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
Lab equipment maker Thermo Fisher Scientific Inc. has agreed to acquire electron microscope maker FEI Co. for about $4.2 billion in cash, the two companies said Friday. Thermo Fisher noted that FEI's electron microscopy platform will complement its own mass spectrometry systems to accelerate advancements in structural biology. While reporting a wider loss for the first quarter, Sears Holdings Corp. said it has decided to "aggressively evaluate" all potential alternatives for its top brands - Kenmore, Craftsman and DieHard or KCD, and the Sears Home Services or SHS businesses. Sears has retained Citigroup Global Markets and LionTree Advisors to assist in its efforts. Philips Lighting, the splinter group of Dutch consumer electronics giant Philips, saw its shares rally around 8.50 percent on its debut on Friday at the Amsterdam stock exchange. The shares are currently at 21.70 euros, above its set pricing of 20 euros per share.
comments powered by Disqus
Follow RTT