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
AIG reported a plunge in second-quarter profit, hurt by a decline at its insurance business, debt-related losses and lower gains from the sale of investments. However, its earnings topped Street estimates, partly on contribution from aircraft leasing giant AerCap. AIG also announced a boost in dividend and said it would buyback an additional $5 billion stock. Automakers on Monday reported strong U.S. vehicle sales for the month of July, driven by continued demand for trucks and sport-utility vehicles amid an improving economy, lower gas prices and easy availability of credit. Detroit's Big Three - General Motors Co., Ford Motor Co. and FCA US, LLC - all reported vehicle sales above analyst expectations. British lender Lloyds Banking Group Plc. Friday reported higher profit in its first half, benefited by increased net interest income and margin as well as lower impairment. Looking ahead, the company lifted its net interest margin forecast.
comments powered by Disqus
Follow RTT