Osteoporosis drug Boniva, a GlaxoSmithKline (NYSE:GSK) and Roche (OTC:RHHBY) product, will soon face its first generic competitors.
Mylan (NASDAQ:MYL), Apotex and Orchid Healthcare all received U.S. Food and Drug Administration approval on March 19 to make their versions of the once-a-month osteoporosis treatment. Boniva’s patent expired in Europe last year. The U.S. Boniva patent expired this month. But even though GSK will take a hit from generic competitors, it stands to benefit from a new treatment in the osteoporosis market developed by another pharmaceutical company — Amgen (NASDAQ:AMGN).
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The global market for osteoporosis treatments was valued at $6.8 billion in 2009, led by bisphosphonate drugs, according to a Transparency Market Research report. Boniva and Novartis (NYSE:NVS) drug Reclast were the top sellers in the class of bisphosphonates.
Osteoporosis is characterized by low bone mass and structural deterioration of bone tissue, which can lead to higher risks of fractures of the hip, spine and wrist. The disease affects both men and women, and the National Institutes of Health estimates that more than 40 million people in the United States either have osteoporosis or are at high risk for the disease due to low bone mass.
Boniva, or ibandronate, helps increase bone mass and reduce the chance of fractures. GSK and Roche received FDA approval on Boniva in 2005 to treat postmenopausal osteoporosis. Britain-based GSK, which has its U.S. headquarters in Research Triangle Park, North Carolina, had entered into a 2001 agreement with Swiss company Roche to codevelop and promote Boniva to treat and prevent postmenopausal osteoporosis in all countries except Japan.
Boniva’s global sales grew to $438 million in 2008 but have steadily declined in recent years. Sales in 2011 totaled just $105 million. But the osteoporosis drug market is changing as the generic competitors emerge to compete against bisphosphonates and new drugs emerge as alternatives to biphosphonates. Amgen’s Prolia, approved in 2010, is expected to become a blockbuster and top the osteoporosis market. Amgen reported global Prolia sales of $203 million in 2011, up from just $33 million in 2010. Transparency Market Research projects Prolia sales will reach $3.8 billion in 2015.
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Even as GSK’s Boniva revenue declines, the company will benefit from growing Prolia sales. Amgen and GSK entered a collaboration agreement in 2009 to commercialize Prolia. Amgen holds commercialization rights in North America. GSK paid Amgen $120 million for the rights to commercialize the drug for the osteoporosis indication in Europe, Australia, New Zealand and Mexico. That $120 million could prove to be a valuable investment. If Prolia sales meet projections, GSK will reap rewards from a blockbuster osteoporosis drug.