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Biotech / Medical : Biotime-Nasdaq's best kept secret? -- Ignore unavailable to you. Want to Upgrade?

To: Jim Roof who wrote (1202)	11/20/1998 11:23:00 AM
From: Gravitar	Respond to of 1432

FDA Completes Review of BioTime's New DrugApplication for Hextend, BioTime Pleased With Quick Response November 20, 1998 11:09 AM BERKELEY, Calif.--(BW HealthWire)--Nov. 20, 1998--BioTime, Inc. BTIM announced today that the Food and Drug Administration (FDA) has completed its review of the New Drug Application (NDA) for BioTime's Hextend(R). The review resulted in BioTime receiving an action letter within 33 weeks of the NDA submission. "We are extremely pleased with the FDA's response," said Dr. Paul Segall, BioTime's chief executive officer. "The FDA requested several clarifications to which we will respond immediately, to further expedite approval of the NDA. We do not anticipate any difficulties in replying. The FDA reviewers did not require any additional clinical trials." "We believe that Hextend(R), BioTime's proprietary physiologically-balanced blood plasma volume expander, will become an important option for replacing blood volume lost during surgery and trauma without the risk of contamination by blood borne pathogens. In BioTime's Phase III clinical trials, an average volume of 1.6 liters of Hextend(R) was administered. The study was designed without the intraoperative use of albumin," said Dr. Segall. Albumin has recently been the subject of an FDA letter alerting physicians to a published review which calls into question the medical benefit of albumin and further urged physicians to exercise discretion in its use. Dr. Segall noted that albumin sales within the United States blood plasma expander market are approximately 1.5 million liters annually. Ronald S. Barkin, BioTime's president, stated that "because of the FDA's timely review of BioTime's NDA, we remain optimistic that Hextend(R) will soon become available as an innovative new product for the substantial domestic plasma volume expander market. In the U.S., there are approximately 2.5 million surgeries in which patients lose so much blood that a transfusion is required. In the clinical trials, patients who lost large quantities of blood received as much as 2 to 5 liters of Hextend(R), generally along with blood and blood products." BioTime, headquartered in Berkeley, California, is engaged in the research and development of synthetic blood plasma expanders and hypothermic blood volume replacement solutions and technology for use in surgery, emergency trauma treatment, the preservation of organs awaiting transplant, and for other biomedical applications. Statements contained herein that are not historical facts may constitute forward-looking statements that are subject to risks and uncertainties that could cause actual results to differ materially from those discussed. These factors include complete statistical analysis of clinical trial data, BioTime's ability to obtain FDA and foreign regulatory approval to market Hextend(R), the availability and terms of additional financing, competition from products manufactured and sold or being developed by other companies, and the price of and demand for any BioTime products that are ultimately sold. Top