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Maxygen Announces Hold on MAXY-alpha Development Program
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FDAnews.com
Roche has placed a voluntary hold on further clinical development of MAXY-alpha, a treatment of hepatitis C and hepatitis B virus infections licensed to Roche by Maxygen.
Preliminary observations from a Phase I trial indicated an unexpected reduction of the pharmacodynamic and pharmacokinetic effects of MAXY-alpha occurred in the majority of subjects who received two doses of MAXY-alpha. In addition, antibodies binding to MAXY-alpha were identified in some subjects, Maxygen and Roche said.
Russell Howard, Maxygen's CEO, said he did not know how these findings will impact the future of the development program, and Roche was conducting additional work to assess the results.
Maxygen and Roche entered an agreement in 2003 to develop novel interferon alpha and beta products for a range of indications.
Roche licensed worldwide commercialization rights to specific novel interferon product candidates for Hepatitis C and B virus infections. Maxygen received an initial payment, R&D funding for the first two years of the collaboration and milestone payments for the advancement of the MAXY-alpha product candidate. Maxygen is also eligible to receive milestone payments and royalties based on any product sales.
Maxygen slid $1.24, or 15%, to $7.
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