PALO ALTO, Calif., Dec. 18 /PRNewswire-FirstCall/ -- Jazz Pharmaceuticals,
Inc. (Nasdaq: JAZZ) announced today that the U.S. Patent and Trademark Office
has issued U.S. Patent No. 7,465,462 covering its Once-A-Day LUVOX CR(R)
(fluvoxamine maleate) Extended-Release Capsule product. The patent was
assigned to Elan Pharma International Limited and is exclusively licensed to
Jazz Pharmaceuticals in the United States through a product license agreement
with Solvay Pharmaceuticals, Inc. The patent claims the formulation
incorporating Elan's SODAS(R) (Spheroidal Oral Drug Absorption System)
technology, as well as a method of using the formulation for the treatment of
obsessive compulsive disorder (OCD).
LUVOX CR(R) was approved on February 28, 2008 by the U.S. Food and Drug
Administration (FDA) for the treatment of social anxiety disorder (SAD) and
obsessive compulsive disorder (OCD) in adults. The patent has been listed for
LUVOX CR(R) in the FDA Orange Book.
About the FDA Orange Book
The FDA's Approved Drug Products List with Therapeutic Equivalence
Evaluations, commonly referred to as the Orange Book, lists all drug products
that have been approved by FDA for safety and effectiveness. The Orange Book
also includes information on patents which claim an approved drug product or
method of use of the drug product, to facilitate the legal requirement that
generic drug applicants include an appropriate certification to each such
patent as part of any Abbreviated New Drug Application (ANDA) for a generic
version of a listed drug.
About Elan Drug Technologies
Elan's Drug Technologies group has developed LUVOX CR using one of its
proprietary Oral Controlled Release Technologies, the SODAS(R) (Spheroidal
Oral Drug Absorption System) Technology. Elan Drug Technologies (EDT) is an
established, profitable and growing specialty pharmaceutical business unit of
Elan Corporation, plc. For nearly 40 years, EDT has been applying its skills
and knowledge to enhance the performance of dozens of drugs that have been
marketed worldwide. EDT is focused on using its extensive experience,
proprietary drug delivery technologies and licensing capabilities to develop
innovative products that deliver clinically meaningful benefits to patients.
More information about EDT's broad range of technologies including their Oral
Controlled Release and NanoCrystal(R) Technology Platforms, and its range of
services is available at http://www.elan.com/EDT.
About Jazz Pharmaceuticals, Inc.
Jazz Pharmaceuticals is a specialty pharmaceutical company that
identifies, develops and commercializes innovative treatments for important,
underserved markets in neurology and psychiatry. The Company has an unwavering
commitment to improving care for patients with serious psychiatric and
neurological conditions through innovative treatments and distinctive and
valuable programs for patients and physicians. For further information see
http://www.JazzPharmaceuticals.com.
"Safe Harbor" Statement under the Private Securities Litigation Reform Act
of 1995
This press release contains forward-looking statements, including, but not
limited to, statements related to LUVOX CR(R). These forward-looking
statements are based on the company's current expectations and inherently
involve significant risks and uncertainties. Jazz Pharmaceuticals' actual
results and the timing of events could differ materially from those
anticipated in such forward-looking statements as a result of these risks and
uncertainties, which include, without limitation, the risk that our
intellectual property rights may not ensure protection of our products and the
risk that our products might infringe the intellectual property rights of
others. These and other risk factors are discussed under "Risk Factors" in
the Quarterly Report on Form 10-Q for the quarter ended September 30, 2008
filed by Jazz Pharmaceuticals with the Securities and Exchange Commission on
November 14, 2008. Jazz Pharmaceuticals undertakes no duty or obligation to
update any forward-looking statements contained in this release as a result of
new information, future events or changes in its expectations.
SODAS(R) and NanoCrystal(R) are registered trademarks of Elan Pharma
International Limited, Ireland, a subsidiary of Elan Corporation, plc
(NYSE: ELN).
LUVOX CR(R) is a registered trademark of Solvay Pharmaceuticals, Inc.
SOURCE Jazz Pharmaceuticals, Inc.
12/18/2008
CONTACT: Karen L. Bergman, +1-650-575-1509, or Michelle Corral,
+1-415-794-8662, both of BCC Partners, for of Jazz Pharmaceuticals, Inc.; or
Jazz Pharmaceuticals, Inc., +1-650-496-2800,
investorinfo@jazzpharmaceuticals.com
Web site: http://www.jazzpharmaceuticals.com
http://www.elan.com/EDT
