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DepoMed and Biovail Report Positive Phase III Clinical Results for Metformin GR Extended Release Formulation.

Business Editors/Health/Medical Writers

MENLO PARK, Calif. and TORONTO--(BUSINESS WIRE)--Feb. 3, 2003

DepoMed's Extended Release Metformin GR Achieves

Clinically Meaningful and Statistically Significant

Once Daily Dosing for Type II Diabetics

DepoMed, Inc. (AMEX:DMI) and Biovail Corporation (NYSE:BVF)(TSX:BVF) today announced positive results for the first pivotal Phase III trial of Metformin GR(TM), DepoMed's extended release formulation of metformin based on its proprietary once-daily gastric retention (GR) technology. North American rights to Metformin GR have been licensed to Biovail Corporation.

In the recently completed study, DepoMed's extended release once-daily Metformin GR produced clinically meaningful and statistically significant reductions in hemoglobin A1C that were at least as large as that seen with immediate release (IR) metformin. The primary efficacy measure was reduction in hemoglobin A1C (HbA1c). Secondary endpoints included various other measures of glycemic control. The trial met its goal of successfully demonstrating non-inferiority of Metformin GR in three different dosing regimens when compared to metformin IR.

Metformin is prescribed for the treatment of Type II diabetes and is currently dosed 2 to 3 times per day as an immediate release product and as a once-a-day product. Bristol- Myers Squibb promotes metformin in the United States as Glucophage(R) (immediate release) and Glucophage XR(R) (once-a-day). Sales of Glucophage and Glucophage XR were approximately $1.3 billion for the twelve months ended September 30, 2002.

"The 'top line' results of this study are both exciting and in line with our expectations," commented John W. Fara, Ph.D., DepoMed's Chairman and CEO. "This is our first product to complete a Phase III trial, and represents a major milestone for the company. A lot of thought went into trial design to maximize our opportunities for success, and the data are right in line with our expectations. We will be analyzing the information in complete detail, but this first look clearly validates our technology and clinical design capabilities."

Rolf K. Reininghaus, President of Biovail Ventures, added, "DepoMed's clinical success is very gratifying, as Metformin GR will be part of Biovail's growing portfolio of pharmaceutical products. DepoMed has consistently met its clinical timeline targets with positive results and we look forward to commercializing this significant product opportunity." Biovail Ventures is a division of Biovail Corporation.

Trial Goals and Next Steps

The Phase III trial was designed to demonstrate non-inferiority to IR dosing of metformin based on primary and secondary endpoints. Patients (250 of the 529) who completed the Phase III trial have been enrolled in an open label follow-on study. A second Phase III trial was begun in June 2002 and is expected to be completed in the second half of 2003. Based on positive trial results, DepoMed and Biovail plan to file an NDA as soon as practicable, currently forecasted for the first half of 2004. While announcing top line data at present, DepoMed intends to present detailed data from the study at a future conference opportunity.

Overall Study Design and Plan

The Phase III clinical trial was designed to evaluate the efficacy and safety of Metformin GR, DepoMed's extended release metformin formulation, in the treatment of Type II diabetes when compared to metformin IR.

Trial Design:

In a randomized, double blind treatment protocol, Type II diabetic patients were randomized to receive Metformin GR doses or metformin IR. Five hundred and thirty six (536) patients completed the 24-week course of treatment. The primary efficacy measure was reduction in hemoglobin A1C (HbA1c). The clinical trial was designed as a multi-center, randomized, double-blind (double-dummy), active controlled, dose ranging, parallel group clinical study of three regimens of Metformin GR compared to metformin IR. Newly diagnosed patients, diet/exercise patients, or patients on antihyperglycemic medication were enrolled.

Efficacy Assessment:

The primary efficacy outcome was glycemic control determined by the baseline-adjusted differences between treatment groups in HbA1c at the completion of the study (week 24). Secondary assessments of efficacy included various other measures of glycemic control.

Assessments of Safety:

GI symptoms and other adverse events were collected, as were laboratory assessments of blood chemistry and hematology and urinalysis, physical examinations, ECG's, and use of concomitant medications.

DepoMed, Inc., a development stage company, is applying its innovative oral drug delivery systems to the development of novel oral products and improved formulations of existing oral drugs. DepoMed's Gastric Retention (GR) System is a patented oral drug delivery technology designed specifically for drugs preferentially absorbed high in the gastrointestinal tract. Using normal physiological processes by which the stomach retains large objects for further digestion, the GR System swells following ingestion and is retained in the stomach for a number of hours, while it continuously releases the incorporated drug at a controlled rate to absorption sites in the upper intestinal tract. The controlled release of the drug at the preferred absorption site optimizes delivery of the drug during the "therapeutic window," potentially maximizing its therapeutic benefits. In addition to developing products jointly with other companies, DepoMed is developing its own line of proprietary products based on off-patent and over-the-counter drugs.

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. The statements that are not historical facts contained in this release are forward-looking statements that involve risks and uncertainties including, but not limited to those related to the drug development process; disputes arising from collaborative agreements; competition; the protection of patents and other proprietary rights; and other risks detailed in the Company's Securities and Exchange Commission filings, including the Company's Annual Report on Form 10-K for the fiscal year ended December 31, 2001 and the Company's most recent Quarterly Report on Form 10-Q. You are cautioned not to place undue reliance on these forward-looking statements which speak only as of the date hereof. The Company undertakes no obligation to publicly release the result of any revisions to these forward-looking statements that may be made to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
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Publication:Business Wire
Geographic Code:1USA
Date:Feb 3, 2003
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