Week of July 23, 2012: Amicus Therapeutics, GSK Expand Fabry Pact; US District Court Rules in Favor of Pfizer, Northwestern University in Lyrica Patent Case; and More

Jul 26, 2012
By Pharmaceutical Technology Editors

Amicus Therapeutics and GlaxoSmithKline (GSK) have agreed to expand the companies’ collaboration to develop and commercialize the investigational pharmacological chaperone migalastat HCl for treating Fabry disease. Under the expansion agreement, Amicus will commercialize all formulations of migalastat HCl in the US, while GSK will commercialize in the rest of the world. Amicus and GSK will continue to share R&D costs for all formulations of migalastat HCl, with Amicus funding 25% and GSK funding 75% of these costs for monotherapy and coadministration during the remainder of 2012. Amicus and GSK will be responsible for 40% and 60% of these costs, respectively, for coformulation immediately and for all formulations in 2013 and beyond. GSK will make an $18.6-million equity investment in Amicus, bringing GSK's total ownership stake in Amicus to 19.9%. GSK will purchase approximately 2.95 million shares of common stock at $6.30 per share, a 7% premium over the 15-day average closing sale price of Amicus’s common stock as reported by Nasdaq. Read More

Pfizer reported that the US District Court for the District of Delaware has ruled in favor of Pfizer and Northwestern University in the Lyrica patent-expiration case. Under the decision, Pfizer will exclusively provide pregabalin as Lyrica to patients through Dec. 30, 2018 in the US, pending generic company appeal and further litigation. Read More

Synergy Pharmaceuticals, a biopharmaceutical company, has agreed to acquire the development-stage biopharmaceutical company Callisto Pharmaceuticals. Under the merger agreement, the outstanding shares of Callisto common stock will be exchanged for 0.17 shares of Synergy common stock and the 22,295,000 shares of Synergy held by Callisto will be canceled. The transaction is expected to close by the end of October 2012. Read More

A roundup of additional company and people news from pharmaceutical and biopharmaceutical companies, their suppliers, and contract-service providers. Read More

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