logo
Share SHARE
FONT-SIZE Plus   Neg

Actelion Says Hypertension Drug Macitentan Met Primary Goals In Pivotal Study

Swiss pharmaceutical firm Actelion Ltd. (ALIOF.PK) Monday announced its drug macitentan, intended to treat pulmonary arterial hypertension, met primary endpoint in a pivotal phase 3 study. Treatment with macitentan in the study, dubbed SERAPHIN, was well tolerated. The company's shares rose more than 18 percent in Zurich.

Lewis Rubin, M.D., Emeritus Professor, University of California, San Diego and Senior Advisor on the study stated, "With this well-designed PAH study, Actelion pursued an ambitious goal to focus on outcome benefits as the primary endpoint. The impressive results of this landmark study are setting a new standard in how to conduct studies in this devastating disease."

Macitentan is a novel dual endothelin receptor antagonist. According to the company, the long-term, event-driven study was conducted in 742 patients suffering from PAH (pulmonary arterial hypertension), who were treated for up to three and a half years.

Macitentan in both 3 mg and 10 mg dosage decreased the risk of a morbidity/mortality event over the treatment period compared to placebo.

Jean-Paul Clozel, M.D. and chief executive officer of the company said, "We are committed to working with the Health Authorities to bring this potentially important advancement in PAH to patients as soon as possible. Submission of the registration dossier to Health Authorities worldwide is expected by the fourth quarter of 2012."

The study was conducted in 151 centers from almost 40 countries in North and Latin America, Europe, Asia-Pacific and Africa.

Macitentan is also investigated in a pivotal Phase III program in patients with ischemic digital ulcers associated with systemic sclerosis. In addition, a Phase I/Ib open-label study was initiated with macitentan in patients with recurring glioblastoma, Actelion noted.

In Zurich, Actelion shares are currently trading at 40.05 francs, up 6.25 francs or 18.49 percent, on a volume of 1.13 million shares.

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Editors Pick
Walt Disney Co. (DIS) is reportedly in talks to buy a stake in Major League Baseball Advanced Media. According to LA Times, citing people with knowledge of the matter, Disney is seeking to acquire one-third interest in the MLB.com, which develops and manages the league's digital products. The deal... Postal Savings Bank of China, one of the biggest banks in China, seeks to raise about $8 billion in an initial public offering, which could be the biggest IPO of the year. Postal Savings Bank of China plans to list its stock in the Hong Kong stock exchange. According to reports, the Postal Savings... Sporting goods retailer Dick's Sporting Goods, Inc. has emerged as the successful bidder in the bankruptcy auction for its former rival Sports Authority Holding Inc.'s intellectual property assets and the right to acquire 31 store leases.
comments powered by Disqus
Follow RTT