Aranesp equivalent to Epogen in Ph III trial

Amgen has presented encouraging pivotal trial data for Aranesp(darbepoetin alfa) at the American Society of Clinical Oncology meeting in San Francisco, USA.

Aranesp, a sustained-release version of Amgen's anemia treatment Epogen (epoetin alfa), was shown in a Phase III trial to have equivalent efficacy to its parent, with both drugs reducing the need for blood transfusions in lung cancer patients undergoing chemotherapy by approximately 50%. This positive news follows a delay in the launch of Aranesp as an anemia treatment for patients with chronic kidney disease by the US Food and Drug Administration, which last week led Denis Harp of Deutsche Banc Alex Brown to cut his forecast for 2001 sales to $150 million from $250 million (Marketletter May 7).

Epogen is marketed outside the USA by Johnson & Johnson under the brand name Procrit, following a 1985 licensing agreement, and is co-marketed in the USA by both companies. Amgen and J&J have been locked in a struggle for years over the marketing rights of Epogen and have been to court several times in their 16-year partnership (Marketletters passim). Procrit generated revenues of $769 million in the first quarter of this year alone, and Amgen is relying on Aranesp, due to be launched this year with a peak sales potential forecast at $2 billion, to circumvent J&J's exclusivity to Epogen, sales of which reached $503 million in the first quarter, in Europe.