logo
Plus   Neg
Share
Email

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 RTTNews Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Editors Pick
The Boeing Company (BA) reported that its first-quarter core earnings per share increased to $3.64 from $2.17, prior year, reflecting strong performance across the company. Core operating earnings improved 35% year-over-year to $2.51 billion from $1.86 billion, previous year. GAAP earnings from operations increased 30% to $2.88 billion. Net earnings improved 57% year-over-year to $2.48 billion. Earnings per share was $4.15 compared to $2.54. Operating cash flow was $3.1 billion for the quarter. Micro-blogging site Twitter Inc. on Wednesday reported a turnaround to profit in the first quarter on strong double-digit revenue growth. This is the company's second quarterly profit. Both revenue and adjusted earnings per share beat analysts' estimates. Twitter's average monthly active users or MAU figure rose 3 percent year-over-year and also increased from the preceding quarter. Shares of Credit Suisse Group AG were gaining around 4 percent in Swiss trading after the banking giant reported Wednesday higher profit in its first quarter, despite lower net interest income. The company said it had planned 2018 to be a year of acceleration in its performance in its 12-quarter restructuring program.
Follow RTT