Vertex Pharmaceuticals Incorporated Updates on Key 2010 Business Priorities

Vertex Pharmaceuticals Incorporated today provided an update on key 2010 business priorities in conjunction with the 28th Annual J.P. Morgan Healthcare Conference in San Francisco. The company also discussed recent progress in its lead development programs in hepatitis C virus (HCV) infection and cystic fibrosis (CF) and outlined proof-of-concept clinical trials planned in other serious diseases for 2010. According to Matthew Emmens, Chairman, President and Chief Executive Officer of Vertex, 2010 will be a defining year for Vertex as it seeks to evolve into a fully-capable biopharmaceutical company.

Key Takeaways:

Vertex is planning multiple proof-of-concept clinical trials in other diseases, such as rheumatoid arthritis and epilepsy, in addition to its ongoing Phase 3 programs in HCV infection and CF.
The company expects to submit a New Drug Application (NDA) for its lead drug candidate, telaprevir, in the second half of 2010 for both treatment-naive and treatment-failure patients with HCV infection.
Vertex is also preparing to initiate the first clinical trial combining telaprevir with the investigational HCV polymerase inhibitor VX-222 in the first quarter of 2010.
The company's Phase 3 registration program for telaprevir is nearing completion, with sustained viral response (SVR) data expected from the ADVANCE and ILLUMINATE trials in the second and third quarters of 2010, respectively.
Vertex is conducting mid-stage and late-stage development of two novel compounds aimed at addressing the underlying mechanism of cystic fibrosis.
The company's Phase 3 registration program for VX-770, a CFTR potentiator compound, is progressing, with the STRIVE trial having completed planned patient enrollment.
Vertex has successfully completed all registration campaigns as well as API validation campaigns for telaprevir and is preparing to complete drug product validation in advance of the potential launch of telaprevir.

Statistics:

More than 2,200 genotype 1 treatment-naive and treatment-failure patients with HCV infection are enrolled in the ADVANCE, ILLUMINATE, and REALIZE trials.
The C208 trial enrolled 161 treatment-naive patients with genotype 1 HCV infection and included the first SVR data for telaprevir-based regimens in treatment-naive patients as part of a response-guided therapy trial design.
Vertex has submitted the Study C208 clinical data to the U.S. FDA, and Vertex and Tibotec have initiated discussions with regulatory authorities in the U.S. and E.U. regarding future development plans for telaprevir as part of an every-12-hour (q12h) dosing regimen.
The company has assembled a global supply chain network to support the potential launch of telaprevir and is currently manufacturing telaprevir at a commercial (metric ton) scale.

Sources:

Vertex Pharmaceuticals Incorporated.
Hepatitis Weekly editors from staff and other reports.