29.10.2007 21:10:00
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Depomed and King Pharmaceuticals Terminate Promotion Agreement for GLUMETZA(TM)
Depomed, Inc. (NASDAQ:DEPO) and King Pharmaceuticals, Inc. (NYSE:KG)
today announced that they have terminated their promotion agreement for
GLUMETZA™ (metformin hydrochloride
extended-release tablets), a once-daily extended-release formulation of
metformin for the treatment of patients with Type 2 diabetes that
Depomed developed utilizing its proprietary AcuForm™
drug delivery technology.
Pursuant to the terms of the termination agreement, King has paid
Depomed termination and other fees of approximately $30 million, and
Depomed will not pay King a promotion fee for the quarter ending
December 31, 2007. King will fulfill its GLUMETZA promotion obligations
through the end of 2007. Payments to Depomed associated with the
termination of the promotion agreement were included as part of the
estimated restructuring charge King announced on October 18, 2007.
"We are very grateful to King for their
efforts and achievements in launching and promoting GLUMETZA, and for
their cooperation in swiftly arriving at an amicable and fair
termination arrangement,” stated Carl A.
Pelzel, president and chief executive officer of Depomed, Inc.
"Our joint efforts in launching GLUMETZA have
demonstrated the product’s value to patients
and its commercial potential. Discussions with potential new marketing
partners for GLUMETZA are already underway. We are confident that we can
identify a partner that will assist us in continuing to drive growth in
the primary care, endocrinology and other key healthcare markets. In the
meantime, a portion of the proceeds from this termination agreement will
be earmarked for the continued marketing and promotion of GLUMETZA,”
Mr. Pelzel added.
Steve Andrzejewski, chief commercial officer of King Pharmaceuticals,
stated, "We believe GLUMETZA is an excellent
product. However, in light of recent events, our strategic plan to
maximize long-term growth requires us to increase our focus on our
neuroscience and hospital/acute care platforms.” About GLUMETZA™
GLUMETZA™ is a once-daily, extended-release
formulation of metformin HCl indicated as an adjunct to diet and
exercise to improve glycemic control in adult patients (18 years and
older) with Type 2 diabetes. GLUMETZA may be used concomitantly with a
sulfonylurea or insulin to improve glycemic control in adults.
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), congestive heart failure, 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
warning regarding lactic acidosis with Glumetza™.
For additional information on the product, please access the package
insert at http://www.depomedinc.com/view.cfm/1330/
Glumetza-Full-Prescribing-Information (Due to its length, this
URL may need to be copied/pasted into your Internet browser's address
field. Remove the extra space if one exists.).
About Diabetes
Diabetes affects an estimated 20 million Americans and its incidence is
increasing by approximately one million new cases each year in the U.S.
alone. Approximately 90-95% of diabetics suffer from Type 2 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
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 the United
States by King Pharmaceuticals and 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 will be 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.
About King Pharmaceuticals
King Pharmaceuticals, Inc., headquartered in Bristol, Tennessee, is a
vertically integrated pharmaceutical company that develops,
manufactures, markets and sells branded prescription pharmaceutical
products. King Pharmaceuticals, Inc., an S&P 500 Index company, seeks to
identify promising opportunities in the pharmaceutical industry through
the development, including through in-licensing arrangements and
acquisitions, of novel branded prescription pharmaceutical products in
attractive markets and the strategic acquisition of branded products
that can benefit from focused promotion and marketing and product
life-cycle management.
"Safe Harbor”
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
transition and commercialization of GLUMETZA™,
should not be regarded as a representation that any of Depomed or King’s
plans will be achieved. Actual results may differ materially from
those set forth in this release due to the risks and uncertainties
inherent in Depomed and King’s business,
including, without limitation, risks and uncertainties related to: Regulation
by the FDA and other government agencies; the timing of product
launches; Depomed and King’s ability to
successfully commercialize their products, including GLUMETZA™;
the success of Depomed and King’s
collaborative arrangements with development and commercialization
partners; and other risks detailed in Depomed and King’s
filings with the Securities and Exchange Commission, including their
most recent Annual Reports on Form 10-K. You are cautioned not to
place undue reliance on these forward-looking statements which speak
only as of the date hereof. Depomed and King undertake no
obligation to revise or update this release to reflect events or
circumstances that occur after the date of this release.
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