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Vertex Acquires VCH-222 and VCH-759, Two Experimental Oral HCV Polymerase Inhibitors

As the experimental HCV protease inhibitor telaprevir from Vertex continues to show promise in clinical studies, the company recently announced that it will buy Canada's ViroChem Pharma for $100 million in cash and $275 million in stock. This acquisition will provide Vertex with access to 2 novel oral HCV polymerase inhibitors for clinical development.

As with telaprevir and other specifically targeted anti-HCV agents (known as "STAT-C"), these 2 drugs would likely be used as part of combination treatment regimens. Vertex plans to file an NDA for telaprevir in the second half of 2010, assuming successful completion of its ongoing Phase 3 program.

Following are edited excerpts from a Vertex press announcement of its acquisition of VCH-222 and VCH-759 and how it expects to move forward with its portfolio of pipeline drugs for the treatment of chronic hepatitis C.

Vertex Pharmaceuticals Strengthens HCV Drug Development Portfolio, Adds Novel Polymerase Inhibitors to Shape New Combinations with Telaprevir

Vertex to acquire privately-held ViroChem Pharma in cash and stock transaction -- Two HCV polymerase inhibitors, VCH-222 and VCH-759, have demonstrated significant antiviral activity in early clinical trials -- First STAT-C combination trial with telaprevir planned for 2H 2009 start.

Cambridge, Mass. & Laval, Quebec -- March 3, 2009 -- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX), which is developing the hepatitis C virus (HCV) protease inhibitor telaprevir, will add two polymerase inhibitors to its HCV drug development portfolio through a definitive agreement to acquire privately-held ViroChem Pharma Inc. in a stock and cash transaction. With the addition of these compounds, Vertex will advance its strategy to pursue novel combinations of Specifically Targeted Antiviral Therapies for hepatitis C (STAT-Cs) for the treatment of HCV infection.

Following completion of the transaction, Vertex will own worldwide rights to ViroChem's HCV drug development portfolio, including VCH-222 and VCH-759, which have demonstrated substantial reductions in plasma HCV RNA when dosed as single agents and have been well-tolerated in clinical studies to date. In particular, VCH-222 dosed as 750 mg twice daily resulted in a median 3.7 log10 decrease in HCV RNA at the end of dosing in a three-day viral kinetic study, representing the most substantial reduction in viral load reported to date with an investigational HCV polymerase inhibitor dosed as a single agent. Vertex expects to begin clinical evaluation of novel combination regimens of its HCV protease inhibitor telaprevir, currently in Phase 3 clinical development, in the second half of 2009. The transaction is subject to customary pre-closing conditions.

"This acquisition significantly strengthens our pipeline in hepatitis C by bringing together Vertex's telaprevir, our HCV protease inhibitor in registration studies, with the HCV non-nucleoside polymerase inhibitors being developed by ViroChem," said Joshua Boger, PhD, Chief Executive Officer of Vertex. "Through this acquisition, we're well positioned as a leader in the development of HCV therapies. Our goal is to further advance HCV care for patients through the creation of novel and highly potent STAT-C combination regimens."

"This move expands Vertex's global presence in HCV and has the potential to enhance the profile and lifecycle of our telaprevir-based combination regimens. We believe it strengthens our ability to compete and stay at the forefront in developing novel STAT-C combination regimens," added Kurt C. Graves, Executive Vice President, Chief Commercial Officer and Head, Strategic Development at Vertex. "We selected ViroChem's compounds following careful evaluation of the STAT-C landscape for more than a year. Key data has emerged that suggest that these compounds could uniquely complement telaprevir and provide a foundation for shaping a potentially new treatment paradigm."

ViroChem HCV Drug Development Portfolio


Two ViroChem HCV polymerase inhibitors, VCH-222 and VCH-759, are currently in clinical development. ViroChem also has a preclinical program directed at the discovery of novel HCV NS5a inhibitors. The status and profile of each clinical compound is detailed below.

VCH-222: VCH-222 is an oral non-nucleoside inhibitor of the HCV NS5B polymerase that recently completed a viral kinetic study in HCV patients. In this study involving five treatment-naive genotype 1a and 1b HCV infected patients, VCH-222 dosed as 750 mg twice daily resulted in a median 3.7 log10 decrease in HCV RNA - equivalent to a 5,000-fold reduction in virus in the blood - at the end of three days of dosing. The results were consistent from patient to patient, and across HCV genotype 1 subtypes, and represent the most substantial reduction in viral load reported to date with an investigational HCV polymerase inhibitor dosed as a single agent. In clinical evaluations to date, VCH-222 has been well-tolerated, with no serious adverse events observed. VCH-222 has completed 28-day non-clinical toxicology studies in two species.

VCH-759: VCH-759 is an oral non-nucleoside inhibitor of the HCV NS5B polymerase that has completed Phase 1b clinical development. In a Phase 1b trial reported at a medical conference in 2007, VCH-759 dosed as 800 mg three times daily showed a mean maximal 2.5 log10 reduction in HCV RNA and a median 1.7 log10 reduction in HCV RNA at the end of 10 days. VCH-759 was also well-tolerated with no serious adverse events observed in clinical studies to date. VCH-759 has completed 28-day non-clinical toxicology studies.

Future clinical plans: Vertex plans to conduct additional dose-ranging studies of VCH-222 as a single agent and in combination with pegylated interferon and ribavirin. Vertex plans to initiate a first clinical study combining telaprevir with a ViroChem HCV polymerase inhibitor in the second half of 2009. Data from in vitro HCV replicon studies suggest that VCH-222 and VCH-759 may provide synergistic or additive antiviral activity to the HCV protease inhibitor telaprevir, thus creating the potential for a non-cross resistant, complementary profile in exploratory clinical studies.
 


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