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BINOSTO(TM) - First and Only Buffered Effervescent Solution
for the Treatment of Osteoporosis Launched in the USA
EffRx to Regain Rights Outside of North America
Freienbach, Switzerland (ots) - EffRx Pharmaceuticals SA is proud to announce that BINOSTO (TM) (alendronate sodium) Effervescent Tablet for buffered oral solution (70 mg) is now available by prescription in the United States. The U.S. Food and Drug Administration earlier this year approved BINOSTO to treat osteoporosis in postmenopausal women and to increase bone mass in men with osteoporosis.
BINOSTO delivers the "gold standard" in osteoporosis treatment and fracture risk reduction - alendronate sodium - in an easy-to-swallow, buffered solution. BINOSTO represents a true breakthrough in the treatment of osteoporosis - especially for those patients who prefer not to swallow tablets, or have difficulties swallowing pills.
"We are extremely proud having our first product, BINOSTO, launched in the United States by our distribution partner Mission Pharmacal," said Christer Rosén, Chairman and CEO of EffRx. "We are stepping into a new business phase and it is very encouraging to get the news from Mission about the positive reaction BINOSTO has received from the healthcare community in the United States. With this exciting new treatment option, physicians can rest easily, knowing they are prescribing an easy-to-take and proven therapy for their osteoporosis patients that protects against fracture risk at the hip and spine."
For anyone with osteoporosis, the best protection against suffering from a life-threatening fracture is taking medications as prescribed. However, studies show that many patients have trouble swallowing pills, are not adherent to therapy, and stop taking their medication. Taken just once a week, with a reduced volume of water to drink and no risk of a tablet getting lodged in the esophagus, BINOSTO has the potential to improve long-term patient compliance and tolerability, thereby decreasing the risks of disabling fractures.
EffRx Pharmaceuticals SA also announces that it will regain the rights to BINOSTO / Steovess® (EX101) in territories outside of North America. The development and commercialization rights were originally licensed to Nycomed (acquired by Takeda in 2011). EffRx will commercialize BINOSTO / Steovess® through partners in Europe, Russia, The Middle East, Africa, Latin America and Asia-Pacific. For Business Development inquiries please contact: Lorenzo Bosisio, firstname.lastname@example.org.
About BINOSTO / STEOVESS®
BINOSTO is a once weekly, strawberry flavored effervescent tablet containing alendronate 70mg that rapidly dissolves in half a glass (4 oz. or 125ml) of plain room temperature water to make a buffered solution. BINOSTO is available in the USA in cartons containing four individual tablets.
BINOSTO (formerly EX101) was developed by EffRx based on an agreement with Merck & Co, Inc. granting EffRx the worldwide rights to all effervescent and related patents of FOSAMAX (alendronate). Patents have been granted to EffRx providing exclusivity for BINOSTO through February 2023. Additional patents are pending.
In the European Union it is known under the name STEOVESS® and was positively accepted under the decentralized procedure (DCP) for National Approvals in December 2011. In the EU STEOVESS® is indicated for the treatment of post-menopausal osteoporosis.
EffRx Pharmaceuticals SA is a drug delivery company based in Freienbach, Switzerland. EffRx specializes in improving existing high volume pharmaceutical products by utilizing its novel techniques in different effervescent executions. The primary focus of EffRx is in metabolic bone disease, oncology supportive care, pediatric medications, and support to larger companies in Life Cycle Management. For more information about the company, visit www.effrx.com
About Mission Pharmacal
Mission Pharmacal is a privately held pharmaceutical company based in San Antonio, Texas. For more than 65 years, the company has been committed to meeting the unique healthcare needs of women throughout all stages of life, pediatric patients, and those persons dealing with urologic and dermatologic conditions. The company has a proven track record of identifying unmet healthcare needs and developing both innovative prescription and over-the-counter products to meet these needs.