Aegerion Pharmaceuticals has signed an agreement to acquire an orphan product Myalept (metreleptin for injection) from AstraZeneca.
AstraZeneca will receive $325m upfront payment to divest the rights to develop, manufacture and commercialise Myalept, subject to an existing distributor license with Shionogi covering Japan, South Korea, and Taiwan.
Myalept is indicated to treat complications of leptin deficiency in patients with generalised lipodystrophy.
AstraZeneca global product and portfolio strategy executive vice-president Luke Miels said: “Generalised lipodystrophy is a rare condition with significant unmet medical need that can impact every aspect of a patient’s health.
Myalept is the first therapy to provide a real option for treating complications of this disease, and we are pleased that patients will benefit from its progress under Aegerion as a company with expertise in rare diseases.”
Known to be the first and only product approved in the US to treat generalised lipodystrophy, the drug has orphan drug designation in the US, EU, and Japan.
“Myalept is indicated to treat complications of leptin deficiency in patients with generalised lipodystrophy.”
According to AstraZeneca, Myalept is a recombinant analogue 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.
Aegerion Pharmaceuticals CEO Marc Beer said: “The therapeutic profile of Myalept is ideally aligned with Aegerion’s commitment to bring innovative therapies to patients with rare diseases.”
The deal will not include the transfer of any AstraZeneca employees or facilities and the transaction is expected to be completed in January 2015. It is subject to closing conditions, including the receipt of antitrust clearance from US Federal Trade Commission.
Generalised lipodystrophy consists of a rare set of syndromes, which are inherited or acquired through an autoimmune response and are characterised by loss of fat tissue, typically from under the skin.
