SAN ANTONIO, April 17, 2012 /PRNewswire/ -- Mission Pharmacal announced today that it has entered into a patent and technology licensing agreement with EffRx Pharmaceuticals SA, Freienbach, Switzerland, for the manufacturing and commercialization of BINOSTO™ (alendronate sodium) Effervescent Tablets in the United States and Canada. The U.S. Food and Drug Administration recently approved BINOSTO to treat osteoporosis in postmenopausal women and to increase bone mass in men with osteoporosis. BINOSTO will be available in the United States in late 2012.
Utilizing EffRx's formulation technology, BINOSTO is the first and only buffered effervescent therapeutic to deliver the gold standard in osteoporosis treatment and fracture prevention of alendronate sodium in an easy-to-swallow, buffered solution. A Harris Interactive Poll concluded that up to 40 percent of American adults have difficulties with swallowing tablets. That difficulty often results in patients having to choose between injections or forgoing treatment for this chronic disease.
Dr. Robert Recker, president of the National Osteoporosis Foundation, notes, "BINOSTO provides an important new innovation for patients with osteoporosis. BINOSTO offers those patients that struggle with taking tablets the opportunity to obtain the proven fracture prevention of alendronate in an easy-to-take, buffered solution."
"We are very excited about our partnership with EffRx and look forward to helping deliver BINOSTO to women with osteoporosis who have difficulty with pills or shots and to men who also struggle with this disease. Men's bone health has previously been overlooked," says Neill Walsdorf, Jr., president of Mission Pharmacal.
EffRx CEO Christer Rosen adds, "We believe Mission is the logical choice for bringing BINOSTO to the U.S. and Canadian markets. Mission is focused on quality first and foremost and they have a long history of educating patients and physicians in bone health. They also have a well-established women's health sales force where they have proven that they can launch a product and drive it to a market leadership position. We are extremely happy to have Mission as a partner."
Osteoporosis is a serious and often debilitating disease affecting more than 200 million people worldwide. According to the National Osteoporosis Foundation, the leading health organization dedicated to the prevention of osteoporosis and broken bones, more than 10 million people in the United States have osteoporosis and another 34 million are estimated to have osteopenia, or low bone density, which is often the precursor to osteoporosis.
Although it is commonly thought of as a "woman's disease," the problem of osteoporosis in men has recently been recognized as an important public health issue. It is true that women have relatively rapid bone loss in the first few years after menopause. However, by about age 65 men and women lose bone mass at the same rate.[i]
"With the commercialization rights to BINOSTO, we can further our investment in promoting and treating bone health with a world-class product that addresses both osteoporosis and pill-swallowing difficulty," notes Terry Herring, president of Mission Pharmacal Consumer Operations. "We look forward to building strategic partnerships that will ensure BINOSTO is widely promoted and available throughout the United States and Canada."
BINOSTO is a once weekly, strawberry flavored effervescent tablet containing alendronate 70mg that rapidly dissolves in half a glass (4 oz.) of plain room temperature water to make a buffered solution. BINOSTO will be available in packs of four and 12 tablets.
BINOSTO 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.
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. Using only the purest ingredients, Mission Pharmacal provides physicians and consumers with the highest quality pharmaceutical and dietary supplement products on the market today. Mission Pharmacal is a proud national supporter of the March of Dimes Foundation, whose mission is to improve the health of babies by preventing birth defects, premature birth, and infant mortality. For more information about the company, visit www.missionpharmacal.com.
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.
EffRx has a licensing agreement with Mission Pharmacal Company based in San Antonio, Texas, for development, manufacturing, and commercialization of EffRx patented effervescent alendronate for the treatment of osteoporosis in the United States and Canada. Mission Pharmacal anticipates that BINOSTO will be commercially available in the third quarter of 2012.
SOURCE Mission Pharmacal