"This sale speaks directly to our company's ongoing commitment to serving the unique needs of patients in specialty markets, in this case pulmonary arterial hypertension (PAH)," said Ron Quadrel, CEO, of GeneraMedix, Inc. "I'm also very pleased to conclude this transaction with Actelion, a company that is committed to improving the lives of PAH patients through improved treatment options," added Quadrel.
On June 27, 2008, the U.S. FDA approved Epoprostenol for Injection (1.5 mg/ml vial) for the long-term intravenous treatment of primary pulmonary hypertension and pulmonary hypertension associated with the scleroderma spectrum of disease in NYHA Class III and Class IV patients who do not respond adequately to conventional therapy.
The new formulation of epoprostenol uses non-proprietary diluents, and once reconstituted prior to use, it may be stored for up to 48 hours at 25 degrees Celsius or for five days in the refrigerator at 2-8 degrees Celsius. Global patents have been filed for this new formulation. Actelion will be responsible for global development, registration and commercialization for the product.
"We are very pleased to acquire this innovative product as it builds on our commitment to PAH therapy. Actelion has always led the drive in developing innovative therapies for PAH patients and treating physicians, and we believe this new improved formulation could potentially play a significant role in the management of PAH," stated Jean-Paul Clozel, M.D. and CEO of Actelion.
Unlike other epoprostenol formulations approved for PAH, this unique formulation is stable at room temperature for up to 24 hours when diluted and filled into the pump for administration and so can be used without frozen gel packs.
"Having developed this specialty therapy for the PAH market is exciting and positively reflects on the GeneraMedix pipeline and growing reputation in specialty markets," said Robin Smith Hoke, President, Commercial Operations for GeneraMedix. "This deal is also the result of strong partnership with the team at Actelion as well as our equity partners GTCR Golder Rauner LLC, and Ferrer Freeman & Company, LLC."
Actelion Ltd
Actelion Ltd is a biopharmaceutical company with its corporate headquarters in Allschwil/Basel, Switzerland. Actelion's first drug Tracleer®, an orally available dual endothelin receptor antagonist, has been approved as a therapy for pulmonary arterial hypertension. Actelion markets Tracleer® through its own subsidiaries in key markets worldwide, including the United States (based in South San Francisco), the European Union, Japan, Canada, Australia and Switzerland. Actelion, founded in late 1997, is a leading player in innovative science related to the endothelium - the single layer of cells separating every blood vessel from the blood stream. Actelion's over 1900 employees focus on the discovery, development and marketing of innovative drugs for significant unmet medical needs. Actelion shares are traded on the SIX Swiss Exchange (ticker symbol: ATLN) as part of the Swiss blue-chip index SMI (Swiss Market Index SMI®)
GeneraMedix, Inc.
GeneraMedix Inc. is a privately held pharmaceutical company specializing in difficult to develop and/or manufacture injectable products for the U.S. hospital and specialty markets. In addition to its marketed products, GeneraMedix has a significant number of injectable products under development, as well as a number of products currently under FDA review. Headquartered in Liberty Corner, New Jersey, the company was founded in July of 2004, with equity partners GTCR Golder Rauner, LLC, and Ferrer Freeman and Company. Additional information is available on the company's website at www.generamedix.com
