Message #28 From:
Stock News Bot Date: December 4, 2006 06:00:00 AM
SVNT News Savient Pharmaceuticals Files 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 has
filed a lawsuit in the U.S. District Court for the District of New
Jersey against Sandoz Pharmaceuticals, a Novartis Pharmaceuticals
company (NYSE: NVS), and Upsher-Smith Laboratories 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. 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.
The suit was brought following the U.S. Food and Drug Administration’s
(FDA) decision late on Friday, December 1, 2006, to deny both Citizens
Petitions filed by Savient, which had been pending since February 2004
and September 2005, and reliable information received by Savient
indicating that Abbreviated New Drug Applications (ANDA) filed by both
Sandoz and Upsher-Smith had also been approved by the FDA. Savient has
also filed a Motion seeking a Temporary Restraining Order and
Preliminary Injunction to restrain Sandoz and Upsher-Smith from
marketing and selling their generic formulations of Oxandrin®.
Savient also announced that it is examining the impact of the FDA
decisions and its agreement with Watson on its pending patent
infringement lawsuit against Barr Laboratories, a wholly owned
subsidiary of Barr Pharmaceuticals, Inc. (NYSE: BRL).
In addition, Savient acknowledged that in anticipation of these
developments it had previously entered into a supply and distribution
agreement with Watson Pharmaceuticals, Inc. (NYSE: WPI) granting Watson
exclusive U.S. distribution rights to Savient’s
A-B rated authorized generic of oxandrolone tablets, USP (C-III), an
Oxandrin® brand
equivalent product, which will be manufactured and supplied to Watson
through Savient. The authorized generic product, when launched into the
market, will be distributed by Watson in both the 2.5 mg and 10 mg
dosage strengths. The A-B rated authorized generic of oxandrolone
tablets will continue to meet all quality control standards of the
Oxandrin® brand,
will contain the same active and inactive pharmaceutical ingredients and
will contain in its labeling the geriatric dosing regime for which
Savient has been granted exclusivity by the FDA. Savient will also
continue to market and distribute the Oxandrin®
brand product.
“We are very pleased to announce our
partnership with Watson, a leading marketer of prescription brand
equivalent products,” said Christopher
Clement, President and Chief Executive Officer, of Savient. “Despite
the actions of the FDA on Friday, we remain determined to take the steps
necessary to defend our patent rights. Since we recognize that generic
'equivalents' of our drug may have an equivalency range from 80 –
125% of our branded and authorized generic tablets, we want to make
certain that both the brand and it’s A-B
rated authorized generic formulation would be available to the patients
who depend on Oxandrin®
to manage involuntary weight loss, which is a debilitating and sometimes
life-threatening condition associated with diseases such as AIDS and
chronic obstructive pulmonary disease.
“Over the last three years we have been
awaiting action by the FDA with respect to our Citizens Petitions, and
in advance of those determinations, have taken the steps necessary to
ensure that if the decisions were ultimately not in our favor, that we,
in collaboration with Watson, would be prepared. We remain resolute in
that regard today and for the future,”
continued Mr. Clement.
“We have a strong balance sheet with nearly
$200 million in cash. We continue to make steady progress with our Phase
3 clinical trial of Puricase®
for treatment failure gout, and do not expect these unrelated activities
to affect those programs in any manner,”
concluded Mr. Clement.
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.
