logo
Plus   Neg
Share
Email
Comment

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
HP Inc. (HPQ), the PC and printer business of the former Hewlett-Packard Co., on Thursday reported a profit for the first quarter that increased from last year and trumped analysts' expectations driven largely by a higher-than-expected revenues. The PC giant detailed a second-quarter and full year... Hormel Foods Corp. (HRL) reported a profit for the first quarter of fiscal 2018 that increased 28.9 percent from the prior year. Total net sales grew 2.2 percent from last year. Earnings per share topped analysts' expectations, while quarterly revenues missed their estimates. The company raised annual earnings per share guidance due to U.S. tax reform, while it maintained annual net sales outlook. Shares of Deutsche Telekom AG were losing around 3 percent in the morning trading in Germany after the telecom giant reported Thursday a decline in fourth-quarter EBITDA, a key earnings metric, with weak revenues. However, the company recorded a net profit, compared to loss last year on positive US tax effect. Deutsche Telekom lifted its dividend and said it expects higher earnings in 2018.
comments powered by Disqus
Follow RTT