Date: 2014-11-06
Type of information: Product acquisition
Compound: Myalept™ (metreleptin for injection)
Company: AstraZeneca (UK) Aegerion Pharmaceuticals (USA - MA)
Therapeutic area: Metabolic diseases - Rare diseases
Type agreement: product acquisition
Action mechanism: peptide. Myalept™ is a recombinant analogue of human peptidic hormone 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.
Disease: leptin deficiency in patients with generalised lipodystrophy
Details: * On November 6, 2014, AstraZeneca announced that it has entered into a definitive agreement with Aegerion Pharmaceuticals to divest Myalept™ (metreleptin for injection), an orphan product that is indicated to treat complications of leptin deficiency in patients with 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 complete in January 2015. Luke Miels, Executive Vice President, Global Product and Portfolio Strategy, AstraZeneca, 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. 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.”
Financial terms: Under the terms of the agreement, Aegerion will pay AstraZeneca $325 million upfront to acquire the global rights to develop, manufacture and commercialise Myalept, subject to an existing distributor licence with Shionogi covering Japan, South Korea, and Taiwan. The transaction does not include the transfer of any AstraZeneca employees or facilities.
Latest news: * On January 12, 2015, Aegerion Pharmaceuticals announced that it has completed the acquisition of Myalept® (metreleptin) for injection, an orphan drug product that is indicated to treat complications of leptin deficiency in patients with generalized lipodystrophy (GLD). Myalept® is approved in the United States for the treatment of GLD, and it has orphan drug designation in the United States, European Union and Japan.
