AstraZeneca said today it agreed to sell its treatment for the rare disease generalized lipodystrophy Myalept™ (metreleptin for injection) to Aegerion Pharmaceuticals for $325 million-plus.
The deal came nine months after AstraZeneca acquired the drug as part of its up-to-$4.3 billion purchase of partner Bristol-Myers Squibb (BMS)’ interest in their global diabetes alliance, completed Febuary 1. BMS, in turn, inherited the drug when it acquired Amilyn Pharmaceuticals in 2012 for $5.3 billion.
Myalept is a recombinant analog of human leptin, indicated in the U.S. as an adjunct to diet as replacement therapy to treat the complications of leptin deficiency in patients with congenital or acquired generalized lipodystrophy.
Myalept is the first and only product approved in the U.S. for the treatment of generalized lipodystrophy, and has obtained orphan drug designations in the U.S., as well as the EU and Japan.
“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,” Luke Miels, AstraZeneca’s evp, global product and portfolio strategy, said in a statement.
Aegerion agreed to pay AstraZeneca $325 million upfront for global rights to develop, manufacture, and commercialize Myalept. Those rights are subject to an existing distributor license with Shionogi covering Japan, South Korea, and Taiwan.
No AstraZeneca employees or facilities will be transferred to Aegerion as part of the deal, which the companies expect will be completed in January 2015. The deal is subject to closing conditions, including antitrust clearance from the U.S. Federal Trade Commission.
Neither AstraZeneca’s announcement today, nor recent financial results announcements, disclosed how much the company has generated in sales from Myalept this year. That number would be part of the $387 million in product revenue generated by “others” products in the cardiovascular and metabolic disease category.
The AstraZeneca-BMS deal designated Myalept to have a “fair value” of $120 million, based on its then-status as a product under FDA registration, with an estimated useful life of 12 years.
The FDA approved the drug on Febuary 24 after awarding a Priority Review designation.
As is typical, FDA followed the recommendation of its Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC). In December 2013, it advised the agency to approve Myalept for its current indication—but not for an additional indication, treatment in patients with metabolic disorders associated with partial lipodystrophy. Back then, AstraZeneca and BMS said they remained committed to the additional indication.
The partial lipodystrophy indication would have accounted for most of the $300 million in annual sales projected for metreleptin by JP Morgan, according to news reports at the time.
In approving Myalept, FDA required AstraZeneca and BMS to conduct seven post-marketing studies, including a long-term prospective observational study (product exposure registry) of patients treated with Myalept, a study to assess for the immunogenicity (antibody formation) of Myalept, and an assessment and analysis of spontaneous reports of potential serious risks related to the use of Myalept. Eight additional studies were requested as post-marketing commitments, but not required.
Miels also said Aegerion was well-suited to continue development of Myalept given its focus on rare diseases. The company’s sole marketed product, Juxtapid (lomitapide), is designed to treat homozygous familial hypercholesterolemia by reducing low-density lipoprotein cholesterol, total cholesterol, apolipoprotein B, and non-high-density lipoprotein cholesterol.
AstraZeneca, by contrast, halved its core therapy areas last year to three, saying it would focus R&D efforts on cardiovascular & metabolic disease; oncology; and respiratory, inflammation & autoimmunity diseases.