A US Court has put a lid on Australian firm Alphapharm’s hopes of getting a generic form of the multibillion-dollar diabetes drug Actos (pioglitazone) onto the world’s largest pharmaceutical market, after ruling in favour of the medicine’s manufacturer Takeda.
The decision supports an earlier appeals court decision and means that Alphapharm – which last year became part of US company Mylan – will now be unable to launch its copycat offering until the patent officially runs out in 2011, giving Japan’s Takeda four more years of lucrative business.
Actos could prove to be an even greater revenue earner for Takeda after data from the PERISCOPE study – presented at the American College of Cardiology meeting in Chicago last month – showed its potential in preventing plaque from being laid down in the arteries of patients with diabetes. This is the first study to demonstrate that a diabetes treatment is capable of preventing the progression of atherosclerosis.
The drug, despite receiving stronger label warnings recently, brought in around $2.86 billion in the last fiscal year, more than 25% of the firm’s total revenues. In January it submitted its Actos follow up – alogliptin – to the US Food and Drug Administration in a bid to get it established on the market ahead of Actos’ 2011 patent expiry.
