Biovail In-Licences Canadian Rights to D-Methylphenidate From Celgene.TORONTO--(BW HealthWire)--June 23, 1998--Biovail Corporation International (NYSE NYSE See: New York Stock Exchange :BVF) (TSE See Tokyo Stock Exchange. TSE 1. See Tokyo Stock Exchange (TSE). 2. See Toronto Stock Exchange (TSE). :BVF) today announced that it has entered into a licensing agreement with Celgene Corporation (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on :CELG) for the exclusive marketing rights to d-methylphenidate (d-MPH) in Canada. Crystaal Corporation, a wholly owned subsidiary Wholly Owned Subsidiary A subsidiary whose parent company owns 100% of its common stock. Notes: In other words, the parent company owns the company outright and there are no minority owners. of Biovail, intends to market d-MPH for use in the treatment of Attention Deficit-Hyperactivity Disorder attention deficit-hyperactivity disorder Attention deficit disorder Psychiatry An inability to control behavior due to difficulty in processing neural stimuli, resulting in ↑ motor activity, ↓ attention span Epidemiology ADHD is the most common (ADHD Attention-Deficit/Hyperactivity Disorder (ADHD) Definition Attention-deficit/hyperactivity disorder (ADHD) is a developmental disorder characterized by distractibility, hyperactivity, impulsive behaviors, and the inability to remain focused on tasks or ). d-MPH is the pure and active form of the marketed raecemic version of methylphenidate, offering advantages such as reduced doses, diminished metabolic load and the possibilities of significant reductions in adverse effects and abuse potential that tend to be associated with the use of the raecemic form. Crystaal Corporation ("Crystaal") anticipates filing a New Drug Submission for d-MPH with the Therapeutic Products Directorate Therapeutic Products Directorate (TPD) is a Canadian federal authority that regulates pharmaceutical drugs and medical devices for human use, a role performed by the Food and Drug Administration in the United States. (TPD) during the course of next year. Rolf Reininghaus, President of Crystaal, commented "due to the growing awareness and recognitionof ADHD in children by the public and the medical community, coupled with the growth of diagnoses in adults, the market for therapies aimed at this condition is expected to grow in Canada to U.S.$50 to $100 million by the year 2000 and beyond. Crystaal plans to become the market leader in this segment with the introduction of d-MPH." Concurrent with the licensing agreement, Biovail has entered into a Stock Purchase Agreement whereby Biovail will purchase U.S. $2.5 million of newly issued Celgene Corporation stock. Biovail Corporation International is an international full-service pharmaceutical company, engaged in the formulation, clinical testing, registration and manufacture of drug products utilizing advanced drug delivery technologies. "Safe Harbor" statement under the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and 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 and TPD 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: Crystaal Corporation
Eugene Melnyk, Kenneth Howling or Rolf Reininghaus,
416/285-6000
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