Hologic, Inc. signed a definitive agreement to sell full US and worldwide rights of Gestiva to KV Pharmaceutical Company. However, Gestiva is awaiting New Drug Application (NDA) approval from the US Food and Drug Administration (FDA). Hence, the agreement would only be realised after the approval of the NDA by the federal regulators.
The development of Gestiva, (17-alpha hydroxyprogesterone caproate) a drug, if approved by FDA, which could be used in the prevention of preterm birth in pregnant women with a history of at least one spontaneous preterm birth, was originally begun by Adeza Biomedical Corporation, which was acquired by Cytyc Corporation on April 2, 2007. On October 22, 2007, Hologic completed its business combination transaction with Cytyc and as a result acquired all rights to Gestiva.
The purchase price to be paid to Hologic as a result of the transaction is $82 million in cash, $7.5 million of which is payable at the closing of the transaction and the balance of which is payable upon final approval by the FDA of the Gestiva NDA and the production of a quantity of Gestiva suitable to enable the commercial launch of the product. The closing of the transaction is expected to occur within 30 days after the satisfaction of customary closing conditions, including the expiration or termination of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976).
Jack Cumming, CEO, Hologic, said, "We are pleased to complete this transaction to sell the Gestiva product line to KV Pharmaceutical. We believe women worldwide will better realize the benefits of Gestiva coming from a dedicated pharmaceutical firm. This will also allow Hologic to remain focused in our primary fields of medical devices and cancer diagnostics for women."
Hologic, Inc. is a leading developer, manufacturer and supplier of premium diagnostics, medical imaging systems and surgical products dedicated to serving the healthcare needs of women.