Recently, Regeneron Pharmaceuticals, Inc. (REGN) and partner Sanofi (SNY) announced that their oncology candidate Zaltrap (aflibercept) will be reviewed on a priority basis by the US Food and Drug Administration (:FDA). A decision from the US regulatory body is expected in the third quarter of 2012 (target date: August 4, 2012).
We note that the US regulatory authority generally reviews those drugs on a priority basis, which offer major advances in treating diseases that do not have adequate therapy. Applications for priority review designated drugs are reviewed by the FDA within six months of submission as against the usual ten months.
Regeneron and Sanofi are looking to get Zaltrap approved in the US for treating previously treated patients suffering from metastatic colorectal cancer. The FDA accepted the new drug application (:NDA) for Zaltrap for the indication on the basis of encouraging data from a phase III study (n=1,226: VELOUR) presented in June 2011.
Zaltrap’s approval would be a major boost for Regeneron - the metastatic colorectal cancer market represents significant commercial opportunity.
However, Regeneron/Sanofi suffered a setback with Zaltrap performing disappointingly in a late-stage study (n=1,224: VENICE). The study evaluated the candidate (in conjunction with docetaxel and prednisone) as a first-line therapy in patients suffering from androgen-independent (hormone-refractory) metastatic prostate cancer. Results revealed that Zaltrap treatment did not result in improvement in overall survival compared to placebo plus the combination of docetaxel and prednisone. The companies are evaluating the result. Detailed results are expected to be presented at a medical conference shortly.
Zaltrap is also being evaluated in a phase II study (:AFFIRM) as a first-line therapy for patients suffering from metastatic colorectal cancer.
Currently, we have a Neutral stance on Regeneron in the long run. The company carries a Zacks #2 Rank (Buy rating) in the short run. We have a Neutral stance on Sanofi in the long run. Sanofi carries a Zacks #3 Rank (Hold rating) in the short run.Read the Full Research Report on REGN
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