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HCV Protease Inhibitor Telaprevir Will Get Priority Review in U.S. and Canada

SUMMARY: Vertex Pharmaceuticals announced last week that the U.S. Food and Drug Administration (FDA) and Health Canada have agreed to priority review of telaprevir, the company's experimental hepatitis C virus (HCV) protease inhibitor currently in Phase 3 clinical trials. FDA's 6-month accelerated review could result in an approval decision by late May. Along with Merck's boceprevir, also under priority review, these first direct-acting oral agents are expected to usher in a new paradigm for chronic hepatitis C treatment.

Below is an edited excerpt of a press release issued by Vertex describing the recent regulatory developments.

U.S. FDA and Health Canada Grant Priority Reviews for Telaprevir for the Treatment of Hepatitis C

Six-month review date of May 23, 2011 set by FDA

Cambridge, Mass. -- January 20, 2011 -- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) announced today that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for telaprevir and granted the company's request for six-month Priority Review. Telaprevir is Vertex's lead medicine in development for people with genotype 1 chronic hepatitis C. The FDA grants Priority Review to medicines that offer major advances in treatment or provide a treatment where no adequate therapy exists. A target review date of May 23, 2011 is set under the Prescription Drug User Fee Act (PDUFA) for the FDA's approval decision, which is four months earlier than the standard review time of 10 months.

Additionally, Vertex today announced the completion of a New Drug Submission (NDS) to the Therapeutic Product Directorate (TPD) of Health Canada seeking approval for telaprevir in Canada. Telaprevir was also granted Priority Review in Canada, which allows for faster review for promising medicines that address life-threatening or severely debilitating conditions and for which there are few effective therapies already available. Standard review in Canada takes 18 months or more and Priority Review typically shortens the review time to approximately six to nine months.

In December 2010, Janssen-Cilag International NV announced that the European Medicines Agency (EMA) accepted telaprevir for accelerated assessment in Europe, which is granted to new medicines of major public health interest.

"Data from Phase 3 studies showed that when compared to currently available medicines, telaprevir-based combination therapy nearly doubled viral cure rates and cut treatment time in half for the majority of patients new to treatment," said Peter Mueller, PhD, Chief Scientific Officer and Executive Vice President of Global Research and Development at Vertex. "We look forward to working with the FDA and Health Canada to make telaprevir available as quickly as possible for people with hepatitis C."

Data to Support the Telaprevir Submissions


The regulatory submissions in the United States, Canada and Europe are supported by data from three Phase 3 studies, known as ADVANCE, ILLUMINATE and REALIZE, which evaluated up to 12 weeks of telaprevir in combination with Pegasys (pegylated-interferon alfa-2a) and Copegus (ribavirin) in people chronically infected with genotype 1 hepatitis C virus (HCV) who were new to treatment as well as those who were treated before with currently available medicines but did not achieve a sustained viral response (SVR, or viral cure). In these studies, treatment with telaprevir-based combination therapy resulted in significantly higher viral cure rates compared to approved medicines, regardless of prior treatment experience, race or stage of liver disease. Up to 75 percent of people new to treatment achieved a viral cure with telaprevir-based therapy. The majority of these people were able to complete their course of treatment at six months -- half the time needed with currently available medicines. Among those who did not achieve a viral cure with a prior treatment course of currently available medicines, Phase 3 data showed that telaprevir-based combination therapy resulted in viral cure rates three to five times higher compared to re-treatment with currently available medicines. The safety and tolerability results of telaprevir-based combination therapy were consistent across the Phase 3 studies. The most common adverse events regardless of treatment regimen were rash, fatigue, pruritis, headache, nausea, anemia, insomnia, diarrhea, flu-like symptoms and pyrexia, with the majority being mild or moderate in severity.

Vertex provided a summary of Phase 3 results, including SVR and safety data for telaprevir, in its November 23, 2010 press release announcing the NDA submission.

About Telaprevir


Telaprevir is an investigational, oral inhibitor that acts directly on the HCV protease, an enzyme essential for viral replication. To date, more than 2,500 people with genotype 1 hepatitis C have received telaprevir in Phase 2 and Phase 3 studies.

Vertex is developing telaprevir in collaboration with Tibotec BVBA and Mitsubishi Tanabe Pharma. Vertex has rights to commercialize telaprevir in North America. Through its affiliate, Janssen, Tibotec has rights to commercialize telaprevir in Europe, South America, Australia, the Middle East and certain other countries. Mitsubishi Tanabe Pharma has rights to commercialize telaprevir in Japan and certain Far East countries.

About Vertex

Vertex creates new possibilities in medicine. Our team aims to discover, develop and commercialize innovative therapies so people with serious diseases can lead better lives. Vertex scientists and our collaborators are working on new medicines to cure or significantly advance the treatment of hepatitis C, cystic fibrosis, epilepsy and other life-threatening diseases. Founded more than 20 years ago in Cambridge, MA, we now have ongoing worldwide research programs and sites in the U.S., U.K. and Canada.

About Vertex in Canada


In 2009, Vertex established a research and development site in Laval, Quebec through the acquisition of Virochem Pharma, Inc. Vertex is expanding its existing research and development infrastructure with the addition of commercial and medical teams to support the potential launch of telaprevir in Canada.

For more information and to view Vertex's press releases, please visit www.vrtx.com.

1/25/11

Source
Vertex Pharmaceuticals. U.S. FDA and Health Canada Grant Priority Reviews for Telaprevir for the Treatment of Hepatitis C. Press release. January 20, 2011.


 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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