May 2011 Updates
Telaprevir FDA Approved
FDA Approves Telaprevir/Incivek For Hepatitis C
Telaprevir/Incivek Prescribing Information
Boceprevir FDA Approved
Vicrelis/Boceprevir IS NOW FDA Approved May 13 2011
VICTRELIS™- Boceprevir: Prescribing Information and Medication Guide
Patient Assistance Program
INCIVEK/Telaprevir and VICTRELIS (Boceprevir) Patient Assistance Programs
Getting Ready; Telaprevir or Boceprevir ?
Good evening folks, yesterday in a press release we heard from Vertex discussing their new drugs and the big 2011 plan. Additional information is available in a web cast presentation, at the Vertex website.
The news coming from Vertex is encouraging for both the ongoing and new clinical trials. Vertex is conducting a Phase 2 trial evaluating multiple 12-week, response-guided regimens of telaprevir dosed in combination with their HCV polymerase inhibitor, VX-222.
*Note : Response guided therapy is intended to enable the physician to determine the duration of combination therapy based on a patients viral response during treatment
The study currently includes three treatment arms.
The Four Drug Combination: Telaprevir, VX-222, Pegasys and RibavirinTwo of the treatment arms are fully enrolled and are evaluating four-drug combinations of telaprevir (1,125 mg; BID), VX-222 (400 mg or 100 mg; BID), Pegasys® (pegylated-interferon alfa-2a) and Copegus® (ribavirin).
Approximately two-thirds of the people in the four-drug treatment arms have received eight weeks or more of treatment. More than one-third of patients have received 10 weeks or more of treatment, with some people having completed all therapy. Interim data from both of the four-drug treatment arms are expected in the first quarter of 2011.
The Three Drug Combination: Interferon-free regimen of Telaprevir, VX-222 and RibavirinIn November 2010, Vertex announced the planned addition of a three-drug treatment arm to evaluate the potential of an all-oral, interferon-free regimen of telaprevir (1,125 mg), VX-222 (400 mg) and ribavirin dosed twice daily. Enrollment in this new treatment arm is anticipated to begin in the first quarter of 2011.
However, not mentioned was that in October of 2010 the VX-222/telaprevir combo being tested in low doses was stopped because of viral breakthrough. Just recently in a higher dose of the VX-222/telaprevir combo was halted in part of the Vertex study.
Additional TrialsVertex and Tibotec also plan to conduct several additional clinical trials of telaprevir in 2011 that aim to expand the future patient population for telaprevir-based regimens.
HIV Co-Infection Trial
Phase 3 HCV/Human Immunodeficiency Virus Co-Infection Trial: Vertex recently completed enrollment in a Phase 2 clinical trial of telaprevir-based regimens in people who are infected with genotype 1 hepatitis C virus and the human immunodeficiency virus (HIV), also known as HCV-HIV co-infection.
If positive, results from this trial could support the planned initiation of a Phase 3 study of telaprevir-based regimens in people co-infected with HCV and HIV in 2011. The Phase 3 trial will be designed to generate data that, if positive, could support the submission of a supplemental NDA for this population.
Vertex Is Initiating A Short-Duration Study:
Regimens involving less than six total months of therapy Phase 2 Short-Duration Treatment Study: In 2011, Vertex and Tibotec plan to initiate a clinical trial to evaluate the role of telaprevir as part of hepatitis C treatment regimens involving less than six total months of therapy. One part of the trial may evaluate a telaprevir-based treatment regimen as short as 12 total weeks in duration for certain subsets of patients.
Phase 2 Post Transplant Study:Vertex recently completed a drug-drug interaction study of telaprevir with immunosuppressive agents commonly used following a liver transplant.
If All Goes Well Vertex Will Initiate A phase 2 study for recurrent hepatitis C following a liver transplant
Based on results from this study, Vertex and Tibotec plan to initiate in 2011 a Phase 2 study of telaprevir-based regimens in people with recurrent hepatitis C following a liver transplant
Vertex is getting ready for the launch of telaprevir, and hired more than 200 new employees. According to the website; " The sales and commercial leadership team is in place, and more than 100 field-based employees have been hired to date and are prepared to support the future use of telaprevir across the United States following the planned launch."
What was not mentioned is that the Shasun pharmaceutical chemical manufacturer obtained a contract from Vertex Pharma for manufacturing telaprevir. As reported Vertex will supposedly source the entire supply from Shasuns UK subsidiary. On Jan 5th Shasun announced; "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. Although Shasun did not name the Vertex drug as telaprevir.
The validation of the contract came from a snippet on Pharma-Markets website, not vertex.
Who is Shasun ?Shasun Chemicals is a pharmaceutical chemical manufacturer headquartered in Chennai, India and one of the largest producers of Ibuprofen worldwide.
The company was incorporated in 1976 - and has facilities in both India and the UK.
Their products are exported across North America, Europe, Latin America, and Asia. According to their website they have positioned themselves in order to develop and supply their products for the U.S. Market. In 2008 the pharmaceutical manufacturer opened development facilities in Piscataway, NJ.
Outsourcing to India
According to the article ; List of Companies Outsourcing Pharmacy Work to India it appears outsourcing to India is a popular practice for drug companies as it provides a cheap labor for manufacturers. In 2008 the drug company Merck felt the heat when Sen. Sherrod Brown of Ohio requested information about their outsourcing practices to India . The Senators concern began after hearing of an announcement made by Merck's Richard Spoor stating that by 2010, Merck plans to outsource about 35 percent of the company's pharmaceutical ingredients and packaging. The senator also sent a letter to the FDA, which expressed his concern about how countries with weaker safety standards might produce contaminated drug ingredients.
On the topic of safety standards: Drug Trials In India: Cheaper and Weak Ethical Controls.
The average cost in America for a pharmaceutical company to develop a drug for FDA approval is close to $802 million with the time taking 10 to 15 years. With these high costs and long wait times, the pharmaceutical industry in the US is now looking at outsourcing.
Noted at the website Chemical and Engineering ;"In recent years, major U.S. drug companies have been laying off people by the thousands while, at the same time, headcounts at contract pharmaceutical research firms in India, China, and Russia have surged. It would seem the two phenomena are linked. But, as with much involving the pharmaceutical industry, things aren’t that straightforward."
We don’t really have a concern or a position concerning R&D (or research and development) capabilities leaving the U.S.,” Goldhammer says. “It’s up to each company to decide what’s best for them.” He adds that even though there may appear to be a very large number of experienced drug R&D scientists who have relocated from the U.S. to China or India, it has on the whole little impact on R&D capabilities in the U.S. “We have a very deep pool of talent in this country,” he says. You may want to read the full 2009 article, its compelling
The confidence I once had in pharmaceutical companies is gradually fading, with news reported on insider trading, Roche paying off nurses to recruit patients, to the report from ProPublica that 83.8% of doctors have some sort of relationship with drug companies.
I was angry and confused when I read that Mr. Sam Waksal, whose insider trading lead to spending time in prison along with Martha Stewart; was then able to go on to purchase Three Rivers Pharmaceuticals. He mentioned in an article that the backbone of his new enterprise is comprised of treatments for hepatitis C, and cancer.
Is it just me, or have the ethics in America's health care system and pharmaceutical industry changed? If so we must change with it, the time has come to be the wise patient because the day of being the good and trusting patient is over.
I assume that the consequences of those few employees/physicians have reflected negatively on the majority of virtuous pharmaceutical companies. Its evident that they have taken the heat for a few individuals who were morally deficient. Personally, for the first time in my life, this long ago "hippie" has become a little cynical and disillusioned.
When I treated HCV ten years ago I did so with an illiterate combination of fear, desperation and blind ambition. From the moment I was diagnosed I was determined to clear the virus, which I did treating with a combination of Intron A and a side of ribavirin. After discovering I was a genotype 2 I felt confident that therapy just might work.
In 1991 Shering's "Intron A" was FDA approved and in 2000 I began treatment in an extraordinarily unnecessary trial. The protocol was for a year which is unheard of with my genotype with a lead in of high dosed "Intron A" at 5 million units/daily for a month and then three times a week for eleven months in combination with 800 mg of Ribavirin. The recommendations for my genotype were to treat for six months, while people with genotype 1 treated for 12 months. The standard dose or protocol was for 3 million units of interferon, three times a week. I understood those stats and decided to treat, I was too hyped up to wait. Over the years I realized how fortunate I was to have achieved my SVR status; I do not regret my choice, instead I rejoice.
In January 2001, the (FDA) approved the use of peglayted interferon in the U.S. Yes, if I knew then, what I know now, I most certainly would have waited.
Over the past year or so I have been diligently reading updates on a few investment sites and their accompanied blogs. The author Adam Feuerstein who is not an investor but a contributor at the The Street, for me, has been instrumental in bringing a clearer understanding of both drugs. Although, I read with caution because until the data is published in a peer reviewed journal there is no bottom line. However, Mr. Feuersteins articles are backed by published data.
The recent news/research/data on telaprevir and boceprevir is staggering, HCV therapy has come a long way folks, with impressive cure rates in people who are difficult to treat; genotype 1, treatment-experienced or people treating for a second time, null responders, relapsers, different ethnic groups and even people with surmountable liver damage.
The good news is that Boceprevir is moving along and assuming all goes well telaprevir will be following close behind . However, the majority of us have little preference on which drug reaches the market first, we still continue to absorb the data before deciding on which drug to use or when and how to proceed with treatment. In the next few months there will be comparisons, not a head to head study, we can only dream, but articles/data from reputable websites. Then the work begins, as we are given the laborious task of steadily reading through the generous information made available to us by our few devoted HCV advocates, pun intended.
In both boceprevir and telaprevir response-guided therapy will be implemented, enabling therapy to be individually tailored, by adapting the treatment duration according to individual patient response.
If the drug of choice is boceprevir your physician may be using a 4 week lead-in strategy of peg/RBV before adding the oral protease inhibitor drug boceprevir. Assuming this protocol is used it can help to identify the responsiveness to interferon before adding boceprevir.
Another new addition to HCV therapy was discussed in detail by HCV advocate in two articles "The Gene that Predicts—by Alan Franciscus." and IL28B Gene Highlighted at AASLD—Liz Highleyman . With the groundbreaking discovery of the IL28B gene comes a little concern for us. On the website is an article put together by information I compiled from data, reports with a speculation of what insurance companies may do with this new discovery; Is IL28B Testing A Threat To Telaprevir Or To Patients ?
The reality is once you begin HCV therapy you will transform into your own advocate. You and you alone will need to address the protocol and over see your blood work.
Before choosing a physician , entering into a clinical trial, or starting therapy ask the hard questions, do the homework, ask for all copies of your blood work and learn what they mean. Ask the treating physician how many patients he has treated with HCV and for how long. If possible go through a teaching hospital/university which is on the cutting edge of these therapies. Report all side effects as they occur and know this folks, trust your gut instinct.
That may be the most valuable advice I can offer folks, trust yourself, and listen to your body.