DepoMed, Inc. Announces Phase I Furosemide GR Results

Business Wire, Nov 13, 2002

Business Editors/Health & Medical Writers

MENLO PARK, Calif.--(BUSINESS WIRE)--Nov. 13, 2002

DepoMed, Inc. (AMEX:DMI) today announced the results of a Phase I human trial comparing its internally developed, extended release dosage form, Furosemide GR(TM), with the currently marketed immediate release furosemide formulation. Furosemide is a widely prescribed, loop diuretic anti-hypertensive drug, currently sold by Aventis as Lasix(R) and as a generic product by a number of other pharmaceutical companies. The study was conducted in healthy volunteers to assess the comparative efficacy, safety and tolerability of extended release and immediate release furosemide formulations.

The Phase I study compared immediate release furosemide (40 mg) to DepoMed's gastric-retentive furosemide tablet (40 mg). In addition to plasma and urinary levels of the drug, the GI transit and the rate of erosional release of furosemide were determined by gamma scintigraphy. Moreover, the urinary volume and electrolytes were measured to yield the PK/PD relationship. The bioavailability and plasma profiles of the GR tablet were both 90% of the immediate release product. With the GR tablet, diuresis was extended with less urgency, and the total urinary volumes and the total amounts of sodium excreted were nearly identical to the immediate release product. The variability was similar to the immediate release product.

Furosemide GR (40 mg) is a gastric retentive tablet to be administered with food and is intended as a once-a-day product with an extended period of diuresis, which is expected to improve patient compliance. The gastric retention is provided by the tablet swelling to a size that is maintained in the stomach with food, and the drug release is provided by erosion. All excipients are on the FDA's Inactive Ingredients List and the product is covered by one issued DepoMed patent and several patent applications.

"The goal of this project is to develop an extended release diuretic product with reduced side effects and improved patient compliance in congestive heart failure (CHF) patients," stated Bret Berner, Ph.D., DepoMed's Vice President of Product Development. "Diuretics such as immediate release furosemide, cause extreme diuresis following administration (we call it the "Niagara effect") followed by a feeling of dehydration. This urgency to urinate forces patients to plan their medication schedule around the availability of a bathroom, and patients often will avoid taking the medication to prevent the inconvenience. When a CHF patient gets edema from such noncompliance, hospitalization usually follows."

"With these strong results in hand," continued Berner, "we are now planning a Phase II PK/PD trial in CHF patients. We are also stepping up our focus on finding a strong licensing partner for this exciting product."

Furosemide is one of the top selling prescribed oral diuretic drugs in the United States. The drug is marketed as a branded product, Lasix, by Aventis and as a generic product by a number of other pharmaceutical companies.

"We are delighted to report these results for Furosemide GR, our third product to have gone into clinical trials," said John W. Fara, DepoMed's President and CEO. "We believe that the benefits of our patented gastric retention technology are becoming more fully recognized, and the completion of this Phase I clinical trial represents another important milestone for the company and our strategy to develop our own product portfolio. This approach complements our strategy of working broadly with the pharmaceutical industry, incorporating their drugs with our delivery technology."

Dr. Fara will discuss these clinical results today at his presentation at BIO's 8th Annual International Partnering Conference for the Life Sciences in Stuttgart, Germany. The slide presentation can be accessed at DepoMed's website at www.depomedinc.com.

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(TM)) 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.

"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, including pre-clinical and clinical testing; regulation by the FDA and other government agencies; drug reimbursement and pricing; 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.