Carfilzomib Receives Orphan Drug Designation for Treatment of Multiple Myeloma

Proteolix, Inc., a clinical-stage company engaged in the development of novel pharmaceutical therapies for the treatment of cancer and immunological conditions, announced today that the U.S. FDA has granted orphan drug designation to carfilzomib, a selective blocker of proteasome activity for the treatment of multiple myeloma.

"I am very pleased by our receipt of this designation for carfilzomib," said Susan Molineaux, Ph.D., the Company's President and CEO. "To date we have been encouraged by carfilzomib's early-stage clinical results in multiple myeloma, and we continue to believe it has the potential to offer cancer patients a new and effective treatment for their disease."

The Orphan Drug Act of 1983 allows the FDA to grant orphan drug status to novel drugs or biologics that treat a rare disease or condition affecting fewer than 200,000 patients in the U.S. According to the SEER Database of the National Cancer Institute (2004), the U.S. prevalence of multiple myeloma was 53,712 patients. The Orphan Drug Act provides the drug developer with several financial benefits and incentives related to the orphan drug, including tax credits for clinical research costs, ability to apply for annual grant funding, clinical research trial design assistance, waiver of Prescription Drug User Fee Act (PDUFA) filing fees, and a seven-year period of U.S. marketing exclusivity if the drug is the first of its type approved for the specified indication.

For more information on multiple myeloma go to http://www.cancer.gov/cancertopics/types/myeloma.

About Proteolix
Proteolix, Inc. is a privately-held biopharmaceutical company, headquartered in South San Francisco, and dedicated to discovering, developing and commercializing pharmaceutical therapies that target certain cancers and immunological conditions by inhibiting the proteasome and thereby disrupting protein turnover in cells. Phase 1 clinical studies with carfilzomib, the Company's lead product, have shown that patients with hematologic malignancies who have relapsed or progressed following multiple therapies can achieve durable anti-tumor responses. Carfilzomib is currently in Phase 2 clinical studies to evaluate its safety and efficacy in multiple myeloma, lymphoma and solid tumor malignancies. Proteolix is also developing a pipeline of next-generation proteasome inhibitors, including an oral proteasome inhibitor and a selective immunoproteasome inhibitor. For more information, visit http://www.proteolix.com/