MINYANVILLE ORIGINAL Aegerion Pharmaceuticals
(NASDAQ:AEGR) has won US approval
to sell a drug that treats a rare genetic condition linked to heart disease in young people.
Aegerion’s cholesterol-lowering capsule drug Juxtapid was approved by the Food and Drug Administration to help fight homozygous familial hypercholesterolemia
. It’s the first drug approved for the money-losing biotech company.
The medicine is aimed at a small patient population. Initially, Aegerion estimates about 3,000 patients in the US can be treated with the product, CEO Marc Beer says.
Beer told analysts on a conference call Monday morning that Juxtapid will be priced between $200,000 and $300,000 per patient per year. He noted that he was encouraged that insurers will pay for the drug as it addresses an unmet need for patients.
“These patients have new hope to reduce their cholesterol levels,” Beer says.
The drug will include warnings about potential side effects, including liver damage. Despite the safety issues, experts advisers to the FDA voted
13-2 in October to approve the treatment. (See also: Aegerion, Isis, Sanofi Make Case for Drugs to Treat Severe Cholesterol
Government advisers were split on another medicine developed by Isis Pharmaceuticals
(NASDAQ:ISIS) and Sanofi
(NYSE:SNY) during a separate review in October. The medicine, Kynamro, developed by those companies, was recommended
by an FDA panel on a 9-6 vote. Split decisions often bode poorly for a drug’s prospects for approval. The FDA is expected to rule on Kynamro next month. A panel that recommends drug approval to European regulators refused to back
the drug earlier this month due to safety concerns.
As part of Aegerion’s approval, the company agreed to a so-called risk evaluation and mitigation strategy for patients. The drug will be available through a restricted program.
Shares of Aegerion dropped 5% to $24.51 in morning trading Monday. The stock is still up 57% over the past three months. Shares of Isis fell 1% to $10.15 Monday morning. That stock declined 29% over the past three months. Sanofi’s US shares dropped less than 1% to $47.34. The French drug maker’s ADRs jumped 30% in the past six months. Sanofi gained the stake in Kynamro when it took over US-based Genzyme last year.
Juxtapid, also known as lomitapide, was originally owned by Bristol-Myers Squibb
(NYSE:BMY), which was trying to develop a cholesterol drug for a broader audience in the 1990s. After a high rate of gastrointestinal side effects, the drug program was scrapped. Bristol-Myers donated the experimental drug to a University of Pennsylvania doctor, Daniel Rader, in 2003. Three years later, Aegerion licensed the drug from the university.
No positions in stocks mentioned.
The information on this website solely reflects the analysis of or opinion about the performance of securities and financial markets by the writers whose articles appear on the site. The views expressed by the writers are not necessarily the views of Minyanville Media, Inc. or members of its management. Nothing contained on the website is intended to constitute a recommendation or advice addressed to an individual investor or category of investors to purchase, sell or hold any security, or to take any action with respect to the prospective movement of the securities markets or to solicit the purchase or sale of any security. Any investment decisions must be made by the reader either individually or in consultation with his or her investment professional. Minyanville writers and staff may trade or hold positions in securities that are discussed in articles appearing on the website. Writers of articles are required to disclose whether they have a position in any stock or fund discussed in an article, but are not permitted to disclose the size or direction of the position. Nothing on this website is intended to solicit business of any kind for a writer's business or fund. Minyanville management and staff as well as contributing writers will not respond to emails or other communications requesting investment advice.
Copyright 2011 Minyanville Media, Inc. All Rights Reserved.