Savient Pharmaceuticals to Present New KRYSTEXXA® Data at the 2013 European League Against Rheumatism (EULAR) Congress

 Savient Pharmaceuticals to Present New KRYSTEXXA® Data at the 2013 European
                  League Against Rheumatism (EULAR) Congress

-- Post-Marketing Data Focuses on Safety of KRYSTEXXA® and the Appropriate
Actions Taken From Post-Approval Safety Surveillance

PR Newswire

BRIDGEWATER, N.J., June 12, 2013

BRIDGEWATER, N.J., June 12, 2013 /PRNewswire/ --Savient Pharmaceuticals, Inc.
(NASDAQ: SVNT) today announced that ongoing KRYSTEXXA^® (pegloticase)
post-marketing surveillance data describing the long-term safety data for
KRYSTEXXA will be presented at the 2013 EULAR Congress in Madrid, Spain June
12-15. The two posters describe a decrease in the rate of reported infusion
reactions (IRs) during the post-FDA approval period in the U.S., as well as
lessons learned from U.S. clinical experience about the safe and effective use

"Data presented at this year's EULAR Congress provide greater clarity around
the safety data for KRYSTEXXA in the post-marketing setting," said Kenneth M.
Bahrt, M.D., Senior Vice President and Chief Medical Officer of Savient.
"These data are important to our continued ability to fill a significant unmet
need for a small subset of patients affected by chronic gout refractory to
conventional therapies. The results also highlight important KRYSTEXXA safety
and surveillance recommendations that enable physicians to determine whether
or not a patient will maintain response to therapy by monitoring uric acid
levels, a biomarker of efficacy and safety."

The data will be featured as poster presentations during the Congress on
Saturday, June 15 and include the following studies:

  oReal World Risk of Infusion Reactions with Pegloticase Treatment: Findings
    from Post-Approval U.S. Safety Data: Post-marketing U.S. safety data
    assessing IRs in patients treated with KRYSTEXXA found the relative risk
    reduction for IRs post-approval compared with the pooled clinical trial
    data was 68.7% (95% CI: 49.8 to 80.5). The incidence of IRs was drawn from
    voluntary AE reporting. An estimate of the total number of infusions given
    was derived from the number of vials sold during that period compared with
    the number administered to a defined number of patients during the six
    months of trial participation. (SAT0355; June 15, 2013, 11:00 a.m. CET)

  oUric Acid Levels as a Biomarker of Efficacy and Safety in Patients Treated
    with Pegloticase: Lessons Learned from U.S. Clinical Experience: U.S.
    post-marketing data examining IRs, uric acid levels and concomitant
    Xanthine Oxidase Inhibitor (XOI) use with KRYSTEXXA identified a potential
    safety concern; as a result, appropriate actions, including a label change
    and Dear HCP letter, were undertaken by Savient. Based on voluntary AE
    reporting, fewer patients were treated with concomitant pegloticase and
    XOIs after U.S. physicians received guidance against this practice.
    (SAT0376; June 15, 2013, 10:15 a.m. CET)


Symptoms of gout are caused by the body's response to the presence of high
uric acid levels which can lead to the formation of urate 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 urate crystals under the skin, called "tophi." Although most cases
of gout can be controlled with conventional urate-lowering therapy, uric acid
levels may remain high and symptoms persist despite treatment efforts, even at
maximum medically appropriate doses.


KRYSTEXXA^® (pegloticase) is a PEGylated uric acid specific enzyme for
administration by intravenous infusion. The active substance pegloticase is a
covalent conjugate of uricase produced by a genetically modified strain of
Escherichia coli and monomethoxypoly (ethylene glycol).

KRYSTEXXA was approved in the U.S. in September 2010.KRYSTEXXA is indicated
in the U.S. for the treatment of chronic gout in adult patients refractory to
conventional therapy.KRYSTEXXA is not recommended for the treatment of
asymptomatic hyperuricemia. KRYSTEXXA was approved by the EMA in January 2013
to treat severe, debilitating chronic tophaceous gout.


The following information is provided in both the U.S. and European
prescribing information.

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

Warnings and Precautions:

  oAnaphylaxis and infusion reactions have been reported to occur during and
    after administration of 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 discontinue treatment if levels rise above
    6mg/dL, particularly when two consecutive levels above 6 mg/dL are
  oAn 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.

In addition, the European Summary of Product Characteristics (SmPC) includes
two other special warnings and precautions for use.

  oIf haemolysis and/or methemoglobinemia occur in patients receiving
    KRYSTEXXA, treatment should be immediately and permanently discontinued
    and appropriate measures initiated.
  oPatients over 100 kg body weight may have higher titers of
    anti-pegloticase antibodies and infusion-related reactions showed a
    tendency to occur in a greater proportion of patients in this weight

The most commonly reported serious adverse reactions were anaphylaxis,
infusion reactions and gout flares. The SmPC includes the following very
common adverse reactions: gout flares, infusion reactions, nausea, dermatitis,
urticaria, pruritus, skin irritation and dry skin. In the U.S. prescribing
information, the most common adverse reactions (5% or greater) reported were
gout flares, infusion reactions, nausea, contusion or ecchymosis,
nasopharyngitis, constipation, chest pain, anaphylaxis, and vomiting.

Please see full prescribing information for KRYSTEXXA.


Savient Pharmaceuticals, Inc. is a specialty biopharmaceutical company focused
on developing and commercializing KRYSTEXXA^® (pegloticase) for the treatment
of chronic gout in adult patients who do not respond 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 that 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, the potential to expand the clinical utility
of KRYSTEXXA, status of our KRYSTEXXA marketing efforts in the U.S. and
additional plans related thereto both in the U.S. and EU, market demand and
reimbursement for KRYSTEXXA, our view of the market size in the U.S. and EU,
and our market expansion plans outside the U.S. and EU 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. Important factors
that may affect our ability to achieve the matters addressed in these
forward-looking statements include, but are not limited to, developments that
may arise in the litigation with Tang Capital; our ability to commercialize
KRYSTEXXA; the risk that the market for KRYSTEXXA is smaller than we have
anticipated; our ability to retain the personnel; our reliance on third
parties to manufacture KRYSTEXXA; competition from existing therapies and
therapies that are currently under development, including therapies that are
significantly less expensive than KRYSTEXXA; our ability to gain market
acceptance for KRYSTEXXA among physicians, patients, health care payers and
others in the medical community; whether we are able to obtain financing, if
needed; economic, political and other risks associated with foreign
operations; risks of maintaining protection for our intellectual property;
risks of an adverse determination in intellectual property litigation; and
risks associated with stringent government regulation of the biopharmaceutical
industry and other important factors and other important factors 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 statements.


Investor Relations            Media Relations
John P. Hamill                Erica Tursi
Savient Pharmaceuticals, Inc. Rx Mosaic Health
(732) 418-9300                (347) 601-5608

SOURCE Savient Pharmaceuticals, Inc.

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