Category: Uncategorized
September 4, 2003

News Release: Depomed Provides Update on Phase III Trial of Ciprofloxacin GR at Thomas Weisel Partners Healthcare Conference

Depomed, Inc. (AMEX: DMI) today announced that Chairman, President and CEO John W. Fara, Ph.D., will present an update on Depomed's Phase III clinical trial of Ciprofloxacin GR(TM) on Thursday, September 4, 2003 at 3:50 p.m. (EST) during the Thomas Weisel Partners Healthcare Tailwinds 2003 Conference. The conference is taking place at the Four Seasons Hotel in Boston, Mass.

Depomed is currently conducting a randomized, double-blind Phase III clinical trial for the treatment of uncomplicated urinary tract infections (UTI) that compares Depomed's once daily, oral antimicrobial Ciprofloxacin GR with CIPRO(R), Bayer's twice daily, immediate release formulation. Clinical laboratory results from the Phase III trial are consistent, with Ciprofloxacin GR and Cipro treatment groups showing comparable eradication of the organisms responsible for UTIs. The trial is designed to show the non-inferiority of once daily Ciprofloxacin GR compared to twice daily CIPRO. The Phase III trial has already enrolled approximately two-thirds of the planned 760 patients, and Depomed expects to complete the trial in the first quarter of 2004. The analysis was conducted on still-blinded current data to date.

'The current data reinforce the results of our previous Phase II trial in which Ciprofloxacin GR was shown to be as effective as CIPRO in the treatment of UTIs, but with the added convenience of once-a-day dosing,'said Fara. 'Patient enrollment for this trial is currently on schedule, and we look forward to continuing our momentum with both Ciprofloxacin GR and Metformin GR(TM), which will complete the clinical portion of its second pivotal Phase III trial for the treatment of Type II diabetes this October.'

The analysis of the Ciprofloxacin GR Phase III trial evaluated the laboratory results of the treated patients, some of whom received 500 mg of once daily Ciprofloxacin GR and the balance of whom received 250 mg of CIPRO twice daily. At both one week and five weeks following treatment, patients in both groups exhibited comparable evidence of eradication of causative organisms of UTI. Additional data, including data relating to any adverse events, will be available following the completion of the Phase III trial.

According to the American Foundation for Urological Disease, urinary tract infections (UTIs) result in as many as 10 million visits to physicians each year. UTIs are bacterial infections frequently caused by E. coli and are typically treated with antibiotics. Bayer's CIPRO is the leading oral antibiotic in the U.S., with sales of $1.5 billion worldwide in 2002. Depomed has utilized its proprietary Gastric Retention (GR(TM)) technology to design once daily Ciprofloxacin GR for preferential absorption in the upper intestine. Ciprofloxacin GR has been shown in Phase I and II trials to eliminate UTIs as effectively as CIPRO, but with fewer side effects.

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.

Depomed, Inc.

Depomed, Inc. is a specialty pharmaceutical company utilizing its innovative Gastric Retention (GR(TM)) system to develop new and novel oral products as well as improved formulations of existing oral drugs. Depomed's products are designed to provide once daily administration and reduced gastrointestinal side effects, improving patient convenience, compliance and pharmacokinetic profiles. Depomed's lead product, Metformin GR(TM), is currently undergoing a second Phase III trial for the treatment of Type II diabetes and the Company anticipates filing an NDA with partner Biovail in the first half of 2004. Depomed is also conducting a Phase III trial with its once daily antibiotic Ciprofloxacin GR(TM) for the treatment of urinary tract infections, which is expected to be complete in the first quarter of 2004. In addition to its Phase III products, Depomed has a strong 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.

'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 pre-clinical and clinical testing, the effect of regulation by the FDA and other agencies, the impact of competitive products, 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 June 30, 2003 and Annual Report on Form 10-K for the fiscal year ended December 31, 2002. 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.

SOURCE: Depomed, Inc.

Depomed, Inc. John F. Hamilton, 650-462-5900 This email address is being protected from spambots. You need JavaScript enabled to view it. or Atkins + Associates Trista Morrison, 858-527-3490 (Media Contact) This email address is being protected from spambots. You need JavaScript enabled to view it.

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