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Hologic Receives Approval for Premature Birth Drug

From Associated Press (February 4, 2011)

BEDFORD, Mass. -- A drug from Hologic Inc. designed to prevent premature birth was approved by federal regulators, the company said Friday, but ongoing studies will be required.

Makena, previously called Gestiva, has faced years of delays at the U.S. Food and Drug Administration. The agency issued an "approvable" letter for the drug in October 2006, but again delayed a decision in January 2009 with a request for more information.

Makena is intended for use by women who have experienced spontaneous premature birth before.

The FDA said Friday that Hologic must do additional studies to demonstrate that the drug has a "clinical benefit," under the accelerated approval process. An international trial is ongoing to learn if there is also improvement in the outcome of babies born to women given the drug.

Under a deal with Bridgeton, Mo.-based KV Pharmaceutical Co., Hologic will begin transferring assets for Makena. That transfer is expected to be complete by Feb. 11.

Hologic has already received $79.5 million in cash payments from KV, plus reimbursements. It expects to receive an additional $12.5 million payment.


Posted: February 2011