Biovail and Celgene Announce d-methylphenidate Filing in Canada.

Business Editors and Health/Medical Writers

WARREN, N.J.--(BW HealthWire)--July 10, 2001

Biovail Corporation (NYSE:BVF)(TSE:BVF) and Celgene Corporation (Nasdaq:CELG) announced today that Biovail Corporation filed a new drug submission (NDS) with Canada's Therapeutic Products Program (TPP) for d-methylphenidate (d-MPH), Celgene's chirally pure version of dl-methylphenidate for the treatment of attention deficit disorder (ADD) and attention deficit hyperactivity disorder (ADHD). As previously announced, Celgene granted Biovail exclusive Canadian marketing rights for d-MPH in exchange for licensing fees and significant royalties. Under Celgene's license with Biovail, the filing of the NDS triggers a milestone payment to Celgene. Biovail's Canadian marketing division Crystaal, will market d-MPH when they receive Notice of Compliance from the TPP. The expected approval of d-MPH is within 18 to 24 months. Celgene licensed the rights to d-MPH for all other markets to Norvartis Pharma AG, which will promote the drug under the trade name RITADEX(TM).

Two pivotal trials evaluating the safety and efficacy of RITADEX in more than 200 children were conducted in both the United States and Canada. Both trials compared RITADEX to placebo. One of the trials also compared the efficacy of both RITADEX and dl-methylphenidate to placebo. Behavioral as well as objective measures were examined and RITADEX demonstrated improved scores over dl-methylphenidate in all parameters measured at the time of last observation (6 hours after dosing). The results of the primary efficacy analysis for the first trial indicated that RITADEX was significantly more effective than placebo (p = 0.0003) as evaluated by a behavioral scale (Teacher SNAP-ADHD), signifying an improvement in the clinical status of the children. The results of the second trial confirmed the drug's efficacy. Both trials confirmed the favorable safety profile of RITADEX.

An open-label study to determine whether a single morning dose of RITADEX will last through the school day has been fully enrolled and will be completed shortly. Celgene also plans to initiate trials to evaluate d-MPH as treatment for cognitive dysfunction and disorders affecting the central nervous system.

The Journal of the American Medical Association has reported that three to six percent of school-age children (elementary to high school) have ADD/ADHD. The condition is characterized by symptoms of inappropriate inattention, hyperactivity and impulsiveness. North American sales of drugs treating the symptoms of ADD and ADHD are estimated to exceed $750 million per year.

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.

Crystaal, a division of Biovail Corporation is dedicated to providing quality pharmaceutical products that create real solutions for Canadian medicine. Founded in 1997, Crystaal's mandate is to achieve strong and sustained growth through partnerships and in-licensing agreements entered into with the global pharmaceutical industry, and with products from Biovail's extensive research and development activities.

Celgene Corporation, located in Warren, New Jersey, is an independent biopharmaceutical company engaged primarily in the discovery, development and commercialization of orally administered, small molecule drugs for the treatment of cancer and inflammatory diseases through gene regulation. Please visit the company's website at www.celgene.com for more information.

This release contains certain forward-looking statements which involve known and unknown risks, delays, uncertainties and other factors not under the Company's control which may cause actual results, performance or achievements of the Company to be materially different from the results, performance or other expectations implied by these forward-looking statements. These factors include results of current or pending research and development activities, actions by the FDA and other regulatory authorities, and those factors detailed in the Company's filings with the Securities and Exchange Commission such as 10K, 10Q and 8K reports.