(VRTX) Vertex Pharmaceuticals Reports Positive Data

Vertex Pharmaceuticals Inc. (VRTX) reported positive data from a mid-stage trial on VX-509, which is being studied for the treatment of moderate to severe rheumatoid arthritis (RA). The 12-week study, which evaluated four doses of the candidate, met both the primary endpoints.

Data from the two highest dose (100 mg and 150 mg) treatment arms demonstrated significant improvement in the proportion of people who achieved at least a 20% improvement in the signs and symptoms of RA (ACR20), and a statistically significant improvement from baseline in Disease Activity Score 28 (DAS28), compared to placebo.

The study also met the secondary endpoints (ACR50 and ACR70) of achieving statistically significant responses compared to placebo.

On the basis of the data from the phase IIa study, Vertex Pharma plans to initiate a six-month phase IIb study, which will evaluate once-daily (QD) and twice-daily (BID) doses of VX-509 in combination with methotrexate, in patients suffering from RA.

We are pleased with this positive data and expect Vertex Pharma to continue performing well in future, riding on Incivek (telaprevir) sales and its strong pipeline. Last month, the Canadian regulatory body had approved Incivek for treating patients with genotype 1 chronic hepatitis C (HCV) with compensated liver disease, including cirrhosis (scarring of the liver).

Incivek was approved in the US in May 2011 for the treatment of HCV. Further, during the second quarter of 2011, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended the approval of Incivek in the European Union (EU) as a treatment for HCV. Partner Johnson & Johnson (JNJ) anticipates a response from the European regulatory body in the third quarter of 2011. Following the approval, Incivek will be marketed in the EU and certain other territories under the brand name Incivo.

The drug is to be used in combination with pegylated-interferon and ribavirin for the treatment of HCV in both treatment-naïve and treatment-failed patients.

Additionally, Vertex Pharma plans to submit a New Drug Application (NDA) to the US Food and Drug Administration (FDA) and a Marketing Authorization Application (MAA) to the EMA for VX-770 in October 2011. The company intends to seek approval of VX-770 for use in patients who are six years of age and older and have at least one copy of the G551D mutation in the CFTR gene.

We currently have a Neutral recommendation on Vertex Pharma. The stock carries a Zacks #3 Rank (Hold rating) in the short-run.

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