exposures. ACH-2684 also exhibits rapid and extensive partitioning to the liver, as well as high liver/plasma ratios in preclinical studies. ACH-2684 has shown pico-molar potency against NS3 protease that is specific to HCV. It is active against the 6 known genotypes of HCV and exhibits equipotent activity against HCV genotypes 1a and 1b at an IC50 of approximately 100 picomolar. The drug candidate was discovered internally and is being advanced by Achillion.

About HCV

The hepatitis C virus is the most common cause of viral hepatitis, which is an inflammation of the liver. It is currently estimated that more than 170 million people are infected with HCV worldwide and The American Association of Liver Disease estimates that up to 80% of individuals become chronically infected following exposure to the virus. If left untreated, chronic hepatitis can lead to permanent liver damage, which can result in the development of liver cancer, liver failure or death. Few therapeutic options currently exist for the treatment of HCV infection. The current standard of care is limited by its specificity for certain types of HCV, significant side-effect profile, and injectable route of administration.

About Achillion Pharmaceuticals

Achillion is an innovative pharmaceutical company dedicated to bringing important new treatments to patients with infectious disease. Achillion's proven discovery and development teams have advanced multiple product candidates with novel mechanisms of action. Achillion is focused on solutions for the most challenging problems in infectious disease including hepatitis C and resistant bacterial infections. For more information on Achillion Pharmaceuticals, please visit www.achillion.com or call 1-203-624-7000.

Forward-Looking Statements

This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including statements with respect to the potency, safety and other characteristics of ACH-2684, which may not be duplicated in clinical studies and Achillion's expectations regarding timing and duration of clinical trials and reporting of results from clinical trials of ACH-1625, ACH-2684 and ACH-2928. Among the factors that could cause actual results to differ materially from those indicated by such forward-looking statements are: uncertainties relating to results of clinical trials, unexpected regulatory actions or delays, and Achillion's ability to obtain additional funding required to conduct its research, development and commercialization activities. These and other risks are described in the reports filed by Achillion with the U.S. Securities and Exchange Commission, including its Annual Report on Form 10-K for the fiscal year ended December 31, 2010.

All forward-looking statements reflect Achillion's expectations only as of the date of this release and should not be relied upon as reflecting Achillion's views, expectations or beliefs at any date subsequent to the date of this release. Achillion anticipates that subsequent events and developments may cause these views, expectations and beliefs to change. However, while Achillion may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so.

CONTACT: Company Contact:
Glenn Schulman
Achillion Pharmaceuticals, Inc.
Tel. (203) 752-5510
gschulman@achillion.com

Investors:
Mary Kay Fenton
Achillion Pharmaceuticals, Inc.
Tel. (203) 624-7000
mfenton@achillion.com

Media:
Christin Culotta Miller
Ogilvy PR
Tel. (646) 229-5178
christin.miller@ogilvypr.com

Source: Achillion Pharmaceuticals, Inc.

Telaprevir/Incivek

With the approval of Incivek™ (telaprevir) for the treatment of those with Hepatitis C, genotype 1, and the potential to cut treatment time to just 24 weeks, many questions arise. Here we have summarized some of these questions.

Incivek™ (Telaprevir) - Your Questions Answered

by Editors at Hepatitis-Central.com

With the approval of a new treatment option for those with Hepatitis C genotype 1 there is bound to be questions. Based on the information provided by Vertex, developer of Incivek™, we have provided summaries for many of the questions that are being asked. Learning more about this new combination therapy and discussing this information with your healthcare provider are essential.

Simply click on any of the links below for more details:

• What is Incivek™ (telaprevir)?
• What is the dosage for Incivek™ (telaprevir)?
• Does the dosage and administration of Incivek™ (telaprevir) differ for various people?
• When is Incivek™ contraindicated?
• What types of adverse reactions were reported when taking Incivek™?
• Are there any other warnings one should know regarding Incivek™ combination therapy?
• At what point would one know the Incivek™ combination therapy is not working?
• Can those co-infected with HIV and Hepatitis C begin Incivek™ combination therapy?
• When can I get a prescription for Incivek™ (telaprevir)?
• How can I get assistance paying for Incivek™ (telaprevir)? Is Incivek™ covered by insurance?

Posted by Editors at May 23, 2011 5:43 PM

Requirements for using and reposting articles


Patient Assistance Program
INCIVEK/Telaprevir and VICTRELIS (Boceprevir) Patient Assistance Programs


 Vertex CEO unfazed by competition, future rivals

(Reuters) - As Vertex Pharmaceuticals (VRTX.O) launches its first commercial product this week, Chief Executive Matthew Emmens appears unfazed by competing against industry behemoths or by the wave of potential rival drugs in development.

Emmens took over for company founder and scientist-at-heart Joshua Boger two years ago because of his extensive commercial experience as CEO of Shire (SHP.L) and many years working for Merck & Co. (MRK.N) With the U.S. approval of Vertex's highly anticipated hepatitis C drug Incivek, Emmens' time in the spotlight has arrived.

"One of the things we really wanted to do is think simple, think focused and think you're launching a company too," Emmens told Reuters on Tuesday, a day after the drug that was Boger's baby for well over a decade won FDA approval.

Incivek, which is expected to be a multibillion-dollar seller, will compete head-to-head with Merck's equally new Victrelis. Both drugs in studies have shown an ability to significantly increase the likelihood of a cure compared with current standard drugs, and can substantially reduce the current 48-week treatment regimen for many patients.

"These are cures. It's an amazingly good thing," Emmens said of the promise of his company's new drug.
While the drugs were not tested against each other, Incivek demonstrated a higher cure rate, a higher percentage of patients who will qualify for shorter treatment, and is simpler to use. Victrelis may prove to be less expensive and does not cause the bothersome rash seen with Incivek.
Merck bolstered its considerable marketing muscle last week by announcing a surprise Victrelis co-promotion deal with Roche (ROG.VX), meaning the Vertex sales force will be up against two of the biggest and most experienced in the business.

"It was a little bit of a surprise because they're arch competitors," Emmens said, referring to the fact that Merck and Roche sell rival interferon products for hepatitis that must be used in combination with the new drugs.

"To me it doesn't change the drugs," Emmens said. "We've got a real strong label; we are simple (to use) and almost 8 out of 10 people who walk in the door as first time patients are going to get cured."
HIGH DOCTOR, PATIENT AWARENESS
Emmens, noting the irony of competing against Merck where he and Boger met and worked for many years, acknowledged that doctors will likely have far greater exposure to Victrelis sales representatives because of the Merck-Roche tie-up.

"It doesn't threaten me," he said.
"It's a relatively small number of prescribers. I don't think we need to shout too loudly," Emmens said.
"Physician awareness is high for both drugs. Awareness is well in the 90 percent range and the awareness of the basic features of both drugs is higher than any drug area I've ever been in," added Emmens.
There have also been estimates of as many as 100,000 people waiting in the wings for the new drugs to arrive.

"I think the patients waiting for treatment and aware of this drug are significant, probably unlike any market I've ever seen," Emmens said.
"I think there will be a flood in the office of patients, at least that's what physicians are telling us. We know we already have prescriptions, yesterday," he said, adding that Incivek will be in pharmacies Wednesday night or Thursday.

Emmens defended the high wholesale price set for Incivek of $49,200 for a 12-week course of treatment, saying it was justified by the cure rate and ability to prevent much more costly treatments, such as liver transplants.

"We've done extensive work to feel out the sensitivity of pricing with payers. I think that we can convince them that it's worth it," Emmens said.
"If your drug is perceived to be a premium drug, which ours is, I think we priced it appropriately," he said, adding that extensive Vertex programs will limit the out-of-pocket cost to patients.
Vertex is planning campaigns to raise hepatitis C awareness and promote greater screening for a disease that most people are unaware they have until serious liver problems develop. But Emmens is reluctant to directly promote the Incivek brand.

"I'll never say never, but I'll just tell you that I don't see it," he said. "I think pummeling the world with advertising in many ways works against what may be best for the physician and patient."
With dozens of hepatitis C drugs in development, analysts have cautioned that the days of Vertex and Merck owning the market could be limited.

Emmens was unfazed, noting that it was easy to become exuberant over early results of small studies and that most experimental drugs fail. In addition, the comparative bar for new treatments has been substantially raised.

"The new standard you have to compare yourself to is tough," Emmens said. "It's us."
While his sales force is well-prepared and raring to get started, Emmens attributes some his gray hair to the two dozen drug launches he has been through in previous roles, including one in which a truck filled with a new medicine skidded off the road in a snowstorm.

"It's always better to have a drug launch in warm weather," he quipped.
(Reporting by Bill Berkrot and Lewis Krauskopf, editing by Matthew Lewis)


VIDEO

Hepatitis C Educational Program
Produced by Liver Specialists of Texas, this is Part 1 of a series of hepatitis C educational classes for patients preparing to start hepatitis C therapy, using Interferon and Ribavirin, as well as the new protease inhibitor, boceprevir, available as Victrelis. The series will review bacground information about the function of the liver, diseases that are common to the liver, the natural history of heppatitis C, as well as treatment options. Management of the side effects of hepatitis C therapy will be stressed in the couse.

Also See The Texas Liver Youtube Channel for more videos





HIV/HCV

Twice-weekly pegylated interferon-α-2a and ribavirin results in superior viral kinetics in HIV/hepatitis C virus co-infected patients compared to standard therapy -
"Our study suggests that twice-weekly peg-IFN-α-2a for 4 weeks followed by weekly dosing and ribavirin has a superior early virologic response compared with the standard therapy of weekly peg-IFN-α-2a and ribavirin among HIV/HCV co-infected genotype 1 individuals, particularly among African-Americans."

Untreated HIV Increases Inflammation in Women
Rifapentine plus isoniazid administered once-weekly for 3 months to treat latent tuberculosis worked better than daily isoniazid for 9 months, with fewer premature treatment discontinuations, researchers reported at the recent American Thoracic Society meeting.

Healthy You

High Calcium Intake No Better for Bone Health
Women with a low dietary intake of calcium are at increased risk of fractures and osteoporosis, Swedish researchers reported, but above a threshold, there's little additional benefit.

Pharmaceuticals

The Problem With Labeling: Too Many Side Effects
In response to regulatory demands and mounting litigation, drugmakers have puffed up their product labeling to the point where the verbiage occupies numerous pages and contains a laundry list of possible side effects. Yet all these warnings have a down side, because they may undermine patient adherence and overwhelm docs as they try to find suitable treatments, according to a new study.


 Vertex Plans Focus On Marketing Against Two Pharma Giants

--Vertex to use small, focused

sales force for new hepatitis C drug against similar treatment from Merck and Roche

--"We designed a sales force around our medicine," CEO says.

--Vertex also supporting campaign for increased hepatitis C screening.

By Thomas Gryta

Of DOW JONES NEWSWIRES

NEW YORK -(Dow Jones)- Vertex Pharmaceuticals Inc. (VRTX) is using a focused strategy in selling its newly approved hepatitis C drug Incivek against two of the world's largest pharmaceutical companies.

While the Cambridge, Mass., drug maker is launching its first drug--the first prescriptions arrived just hours after Monday's approval from the Food and Drug Administration--it is facing a formidable opponent. Merck & Co. (MRK) got approval for its own hepatitis C pill Victrelis earlier this month and has signed a promotional agreement with Roche Holding AG (RHHBY). Both drugs work in similar ways, improving cure rates.

Vertex said it is using a small, experienced sales force to get its message to doctors about the viral liver disease, mixed with support for a coming awareness program to help identify new patients.

"It is a very focused market, and we have highly specialized sales force," Vertex Chief Executive Matthew Emmens said in an interview Monday. "You only need a 100 or so representatives to cover the doctors."

Emmens projected that the ideal sales force would visit the top half of prescribing physicians eight to 10 times a year, but frequency isn't as important with Incivek, he said, because physicians have generally been following its development.

In general, Wall Street has been predicting that Vertex will lead the market because of its effectiveness, simpler dosing and broader range of data.

A Merck spokeswoman said the availability of new drugs for hepatitis C is " great news" and that the company looks forward to being part of the "exciting new era" with Victrelis.

Although it is a smaller company, many of Vertex's leaders previously have worked in large pharmaceutical companies and are using that experience to their advantage, according to Emmens.

Vertex started building its marketing organization two years ago and its sales force about a year ago, getting 10 applications for every hire.

"We designed a sales force around our medicine from scratch," Emmens said, contrasting that strategy with large companies that push new drugs on an already active sales force.

Aside from a traditional sales effort and the initial demand for the drug, Emmens expects that new patients will continue to be identified through increased awareness and testing.

Hepatitis C can lead to liver failure, liver cancer and the need for a transplant, but patients can carry the disease for decades before it is detected and severe damage has already been done.

Vertex cited estimates of 700,000 to 1 million U.S. diagnosed patients, with 3 million to 4 million total patients infected with the blood borne virus.

To raise awareness among those undiagnosed patients, Vertex is supporting plans for a grass-roots effort that will involve local governments and community organizations to encourage people to be tested for the hepatitis C virus.

Along with other companies, including Roche, Merck and Johnson & Johnson (JNJ) , Vertex has donated to an organization that is helping the Centers for Disease Control to evaluate changing the screening methods for the disease.

The disease typically is spread through injectible drug use and blood transfusions before 1992, when screening for the virus in the blood supply began.

Currently, testing is typically done in so-called high-risk individuals, but the CDC is evaluating using a one-time age-based test for all people. The CDC estimates that 75% of hepatitis C patients were born from 1945 to 1965 and Emmens expects the new recommendations to come in early 2012.

Although Emmens declined to talk about his own sales expectations for Incivek, he contended that Wall Street's expectations for new hepatitis drugs to quickly challenge Incivek and Victrelis may be overly optimistic.

Emmens said new treatments would likely have to prove themselves against the latest generation of drugs, effectively raising the barrier for new entrants.

"The best anyone can do is three years from now. We'll see if they make it," he said.

-By Thomas Gryta, Dow Jones Newswires; 212-416-2169; thomas.gryta@dowjones.com

--Katherine Hobson contributed to this article. (END) Dow Jones Newswires 05-24-111802ET Copyright (c) 2011 Dow Jones & Company, Inc.


FDA Oversight Of J&J Is ‘Deeply Troubling’

The ‘phantom recall’ scandal last year in which Johnson & Johnson hired contractors to yank over-the-counter meds such as Motrin from store shelves rather than conduct a proper recall prompted congressional hearings and contributed to a consent decree, among many other things. And during one hearing, the FDA agreed to review procedures that allowed the health care giant to, essentially, circumvent agency oversight (back stories here, here and here). Now, though, Darrell Issa, who chairs the House Committee on Oversight and Government Reform, which held those hearings, has written FDA commish Margaret Hamburg to say the agency has failed to take “promised and necessary corrective actions at its San Juan office.”