is an edited excerpt of a press release issued by Vertex describing
the recent regulatory developments.
FDA and Health Canada Grant Priority Reviews for Telaprevir
for the Treatment of Hepatitis C
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
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.
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.
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
Vertex Pharmaceuticals. U.S. FDA and Health Canada Grant Priority
Reviews for Telaprevir for the Treatment of Hepatitis C. Press
release. January 20, 2011.