Depomed Submits New Drug Application to FDA for Proquin XR -- Ciprofloxacin GR.

MENLO PARK, Calif. -- Depomed, Inc. (Nasdaq:DEPO) today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Proquin(TM) XR , a once daily, extended release formulation of the antibiotic ciprofloxacin. The company is seeking marketing approval for the treatment of uncomplicated urinary tract infections.

"We are pleased to meet our objective of submitting an application for Proquin XR," said John W. Fara, Ph.D., chairman, president and chief executive officer of Depomed. "We are in discussions with potential marketing partners and are evaluating the opportunity for us to co-promote the product in certain markets. Upon potential approval of Proquin XR, we look forward to providing patients with a once-daily antibiotic that has been shown in our pivotal Phase III trial to offer fewer gastrointestinal side effects, the most common reason patients discontinue treatment."

The company is submitting the NDA based on results seen in its pivotal Phase III clinical trial. The randomized, double-blind Phase III trial involved 1,037 patients with uncomplicated urinary tract infections (UTI). The trial was designed to evaluate the efficacy and safety of a three-day course of treatment with Depomed's once-daily Proquin XR compared to a three-day course of treatment with twice-daily CIPRO(R), an immediate release formulation. The preliminary analysis showed a microbial eradication rate of 93.4 percent in the Proquin XR arm compared with 89.6 percent with CIPRO. Overall gastrointestinal disorders, a complaint of some patients taking ciprofloxacin, were reported in 2.9 percent of patients treated with Proquin XR and 5.1 percent in patients treated with CIPRO. Notably, there were five-fold fewer complaints of nausea and seven-fold fewer cases of diarrhea reported in the Proquin XR group compared to patients treated with CIPRO.

According to the American Foundation for Urological Disease, urinary tract infections 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 $1.1 billion in 2003. Depomed has utilized its proprietary Gastric Retention (GR(TM)) technology to design Proquin XR for preferential absorption in the upper intestine.

Gastric Retention Technology

Depomed's Gastric Retention (GR) System is a patented, oral drug delivery technology designed specifically for drugs that are 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. GR-based products are designed to provide once daily administration, improving patient convenience, compliance and pharmacokinetic profiles.

About Depomed

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. Regulatory applications for once daily Glumetza(TM) (Metformin GR) for the treatment of Type II diabetes have been submitted to agencies in the U.S. and Canada, and the company has completed its Phase III clinical trial with once daily Proquin (TM) XR (ciprofloxacin HCl extended-release tablets) for the treatment of urinary tract infections. The company is also conducting a Phase II trial with the diuretic Furosemide GR and plans to initiate a Phase II trial with the seizure and pain drug Gabapentin GR later in 2004. 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 those related to our research and development efforts, including pre-clinical and clinical testing; regulation by the FDA and other government agencies; arrangements with our collaborative partners; the timing of regulatory applications and product launches; and other risks detailed in the Company's Securities and Exchange Commission filings, including the Company's Annual Report on Form 10-K and Quarterly Reports 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.