2010 will be a year of defining moments as Vertex evolves toward becoming a fully capable biopharmaceutical company.
In HCV, clinical data presented throughout 2009 provided further support for the potential future role of telaprevir, our lead hepatitis C virus (HCV) protease inhibitor, to improve patient care in HCV - a disease that is estimated to affect more than three million people in the U.S. We remain on track to submit a New Drug Application (NDA) for telaprevir in the second half of 2010 for both treatment-naïve and treatment-failure HCV patients. Importantly, we also recognize the need for continued innovation in the treatment of HCV, and an ongoing clinical trial combining telaprevir with VX-222, our lead HCV polymerase inhibitor, will help define the potential role that this combination regimen may play in the future treatment of this disease.
Beyond our development progress in HCV, Vertex also continues to build its commercial capabilities to support the potential launch of telaprevir and other drug candidates. The submission of the telaprevir NDA is but one of many critical steps toward ensuring the long-term success of our business. We have in place a highly experienced team charged with leading key pre-launch and commercialization activities, and we continue to make significant strides in our efforts to fully understand the disease areas where we expect to operate. We are well-positioned to advance our commercial infrastructure over the coming months, and I look forward to this function playing a prominent role within our growing business in 2010.
And while telaprevir may represent a potentially significant advance in the treatment of HCV, Vertex will not become the fully capable company that we envision based solely on the success of a single product.
We are also focused on advancing two novel compounds – VX-770 and VX-809 – for the treatment of cystic fibrosis (CF), a devastating genetic disease that robs patients of a normal lifespan. Unlike currently approved therapies, our approach to CF aims to directly treat the underlying defect of this orphan disease. A Phase 3 registration program is advancing rapidly for our lead CF compound VX-770, and we expect to submit an NDA in the second half of 2011 for CF patients with the G551D mutation. We are also evaluating the potential development path for a combination regimen with VX-770 and VX-809 in patients with the most common mutation of CF, known as F508del, potentially broadening the opportunity for our CF compounds to address the majority of CF patients.
To support our long-term growth, Vertex is also conducting clinical trials of VX-509, a novel, oral compound aimed at treating a key inflammatory pathway in rheumatoid arthritis, and VX-765, an innovative, oral approach to the treatment of epilepsy. These proof-of-concept trials will provide important information in 2010 to help us begin to define the potential value of these compounds to patients and to Vertex.
What truly excites me about Vertex is that our clinical development programs represent only a fraction of our broad interests across multiple disease areas. Vertex has some of the world’s leading scientists, and as a result, we currently have more than a dozen innovative preclinical programs ongoing in areas such as cancer, multiple sclerosis, pandemic influenza, Huntington’s disease and tuberculosis. These and other early-stage programs may lead to additional clinical development candidates emerging in 2010.
Today, Vertex is operating at a scale never before seen within our company. Our commitment to cutting-edge science and breakthrough products for patients with serious diseases is unwavering, and we continue to progress toward our goal of becoming a fully capable biopharmaceutical company.
I look forward to updating you as the year progresses. Thank you for your continued support of Vertex.
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