Savient Pharmaceuticals Files Citizens' Petition with the FDA for Oxandrin(R); Requests FDA to Not Approve Any ANDA Prior to Exp
21 September 2005 - 1:10PM
Business Wire
Savient Pharmaceuticals, Inc. (NASDAQ: SVNTE) an emerging specialty
pharmaceuticals company focused on developing, manufacturing and
marketing novel therapeutic products for unmet medical needs, today
announced it has filed a Citizens' Petition with the United States
Food and Drug Administration (FDA) requesting that the Commissioner
of Food and Drugs not approve any Abbreviated New Drug Application
(ANDA) for generic oral products containing oxandrolone prior to
the expiration of the Company's exclusive labeling for geriatric
dosing on June 20, 2008. The FDA's guidance on geriatric labeling
requires that ANDA's contain the same geriatric labeling as the
Reference Listed Drug (RLD). In 1997, the Agency established
specific requirements for the labeling of pharmaceuticals used by
the elderly. It required that all marketed products contain
information specific to their use by the elderly. Savient was
granted three-years of market exclusivity under section 505(j) of
the Federal Food, Drug and Cosmetic Act (FFDCA) for changes to the
labeling of Oxandrin(R) for its use in geriatric patients. The
labeling changes and related clinical data were submitted to the
FDA in a supplement New Drug Application (sNDA), which was approved
on June 20, 2005. Oxandrin's new labeling now recommends a lower
starting dose in the elderly. A significant number of patients who
are treated with Oxandrin(R) are geriatric patients. Savient's
clinical data confirmed that elderly patients have different
pharmacological reactions to Oxandrin(R), therefore, geriatric
labeling for Oxandrin(R) is necessary for its safe use. The Company
believes that if fully substitutable generic versions of
oxandrolone were to be approved without Oxandrin's(R) protected
geriatric labeling such drugs would have labeling that is less
restrictive and potentially less safe than that of Oxandrin(R) for
use by the elderly. This is the second Citizens' Petition filed by
the Company relating to the approval of generic oral products
containing oxandrolone. About Oxandrin(R) Oxandrin(R) is an oral
tablet, which contains oxandrolone, indicated as adjunctive therapy
to promote weight gain after involuntary weight loss following
extensive surgery, chronic infections, or severe trauma, and in
some patients who without definite pathophysiologic reasons fail to
gain weight or to maintain normal weight, to offset the protein
catabolism associated with prolonged administration of
corticosteroids, and for the relief of the bone pain frequently
accompanying osteoporosis. About Savient Pharmaceuticals, Inc.
Based in East Brunswick, New Jersey, Savient Pharmaceuticals, Inc.
is a specialty pharmaceutical company dedicated to developing,
manufacturing and marketing novel therapeutic products that address
unmet medical needs. The Company's lead product development
candidate, Puricase(R), for the treatment of refractory gout has
reported positive Phase 1 and 2 clinical data. 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 initial focus in rheumatology. The Company's
operations also include a wholly-owned U.K. subsidiary, Rosemont
Pharmaceuticals Ltd., which develops, manufactures and markets
liquid formulations of prescription pharmaceutical products.
Rosemont's product portfolio includes over 90 liquid formulations
primarily targeting the geriatric population. Further information
on the Company can be accessed by visiting www.savientpharma.com.
Safe Harbor Statement This news release contains forward-looking
statements within the meaning of Section 21E of the Securities
Exchange Act of 1934. All statements, other than statements of
historical facts, included in this report regarding the Company's
strategy, expected future financial position, discovery and
development of products, strategic alliances, competitive position,
plans and objectives of management are forward-looking statements.
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. In
particular, statements as to the possible outcome of the Company's
Citizens' Petition and the approval of generic oral products
containing oxandrolone are forward-looking statements. These
forward-looking statements involve substantial risks and
uncertainties and are based on current expectations, assumptions,
estimates and projections about the Company's business and the
biopharmaceutical and specialty pharmaceutical industries in which
the Company operates. Such risks and uncertainties include, but are
not limited to, delisting of the Company's common stock from The
Nasdaq Stock Market, delay or failure in developing Prosaptide,
Puricase and other product candidates; difficulties of expanding
the Company'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; our 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 the Company's products; economic,
political and other risks associated with foreign operations; risks
of maintaining protection for the Company's intellectual property;
risks of an adverse determination in on-going or future
intellectual property litigation; and risks associated with
stringent government regulation of the biopharmaceutical and
specialty pharmaceutical industries. The Company may not actually
achieve the plans, intentions or expectations disclosed in its
forward-looking statements, and you should not place undue reliance
on the Company's forward-looking statements. Actual results or
events could differ materially from the plans, intentions and
expectations disclosed in the forward-looking statements that the
Company makes. The Company's forward-looking statements do not
reflect the potential impact of any future acquisitions, mergers,
dispositions, joint ventures or investments that the Company may
make. The Company does not assume any obligation to update any
forward-looking statements.
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