Message #61 From:
NewsBot Date: January 16, 2008 09:31:34 AM
Depomed Receives FDA Approval for 1000 mg Strength Tablets of Glumetza
Depomed, Inc. (NASDAQ:DEPO) announced today that it has received
approval from the U.S. Food and Drug Administration (FDA) for the 1000
mg strength tablets of GlumetzaTM (metformin
hydrochloride extended release tablets).
“This approval is good news for patients with
type 2 diabetes who are on metformin therapy and prefer to take fewer
tablets per day,” stated Carl A. Pelzel,
president and chief executive officer of Depomed. “The
American Diabetes Association guidelines recommend that metformin
therapy be titrated to its maximally effective dose, generally regarded
as 2000 mg/day as tolerated. We believe this 1000 mg dosage form is a
great addition to the Glumetza franchise, as we now have two ways for
patients to achieve 24-hour glycemic control: the original Glumetza 500
mg tablets, which start out as small, easy-to-swallow tablets that
expand once in the stomach, and the new 1000 mg tablets, which require
fewer tablets to hit the target dose. We are working very closely with
our commercial supplier, Biovail, to make these tablets commercially
available in the United States in the near future.”
Depomed acquired exclusive United States rights to the 1000 mg
formulation of Glumetza in December 2005 from Biovail, and has a supply
agreement with Biovail related to the formulation. Biovail developed the
new formulation with its Smartcoat™ AQ
technology.
About Diabetes
Diabetes affects an estimated 21 million Americans and its incidence is
increasing by approximately 1.5 million new cases each year in the
United States alone. Approximately 90 percent to 95 percent of people
with diabetes suffer from type 2 diabetes, the most common metabolic
disease in the world and the fifth deadliest disease in the United
States. Diabetes is the leading cause of blindness, end-stage renal
disease, and non-traumatic loss of limb. It can also lead to heart
disease, stroke, high blood pressure, kidney disease, and other serious
conditions. In the United States, the public health cost of diabetes is
more than $130 billion per year. In August 2006, the American Diabetes
Association and the European Association for the Study of Diabetes
issued a consensus statement recommending that treatment with metformin
be initiated at diagnosis along with diet and lifestyle changes in
patients with type 2 diabetes.
About Glumetza™
Glumetza (metformin hydrochloride extended release tablets) is indicated
alone or in combination with a sulfonylurea or insulin as an adjunct to
diet and exercise to improve glycemic control in adult patients (18
years and older) with type 2 diabetes.
Glumetza is contraindicated in patients with renal disease or renal
dysfunction (e.g., as suggested by serum creatinine levels greater than
or equal to 1.5 mg/dL in males and greater than or equal to 1.4 mg/dL in
females), known hypersensitivity to metformin HCl, and acute or chronic
metabolic acidosis, including diabetic ketoacidosis with or without
coma. As with all metformins, there is a boxed warning regarding lactic
acidosis with Glumetza due to metformin accumulation during treatment.
Lactic acidosis is a rare but potentially fatal occurrence. It may also
occur in association with a number of pathophysiologic conditions. The
risk of lactic acidosis increases with the degree of renal dysfunction
and the patient's age, especially patients 80 years of age or older. In
clinical trials of Glumetza combined with a sulfonylurea, the most
common side effects included hypoglycemia, diarrhea, and nausea. For
additional information on the product, please access the prescribing
information at www.glumetzaxr.com.
Smartcoat™ AQ
Smartcoat™ AQ is a proprietary technology
owned by Biovail that allows the manufacturing of very high potency,
controlled-release tablets. A key benefit of the technology is that it
produces high drug loads in smaller-sized tablets while controlling the
release over a 24-hour period. A thin, very strong molecular diffusion
membrane controls the release of the active product ingredient at the
required rate.
Depomed, Inc. is a specialty pharmaceutical company with two approved
products on the market and other product candidates in its pipeline. The
company utilizes its proven, proprietary AcuFormTM
drug delivery technology to improve existing oral medications, allowing
for extended, controlled release of medications to the upper
gastrointestinal tract. Benefits of AcuForm-enhanced pharmaceuticals
include the convenience of once-daily administration, improved treatment
tolerability and enhanced compliance and efficacy. GLUMETZATM
(metformin hydrochloride extended release tablets) is approved for use
in adults with type 2 diabetes and is being marketed in Canada by
Biovail Corporation. ProQuin®
XR (ciprofloxacin hydrochloride) extended release tablets are approved
in the United States for the once-daily treatment of uncomplicated
urinary tract infections and is being marketed in the United States
within the urology and Ob/Gyn specialties by Watson Pharmaceuticals.
Product candidate Gabapentin GR is currently in clinical development for
the treatment of two pain indications. A Phase 2 clinical trial of
Gabapentin GR in menopausal hot flashes is also underway. Additional
information about Depomed may be found on its web site, www.depomedinc.com.
“Safe Harbor" Statement under the
Private Securities Litigation Reform Act of 1995.
Statements in this press release that are not historical facts are
forward-looking statements that involve risks and uncertainties.The
inclusion of forward-looking statements, including those related to the
commercialization of our GLUMETZA 1000 mg tablet, and anticipated
benefits of the 1000 mg formulation of GLUMETZA, should not be regarded
as a representation that any of our plans will be achieved.Actual
results may differ materially from those set forth in this release due
to the risks and uncertainties inherent in our business, including,
without limitation, risks and uncertainties related to:our
research and development efforts, including pre-clinical and clinical
testing; regulation by the FDA and other government agencies; the timing
of regulatory applications and product launches; our ability to
successfully commercialize our products; the success of our
collaborative arrangements with development and commercialization
partners; and other risks detailed in our filings with the Securities
and Exchange Commission filings, including our most recent Annual Report
on Form 10-K and Quarterly report on form 10Q.You are cautioned
not to place undue reliance on these forward-looking statements which
speak only as of the date hereof.We undertake no obligation to
revise or update this release to reflect events or circumstances that
occur after the date of this release.
