Roche has released new phase II data for a highly promising new anaemia treatment - but Amgen are determined to block the product ever reaching the market.

Amgen is the world's biggest biotech company, and is big as many pharma companies, having made its name through a series of innovative treatments for anaemia, many achieving blockbuster status. These include Epogen, Aranesp and Neulasta, which are all based on the active ingredient erythropoietin or EPO.

Neulasta is a special 'pegylated' form of EPO which allows the drug to stay in the body longer, thereby reducing the number of doses needed.

Roche's promising new drug R744 or CERA (continuous erythropoietin receptor activator) is also a pegylated form of EPO, and Amgen have filed a lawsuit alleging Roche's product infringes six of its product patents.

Amgen says they are seeking a permanent injunction preventing Roche from making, or selling any EPO related products in the US.

Roche have not officially responded to the legal challenge, but will be preparing for a courtroom battle in order to get its new product on the market.

Latest phase II trial results show the CERA was very effective in treating anaemia in patients suffering chronic kidney disease, and only needed to be given every three to four weeks - a first for any EPO product.

CERA is already in phase III and Roche plans to file for approval in 2006. US and European launches would be projected for the following year, but Amgen's legal action could hold the drug up for some time.

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pharmafocus@wiley.co.uk