Message #29 From:
NewsBot Date: December 5, 2006 06:08:00 AM
SVNT News Savient Pharmaceuticals Obtains Temporary Restraining Order in Patent Infringement Lawsuit Against Sandoz Pharmaceuticals and Upsher-Smith Laboratories
EAST BRUNSWICK, N.J.--(BUSINESS WIRE)--Savient Pharmaceuticals, Inc. (NASDAQ: SVNT) announced today that it was
granted late yesterday a Temporary Restraining Order (“TRO”)
enjoining all sales of generic oxandrolone tablets by Sandoz
Pharmaceuticals, a Novartis Pharmaceuticals company (NYSE: NVS), and
Upsher-Smith Laboratories. The TRO was granted in the lawsuit filed
yesterday by Savient against Sandoz and Upsher-Smith in the U.S.
District Court for the District of New Jersey for infringement of
Savient's U.S. Patent Nos. 5,872,147 ("the '147' patent"); 6,090,799
("the '799 patent"); 6,576,659 ("the '659 patent"); 6,670,351 ("the '351
patent"); and 6,828,313 ("the '313 patent"). These patents relate to
various methods of using Savient's product Oxandrin®
(oxandrolone tablets, USP) CIII.
Under the terms of the TRO, Savient also will not launch sales of the
A-B rated authorized generic of oxandrolone tablets, USP (C-III), an
Oxandrin® brand
equivalent product, through Watson Pharmaceuticals, Inc. (NYSE: WPI)
while the TRO is in place, and Sandoz and Upsher-Smith have the right to
move to vacate the TRO upon two days notice and the presentation of
additional evidence. While the TRO is in place, Savient is permitted to
and will continue to market and distribute the Oxandrin®
brand product.
Christopher Clement, President and Chief Executive Officer of Savient
Pharmaceuticals Inc., said, "We are very pleased with the action taken
by the Court late yesterday and remain unwavering in our intention to
take the actions necessary to defend our patent rights relating to the
use of Oxandrin(R). We believe our patent position is strong and
anticipate a favorable outcome."
About Oxandrin®
Oxandrin® is Savient’s
oral anabolic agent indicated as adjunctive therapy to promote weight
gain after weight loss following extensive surgery, chronic infection,
or severe trauma. Oxandrin®
is also indicated for patients who, without definite pathophysiologic
reason, fail to gain or maintain normal weight. Oxandrin®
can also be used to offset the protein catabolism associated with
prolonged corticosteroid use.
About Savient Pharmaceuticals, Inc.
Savient Pharmaceuticals is a biopharmaceutical company engaged in
developing and marketing pharmaceutical products that target unmet
medical needs in both niche and broader markets. The Company's lead
product development candidate, Puricase®
(PEG-uricase) for treatment failure gout, has reported positive Phase 1
and 2 clinical data; patient dosing in Phase 3 clinical studies began in
May 2006. Savient's experienced management team is committed to
advancing its pipeline and expanding its product portfolio by in-
licensing late-stage compounds and exploring co-promotion and
co-development opportunities that fit the Company's expertise in
specialty pharmaceuticals and biopharmaceuticals with an initial focus
in rheumatology. Savient also markets Oxandrin(R) (oxandrolone tablets,
USP) CIII in the U.S. Puricase®
is a registered trademark of Mountain View Pharmaceuticals, Inc. Further
information on Savient can be accessed by visiting: http://www.savientpharma.com.
FORWARD LOOKING LANGUAGE
This news release contains forward-looking statements that are subject
to certain risks, trends and uncertainties that could cause actual
results and achievements to differ materially from those expressed in
such statements. These risks, trends and uncertainties are in some
instances beyond Savient's control.
Words such as "anticipate," "believe," "estimate," "expect," "intend,"
"plan," "will" and other similar expressions help identify
forward-looking statements, although not all forward-looking statements
contain these identifying words. These forward-looking statements
involve substantial risks and uncertainties and are based on current
expectations, assumptions, estimates and projections about Savient's
business and the biopharmaceutical and specialty pharmaceutical
industries in which Savient operates. Such risks and uncertainties
include, but are not limited to, Savient's stock price and market
conditions, delay or failure in developing Puricase (PEG-uricase) and
other product candidates, difficulties of expanding Savient's product
portfolio through in-licensing, introduction of generic competition for
Oxandrin, fluctuations in buying patterns of wholesalers, potential
future returns of Oxandrin or other products, Savient's continuing to
incur substantial net losses for the foreseeable future, difficulties in
obtaining financing, potential development of alternative technologies
or more effective products by competitors, reliance on third-parties to
manufacture, market and distribute many of Savient's products, economic,
political and other risks associated with foreign operations, risks of
maintaining protection for Savient's intellectual property, risks of an
adverse determination in ongoing or future intellectual property
litigation, and risks associated with stringent government regulation of
the biopharmaceutical industry. Savient may not actually achieve the
plans, intentions or expectations disclosed in Savient's forward-looking
statements. Actual results or events could differ materially from the
plans, intentions and expectations disclosed in the forward-looking
statements that Savient makes. Stockholders should not place undue
reliance on the forward-looking statements, which speak only as to the
date of this press release. Savient's forward-looking statements do not
reflect the potential impact of any future acquisitions, mergers,
dispositions, joint ventures or investments that Savient may make.
Except as required by law, Savient does not assume any obligation to
update any forward-looking statements.
