AstraZeneca has entered into a definitive agreement with Aegerion Pharmaceuticals, Inc. to divest Myalept™ (metreleptin for injection), an orphan product that is indicated to treat complications of leptin deficiency in patients with generalized lipodystrophy.
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 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 generalized lipodystrophy.
Under the terms of 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.
Luke Miels, Executive Vice President, Global Product and Portfolio Strategy, AstraZeneca, said: “Generalized 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. The divestment of Myalept reinforces our focus on core strategic priorities and will allow us to concentrate our resources on disease areas where we can make the biggest difference to patients.”
Marc Beer, Chief Executive Officer at Aegerion, said: “The therapeutic profile of Myalept is ideally aligned with Aegerion’s commitment to bring innovative therapies to patients with rare diseases. We plan to apply our team’s first-hand experience in bringing a novel therapy for a rare dyslipidaemia to patients who have previously had no therapeutic alternatives. We expect the Myalept business to be highly synergistic with our current operations.”
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 complete in January 2015.