New Data Published in Annals of the Rheumatic Diseases Confirm Long-Term Safety and Efficacy of KRYSTEXXA® for the Treatment of

   New Data Published in Annals of the Rheumatic Diseases Confirm Long-Term
Safety and Efficacy of KRYSTEXXA® for the Treatment of Refractory Chronic Gout

Two Supportive Posters Presented at the ACR/AHRP Annual Meeting Also
Demonstrate Positive Safety and Efficacy Outcomes from the KRYSTEXXA
Open-Label Extension Study

PR Newswire

BRIDGEWATER, N.J., Nov. 12, 2012

BRIDGEWATER, N.J., Nov. 12, 2012 /PRNewswire/ --Savient Pharmaceuticals, Inc.
(NASDAQ: SVNT) today announced that new data from an open-label extension
(OLE) study published in the Annals of the Rheumatic Diseases reinforced the
safety and efficacy profile of KRYSTEXXA^® (pegloticase) treatment for
refractory chronic gout (RCG) over the long-term. OLE data aligned with
outcomes seen in the KRYSTEXXA pivotal Phase III clinical trials, with no new
safety signals identified. Improvements in clinical status were sustained or
advanced during and up to two and a half years of additional treatment as
evidenced by flare and tophus reduction first initiated in KRYSTEXXA-treated
Phase III trial participants who maintained goal range urate-lowering
responses. In addition to publication in the international peer-reviewed
journal, two posters further demonstrating the safety and efficacy seen in the
OLE study will be presented this week at the American College of
Rheumatology/Associate Rheumatology Health Professional (ACR/AHRP) Annual
Meeting, November 9-14, 2012.

"These data are encouraging because they confirm the long-term safety of
KRYSTEXXA as well as a durable and progressive response to treatment," said
Michael A. Becker, M.D., principal investigator, Professor Emeritus of
Medicine, University of Chicago. "This is great news for those patients who
have refractory chronic gout, or RCG, since treatment options are limited for
this severe, debilitating and progressive form of gout."

The study enrolled 151 patients who completed one of the two Phase III
randomized, double-blind, placebo-controlled registration trials. Patients
received either 8 mg KRYSTEXXA every two weeks, or the same dose every four
weeks, for the management of RCG. Consistent with Phase III trials, gout
flares and injection reactions were the most frequently reported adverse
events (71 percent and 44 percent of patients, respectively), and they were
least common in patients with a sustained response to KRYSTEXXA and those
receiving treatment every two weeks. In most patients defined as KRYSTEXXA
responders in the Phase III trials, plasma and serum uric acid levels remained
less than 6 mg/dL, and sustained and progressive improvements in tophus
resolution and flare incidence were seen throughout the study period.

"We are pleased that the results from the open-label extension study were
selected for publication by the peer-reviewed Annals of the Rheumatic Diseases
and presentation at ACR/ARHP, further validating the benefits of long-term
treatment with KRYSTEXXA for RCG patients," said Kenneth M. Bahrt, M.D.,
Senior Vice President and Chief Medical Officer of Savient. "These results
mark an important milestone for KRYSTEXXA as the medical community continues
to establish its place in the RCG treatment paradigm."

The KRYSTEXXA OLE publication in the ARD and the supportive full text ACR/ARHP
abstracts can be found via the following links:

  oLong-Term Safety of Pegloticase in Chronic Gout Refractory to Conventional
    Treatment; Annals of the Rheumatic Diseases
  oClinical Efficacy Outcomes with Up to 3 Years of Pegloticase Treatment for
    Refractory Chronic Gout; Abstract #159 
  oPegloticase Long Term Safety: Data from the Open Label Extension Trial;
    Abstract #160

Annals of the Rheumatic Diseases (ARD) is an international peer review
journal, and one of more than 40 specialist titles published by BMJ Group. It isco-ownedwith the European League Against Rheumatism

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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