Novartis has been boosted by a study which claims that a once-yearly infusion of the firm’s osteoporosis drug Reclast after a hip fracture helps prevent future broken bones and prolongs life.
The 2,100-patient study, published by the New England Journal of Medicine and presented at the American Society of Bone and Mineral Research's annual meeting in Hawaii, showed that an annual infusion of Reclast (zoledronic acid), which is also sold as Aclasta, reduced the risk of subsequent fractures by 35% compared to osteoporosis patients treated with placebo. It also found that the risk of death was significantly reduced, by 28%, in the Reclast group compared to placebo, which is especially important, says Novartis, since almost a quarter of people over 50 who suffer a hip fracture die within one year.
The company acknowledged that the reduction in the risk of death “was probably due to a range of factors”, including fewer cases of new fractures, and said that “further investigation is needed to understand this finding more clearly”. Data from the new study, which is called the Recurrent Fracture Trial, will be submitted to regulatory authorities by the end of 2007 to broaden the treatment indication for Reclast, the Swiss firm added.
Reclast was approved by the US Food and Drug Administration in August as the only once-yearly treatment for postmenopausal osteoporosis and a month earlier, the Committee for Medicinal Products for Human Use issued a positive opinion recommending approval in the European Union. It is also marketed in over 60 countries for Paget's disease, the second most common metabolic bone disorder and is being studied for other types of osteoporosis.
A fresh approval would boost Reclast sales and a number of analysts believe it can reach blockbuster status, especially given the way the market is expanding, seeing as osteoporosis affects more than 200 million people. The active ingredient in the drug is also found in Zometa, Novartis’ cancer treatment which had first-half sales of $636 million.
Novartis signs osteoporosis deal with Radius
Meantime, the Basel-based drugs giant has teamed up with the USA’s Radius Health and been granted the option to obtain an exclusive global licence to develop and commercialise the latter’s osteoporosis drug, BA058. If the option is exercised and everything goes to plan, the deal could be worth over $500 million to Radius, though part of that sum would be paid to French drugmaker Ipsen, from which Radius licensed the drug in 2005. BA058 is currently in mid-stage human clinical trials to treat osteoporosis in postmenopausal women.