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Strategies & Market Trends : Sharck Soup -- Ignore unavailable to you. Want to Upgrade?

To: Sharck who wrote (33355)	8/22/2001 1:12:54 PM
From: canmar	Respond to of 37746

Biomira and Merck KGaA Plan FDA Meeting For Theratope(R) Vaccine Program Review 8/22/2001 12:07:00 PM EDMONTON, Aug 22, 2001 /PRNewswire via COMTEX/ -- Biomira Inc., (BIOM) (BRA) and its collaborator, Merck KGaA, announced today plans for a meeting with the US Food and Drug Administration (FDA). The purpose of the meeting is to review the THERATOPE(R) vaccine regulatory strategy, and agree on the best approach for bringing this product candidate to market. The meeting is expected to take place in early October. To date, Biomira has conducted all meetings with the FDA regarding THERATOPE(R) vaccine. "This will be the first opportunity for Biomira and Merck KGaA, through its US affiliate, EMD Pharmaceuticals, Inc., to collectively meet with the FDA to review the THERATOPE(R) vaccine regulatory strategy," said Alex McPherson, MD, PhD, President and CEO of Biomira. The Company's Phase III trial is progressing as planned with full enrolment of 1,030 patients achieved in March of this year. An interim analysis was to be triggered when a pre-determined number of events for both progression of disease and survival were achieved. Biomira and Merck KGaA will make a decision regarding the analysis of the data upon the completion of this FDA meeting. The Company will provide an update following the results of the discussions with the FDA. Biomira is a biotechnology company specializing in the development of innovative therapeutic approaches to cancer management. The Company has completed enrolment in a multinational Phase III trial with THERATOPE(R) vaccine, as well as developing a portfolio of complementary vaccine candidates, including BLP25 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). This release contains forward-looking statements. Various factors could cause actual results to differ materially from those projected in forward- looking statements, including those predicting the timing or availability of clinical trial analyses, efficacy and clinical benefit of products, timing of regulatory clearances, timing of product launches in different markets, adequacy of financing and reserves on hand, and the achievement of contract milestones. Although the Company believes that the forward-looking statements contained herein are reasonable, it can give no assurance that the Company's expectations are correct. A full discussion of the Company's operations and financial condition, including factors that may affect business and future prospects, is contained in the Company's Annual Information Form filed with regulatory agencies. All forward-looking statements are expressly qualified in their entirety by this Cautionary Statement. For a complete account of our official corporate documents, you are encouraged to review documents filed with the securities regulators. SOURCE Biomira Inc.