AstraZeneca Sells Lipodystrophy Drug Myalept To Aegerion

AstraZeneca announced that it has agreed to divest its orphan drug Myalept (metreleptin for injection) to Aegerion Pharmaceuticals.

Myalept is a recombinant human leptin analog indicated as an adjunct therapy to diet as replacement therapy for the treatment of leptin deficiency in patients with congenital or acquired generalized lipodystrophy. The drug is the first in the U.S. to receive approval in the indication.

Generalized lipodystrophy is an inherited or acquired condition that is characterized by the loss of fat tissue under the skin. Patients with the condition do not have enough liptin, which normally helps the body store triglycerides in normal fat deposits. Without the proper amount of liptin, however, generalized lipodystrophy often results in diabetes and an increased risk of acute pancreatitis and hepatic steatosis.

Luke Miels, EVP of Global Product and Portfolio Strategy at AstraZeneca, said that Aegerion’s expertise in rare diseases will benefit the further development of Myalept. “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… 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.”

According to the terms of the agreement, AstraZeneca will receive an upfront payment of $325 million from Aegerion. Aegerion will acquire the global rights to develop, produce, and market Myalept subject to a distributor license with Shionogi, which holds existing distributor rights to Japan, South Korea, and Taiwan. No employees or facilities will be transferred from AstraZeneca to Aegerion.

Marc Beer, CEO of Aegerion, said that the drug’s therapeutic profile complements the company’s focus on rare diseases. “We plan to apply our team’s first-hand experience in bringing a novel therapy for a rare dyslipidemia to patients who have previously had no therapeutic alternatives. We expect the Myalept business to be highly synergistic with our current operations.”

The transaction is expected to be completed in January next year.