Novartis Says Bone Drug AclastaGains European Union Approval


Novartis AG said Friday that the European Union approved its bone drug Aclasta, a treatment that needs to be taken only once a year.
Switzerland-based Novartis said the EU regulator approved Aclasta for the treatment of women with postmenopausal osteoporosis.
The drug was recently approved in the U.S., where it is sold under the brand name Reclast. Aclasta has been shown to reduce the risk of fractures in areas of the body typically affected by osteoporosis, including the spine, wrists and hips.
It belongs to a type of drugs called bisphosphonates, which have long been used to treat osteoporosis, a condition that affects more than 50 million people in the EU and 44 million people in the U.S. Aclasta is given as a 15-minute infusion once a year, while established drugs of this type are taken orally, typically once a week or once a month. They are cumbersome to take, which leads to low compliance, and thereby compromises efficacy of the drug.
Karl Heinz Koch, pharmaceutical analyst at Swiss private bank Vontobel, expects the drug to generate $1.2 billion in sales in 2011, an estimate based on an expected 10% market share. He cautioned that the drug's active ingredient will lose patent protection in 2011.