Roche Moving Two Novel Biotech Agents Into Phase III In 2004
This article was originally published in The Pink Sheet Daily
Executive Summary
Continuous-acting erythropoietin CERA and rheumatoid arthritis agent MRA will join ovarian cancer treatment pemtumomab to give Roche a total of three novel Phase III agents in 2004. All three biotech agents are projected for filing in next five years.
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Roche is adding two novel biotech products to its Phase III pipeline in 2004, which will give the firm a total of three new agents in late-stage development. Phase III trials for Roche's long-acting erythropoetin, the continuous erythropoiesis receptor activator (CERA) R-744, are set to begin in the first quarter. The rheumatoid arthritis therapy altizumab (R-1569, also known as MRA), a humanized monoclonal antibody targeting the human interleukin-6 receptor, is slated to enter Phase III in the second half of the year. The two products will join Roche's single novel agent in Phase III, the radiolabeled anti-polymorphic epithelial mucin monoclonal antibody pemtumomab (R-1549) for ovarian cancer, licensed from Antisoma. MRA also was not developed by Roche: the company gained co-development and marketing rights to the compound outside Japan, South Korea and Taiwan via its majority stake in Chugai. The predominance of biotech NMEs in Roche's Phase III pipeline, along with its alliances with Chugai and Genentech, reinforce Roche's position as a major player in the biotech arena. The company recently declared itself the second-largest biotech firm in the world and intends to claim the number one position. However, both MRA and CERA are likely to face significant competitive challenges. The CERA patents, published in the U.S. in 2003, are almost certain to be challenged by EPO innovator Amgen, while MRA, which is similar to Amgen/Biovitrum's IL-1 receptor antagonist Kineret (anakinra), would be entering an already crowded U.S. RA market. Roche appears confident about its CERA patents, which it has described as "rock-solid." The firm told analysts Feb. 4 in London that it plans a "global" launch of the anemia agent in 2006. The company also declared that its anemia drug NeoRecormon (epoetin beta) is now the number-one EPO brand outside the U.S. (where it competes with Johnson& Johnson's epoetin alfa Eprex , licensed from Amgen). Roche projects filing the BLAs for pemtumomab in 2005 and for MRA in 2007. - Alla Rutstein Bobbitt |