Two Abstracts Highlighting Savient Pharmaceuticals' Puricase(R) Accepted for American College of Rheumatology Annual Scientific
03 Oktober 2005 - 12:30PM
Business Wire
-Clinical Results Indicate Puricase's Activity in Patients with
Severe Gout with Whom Conventional Therapy is Contraindicated or
Has Been Ineffective- Savient Pharmaceuticals, Inc., (NASDAQ:
SVNTE) an emerging specialty pharmaceuticals company focused on
developing, manufacturing and marketing novel therapeutic products
for unmet medical needs, announced today that two abstracts
detailing data on the Phase 2 clinical trial results of its drug
development candidate, Puricase(R) (PEG-uricase), will be presented
at the 2005 American College of Rheumatology (ACR) Annual
Scientific Meeting in San Diego, California being held November 12
- 17, 2005. The first abstract to be presented is entitled
"Resolution of Tophi with Intravenous PEG-uricase in Refractory
Gout." The abstract by Herbert S.B. Baraf, M.D. of George
Washington University will be presented in a poster session on
November 14, 2005. The second abstract to be presented is entitled,
"A Phase 2 Study of Multiple Doses of Intravenous Polyethylene
Glycol (PEG)-uricase in Patients with Hyperuricemia and Refractory
Gout." The abstract will be an oral presentation by lead
investigator John S. Sundy, M.D. of Duke University during the
"Crystals and Bugs in the Rheumatic Diseases" concurrent session on
November 16, 2005. The Phase 2 study was a randomized, open label,
multi-center, parallel group study. It was designed to assess the
plasma urate response and pharmacokinetic and safety profiles of
PEG-uricase in patients with severe gout with whom conventional
therapy is contraindicated or has been ineffective. The study
indicated that multiple dose administration of Puricase leads to
substantial, sustained lowering of plasma urate levels in the
majority of patients. The results support progression into full
development in Phase 3 studies. Christopher Clement, President and
Chief Executive Officer of Savient, said, "We are extremely pleased
about the acceptance of these abstracts on Puricase at this
prestigious scientific meeting for the rheumatology community. We
are encouraged by the results of our Phase 2 study, which we
believe suggest that Puricase has the potential to be an effective
treatment for patients suffering from severe gout. We look forward
to beginning the Phase 3 clinical development program during the
first quarter of 2006 and continuing to advance Puricase towards
commercialization." To view the abstracts, visit the conference
website at: www.rheumatology.org/annual/index.asp. 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. Puricase
is a registered trademark of Mountain View Pharmaceuticals, Inc.
Further information on the Company can be accessed by visiting
www.savientpharma.com (http://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, the statements as to the
commencement of the Phase 3 studies of Puricase, its effectiveness
in treating patients suffering from severe gout and its eventual
commercialization 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, 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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