Swiss drug major Roche has been given a green light to continue importing its anaemia candidate CERA (peg-EPO) into the USA, after a challenge by biotechnology giant Amgen was rejected by the US International Trade Commission.
Earlier this year, Amgen sought to ban the importation of CERA into the USA on grounds that the drug contravenes its patent armoury. The US group filed for an injunction preventing the manufacture or sale of the product at the end of 2005, claiming infringement on its patents for recombinant human erythropoietin, the red blood cell stimulating factor that lies at the heart of both CERA and Amgen's Epogen (epoetin alfa) and Aranesp (darbepoetin alfa) products, which had combined sales of $5.7 billion last year.
The ITC’s decision not to ban the drug’s entry into the country does not affect Amgen's pending patent infringement lawsuit against Roche, said David Scott, Senior Vice President, General Counsel and Secretary, adding: “Nor does it preclude Amgen from re-filing with the ITC at a later date.” But it does mean that, in the meantime, Roche can carry on with its CERA clinical program as planned.
CERA, which was filed with regulators on both sides of the Atlantic, is a long-acting erythropoietin product that is considered to be one of the biggest hopes in Roche's near-term pipeline. Analysts have suggested the new product could make 1.3 billion Swiss francs ($1bn) in 2010 outside the USA alone, and more if it gets access to the US market and a follow-up indication in chemotherapy-associated anaemia.