EAST HANOVER, N.J., and WARREN, N.J., Oct. 2 /PRNewswire/ --
Novartis Pharmaceuticals Corporation and Celgene Corporation announced today
that they received an approvable letter from the U.S. Food and Drug
Administration (FDA) for Ritalin (R) LA (methylphenidate HCl extended-release
capsules) for the treatment of Attention Deficit/Hyperactivity Disorder
(ADHD
). Ritalin LA is a new, once-daily formulation of Ritalin (R)
(methylphenidate HCl), which eliminates the need for a mid-day dose during
school.
An approvable letter usually represents the final step before a product
receives FDA clearance for marketing in the United States. Ritalin LA is part
of a broad partnering agreement between Novartis and Celgene Corporation
(Nasdaq: CELG) encompassing the entire Ritalin product line. Novartis
licensed intellectual property rights related to the formulation of Ritalin LA
from Celgene.
"Novartis is very pleased that the FDA has issued an approvable letter for
Ritalin LA and will work closely with the agency to finalize approval and make
it available in the United States," said Larry Perlow, M.D., Senior Vice
President and General Manager, Commercial Operations, Novartis Pharmaceuticals
Corporation. "Ritalin LA represents an important advance in ADHD treatment.
It will offer physicians, patients and parents a new once-a-day option with
the known safety and efficacy of Ritalin, a product that has helped
generations of people with ADHD. Ritalin LA will be taken once daily, which
will eliminate the need for children to take their medication during the
school day."
Novartis submitted a new drug application (NDA) to the FDA on November 29,
2000. Ritalin LA was shown to significantly improve ADHD symptoms. Overall,
Ritalin LA was considered effective, safe and well tolerated in clinical
trials involving children aged 6 to 12 years.
"Ritalin LA will offer physicians more flexibility in treating children
with ADD and ADHD," said Sol J. Barer, Ph.D., President and Chief Operating
Officer, Celgene Corporation.
ADHD is a neurobiologic disorder that interferes with an individual's
ability to regulate activity level and behavior, and sustain focus in ways
appropriate to his or her age. ADHD is the most studied childhood psychiatric
disorder and is supported by a substantial body of scientific evidence.
Scientific research indicates that ADHD may be related to deficiencies in
certain neurotransmitters in the brain. Novartis supports only the proper
diagnosis and treatment of ADHD.
Ritalin LA will join the Novartis ADHD product portfolio, which includes
Ritalin, Ritalin SR (methylphenidate HCl sustained-release tablets), and
dexmethylphenidate HCl, a refined formulation of Ritalin. Novartis licensed
the worldwide (excluding Canada) marketing and development rights to
dexmethylphenidate HCl from Celgene Corporation.
Novartis Pharmaceuticals Corporation researches, develops, manufactures
and markets leading innovative prescription drugs used to treat a number of
diseases and conditions, including central nervous system disorders, organ
transplantation, cardiovascular diseases, dermatological diseases, respiratory
disorders, cancer and arthritis. The company's mission is to improve people's
lives by pioneering novel healthcare solutions.
The Novartis Group (NYSE: NVS) is a world leader in healthcare with core
businesses in pharmaceuticals, consumer health, generics, eye-care, and animal
health. In 2000, the Group's ongoing businesses achieved sales of CHF 29.1
billion (USD 17.2 billion) and a net income of CHF 6.5 billion (USD 3.9
billion). The Group invested approximately CHF 4.0 billion (USD 2.4 billion)
in R&D. Headquartered in Basel, Switzerland, Novartis employs about 70,000
people and operates in over 140 countries around the world. For further
information please consult http://www.novartis.com.
Celgene Corporation, located in Warren, New Jersey, is an independent
biopharmaceutical company engaged primarily in the discovery, development and
commercialization of orally administered, small molecule drugs for the
treatment of cancer and inflammatory diseases through gene regulation. Please
feel free to visit the Company's web site at http://www.celgene.com.
The foregoing press release contains forward-looking statements that can
be identified by forward looking terminology such as "will", "may", "look
forward to making this new product available", "look forward to working
closely", "should", "can" or similar expressions. Such forward looking
statements involve known and unknown risks, uncertainties and other factors
that may cause the actual results to be materially different from any future
results, performance, or achievements expressed or implied by such statements.
In particular, management's expectation regarding the commercialization of
Ritalin LA could be affected by amongst other things, uncertainties relating
to product development, regulatory actions or delays or government regulation
generally, the ability to obtain or maintain patent or other proprietary
intellectual property protection and competition in general, as well as
factors discussed in the Company's Form 20F filed with the Securities and
Exchange Commission. Should one or more of these risks or uncertainties
materialise, or should underlying assumptions prove incorrect, actual results
may vary materially from those described herein anticipated, believed,
estimated or expected.
Contact:
Regina Moran
Novartis Pharmaceuticals Corporation
973-781-5567
regina.moran@pharma.novartis.com
Denise Brashear
Novartis Pharmaceuticals Corporation
973-781-7336
denise.brashear@pharma.novartis.com
- OR -
Robert J. Hugin
Celgene Corporation
(732) 271-4102
rhugin@celgene.com
Todd Ringler
Feinstein Kean Healthcare
617-761-6791
tringler@fkhealth.com
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SOURCE Novartis Pharmaceuticals Corporation
