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Biotech / Medical : ONXX -- Ignore unavailable to you. Want to Upgrade?

To: Charles Tutt who wrote (711)	8/8/2001 11:02:39 AM
From: tuck	Read Replies (1) \| Respond to of 810

Onyx gets INGNed: >>RICHMOND, Calif., Aug 8 (Reuters) - Onyx Pharmaceuticals Inc. (NasdaqNM:ONXX - news) said on Wednesday it has amended its 1999 collaboration pact with Warner-Lambert for the development of Onyx's anti-cancer virus, ONYX-015, giving Onyx full ownership of local and regional indications of ONYX-015. Onyx said it will regain full rights to develop and commercialize ONYX-015 for cancers that are treated via direct injections to the tumors and other local and regional routes of administration, while Warner-Lambert will retain development rights for ONYX-015 for cancers where the drug will be administered intravenously. Richmond, Calif.-based Onyx said that due to the amendment, its research and development expenses will increase over current levels, and revenues from Warner-Lambert will stop until trials for intravenous indications are reinitiated. ONYX-015 has been genetically engineered to replicate in and kill cancer cells that have an abnormal p53 pathway while sparing normal cells that have functioning p53 protein. The p53 gene is considered one of the body's most important naturally occurring tumor-suppressor genes. These genes are believed to help control runaway growth of cells and thereby prevent cancer. Under the amended agreement, all drugs currently produced by Onyx's contract manufacturers can be used to supply the Phase III study in recurrent head and neck cancer and other clinical trials involving local/regional administration. That Phase III study has experienced delays which could impact Onyx's timeline to approval by six months or more, Scott Freeman, vice president of clinical development, said in a statement. He added that Onyx's revised clinical plan will focus on minimizing the delay and obtaining market approval as quickly as possible in head and neck cancer. If ONYX-015 receives U.S. marketing approval for intravenous administration, Onyx and Warner-Lambert will resume the collaboration as originally intended. Warner-Lambert and Onyx will continue their collaboration under the research, development and commercialization agreement on the two additional adenovirus products, a prodrug armed virus and a cytokine armed virus. Onyx now assumes responsibility for all development, regulatory approval and commercialization of ONYX-015 in head and neck cancer and other cancers that are treated by administering ONYX-015 via direct injections or by local or regional routes of administration. Onyx said it will also fund all associated costs and retain all profit derived from worldwide sales of ONYX-015 in these applications. Onyx said Warner-Lambert will retain an option to pursue development and regulatory approval of ONYX-015 for intravenous administration and if it exercises that option, will fund all related costs. If Warner-Lambert obtains U.S. marketing approval for an intravenous indication, Onyx and Warner-Lambert will reestablish the collaboration under the original structure and terms of their 1999 agreement. Freeman also said Onyx will start Phase II/III studies in refractory head and neck cancer and in liver metastases of colorectal cancer which could potentially lead to a faster path to registration. ONYX-015 is currently being manufactured on a small-scale process and clinical trials have been prioritized to reflect the limitations of the manufacturing scale and a lack of sufficient materials for use in multiple clinical studies. Ongoing intravenous studies have been discontinued and could resume when sufficient material is available from the large-scale production processes being implemented at XOMA LLC, Onyx's strategic partner. Scott Geyer, vice president of technical operations said Onyx expects initial ONYX-015 clinical supplies from XOMA in the first quarter of 2002. Onyx posted a second-quarter net loss of $5.9 million, or 32 cents per share, compared with net income of $1.4 million, or 10 cents, a year earlier. Total revenue slipped to $5.3 million from $9.0 million in the year earlier period. Onyx said the main reason for the drop in revenue was that the year-ago quarter included a $3.7 million payment from Warner-Lambert on the completion of a research milestone for the armed anti-cancer virus collaboration.<< snip Cheers, Tuck