Amgen/Wyeth/Takeda: new data to boost Enbrel's position

Sep 26, 2008 (Datamonitor via COMTEX) -- WYE | Quote | Chart | News | PowerRating -- Evidence of Enbrel's efficacy in the early treatment of Asian rheumatoid arthritis patients has been presented to the Asia Pacific League of Associations for Rheumatology. With early intervention in RA treatment becoming increasingly important in Japan, this new evidence will be invaluable for Enbrel in the face of mounting competition.

Rheumatoid arthritis (RA) is a chronic, progressive disease, and there has been a considerable shift, particularly in the US and EU, towards early aggressive treatment with TNF inhibitors in combination with methotrexate, within the first years of disease onset. Such a treatment strategy should start as early as possible after diagnosis to limit joint damage and control disease progression.

Takeda, which co-markets Enbrel with Wyeth in Japan, presented data this week at the Asia Pacific League of Associations for Rheumatology (APLAR) showing the importance of Enbrel in the early treatment of RA for the first time in Asian patients. 13,894 RA patients were included in the surveillance program between March 2005 and April 2007. 80% of patients with early active RA achieved radiographic remission at one year with Enbrel treatment compared with 59% who received methotrexate alone.

There are currently three TNF inhibitors approved in Japan: Mitsubishi Tanabe's Remicade (infliximab), Takeda/Wyeth's Enbrel (etanercept) and Abbott/Eisai's Humira (adalimumab). These are all indicated for the treatment of moderate-to-severe RA patients who have had an inadequate response to existing therapies, such as methotrexate. Remicade, which is administered by IV infusion, was the first-to-market for RA in Japan in July 2003, and Datamonitor estimates sales of $190m for this indication in 2007. Subcutaneously delivered Enbrel was introduced for RA in January 2005, and Datamonitor estimates RA sales of $130m in 2007. Abbott/Eisai launched Humira in June 2008.

Enbrel has the least attractive dosing schedule of the TNF inhibitors (two sc injections per week), and could see market share taken by Humira, with its more convenient fortnightly sc injection. However, these post-marketing data, and new treatment guidelines, indicate that the early treatment of RA will be an important future market segment in Japan. Enbrel should seek approval for the early treatment of RA to enhance its competitive position relative to Remicade, which does not have early RA approval in Japan, and at the same time stave off competition from Humira.

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