New Data Demonstrate KRYSTEXXA®-Treated Refractory Chronic Gout Patients Experienced Significantly Improved Health-Related

   New Data Demonstrate KRYSTEXXA®-Treated Refractory Chronic Gout Patients
      Experienced Significantly Improved Health-Related Quality of Life

Post-Hoc Analyses Examining HRQOL, Tophus Reduction and Infusion Reaction
Mitigation Presented at the 2012 ACR/ARHP Annual Meeting

PR Newswire

BRIDGEWATER, N.J., Nov. 13, 2012

BRIDGEWATER, N.J., Nov. 13, 2012 /PRNewswire/ --Savient Pharmaceuticals, Inc.
(NASDAQ: SVNT) today announced results from new post-hoc analyses of
KRYSTEXXA^® (pegloticase) pivotal Phase III and open-label extension trials
that reinforced the health-related quality of life (HRQOL) benefits of
KRYSTEXXA treatment in adult patients with refractory chronic gout (RCG),
including tophus reduction outcomes. New data also demonstrated that guidance
on measuring serum uric acid (sUA) levels as a biomarker of therapeutic
response and infusion reaction (IR) risk significantly reduced the rate of IRs
in the post-approval setting, as compared to rates seen during randomized
clinical trials. These data will be presented this week at the American
College of Rheumatology/Associate Rheumatology Health Professional (ACR/ARHP)
Annual Meeting this week, November 9-14, 2012.

An analysis examining relative risk of IRs with KRYSTEXXA during a defined
post-approval period (September 2010 – September 2012) supported the
effectiveness of the clinical guidance contained in the current U.S. label
designed to identify patients at potentially higher risk for IRs by monitoring
sUA response and discontinuing treatment if levels increase to above 6 mg/dL,
particularly when two consecutive levels above 6 mg/dL are observed. The
analysis showed that there was an approximate two-thirds reduction in the
incidence of IRs in the post-approval period compared to the rate seen in the
randomized clinical trials where there was no clinical guidance in effect.

In another analysis, researchers observed sustained patient-reported HRQOL
improvements among participants identified as responders during their first
six months of treatment in the six-month, randomized, placebo-controlled Phase
III trials for an additional two-and-a-half years when treated with KRYSTEXXA
8 mg every two weeks during open-label extension study. These outcomes were
measured through widely-utilized assessment tools, including Medical Outcomes
Study Short Form-36 (SF-36) physical component summary scores and the Health
Assessment Questionnaire-Disability Index (HAQ-DI).

"This is the first therapy for chronic gout that has shown sustained
improvement in the health-related quality of life. Further knowledge of how
KRYSTEXXA can improve long-term health-related quality of life outcomes for
responsive RCG patients helps us to better understand the treatment's utility
for these severe gout patients," said Dinesh Khanna, M.D., M.Sc., Associate
Professor, Department of Internal Medicine at The University of Michigan.

For patients with RCG, tophus burden is a serious factor in the condition's
impact on long-term functionality. Tophi form when uric acid collects and
crystallizes in and around the joints. Over time, if not treated
appropriately, tophi can lead to the disabling of joints, immobility and bone
destruction. Another analysis characterized the reduction in tophus burden
experienced by RCG patients treated with KRYSTEXXA. The study examined
patients' tophi response to KRYSTEXXA from baseline of Phase III trials
through the conclusion of the open-label extension trial. Of the 212 patients
with RCG enrolled in the Phase III trials, 155 (73 percent) had tophi at
baseline. A complete response to therapy was defined as a 100 percent decrease
in the area of the target tophus and the absence of any new or enlarging
tophi. Complete response of at least one tophus was significantly more
frequent among patients receiving KRYSTEXXA at 13 weeks of treatment and at
all subsequent times of measurement in the pivotal trials, with 40 percent of
patients achieving complete response after six months as compared to seven
percent treated with placebo (p=0.002). After one year in the open-label
extension study, complete response was achieved for 74 percent of patients
receiving KRYSTEXXA. Despite receiving no urate-lowering therapy during six
months of enrollment in the Phase III study, approximately 50 percent of
previously placebo-treated patients achieved tophus complete response within
six months of treatment with KRYSTEXXA 8 mg every two weeks in the open-label
extension study.

"Savient is committed to supporting research that will further understanding
surrounding KRYSTEXXA, RCG and how these patients' treatment experiences and
ultimately their quality of life may be improved," said Kenneth M. Bahrt,
M.D., Senior Vice President and Chief Medical Officer of Savient. "These
analyses reinforce our confidence in KRYSTEXXA and its ability to fulfill a
significant unmet need for many patients who face the debilitating effects of
RCG on a daily basis."

Full text ACR/ARHP abstracts on these studies can be found via the following

  oRelative Risk of Infusion Reactions with KRYSTEXXA^® (pegloticase) From
    Post-Approval Safety Data: Results From Sept 2010 to June 2012; Abstract
  oImprovements in Long-Term Health-Related Quality of Life in Chronic Gout
    Patients Refractory to Conventional Therapies Treated with Pegloticase:
    Results From Responder Cohort; Abstract #147
  oComplete Tophus Response in Patients with Chronic Gout Initiating
    Pegloticase Treatment; Abstract #1913

KRYSTEXXA^®  (pegloticase) is a PEGylated uric acid specific enzyme for
administration by intravenous infusion for the treatment of refractory chronic
gout (RCG) in adult patients. KRYSTEXXA ^ became commercially available in the
U.S. by prescription on December 1, 2010 and is the only U.S. Food and Drug
Administration approved product specifically indicated for the treatment of
RCG. KRYSTEXXA is not recommended for the treatment of asymptomatic

For more information about KRYSTEXXA,  please visit:

KRYSTEXXA is not indicated for the treatment of asymptomatic hyperuricemia.
Patients who are at risk of having a condition known as G6PD deficiency should
be screened by their physician prior to starting therapy with KRYSTEXXA.

Discontinue oral urate-lowering therapies before instituting KRYSTEXXA and do
not institute oral urate-lowering therapy while the patient is on KRYSTEXXA

Possible side effects of KRYSTEXXA include:

  oAnaphylaxis which occurred in some patients treated with KRYSTEXXA.
    KRYSTEXXA should be administered in healthcare settings and by healthcare
    providers prepared to manage anaphylaxis. Patients should be pre-medicated
    with antihistamines and corticosteroids. Patients should be closely
    monitored for an appropriate period of time for anaphylaxis after
    administration of KRYSTEXXA.
  oInfusion reactions which occurred in some patients treated with KRYSTEXXA.
    The risk of an infusion reaction is higher in patients who have lost
    therapeutic response. Because the risk of infusion reactions is higher in
    patients who lose therapeutic response to KRYSTEXXA, monitor serum uric
    acid before each infusion and consider discontinuing treatment if levels
    rise above 6mg/dL, particularly when two consecutive levels above 6 mg/dL
    are observed.
  oAs with other urate-lowering therapies, an increase in gout flares was
    seen in some patients treated with KRYSTEXXA. Gout flare prophylaxis with
    a non-steroidal anti-inflammatory drug (NSAID) or colchicine is
    recommended starting at least 1 week before initiation of KRYSTEXXA
    therapy and lasting at least 6 months, unless medically contraindicated or
    not tolerated.

KRYSTEXXA has not been formally studied in patients with congestive heart
failure, but some patients in clinical trials experienced exacerbation.
Exercise caution when using KRYSTEXXA in patients who have congestive heart
failure and monitor patients closely following infusion. Patients receiving
re-treatment may be at increased risk for anaphylaxis and infusion reactions
and should be monitored carefully.

The most commonly reported serious adverse reactions are anaphylaxis, infusion
reactions and gout flares. Most common adverse reactions: gout flares (77%),
infusion reactions (26%), nausea (12%), contusion or ecchymosis (11%),
nasopharyngitis (7%), constipation (6%), chest pain (6%), anaphylaxis (5%),
and vomiting (5%).

Please see the Full Prescribing Information and Medication Guide at

Gout is a painful, debilitating form of arthritis and affects approximately
eight million people in the U.S. alone. A significant sub-population of gout
patients, approximately 120,000, are burdened with a difficult-to-treat form
of the condition, known as refractory chronic gout (RCG). Symptoms of gout are
caused by the body's response to the presence of uric acid crystals in the
joints and surrounding tissue, which form when uric acid levels in the blood
are elevated (a condition called hyperuricemia). The longer hyperuricemia
persists, the higher the risk of developing gout. Symptoms of gout may include
painful flares, pain or swelling in the joints (known as "gouty arthritis") or
deposits of uric acid crystals under the skin, called "tophi." In cases of
RCG, these symptoms may have a major influence on patient health-related
quality of life due to the frequency and severity of episodes, the recurrent
pain and the disfigurement associated with this condition. Although most cases
of gout can be controlled with conventional urate-lowering therapy, when uric
acid levels remain high and symptoms persist despite treatment efforts,
chronic gout may be defined as refractory.

Savient Pharmaceuticals, Inc. is a specialty biopharmaceutical company focused
on developing and commercializing KRYSTEXXA^® (pegloticase) for the treatment
of chronic gout in adult patients refractory to conventional therapy. Savient
has exclusively licensed worldwide rights to the technology related to
KRYSTEXXA and its uses from Duke University ("Duke") and Mountain View
Pharmaceuticals, Inc. ("MVP"). Duke developed the recombinant uricase enzyme
and MVP developed the PEGylation technology used in the manufacture of
KRYSTEXXA. MVP and Duke have been granted U.S. and foreign patents disclosing
and claiming the licensed technology and, in addition, Savient owns or co-owns
U.S. and foreign patents and patent applications, which collectively form a
broad portfolio of patents covering the composition, manufacture and methods
of use and administration of KRYSTEXXA. Savient also supplies Oxandrin^®
(oxandrolone tablets, USP) CIII in the U.S. For more information, please visit
the Company's website at

All statements other than statements of historical facts included in this
press release are forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995 and Section 21E of the Securities
Exchange Act of 1934, as amended, and 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 our control. Words such as
"anticipate," "believe," "estimate," "expect," "intend," "plan," "will" and
other similar expressions identify forward-looking statements, although not
all forward-looking statements contain these identifying words. In particular,
any statements regarding the safety and efficacy of KRYSTEXXA^®, market demand
and our ability to gain market acceptance for KRYSTEXXA among physicians,
patients, health care payors and others in the medical community; our ability
to execute on our plans for the expansion of clinical utility for KRYSTEXXA;
our market expansion plans for KRYSTEXXA outside the United States, including
our Marketing Authorization Application which is pending before the European
Medicine Agency, our ability to service our outstanding debt obligations, our
financing needs and liquidity, market acceptance of reimbursement risks with
third party payors, and our view of the market size for KRYSTEXXA in the US
and ex-US and our view of our penetration of this market are forward-looking
statements. These forward-looking statements involve substantial risks and
uncertainties and are based on our assessment and interpretation of the
currently available data and information, current expectations, assumptions,
estimates and projections about our business and the biopharmaceutical and
specialty pharmaceutical industries in which we operate. Other important
factors that may affect our business are set forth more fully in our reports
filed with the Securities and Exchange Commission, to which investors are
referred for further information. We may not actually achieve the plans,
intentions or expectations disclosed in our forward-looking statements, and
you should not place undue reliance on our forward-looking statements, which
speak only as of the date of publication of this press release. Actual results
or events could differ materially from the plans, intentions and expectations
disclosed in the forward-looking statements that we make. Our forward-looking
statements do not reflect the potential impact of any future acquisitions,
mergers, dispositions, joint ventures or investments that we may make. We do
not have a policy of updating or revising forward-looking statements and,
except as required by law, assume no obligation to update any forward-looking


Investor Relations      Media Relations
John P. Hamill Camille Scott
Savient Pharmaceuticals, Inc.  Rx Mosaic Health
(732) 418-9300    (347) 721-5801

SOURCE Savient Pharmaceuticals, Inc.

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