Savient's Puricase(R) (PEG-uricase) Substantially Reduces and Sustains Lower Plasma Urate Levels in Patients with Treatment-Resi
November 14 2005 - 8:01AM
PR Newswire (US)
Anecdotal Evidence Shows Resolution of Tophi - Phase 2 Data
Presented at the 2005 Annual Meeting of the American College of
Rheumatology SAN DIEGO, Calif., Nov. 14 /PRNewswire-FirstCall/ --
Savient Pharmaceuticals, Inc. (NASDAQ:SVNTE) announced today that
patients with elevated blood uric acid levels and
treatment-resistant gout who were treated with its investigational
drug Puricase(R) (PEG-uricase) had substantial and sustained
reduction in plasma urate levels, according to study results that
will be presented on Wednesday, November 16 at the American College
of Rheumatology 2005 Annual Meeting. In addition, two case studies
from the Phase 2 open-label trial that will be presented today show
anecdotal photographic evidence that treatment with PEG-uricase
unexpectedly resolved tophi, the nodular deposits of urate that can
cause pain, local ulceration, disfigurement and joint destruction.
It is unknown whether tophi were resolved in patients at other
investigational sites as clinical outcome measures were not part of
the phase 2 protocol design. "Lowering urate levels is an important
goal in treating gout because urate deposits in joint spaces
provoke attacks of this painful and often disabling disease," said
John S. Sundy, MD, PhD, Division of Rheumatology at Duke University
Medical Center and lead investigator. "These encouraging results
support further studies to determine the efficacy of PEG-uricase as
a therapeutic option for lowering uric acid levels in patients with
treatment-resistant gout." PEG-uricase is a poly(ethylene glycol)
conjugate of recombinant porcine uricase (urate oxidase) for the
treatment of patients with severe gout for whom conventional
therapy is contraindicated or has been ineffective. Duke University
developed the recombinant porcine uricase enzyme. In February 2001,
Savient received FDA Orphan Drug designation from the U.S. Food and
Drug Administration for PEG-uricase, and the Company expects to
initiate its Phase 3 clinical testing program during the first
quarter of 2006. About Gout According to the National Institutes of
Health, gout accounts for approximately 5 percent of all cases of
arthritis and is one of the most painful rheumatic diseases. There
are an estimated 5 million Americans with gout, including
50,000-70,000 patients for whom conventional therapy is
contraindicated or has been ineffective. Gout results from deposits
of needle-like crystals of uric acid in connective tissue and in
the joints. These deposits lead to inflammatory arthritis, which
causes joint swelling, redness, heat, pain, and stiffness and
damage to the affected joints. In patients for whom conventional
therapy is contraindicated or has been ineffective, the disease can
become chronic, progressively worsen and cause debilitating flares
of pain and swelling, development of tophi, loss of joint
functionality, renal disease and kidney stones. About the Phase 2
Study Oral Presentation This Phase 2, randomized, open-label,
multicenter, parallel group study assessed the urate response, and
pharmacokinetic and safety profiles of PEG-uricase in patients with
hyperuricemia and severe gout who are unresponsive to or intolerant
of conventional therapy. The mean duration of disease was 14 years
and 70 percent of the study population had one or more tophi. In
the study, 41 patients (mean age of 58.1 years) were randomized to
12 weeks of treatment with intravenous PEG-uricase at one of four
dose regimens: 4 mg every two weeks (7 patients); 8 mg every two
weeks (8 patients); 8 mg every four weeks (13 patients); or 12 mg
every four weeks (13 patients). Plasma uricase activity and urate
levels were measured at defined intervals. Pharmacokinetic
parameters, mean plasma urate concentration and the percentage of
time that plasma urate was less than or equal to 6 mg/dL were
derived from analyses of the uricase activities and urate levels.
Patients who received 8 mg of PEG-uricase every two weeks had the
greatest reduction in plasma urate with levels below 6mg/dL 92
percent of the treatment time (pre-treatment plasma urate of
9.1mg/dL vs. mean plasma urate of 1.4mg/dL over 12 weeks).
Substantial and sustained lower plasma urate levels were observed
in the other PEG-uricase treatment dosing groups: -- 86 percent of
the treatment time in the 8 mg every four weeks group
(pre-treatment plasma urate of 9.1mg/dL vs. mean plasma urate of
2.6mg/dL over 12 weeks); -- 84 percent of the treatment time in the
12 mg every four weeks group (pre-treatment plasma urate of
8.5mg/dL vs. mean plasma urate of 2.6mg/dL over 12 weeks); and --
73 percent of the treatment time in the 4 mg every two weeks group
(pre-treatment plasma urate of 7.6mg/dL vs. mean plasma urate of
4.2mg/dL over 12 weeks). About the Two Case Studies Poster
Presentation At one clinical investigation site, two patients out
of six were asked to be photographed pre- and post PEG-uricase
therapy while participating in a randomized, phase 2 open-label,
multi center study to determine safety, pharmacokinetics and
changes in uric acid (UA) levels with PEG-uricase. Photography was
not required by the original protocol because a clinical outcome
such as regression of tophi was not anticipated during the
relatively brief treatment period of only three months. "For
patients with tophaceous deposits caused by gout, treatment with
currently available therapies takes a period of years to achieve
tophus resolution," said Herbert S.B. Baraf, MD, FACP, FACR,
Clinical Professor of Medicine at George Washington University, and
a participating investigator at the Center for Rheumatology and
Bone Research, Wheaton, Md. "Our findings, while anecdotal, support
further investigation of the potential benefits of PEG-uricase
treatment in patients with chronic tophaceous gout." While
scientifically intriguing, anecdotal observations are not
indicative of efficacy. The safety and efficacy of PEG-uricase will
be determined in the Phase 3 clinical trial. A total of 27 study
patients received all intended doses of PEG-uricase. Thirty-eight
patients experienced an adverse event that was possibly
treatment-related, most commonly gout flare (36 patients). As
expected with biological administration, there was a high rate of
infusion reaction: 23 patients (150 infusions) experienced 34
events that occurred within 24 hours of infusion; 21 of these
events in 18 subjects were considered possible infusion reactions,
and 14 of these subjects were withdrawn without repeated
administration. During the study, the rate of administration was
adjusted and infusion reactions subsequently declined. There were
no anaphylactic reactions. Of the nine serious adverse events
reported, five were described as possibly treatment-related: gout
flare (3), hypersensitivity reaction (1), and anemia (1). 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. Positive
Phase 1 and 2 clinical data have been reported for the Company's
lead product development candidate, Puricase(R) (PEG-uricase), for
the treatment of refractory gout. 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 http://www.savientpharma.com/. Savient
licensed exclusive, worldwide rights to the technologies related to
Puricase from Duke University ("Duke") of North Carolina and
Mountain View Pharmaceuticals, Inc. ("MVP"), a California
corporation. Duke developed the recombinant porcine uricase enzyme
and MVP developed the PEGylation technology. MVP and Duke were
granted U.S. and foreign patents covering the licensed technology.
Puricase is a registered trademark of Mountain View
Pharmaceuticals, Inc. 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 commencement
of Phase 3 trials for PEG-uricase and the timing of such trial 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 ongoing 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. Media Contact: Carol Cartwright At ACR:
(908) 244-6406 After ACR: (800) 477-9626 Investor Contact: Jenene
Thomas (732) 925-3093 DATASOURCE: Savient Pharmaceuticals, Inc.
CONTACT: Media: Carol Cartwright, at ACR: +1-908-244-6406, after
ACR: 1-800-477-9626, , or Investor: Jenene Thomas, +1-732-925-3093,
both for Savient Pharmaceuticals, Inc. Web Site:
http://www.savientpharma.com/
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