|Aegerion CEO Mary Szela|
Aegerion Pharmaceuticals ($AEGR), which dumped controversial CEO Marc Beer last summer, has named industry veteran Mary Szela as its new chief executive.
Szela succeeds Sandford "Sandy" Smith, who took over as interim CEO when Aegerion investors pushed out Beer after he got into trouble with the FDA for speaking too freely on TV about the upside of his company's lead drug. Smith was named chairman of the board so he can "continue to work closely with the management team to maintain the momentum on key company initiatives," the company said in a statement.
Szela, who stepped down as CEO of biotech Melinta Therapeutics in September, said in an interview today with FiercePharma, that while Cambridge, MA-based Aegerion has had "historical challenges," she was impressed by the board's vision and the management's commitment to making it a best-in-class rare disease drug company.
"When I looked at the company and I looked at the challenges, not all companies have solvable challenges. These are all solvable challenges," Szela said.
One of the biggest challenges for the Cambridge, MA-based company is to decide where to go with the he company's two orphan drugs. Juxtapid was approved by the FDA in 2012 to treat patients with homozygous familial hypercholesterolemia (HoFH), a rare inherited condition that makes the body unable to remove LDL cholesterol, leaving sufferers with abnormally high levels of bad cholesterol circulating LDL cholesterol. The other, Myalept, was approved by the FDA in 2014 to treat generalized lipodystrophy, a condition associated with a lack of fat tissue.
But Juxtapid, which generated $58.8 million of the company's $67.3 million in the third quarter sales, has been somewhat eclipsed by the advent of the new PCSK9 cholesterol fighters, Praluent from Sanofi ($SNY) and Regeneron ($REGN) and Repatha from Amgen ($AMGN). Szela says her experience in the "lipid space" when she was an Abbott ($ABT) executive tells her the lead product "still has a meaningful role in the market." The company is focused on determining the appropriate patient population and "where the unmet need is."
First, Szela is headed to the JP Morgan Healthcare Conference in San Francisco next week where she will listen to the concerns and get input from stakeholders and investors. It was investors who were the force behind pushing out Beer last summer. The company got nailed by the FDA with a warning letter in late 2013 for Beer exaggerating the benefits of its cholesterol-lowering drug during a television appearance on CNBC's "Fast Money" program. Then things got worse. The company got a subpoena from the Department of Justice seeking info about marketing the company had done.
The FDA's approval of Juxtapid was based on data showing that the pill lowers cholesterol levels in patients with a rare genetic disease, familial homozygous hypercholesterolemia. But the study didn't prove the drug actually lowered the risk of heart attack or death. Among the comments the FDA highlighted from Beer was this: "These patients are going to die of a cardiac event, either a stroke or a heart attack, if we don't have them on therapy."
The company resolved its issues with the FDA but some investors were not happy that those corrective actions had not included getting rid of Beer. Last year, Sarissa Capital, run by former Carl Icahn associate Alex Denner, disclosed a 5.8% stake in Aegerion and began agitating for changes. The investment firm dropped its threat of a proxy fight after being granted a board seat and a promise of working with the company to improve its value. Shortly after, Beer was out.
When Szela returns from San Francisco, she says the company's focus for the next three months will be to determine whether, in light of the new competition from PCSK9s, to "continue programs that have already started or brainstorm and manage where we can go."
- here's the release