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Next Generation Hepatitis C Drug Begins Clinical Trial

November 9, 2006

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Designed to have more anti-viral and immune-stimulating activity, Maxy-alpha is Roche’s next generation interferon alpha for Hepatitis C treatment. Roche has initiated a Phase 1a study to determine the safety and efficacy of this drug.

Maxygen’s Next-Generation Interferon Alpha Enters Phase 1a Clinical Trial

PR Newswire

REDWOOD CITY, Calif., Nov. 7 /PRNewswire-FirstCall/ — Maxygen, Inc. announced today that Roche has initiated a Phase Ia clinical trial in New Zealand to evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic profile of Maxy-alpha, a next-generation interferon alpha for the treatment of hepatitis C virus infection.

The Phase Ia clinical trial is a double-blind, dose-escalation, controlled study of a single sub-cutaneous administration of Maxy-alpha in healthy volunteers with both placebo and PEGASYS(R) (peginterferon alfa-2a (40KD)) control groups. Maxy-alpha, also known as R7025, Roche’s internal designation for the molecule, is a novel PEGylated interferon alpha variant created through the use of Maxygen’s proprietary MolecularBreeding(TM) directed molecular evolution technologies. Maxy-alpha has been designed to have more anti-viral activity against the hepatitis C virus and be more effective in stimulating immune responses to help combat the infection. Preclinical data comparing Maxy-alpha to PEGASYS(R) demonstrated that Maxy-alpha has increased anti-viral and immune stimulatory activity compared to PEGASYS(R). Roche and Maxygen worked together to PEGylate Maxy-alpha to ensure comparable pharmacokinetics and dosing convenience to Roche’s currently marketed PEGylated interferon alpha, PEGASYS(R).

Maxygen will receive a $2 million dollar milestone payment for the commencement of the Phase Ia trial.

“Maxy-alpha is the first ‘shuffled’ protein to enter clinical development,” said Russell Howard, Chief Executive Officer of Maxygen. “This demonstrates how Maxygen’s proprietary technologies can be used to specifically enhance desired properties of potential protein drugs. We designed this molecule to have greater potency over the currently marketed interferon alpha drugs in the hopes of addressing the large percentage of patients that are not effectively served by current therapies. We are hopeful that the forthcoming clinical trials of Maxy-alpha will demonstrate a significant improvement in the treatment of hepatitis C virus infection. Roche is an ideal partner for Maxygen’s next-generation interferon alpha and we are encouraged by their enthusiasm and commitment to the program.”

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