Oscient Pharmaceuticals Corp. (OSCI) Message Board

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Biotech / Medical : Oscient Pharmaceuticals Corp. (OSCI)

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From: mlkr	6/22/2009 7:27:24 PM
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Only 022.. looked like halted AH.. Rumors.. At bottom for sure.. Credit repayment is an issue.. MA based manufacturer.. FACTIVE was not withdrawn, rather, Menarini withdrew. See the filing below: phx.corporate-ir.net. ITEM 8.01. OTHER EVENTS. On June 17, 2009, Oscient Pharmaceuticals Corporation’s (the “Company”) sublicensee Menarini International Operations Luxembourg S.A. (“Menarini”) voluntarily withdrew its application to the European Medicines Agency (EMEA) seeking Marketing Authorization of FACTIVE® (gemifloxacin mesylate) Tablets for the treatment of Community Acquired Pneumonia (CAP) of mild to moderate severity, and for Acute Exacerbation of Chronic Bronchitis (AECB). Menarini indicated that its decision to withdraw the application for Marketing Authorization was based on the view of the Committee for Medicinal Products for Human Use (CHMP) that the data submitted does not allow the CHMP to conclude a positive risk-benefit balance in support of the use of FACTIVE for the proposed indications at this time. The Company entered into a License, Supply and Marketing Agreement with Menarini dated December 28, 2006, whereby the Company sublicensed its rights to sell FACTIVE tablets in the European Union to Menarini. That agreement may be terminated by either party upon the occurrence of certain termination events, which include Menarini’s right to terminate if the European regulatory authorities do not recommend approval of FACTIVE at various stages of the approval process with a package insert, or label, that meets certain requirements as to the safety, dosing and indications for which FACTIVE may be prescribed.

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