Affymax
Based: Palo Alto, CA
Why It's Fierce: A few weeks ago, when Affymax signed a $100 million Japan-only licensing deal ($27 million up front) with Japan's Takeda for its lead product, the company validated the technology that had motivated its creation four years earlier. Spun out of GlaxoSmithKline, Affymax believed that new technology would gin a new generation of peptide drugs. Its lead product, Hematide, is a synthetic peptide-based erythropoiesis-stimulating agent that is now in three Phase II trials. In short, the therapy is being tested as a treatment for cancer and chronic kidney disease patients by promoting red blood cell production. Those small Phase IIb studies have produced data that backs up their scientific gamble, delivering early proof-of-concept data. By the end of this year, says Dr. Robert Naso, executive vice president of research, two Phase II studies should be complete for anemia in chronic kidney disease. Phase II results in cancer will follow in 2007. Armed with that safety and efficacy data, Affymax will go to the regulators to discuss starting a pivotal trial. "The mechanism of action is very similar to EPO (a genetically engineered version of the natural hormone)," says Dr. Naso. "It binds and activates that receptor and turns on signaling pathways in the cell that result in red blood cell production." Because the molecule is made synthetically, Affymax believes they have a product with superior characteristics to standard therapy, including monthly dosing and no need for cold storage. Affymax also has a preclinical program for treating a deficit of white blood cells with other early drug candidates in the pipeline. Last summer, Affymax raised $60 million in its fourth round of venture capital, with JAFCO and Bear Stearns Health Innoventures leading. Affymax partnered with EntreMed in 2004 to identify lead drug candidates for cancer.
What to look for: Affymax intends to sign up a worldwide (excluding Japan) partner for Hematide by the end of this year. An IPO may happen this year, but with $70 million in the bank at the end of this quarter, Affymax has the staying power to wait for the right conditions.
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