Depomed, Biovail Update Status of Glumetza NDA.MENLO PARK, Calif. -- Depomed, Inc. (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on :DEPO DEPO Delegated Episcopal Pastoral Oversight DEPO Devils Postpile National Monument (US National Park Service) DEPO Defence Export Promotion Organization (Pakistan) DEPO Double Even Pass Odd ) and Biovail Corporation (NYSE NYSE See: New York Stock Exchange :BVF BVF Biovail Corporation (stock symbol) BVF Berufsverband der Frauenärzte eV (Muenchen, Germany) BVF Bearing Versus Frequency )(TSX:BVF) today announced that a response has been submitted to the United States Food and Drug Administration United States Food and Drug Administration (FDA), n.pr a unit of the Public Health Service created to protect the health of the nation against impure and unsafe foods, drugs, and cosmetics. (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) regarding an outstanding inquiry on the New Drug Application (NDA (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any ) for Glumetza(TM), a once-daily, extended-release formulation of metformin hydrochloride (HCl) for the treatment of Type II diabetes Type II diabetes Type II diabetes is the most common form of diabetes and usually appears in middle aged adults. It is often associated with obesity and may be delayed or controlled with diet and exercise. Mentioned in: Diabetic Ketoacidosis . Last month, the companies announced that the NDA for Glumetza was deemed "Approvable" by the FDA, pending the resolution of an issue related to finalizing a manufacturing specification. This issue was addressed in a response which was filed at the FDA on April 8, 2005. Depomed and Biovail believe that the response will be considered as a Class I response, which carries a 60-day review period. Within 30 days of final approval, Biovail will make a $25 million milestone payment to Depomed. Biovail, which holds the commercialization rights for Glumetza for the United States and Canada, is currently in discussions with several potential partners to market Glumetza in the U.S. A New Drug Submission for Glumetza in Canada is currently under review by the Therapeutic Products Directorate Therapeutic Products Directorate (TPD) is a Canadian federal authority that regulates pharmaceutical drugs and medical devices for human use, a role performed by the Food and Drug Administration in the United States. . Upon final approval from the TPD, Biovail intends to commercialize Glumetza in Canada through Biovail Pharmaceuticals Canada, the Canadian sales and marketing division of Biovail Corporation. Elsewhere, Depomed has entered into an agreement with LG Life Sciences for the commercialization and distribution of Glumetza in Korea. Depomed is also in discussions with potential partners regarding additional territories. About Glumetza(TM) Glumetza(TM) is a once-daily extended-release formulation of metformin HCl and is intended to control diabetes mellitus -- a condition characterized by high levels of blood glucose resulting from defects in insulin secretion, insulin activity or both. Metformin is indicated for the control of hyperglycemia hyperglycemia: see diabetes. in metformin-responsive, stable, mild, non-ketosis prone maturity onset type of diabetes (Type II) which cannot be controlled by proper dietary management, exercise and weight reduction and when insulin therapy is not appropriate. Glumetza(TM) may offer potential advantages and prescribing flexibility to physicians that may be advantageous when addressing the needs of certain patients who suffer from diabetes. The benefits of Glumetza(TM) may include less frequent dosing, excellent tolerability, and the ability to more quickly administer a high enough dose to provide glycemic Glycemic The presence of glucose in the blood. Mentioned in: Cholesterol, High glycemic pertaining to the level of glucose in the blood. control without significantly increasing the incidence of nausea, diarrhea and other side effects that are sometimes caused by metformin products. About Diabetes Diabetes affects an estimated 18 million Americans and is increasing by about one million new cases each year in the U.S. alone. Approximately 90% of diabetics suffer from Type II diabetes, the most common metabolic disease in the world and the fifth-deadliest disease in the U.S. Diabetes is the leading cause of blindness, end-stage renal disease End-stage renal disease (ESRD) Total kidney failure; chronic kidney failure is diagnosed as ESRD when kidney function falls to 5-10% of capacity. Mentioned in: Chronic Kidney Failure end-stage renal disease and non-traumatic loss of limb and can also lead to heart disease, stroke, high blood pressure, kidney disease and other serious conditions. In the U.S., the public health cost of diabetes is more than $130 billion per year. About 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. For more information about Biovail, visit the company's Web site at www.biovail.com. For further information, please contact Ken Howling at 905-286-3000 or send inquiries to ir@biovail.com. Depomed, Inc. Depomed, Inc. is a specialty pharmaceutical company utilizing its innovative Gastric Retention (GR(TM)) system to develop novel oral products and improved, extended release 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. Depomed has been notified that the NDA for Glumetza is approvable. In addition, an NDA has been submitted to the FDA for once daily Proquin(TM) (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 furosemide /fu·ro·sem·ide/ (fu-ro´se-mid) a loop diuretic used in the treatment of edema and hypertension. fu·ro·se·mide n. A white to yellow crystalline powder used as a diuretic. GR and a Phase II trial with the pain drug Gabapentin GR. Additional information about Depomed may be found at its web site, www.depomedinc.com. "Safe Harbor" Statement Under the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and of 1995 To the extent any statements made in this release contain information that is not historical, these statements are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. We have based these forward-looking statements on our current expectations and projections about future events. Our actual results could differ materially from those discussed in, or implied by, these forward-looking statements. Forward-looking statements are identified by words such as "believe", "anticipate", "expect", "intend", "plan", "will", "may" and other similar expressions. In addition, any statements that refer to expectations, projections or other characterizations of future events or circumstances are forward-looking statements. Forward-looking statements include, but are not necessarily limited to, risks and uncertainties, including the difficulty of predicting U.S. Food and Drug Administration ("FDA") and Canadian Therapeutic Products Directorate ("TPD") approvals, acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, new product development and launch, reliance on key strategic alliances, availability of raw materials and finished products, third parties, the regulatory environment, fluctuations in operating results and other risks detailed from time to time in the companies' filings with the Securities and Exchange Commission ("SEC") and the Ontario Securities Commission The Ontario Securities Commission (OSC) is a regulatory agency which administers and enforces securities legislation in the Canadian province of Ontario. The OSC is an Ontario Crown corporation which reports to the Ontario legislature through the Minister of Finance. ("OSC O.S.C. n. short for Order to Show Cause. (See: Order to Show Cause) "). Biovail Corporation and Depomed, Inc. undertake no obligation to update or revise any forward-looking statement. |
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