Actelion Says Hypertension Drug Macitentan Met Primary Goals In Pivotal Study

4/30/2012 3:44 AM ET

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.

To receive FREE breaking news email alerts for Actelion Ltd., and others in your portfolio

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

More Breaking News

<<Previous 51 Articles

Editors Pick

Fed Concerns Contribute To Lackluster Session On Wall Street - U.S. Commentary

There was a mixed performance on Wall Street on Friday. Shares suffered an early decline, as investors continued to express worries about the Federal Reserve. A recovery through the rest of the day allowed the Dow to edge into positive territory by the close. The Nasdaq and S&P 500 posted fractional losses.

Stocks Come Under Pressure Amid Worries About The Fed - U.S. Commentary

Stocks have shown a notable move to the downside in early trading on Friday amid lingering concerns about the outlook for the Federal Reserve's asset purchase program. The major averages have slid firmly into negative territory, adding to the modest losses posted in the previous session. The major averages are currently posting notable losses, near their lows for the young session.

U.S. Durable Goods Orders Rise 3.3% In April, More Than Expected

After reporting a sharp drop in new orders for manufactured durable goods in the previous month, the Commerce Department released a report on Friday showing that durable goods orders rebounded by more than anticipated in the month of April. The report said durable goods orders surged up by 3.3 percent in April after tumbling by a revised 5.9 percent in March.