Message #32 From:
Stock News Bot Date: December 29, 2006 06:25:00 AM
SVNT News Savient Pharmaceuticals Announces Launch of Authorized Generic of Oxandrin(R) with Watson Pharmaceuticals
EAST BRUNSWICK, N.J.--(BUSINESS WIRE)--Savient Pharmaceuticals, Inc. (NASDAQ:SVNT) (“Savient”
or “the Company”)
announced today that Watson Pharmaceuticals (NYSE:WPI), under the terms
of its previous supply and distribution agreement with Savient, has
launched an A-B rated authorized generic of oxandrolone tablets, USP
(C-III), an Oxandrin®
brand equivalent product manufactured and supplied through Savient. The
authorized generic product will be launched immediately and distributed
by Watson in both the 2.5 mg and 10 mg dosages. The A-B rated authorized
generic of oxandrolone tablets will continue to meet all quality control
standards of the Oxandrin®
brand and will contain the same active and inactive pharmaceutical
ingredients. Oxandrin®is
Savient’s oral anabolic agent for the
treatment of involuntary weight loss, a frequent and sometimes
life-threatening condition associated with numerous disease states.
Savient will continue to market and distribute the Oxandrin®
brand product.
This action by Savient follows the denial by the Court of Appeals for
the Federal Circuit on December 28, 2006, of the Company’s
motion for a preliminary injunction pending its appeal of the action of
U.S. District Court for the District of New Jersey on December 12, 2006
lifting of the Temporary Restraining Order (“TRO”)
it had previously granted on December 4, 2006. Savient has been seeking
these restraints under its pending lawsuit against Sandoz
Pharmaceuticals, a Novartis Pharmaceuticals company (NYSE:NVS), and
Upsher-Smith Laboratories for infringement of Savient's methods of use
patents for Oxandrin®,
in particular 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").
“We are pleased to be launching our
authorized generic of Oxandrin®
with Watson, a leading marketer of prescription brand equivalent
products,” said Christopher Clement,
President and Chief Executive Officer, of Savient. “Over
the last three years we have been anticipating potential generic
competition, and, as previously announced, made sure that we, in
collaboration with Watson, would be prepared to make certain that both
the brand and its A-B rated authorized generic formulation would be
available to the patients who depend on Oxandrin®
to manage involuntary weight loss, a debilitating and sometimes
life-threatening condition associated with diseases such as AIDS,
cancer, and chronic obstructive pulmonary disease. We remain resolute in
that regard today and for the future.
“We have a strong balance sheet with nearly
$200 million in cash and continue to make progress with our Phase 3
clinical trial of Puricase®
for treatment failure gout, and do not expect these unrelated activities
to affect those programs,” concluded Mr.
Clement.
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.
About Watson Pharmaceuticals, Inc.
Headquartered in Corona, California, Watson Pharmaceuticals is a leading
specialty pharmaceutical company that develops, manufactures, markets,
sells and distributes brand and generic pharmaceutical products. Watson
pursues a growth strategy combining internal product development,
strategic alliances and collaborations and synergistic acquisitions of
products and businesses.
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.
