Swiss pharmaceutical giant, Roche, had two causes for celebration this morning after the European regulatory authorities gave their backing to the company’s Bonviva (ibandronic acid) osteoporosis offering and its anti-cancer agent, Tarceva (erlotinib), in the treatment of non-small cell lung cancer.
The recommendation to approve Tarceva was based on pivotal Phase III data showing the product to be superior to placebo for the treatment of patients with advanced NSCLC, following failure of first or second-line chemotherapy. Patients receiving Tarceva also lived significantly longer than those in the placebo arm, with a significant increase in both the length of time before patients’ disease symptoms deteriorated and the time when patients were stable and there was no progression of their cancer [[26/08/04b]].
Tarceva, which was approved in the US in November last year [[22/11/04d]], and won the Swiss green light last month [[22/03/05a]], generated first-quarter sales of some 57 million Swiss francs [[19/04/05b]].
* Meanwhile, Bonviva – or Boniva as it is known in the US – which is partnered with GlaxoSmithKline, looks set to become the first and only once-monthly tablet for the treatment of postmenopausal osteoporosis in nthe European Union. The European backing of the pill comes on the back of the so-called Mobile trial, which included 1,609 women with postmenopausal osteoporosis and showed that monthly Bonviva dose was at least as effective as the daily version of the product [[14/01/04a]]. In addition, the monthly dose resulted in even larger increases in bone mineral density at lumbar spine and all hip sites, when compared with the daily dose, and was statistically superior to the daily dose at all these sites after two years.
Boniva was approved by the US Food and Drug Administration in March 2005 [[29/03/05a]], and is expected to make a significant impact on the market currently dominated by the likes of Merck & Co’s $3.2 billion-dollar-a-year market leader, Fosamax (alendronate), with ease of dosing.