Advertisement Amgen submits biologics license application for FDA approval of denosumab - Pharmaceutical Business review
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Amgen submits biologics license application for FDA approval of denosumab

Amgen has announced the submission of a biologics license application with the FDA for denosumab, an investigational RANK ligand inhibitor.

EXACT’s total revenues increased due to strategic relationship with Genzyme Corp. Exact in January entered into an intellectual property transaction with Genzyme that generated $17.2 million in cash. The $17.2 million from Genzyme will be recognized as revenue over 20 quarters as a non-cash allocation.

Operating expenses of the company for the first quarter of 2009 were $4.9 million, compared to $2.7 million for the same period of 2006. The increase in operating expenses was determined by expenses associated with the Genzyme transaction, and by severance and stock-based compensation expenses related to the recently announced senior management changes.

The company ended the first quarter of 2009 with cash, cash equivalents and marketable securities of $20.6 million, compared to $4.9 million at December 31, 2008. The increase was due to a $17.2 million increase in deferred revenue associated with the Genzyme transaction.

“We are excited about setting a new strategic direction for Exact Sciences, one focused on simultaneously creating value for both patients and shareholders,” said Kevin T. Conroy, president and chief executive of the company, “We have a straight shot to achieving our strategic goals and creating shareholder value by focusing intently on product development and clinical trial preparation.”