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EU Approves Shire's Vpriv For Gaucher Disease, As Shortages Of Genzyme's Rival Product Ease

This article was originally published in The Pink Sheet Daily

Executive Summary

Shire's Vpriv gains approval in 30 European countries for Gaucher disease, but competition from rival products looks set to increase.

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Shire Says Vpriv Is A Viable Option for Cerezyme Patients; Gets PDUFA For Firazyr

Firazyr could enjoy a dosing advantage over other HAE drugs currently on the U.S. marketplace if it can get approval from FDA.

Business News, In Brief

Vectibix disappoints in head and neck cancer: Amgen's anti-EGFR antibody Vectibix (panitumumab) failed to meet the primary endpoint in the Phase III SPECTRUM trial in head and neck cancer, the firm announced Aug. 11, but the disappointing trial results will have little impact - as most analysts expected only modest contributions to sales of the colorectal cancer drug. Adding Vectibix to platinum-based chemotherapy in patients with recurrent and/or metastatic squamous cell head and neck cancer did not result in a statistically significant improvement in overall survival compared to chemo alone: 11.1 months versus 9.0 months. There were numeric improvements in the secondary endpoints of progression-free survival (5.8 months vs. 4.6 months) and objective response rate (36 percent vs. 25 percent), but those were not tested for statistical significance. The study enrolled 658 patients. Full data will be presented at the European Society for Medical Oncology meeting in Milan in October. In an Aug. 11 note, Lazard analyst Joel Sendak noted that Vectibix would always have challenges in taking market share in head and neck cancer from Erbitux - though the lack of effect was "somewhat surprising" given that the two agents share the same mechanism of action. Sendak sees the most opportunity for Vectibix in front-line CRC, and the most opportunity for Amgen in the pending Prolia (denosumab)

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