Exhibit 99.1
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400 Chestnut
Ridge Road
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Cranbury, New
Jersey 08512
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Woodcliff Lake,
NJ 07677
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201-930-3300
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CONTACT:
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Constance
Bienfait, 954-331-3760
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Carol A. Cox,
201-930-3720
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EMAIL:
cbienfait@kospharm.com
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EMAIL:
ccox@barrlabs.com
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KOS AND BARR ANNOUNCE DEFINITIVE CO-PROMOTION,
MANUFACTURING, AND
SETTLEMENT AGREEMENTS
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Agreements offer benefits to
expanded universe of female patients
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Barr to co-promote
Niaspan ® and Advicor
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to health care
professionals with an interest in women’s
healthcare
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Barr to provide back-up
manufacturing for Kos’ Niaspan product
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License and Settlement Agreement
resolves Niaspan patent litigation
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WOODCLIFF, NJ and CRANBURY, NJ,
April X, 2005 – Kos Pharmaceuticals, Inc. (Nasdaq: KOSP) and
Barr Pharmaceuticals, Inc. (NYSE: BRL) today announced that that
they have signed Co-Promotion, Licensing and Manufacturing, and
Settlement and License Agreements relating to the resolution of the
patent litigation involving Kos’ Niaspan
® products. The United States District Court for
the Southern District of New York entered into a Consent Dismissal
ending the pending litigation between the two companies. These
arrangements have been established to provide benefits to millions
of female patients who have multiple lipid disorders and are
candidates for Kos’ niacin-based pharmaceutical cholesterol
products.
Co-Promotion
Agreement
The Co-Promotion Agreement
provides that Kos and Duramed Pharmaceuticals, a subsidiary of Barr
Pharmaceuticals, will co-promote the current Niaspan and
Advicor ® products, as well as future dosage formulations,
strengths or modified versions of those products (“the
Products”), to obstetricians, gynecologists and other
practitioners with a focus on women’s healthcare in the
United States using a Duramed specialty sales force. Under the
terms of the seven-year agreement (with renewal rights), Kos will
train a 40-person Duramed specialty sales force, which will begin
promoting the Products in mid-2005. In consideration of the
Co-Promotion, Kos will pay Duramed royalties based on quarterly and
yearly net sales of the Products, subject to certain maximum sales
levels. The Co-Promotion would address a new discrete population of
obstetricians, gynecologists and other practitioners with a focus
on women’s healthcare who have not previously been detailed
on Kos’ cholesterol products. Kos’ cholesterol products
could directly serve the growing need to treat the risks of
cardiovascular disease in the 28 million women identified by
the American Heart Association (AHA) who require HDL-C (the
“good” cholesterol) raising therapy.
In February 2004, the AHA
raised its guidelines for HDL-C in women from 40 mg/dl to 50 mg/dl.
The new guidelines also recommended that women maintain
triglycerides levels below 150 mg/dl, a 25% change from past
guidelines. These new guidelines essentially tripled the number of
women who are candidates for Niaspan and Advicor
therapy to about 28 million.
At the same time, a second study
published in Circulation found that nearly two-thirds of
women at highest risk for a heart attack receive no treatment at
all, despite having levels of “good” and
“bad” cholesterol that endanger them . Only
7 percent of women had lipid levels considered optimal by the
AHA women’s guidelines issued last year (LDL-C of less than
100mg/dL and HDL-C above 50 mg/dL).
Settlement and License
Agreement
The Settlement and License
Agreement permits Barr Laboratories to launch generic versions of
Niaspan and
Advicor , as well as future dosage formulations, strengths
or modified versions of the Products, under terms of an exclusive
license commencing on September 20, 2013, approximately four
years earlier than the last-to-expire Kos patent. Upon launch, Barr
would pay Kos a royalty equal to a portion of profits generated
from the sales of generic versions of the Products. As part of the
settlement, Barr admits that Kos’ patents are valid and
enforceable and that Barr infringes the Kos patents.
License and Manufacturing
Agreement
In a separa