AFFY
(sell)
EMEA to assess safety of EPO use in oncology The announcement that the EMEA will convene a Scientific Advisory Group on May 15th to assess recent clinical trial results concerning EPO use in cancer patients suggests that safety concerns are increasing in Europe, and that this market may face similar pressures to the U.S. market. We are concerned that the contracting worldwide opportunity for EPO in oncology may lead to a reassessment of the current collaboration agreement by Hematide partner Takeda, especially given the company’s focus on establishing an oncology franchise to complement the Millennium acquisition. While Affymax’s management has maintained that Takeda remains committed to the current terms, we believe that the favorable financial agreement in the U.S. was partially motivated by anticipated ex-U.S opportunities. Continued contraction of these opportunities with increased regulatory hurdles could limit the value of Hematide to Takeda.
Terms could be pressured if opportunities/hurdles change The Affymax/Takeda Hematide agreement provides very favorable U.S. terms for Affymax, who will receive 50% of U.S. profits, while contributing 30% of the U.S. development expenses (after the initial $50 Mn) and exclusive of various, undisclosed milestone payments. We believe that these favorable terms were partially motivated by the anticipated ex-U.S. opportunity, where Takeda pays a royalty to Affymax, and the focus of Takeda on developing an oncology platform.
Management maintains that Takeda remains committed Affymax management indicates that, despite Takeda’s particular interest in oncology, the company remains committed to the Hematide development program. However, the collaboration agreement does not have a termination penalty incurred after 2-years from inception (mid-2006), and continued erosion of market opportunities with increased regulatory hurdles/expenses may cause the company to reconsider the value of this product with the current terms. Maintain Sell. |