Biovail Corporation

Biovail Corporation
Depomed, Inc.

Depomed, Inc.

March 01, 2005 08:31 ET

Biovail, Depomed Receive Approvable Letter from FDA for Extended-Release Glumetza for Type II Diabetes


NEWS RELEASE TRANSMITTED BY CCNMatthews

FOR: BIOVAIL CORPORATION

NYSE, TSX SYMBOL: BVF

AND DEPOMED, INC.

NASDAQ SYMBOL: DEPO

MARCH 1, 2005 - 08:31 ET

Biovail, Depomed Receive Approvable Letter from FDA
for Extended-Release Glumetza for Type II Diabetes

TORONTO and MENLO PARK, Calif.--(CCNMatthews - Mar 1, 2005) -

Biovail Corporation (NYSE:BVF) (TSX:BVF) and Depomed, Inc. (Nasdaq:DEPO)
announced today that they have received an Approvable Letter from the
United States Food and Drug Administration (FDA) regarding a New Drug
Application (NDA) for Glumetza™, a once-daily, extended-release
formulation of metformin hydrochloride (HCl) for the treatment of Type
II diabetes.

The letter indicated that Glumetza™ is approvable pending the
completion of discussions with regard to an issue related to finalizing
one manufacturing specification. Biovail anticipates submitting a
response to the FDA in the coming weeks. No clinical or labeling issues
were identified in the letter.

Biovail's NDA for Glumetza™ - in 500mg and 1,000mg dosage forms - was
filed with the FDA for review in April 2004. Subject to final FDA
approval, the companies believe extended-release Glumetza™ 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™ may include less frequent
dosing, excellent tolerability, and the ability to more quickly
administer a high enough dose to provide glycemic control without
significantly increasing the incidence of nausea, diarrhea and other
side effects that are sometimes caused by metformin products.

The 500mg dosage strength was developed using Depomed's Gastric
Retention (GR™) drug- delivery technology. The 1,000mg dosage
strength was developed using Biovail's Smartcoat delivery technology.

"Glumetza™ is an excellent product that, upon approval, will greatly
enhance the quality of life of Americans who suffer from Type II
diabetes," said Dr. Douglas Squires, Chief Executive Officer of Biovail
Corporation. "The large majority of patients who currently take
metformin use the 500mg dosage. Our once-daily 1,000mg dosage will
especially benefit the roughly 35 per cent of diabetes patients who
require additional glycemic control."

Dr. John W. Fara, Chairman, President and Chief Executive Officer of
Depomed, added that metformin is extremely well suited to improvement
with Depomed's patented Gastric Retention (GR™) drug-delivery
technology because it is preferentially absorbed in the upper GI tract.

"Not only have we created a product that offers the convenience of
once-daily dosing, but in clinical trials, we saw that Glumetza™ has
excellent tolerability, which is important because side effects, such as
nausea and diarrhea, are thought to be a primary reason that 60% of
patients prescribed metformin are no longer taking their medication as
prescribed after the first year," Dr. Fara explained.

Biovail and Depomed are also able to provide doctors with Phase III data
confirming Glumetza™'s effectiveness in combination with the
sulfonylurea glyburide, which is frequently prescribed with metformin.

"Glumetza™'s effectiveness in combination with other diabetes drugs
is key because the American College of Endocrinology and American
Association of Clinical Endocrinologists recently recommended that
physicians aggressively treat diabetes early, often with two or more
drugs," Dr. Fara said.

Glumetza™ will vie for a share of the $6-billion oral diabetes drug
market in the United States, which was characterized by year-over-year
growth of 4.5% in 2004. In 2004, about 108.5 million prescriptions were
written for oral diabetes products to treat Type II diabetes, and
metformin products captured 34% of that market in terms of total
prescriptions. Additionally, metformin products captured the highest
share of the market in terms of new prescriptions in 2004.

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. Biovail
anticipates having an agreement in place with a marketing partner during
the first half of 2005.

A New Drug Submission for Glumetza™ in Canada is currently under
review by the Therapeutic Products Directorate. Upon final approval from
the TPD, Biovail fully 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. The
Company is also in negotiations with potential partners regarding
additional territories.

About Glumetza™

Glumetza™ 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 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.

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 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 Depomed Inc.

Depomed, Inc. is a specialty pharmaceutical company utilizing its
innovative Gastric Retention (GR™) 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. In addition to Glumetza™, an NDA has
been submitted to the FDA for once daily Proquin™ XR (ciprofloxacin
HCl extended-release tablets) for the treatment of urinary tract
infections. The company is also conducting Phase II trials with the
diuretic Furosemide GR and the seizure and pain drug Gabapentin GR.
Additional information about Depomed may be found at its Web site, at
www.depomedinc.com.

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.

"Safe Harbor" Statement Under the Private Securities Litigation Reform
Act 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 ("OSC"). Biovail Corporation and Depomed, Inc. undertake no
obligation to update or revise any forward-looking statement.

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Contact Information

  • FOR FURTHER INFORMATION PLEASE CONTACT:
    Biovail Corporation
    Kenneth G. Howling, 905-286-3000
    or
    Depomed, Inc.
    John Hamilton, 650-462-5900