|InterMune soars on EU agency positive opinion, shares double. FDA approves Medtronic erratic heart rate device|
|By Staff and Wire Reports|
|Friday, 17 December 2010 19:41|
Santa came early this year for the shareholders of InterMune, Inc. (Nasdaq:ITMN) The company Friday reported that the European Medicines Agency (EMA) recommended the granting of marketing authorization for the companies potential blockbuster drug, Esbriet. Also known as pirfenidone, the drug is used for the treatment of mild to moderate idiopathic pulmonary fibrosis (IPF), a rare and fatal lung disease.
After hitting a 52 week high of $49.46 in May, shares of ImterMune were hit hard that month after the drug was shot down by the FDA, eventually falling as low as $8.34. Esberet is already sold in Japan and has orphan drug designation in Europe. Despite this, todays decision came much earlier than expected and caught many investors by surprise. InterMune is expecting European approval by the end of Q1 2011 and anticipates launching the drug in Q3. Speculation has several big pharmas interested in acquiring the company.
Shares of InterMune more than doubled on the news, closing the day at $28.18, up $20.62 or 144.5%
Heavy volume pushed shares of Medtronic, Inc. (NYSE:MDT) higher today after the company announced that the FDA approved Cardiac CryoAblation Catheter system, Arctic Front, system to treat a form of atrial fibrillation in patients who do not respond to drug therapy. The Cryoballoon treatment involves a minimally-invasive procedure that efficiently creates circumferential lesions around the pulmonary vein, which is the source of erratic electrical signals that cause the irregular heartbeat.
Balloon-based technology is novel because it ablates or blocks the conduction of atrial fibrillation (AF) in cardiac tissue through the use of a coolant rather than heat, which is delivered through a catheter. This freezing technology allows the catheter to adhere to the tissue during ablation, allowing for greater catheter stability.
The company said that approval was based on a study that showed about 70 percent of patients treated with Arctic Front were free from atrial fibrillation a year later, compared to 7 percent of patients treated only with drug therapy. Already marketed in Europe, Medtronic is planning to start selling the system in the U.S. in the next few weeks.
Shares of Medtronic jumped $1.22 to $37.40.
Adherex Technologies Inc. (TSX:AHX)(PINK SHEETS:ADHXF) , a biopharmaceutical company focused on the development of eniluracil and 5-fluorouracil, is responding to a request from the Investment Industry Regulatory Organization of Canada (IIROC) on behalf of the Toronto Stock Exchange (TSX) following recent trading activity.