More woe for Aegerion as ax swings again; withdraws Juxtapid from EU

CEO Mary Szela

It’s been a torrid first half for Aegerion Pharmaceuticals ($AEGR) that began the year with a 25% cut to its staff, but the biotech is swinging the ax again--this time to a further 13% of its workers.

And that’s not all as the company, now run by new CEO Mary Szela after its former chief Marc Beers quit last year, is also withdrawing its troubled homozygous familial hypercholesterolemia (HoFH) drug Juxtapid (lomitapide) from a host of markets outside of the U.S., including the European Union.

Juxtapid gained FDA approval back in 2012 and an EMA green light a year later (under the name Lojuxta), but has failed to gain a strong sales trajectory and will only come under increasing pressure from rival drugs, namely the new class of PCSK9 inhibitors.

It will keep its drug on the market in the U.S., but will yank it out of the EU. “Aegerion intends to evaluate its strategic options, including divestiture or licensing of Aegerion’s rights to lomitapide to a partner that can continue to provide access to the therapy for HoFH patients in need,” the Cambridge, MA-based biotech said in a statement.  

Unless it can find someone willing to take the drug on, Lojuxta will be gone from Europe by the end of the year.

The biotech added: “This revised lomitapide strategy and reduction in force are part of a broad cost reduction program taken by Aegerion in response to the continuing impact of competitive therapies on Juxtapid. The goals of the program are to significantly reduce operating expenses, extend the company’s cash position, and facilitate cash generation from operations in 2017.”

But it added that it will “maintain certain infrastructure in the EU” to support the launch of Myalept (metreleptin for injection) on the continent, ahead of an anticipated approval next year. The FDA gave it the green light back in 2014.

The drug treats congenital generalized or acquired generalized lipodystrophy, a condition associated with a lack of fat tissue. Aegerion bought the rights to Myalept from AstraZeneca ($AZN) two years ago, paying $325 million upfront.

The company is also in the middle of a merger deal with Vancouver-based QLT ($QLTI)--which should go through in the second half of this year--that will combine to create a new biotech to be known as Novelion.

Under the terms of the deal, QLT shareholders will own the lion’s share of the stock, with Szela at the helm.

Szela, who was responsible for cutting the 80 staffers back in February, said: “We are making difficult but necessary decisions to realign our business with the goal to position the company for future growth and financial strength. … We are disappointed to announce that we intend to withdraw lomitapide from these markets, but 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.”

She said the company still believes that Juxtapid is “an important treatment option” for HoFH patients globally, adding that she plans to continue its marketing efforts in the U.S., Brazil and, should it gain approval, in Japan.

The changes are geared toward cutting down its 2017 operating expenses by around $25 million to $35 million. The staffers losing their jobs will be out by the third quarter of 2016, the company said.

Aegerion ended the day 3.38% up yesterday.

- check out the release

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