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Biovail Files NDA for Zolpidem FlashDose Product TORONTO, Jan 10, 2002 (BW HealthWire) -- Biovail Corporation (NYSE:BVF)(TSE:BVF) today announced the filing of a New Drug Application (NDA) for a FlashDose(R) version of zolpidem tartrate with the Food and Drug Administration (FDA). Zolpidem tartrate is indicated for the short-term treatment of insomnia and is marketed under the brand name Ambien(R) by Pharmacia Corporation. Ambien(R) sales for the twelve month period ended September 2001 were in excess of $900 million. FlashDose(R), Biovail's proprietary oral drug delivery dosage format, represents a novel, convenient method of administration versus traditional tablets and capsules and in certain circumstances, can provide enhancements to the performance of the medication including a more rapid onset of action and a reduction in adverse effects. FlashDose(R) administration provides doctors with prescribing flexibility that can be advantageous when addressing the needs of certain patients. Ease of administration, an important consideration in various health care facility settings, is of particular interest to the segment of patients that have difficulty ingesting conventional dosage forms, which is estimated to be approximately 15% of patient populations. Biovail also will be commencing a number of clinical studies to show product differentiation and advantages over the currently marketed competitive products. Biovail Corporation is an international full-service pharmaceutical company, engaged in the formulation, clinical testing, registration, manufacture, sale and promotion of pharmaceutical products utilizing advanced drug delivery technologies.
"Safe Harbor" Statement under the Private Securities Litigation
Reform Act of 1995.
To the extent any statements made in this release contain information that is
not historical, these statements are essentially forward looking and are subject
to risks and uncertainties, including the difficulty of predicting FDA
approvals, acceptance and demand for new pharmaceutical products, the impact of
competitive products and pricing, new product development and launch, reliance
on key strategic alliances, availability of raw materials, the regulatory
environment, fluctuations in operating results and other risks detailed from
time to time in the company's filings with the Securities and Exchange
Commission.
CONTACT: Biovail Corporation
Ken Howling, 416/285-6000
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