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

To: Jibacoa who wrote (1728)	5/23/2001 4:36:45 PM
From: Ian@SI	Read Replies (1) \| Respond to of 2344

Biomira Reports on Collaboration and Product Advancement at Annual General Meeting TORONTO, May 23, 2001 /PRNewswire via COMTEX/ -- Biomira Inc. (NASD: BIOM) (TSE: BRA) announced today highlights of its collaboration with Merck KGaA, which was the largest therapeutic cancer vaccine collaboration ever announced. The Company also discussed the progress of THERATOPE(R) vaccine and BLP25 vaccine at the Annual General Meeting (AGM) held at the Toronto Stock Exchange Conference Centre. On May 3, 2001, Biomira and Merck KGaA entered into a global product development, licensing and co-promotion collaboration for Biomira's two most advanced products: THERATOPE(R) vaccine, to treat metastatic breast cancer, and BLP25 vaccine for non-small cell lung cancer. Under the terms of the agreement, Merck KGaA and Biomira will co-promote products in the U.S. Merck KGaA will market the products in the United States through its U.S. affiliate, EMD Pharmaceuticals. The total potential value of the collaboration to Biomira is more than US$150 million in upfront and milestone payments and equity investments. The aggregate upfront payment, equity investment and retroactive equal share of development costs are significant, amounting to Canadian $33.7 million or U.S. $22 million, which is approximately 75% of last year's burn rate. Alex McPherson, MD, PhD, President and CEO stated, "The collaboration signifies Merck KGaA's commitment to oncology and Biomira's goal to become a forward integrated biotechnology development, sales and marketing organization. Together, we have the ability to commercialize a revolutionary approach to cancer treatment that benefits cancer patients worldwide." In March, Biomira announced it had completed enrolment of 1,030 women in its Phase III clinical trial with THERATOPE(R) vaccine for metastatic breast cancer. Women were enrolled at over 120 clinical sites in North America, the U.K., Europe, Australia and New Zealand. Final analysis of the trial data is expected to commence in mid-2003 with possible submission to the FDA in 2004. Interim analyses are planned to take advantage of the potential to make THERATOPE(R) vaccine available as soon as possible should results of interim analyses support an earlier filing. In other recent product developments, data from Biomira's pivotal THERATOPE(R) vaccine Phase III trial for approximately 800 patients was reviewed by an independent Data Safety Monitoring Board (DSMB) with a recommendation that the Company should continue its Phase III study for metastatic breast cancer as planned. This is the DSMB's third safety review of the trial. According to the DSMB, "Having reviewed the safety data, the DSMB feels the trial should continue without any modifications." Dr. Alex McPherson explained, "This review from the Data Safety Monitoring Board indicates that we are on track to potentially commence our first interim analysis of the data in the third quarter of this year". Last May the U.S. Food and Drug Administration (FDA) designated THERATOPE(R) vaccine as a Fast Track drug development program in the treatment of metastatic breast cancer. The FDA's Fast Track programs are designed to facilitate the development of drugs for serious or life-threatening conditions that address unmet medical needs, which may lead to an expedited review. In related THERATOPE(R) vaccine developments, Biomira's investigator, Dr. Margaret Tempero of the University of California at San Francisco, presented data at the 37th American Society of Clinical Oncology Meeting, May 12-15, on new data from a Phase II clinical trial of THERATOPE(R) vaccine being tested in metastatic colorectal cancer. The data suggest a survival benefit and that THERATOPE(R) vaccine is well tolerated. This encouraging data, along with data from Biomira's other Phase II colorectal clinical trials, will allow the Company to explore moving into a registration program. Also today, Dr. McPherson described the program advancement of Biomira's second lead product candidate, BLP25 vaccine. Biomira is currently testing BLP25 vaccine in a Phase IIb clinical trial of 166 patients with metastatic non-small cell lung cancer to establish the drug's safety profile and determine whether an immune response against the vaccine translates into clinical survival benefit. The randomized and controlled study is currently being conducted in Canada and the United Kingdom. Dr. McPherson continued, "This year has been an extraordinary one for Biomira. We have worked hard to accomplish our goals, and we believe we have thoroughly succeeded, especially having signed the largest cancer vaccine collaboration with Merck KGaA." Biomira is a biotechnology company specializing in the development of innovative therapeutic approaches to cancer management. Besides completion of enrolment of the multinational Phase III trial with THERATOPE(R) vaccine which is mixed with Corixa's ENHANZYN(TM) adjuvant, Biomira is developing a portfolio of complementary vaccine candidates, including BLP25 vaccine for non- small cell lung cancer, now in Phase IIb trials. The commitment to the treatment of cancer currently focuses on the development of synthetic vaccines and novel strategies for cancer immunotherapy. We are The Cancer Vaccine People(TM). There will be a webcast of the Annual General Meeting commencing at 4:30 p.m. EST and can be accessed at biomira.com. The webcast will be archived for at least 90 days following the meeting at Biomira's website.