July 21, 2016
By Alex Keown, BioSpace.com Breaking News Staff
CAMBRIDGE, Mass. – Aegerion Pharmaceuticals continues to struggle as it moves to merge with QLT, Inc. and has announced that not only will it withdraw its high cholesterol drug lomitapide from the European Union and other global markets, the company will also slash another 13 percent of its workforce.
Aegerion said the decision to withdraw the drug from those markets and the termination of more employees, about 25 this time, are part of a broad cost reduction program as the company deals with increased competitiveness to sales of Juxtapid. Juxtapid is used to treat homozygous familial hypercholesterolemia (HoFH), high cholesterol caused by a rare genetic mutation. The drug has an annual price tag of $295,000. It faces stiff competition from the recently approved Praluent, co-developed by Sanofi and Regeneron , which has a lower price tag of $14,600. Amgen ’s injectable anti-cholesterol drug, Repatha, has an even smaller price point of $14,600 per year.
Earlier this year the company terminated 25 percent of its workforce, which brings total reduction to nearly 40 percent.
The cost-cutting strategy comes about a month after Aegerion agreed to become a wholly-owned subsidiary of Vancouver-based QLT Inc. The newly formed company will do business as Novelion Therapeutics, with Aegerion’s Chief Executive Officer Mary Szela helming the new company.
With the withdrawal of the lipid-lowering high cholesterol drug, Aegerion said it was looking to evaluate any strategies moving forward, including divesting itself of lomitapide. The company said it was looking for a potential buyer “that can continue to provide access to the therapy” for Homozygous Familial Hypercholesterolemi (HoFH) patients in need.
Szela said the company is taking the strategy with lomitapide due to pricing and reimbursement issues in the European Union.
“…after significant time and investment to obtain pricing and reimbursement approvals in these regions, with limited success, we feel we have exhausted these efforts and must reprioritize our resources,” Szela said in a statement.Szela said the company continues to believe lomitapide is an important treatment option for adult HoFH patients globally and plans to continue efforts to provide the drug in other regions, including the United States, Brazil and Japan, as soon as they receive marketing approval.
Although Aegerion has withdrawn some of its presence in the EU, it will continue to maintain enough to support the launch of Myalept, an injectable to treat complications of leptin deficiency expected to be approved for use in Europe next year. Myalept was approved for use in the U.S. by the U.S. Food and Drug Administration in 2014.
“Our focus on other initiatives, including the expansion of MYALEPT globally and into additional indications, is unwavering,” Szela said.
With the headcount reduction and the withdrawal of lomitapide from the EU, Aegerion said it anticipates to reduce 2017 operating expenses by between $25 and $35 million.
The terminations are expected to be completed by the end of the third quarter and the withdrawal of lomitapide by the end of 2016, Aegerion said.
Shares of Aegerion are up this morning, trading at $1.59 per share. The stock has fallen dramatically since this same time last year, when it was trading at $20.06 per share on July 25, 2015.
