MENLO PARK, Calif. & TORONTO, Ontario, Dec 10, 2003 (BUSINESS WIRE) -- Depomed, Inc. (AMEX: DMI) and Biovail Corporation (NYSE, TSX: BVF) today announced positive top line results from the second pivotal Phase III clinical trial of Metformin GR(TM), a once daily, extended release formulation of the leading diabetes drug metformin based on Depomed's proprietary Gastric Retention (GR(TM)) drug delivery system.
Having demonstrated safety and efficacy of Metformin GR alone in the first Phase III pivotal trial conducted earlier this year, Depomed's second pivotal trial addressed, among other parameters, the common prescribing and dosing practices in the treatment of Type II diabetic patients in which sulfonylureas are often administered. The multi-center, double blind, randomized Phase III trial compared the safety, efficacy and tolerability of Metformin GR in combination with glyburide, a sulfonylurea (SU), and glyburide alone in Type II diabetes patients. Following a six-week stabilization period on SU alone, 575 Type II diabetes patients were randomized to one of four treatment groups: SU alone or SU and one of three different Metformin GR doses for six months. In the trial, the Metformin GR+glyburide combination treatment achieved its primary endpoint of producing clinically large and statistically significant (p<.001 reductions="" in="" hemoglobin="" a1c="" an="" indicator="" of="" long-term="" control="" glucose="" levels="" type="" ii="" diabetes.="" additionally="" metformin="" gr="" produced="" clinically="" large="" and="" statistically="" significant="" every="" other="" measure="" glycemic="" lipid="" compared="" to="" treatment="" with="" the="" sulfonylurea="" alone.="" trial="" showed="" combination="" be="" extremely="" well="" tolerated="" a="" low="" incidence="" gi="" side="" effects.="" depomed="" biovail="" expect="" file="" new="" drug="" application="" for="" once="" daily="" first="" half="">
In Depomed's first pivotal Phase III trial of Metformin GR, 536 patients were randomized to receive one of several doses of Metformin GR or Glucophage(R), Bristol-Myers Squibb's immediate release, twice daily formulation of metformin HCl. Treatment with Metformin GR produced clinically meaningful and statistically significant reductions in HbA1c, and all doses of Metformin GR were well tolerated and controlled glucose levels as effectively as immediate release metformin. For complete results, please refer to Depomed's news release dated February 3, 2003. Similar outcomes were seen in the open-label extension study following the Phase III trial, the results of which were announced in August 2003. In the open-label trial, all 250 patients, including those switched from Glucophage in the Phase III trial to Metformin GR in the open-label trial, maintained good control of glucose levels.
"We are delighted to see the results of this latest trial. Metformin GR will be a key component of Biovail's portfolio of products addressing the $8 billion diabetes market," said Eugene Melnyk, Chairman and CEO of Biovail Corporation. "Once daily metformin products such as Metformin GR are quickly growing in popularity among both physicians and patients, and we look forward to continuing our collaboration with Depomed and filing an NDA for Metformin GR in the first half of 2004."
"The preliminary analyses of our second pivotal Phase III trial of Metformin GR reinforce the positive results obtained in our first Phase III trial and in our open-label extension follow-on study. In all three trials, Metformin GR was well tolerated and controlled glucose levels in patients with Type II diabetes," said John W. Fara, Ph.D., Chairman, President and CEO of Depomed. "Additionally, the clinical superiority of Metformin GR in combination therapy highlights the value of Depomed's technology and may provide a powerful new treatment tool to physicians. These consistently positive results further validate the ability of our Gastric Retention system to optimize controlled-release drug delivery, and we look forward to maintaining this momentum as we continue to advance clinical development of the additional Gastric Retention products we have in our pipeline."
Diabetes affects an estimated 17 million Americans and is increasing by approximately 1 million new cases each year in the U.S. alone. Approximately 90% of diabetics suffer from Type II diabetes, which can cause symptoms including weight loss, blindness, kidney failure, heart disease and death if not treated. Metformin is a leading treatment for Type II diabetes, and while immediate release formulations must be administered two to three times per day, newer extended release formulations offer the increasingly popular option of once daily dosing. In 2002, sales of the extended release metformin product Glucophage XR accounted for approximately 38% of the $778 million Glucophage franchise, growing to 43% by the end of Q3 2003. Depomed's Metformin GR is a once daily formulation of metformin that offers the therapeutic benefits of Depomed's proprietary Gastric Retention (GR) System. North American rights to Metformin GR have been licensed to Biovail Corporation.
PADDERS Taupe Sunshine Mary Women's Beige Jane Depomed's Gastric Retention (GR) Technology
Depomed's 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 and decreasing gastrointestinal side effects.
Sunshine PADDERS Mary Women's Beige Taupe Jane Depomed, Inc. is a specialty pharmaceutical company utilizing its innovative Gastric Retention (GR(TM)) system to develop novel oral products and improved formulations of existing oral drugs. GR-based products are designed to provide once daily administration and reduced gastrointestinal side effects, improving patient convenience, compliance and pharmacokinetic profiles. Depomed has completed Phase III clinical trials with once daily Metformin GR(TM) for the treatment of Type II diabetes and once daily Ciprofloxacin GR(TM) for the treatment of urinary tract infections, and anticipates filing NDAs with both products in the first half of 2004. The Company has also completed Phase I trials with the seizure and pain drug Gabapentin GR(TM) and the diuretic Furosemide GR(TM), and anticipates initiating Phase II trials with both products in the first half of 2004. Additionally, Depomed has a strong early-stage pipeline of proprietary and co-development products based on off-patent and over-the-counter drugs. Additional information about Depomed may be found at its web site, www.depomedinc.com.
Mary Jane Beige Taupe PADDERS Women's Sunshine Biovail Corporation
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, the results of research and development efforts, the results of pre-clinical and clinical testing, the effect of regulation by the FDA and other agencies, dependence on collaborative partners, our need for additional capital and other risks detailed in Depomed's Securities and Exchange Commission filings, including, Depomed's Quarterly Report on Form 10-Q for the fiscal quarter ended September 30, 2003 and Registration Statement on Form S-3 filed on September 22, 2003, as amended. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Depomed 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.
Jane Mary PADDERS Women's Taupe Beige Sunshine SOURCE: Depomed Inc. Depomed, Inc. John F. Hamilton, VP & CFO, 650-462-5900 email@example.com or Biovail Corporation Ken Howling, Vice President, Finance, 905-286-3000 or Media Contact: Atkins + Associates for Depomed, Inc. Trista Morrison, 858-527-3490 firstname.lastname@example.org Customize your Business Wire news & multimedia to match your needs. Get breaking news from companies and organizations worldwide. Logon for FREE today at www.BusinessWire.com. Copyright (C) 2003 Business Wire. All rights reserved. News Provided by COMTEX