Nov 10 2011
Maxygen, Inc. (Nasdaq:MAXY) today announced that it has been advised by the Biomedical Advanced Research and Development Authority (BARDA) that Maxygen's proposal for the development of its MAXY-G34 product candidate as a potential medical countermeasure for Acute Radiation Syndrome (ARS) will not be considered for a contract award.
“We are disappointed and surprised by this outcome given the positive nature of the discussions we have had with BARDA during the proposal review period, but we accept this final decision by them”
Maxygen submitted a white paper entitled Development of MAXY-G34 as a Medical Countermeasure for Acute Radiation Syndrome in December 2010 in response to a Broad Agency Announcement (BAA-10-100-SOL-00012). Following review of the white paper, in February 2011 BARDA invited Maxygen to prepare a full proposal which the company then submitted in May 2011.
BARDA found Maxygen's proposal technically sound and highlighted the novel attributes of MAXY-G34, the comprehensive nature of the development plan, the promising efficacy data in animal models and the safety data in previous studies of MAXY-G34 in breast cancer patients. However, BARDA also noted several weaknesses in the proposal, including dependence on overseas manufacturing, uncertainty regarding intellectual property issues with respect to MAXY-G34 and the company's reliance on consultants and subcontractors.
"We are disappointed and surprised by this outcome given the positive nature of the discussions we have had with BARDA during the proposal review period, but we accept this final decision by them," said James R. Sulat, Maxygen's Chief Executive Officer. "We will evaluate our plans for the MAXY-G34 program in light of this development, and we will seek to create value from the program in other ways."