AstraZeneca To Divest Orphan Drug to AegerionBy
AstraZeneca has entered into a definitive agreement with Aegerion Pharmaceuticals, Inc., a biopharmaceutical company focused on developing drugs to treat rare diseases, to divest Myalept (metreleptin for injection), an orphan product that is indicated to treat complications of leptin deficiency in patients with generalized lipodystrophy.
Under the agreement, Aegerion will pay AstraZeneca $325 million upfront to acquire the global rights to develop, manufacture, and commercialize Myalept, subject to an existing distributor license with Shionogi covering Japan, South Korea, and Taiwan. The transaction does not include the transfer of any AstraZeneca employees or facilities.
AstraZeneca acquired Myalept earlier this year from Bristol-Myers Squibb as part of AstraZeneca’s acquisition of its diabetes alliance with Bristol-Myers Squibb, including Myalept, and Amylin Pharmaceuticals, which was completed on February 1, 2014. Myalept was approved by the US Food and Drug Administration earlier this year in February. Myalept is the first and only product approved in the US for the treatment of generalized lipodystrophy and it has orphan drug designation in the US, EU, and Japan. Myalept is a recombinant analog of human leptin, indicated in the US as an adjunct to diet as replacement therapy to treat the complications of leptin deficiency in patients with congenital or acquired generalised lipodystrophy.
The divestment transaction is subject to closing conditions, including the receipt of antitrust clearance from the US Federal Trade Commission. The companies expect the transaction to be completed in January 2015.