Tags: pulmonary arterial hypertension | predecessor | FDA approvals | lung drug

FDA Approves Lung Drug With Fewer Side Effects

Monday, 21 Oct 2013 12:48 PM


Actelion Ltd. (ATLN) rose the most in more than 17 months after winning U.S. approval for the lung drug Opsumit, giving the Swiss company a successor to a best-selling medicine that loses patent protection in late 2015.
Opsumit, also known as macitentan, won approval from the Food and Drug Administration as a once-daily pill for the treatment of pulmonary arterial hypertension, the agency said Oct. 18 in a statement. The agency didn’t require a “black-box warning” that the drug may cause liver damage.
 “The absence of a black box warning on Opsumit’s label for liver toxicity and no mandated liver function tests should drive the shares to outperform today,” Peter Welford, an analyst at Jefferies International Ltd., wrote in a report.
The approval may revive interest in Actelion as a takeover target, Andrew Weiss, an analyst at Bank Vontobel AG, said in a report today. Actelion Chief Executive Officer Jean-Paul Clozel bet the future of the company he co-founded on Opsumit, including fighting off a hedge fund that sought seats on the board and wanted the company to consider selling itself in 2011.
Actelion rose 7 percent to 69.15 Swiss francs at 9:21 a.m. in Zurich. The stock gained as much as 8.2 percent, the biggest intraday advance since April 30, 2012. Actelion returned 51 percent this year through Oct. 18, compared with a 20 percent return for the Bloomberg Europe Pharmaceutical Index.
Sales of the drug will reach about 996 million francs ($1.1 billion) in 2017, according to the average of six analyst estimates compiled by Bloomberg.
Opsumit Availability
The company’s current top seller, Tracleer, had sales of 1.5 billion francs last year, accounting for 87 percent of revenue. The drug has been losing market share to Gilead Sciences Inc. (GILD)’s Letairis, after the FDA allowed the Foster City, California-based company to remove a reference to the risk of liver damage from the drug’s label in 2011.
Similar to other members of its class, Opsumit will carry a warning that it shouldn’t be used by people who are pregnant, the FDA said.
Physicians are advised to measure signs of liver damage prior to initiation of Opsumit and repeat during treatment as clinically indicated, Actelion said in a statement. Opsumit will be available to U.S. patients next month, the company said.
Actelion will hold a conference call with analysts at 2 p.m. Zurich time to discuss the approval.
GlaxoSmithKline Plc (GSK) sells Letairis outside the U.S. under the brand name Volibris. Tracleer’s U.S. patent expires in November 2015, and in Europe it may face generic competition from the first half of 2017.
Drugs Class
Opsumit, Tracleer and Letairis belong to a class of drugs called endothelin receptor antagonists that are designed to treat pulmonary arterial hypertension, an incurable disease in which the arteries that carry blood from the heart to the lungs narrow, making the heart work harder and causing elevated blood pressure. That causes symptoms such as chest pain, dizziness and shortness of breath. The disease affects from 1 in 100,000 people to 1 in 1 million people, according to the American Lung Association.
 

© Copyright 2017 Bloomberg News. All rights reserved.

   
1Like our page
2Share
Health-News
Actelion Ltd. (ATLN) rose the most in more than 17 months after winning U.S. approval for the lung drug Opsumit, giving the Swiss company a successor to a best-selling medicine that loses patent protection in late 2015. Opsumit, also known as macitentan, won approval from...
pulmonary arterial hypertension,predecessor,FDA approvals,lung drug
516
2013-48-21
Monday, 21 Oct 2013 12:48 PM
Newsmax Inc.
 

The information presented on this website is not intended as specific medical advice and is not a substitute for professional medical treatment or diagnosis. Read Newsmax Terms and Conditions of Service.

Newsmax, Moneynews, Newsmax Health, and Independent. American. are registered trademarks of Newsmax Media, Inc. Newsmax TV, and Newsmax World are trademarks of Newsmax Media, Inc.

NEWSMAX.COM
© Newsmax Media, Inc.
All Rights Reserved