Savient's KRYSTEXXA® (pegloticase) Receives European Commission Marketing
Authorization for the Treatment of Certain Patients with Chronic Tophaceous
- First approved therapy in the European Union to address a significant unmet
medical need for patients with chronic tophaceous gout
BRIDGEWATER, N.J. and DUBLIN, Jan. 8, 2013
BRIDGEWATER, N.J. and DUBLIN, Jan. 8, 2013 /PRNewswire/ -- Savient
Pharmaceuticals, Inc. (NASDAQ: SVNT) and its wholly owned subsidiary, Savient
Pharma Ireland Ltd., today announced that the European Commission has granted
a marketing authorization for KRYSTEXXA^® (pegloticase) for the treatment of
severe debilitating chronic tophaceous gout in adult patients who may also
have erosive joint involvement and who have failed to normalize serum uric
acid with xanthine oxidase inhibitors at the maximum medically appropriate
dose or for whom these medicines are contraindicated.
"There is currently no other treatment option in the EU for patients with
severe chronic tophaceous gout who do not respond to oral xanthine oxidase
inhibitors," said Dr. Thomas Bardin, MD, Professor and Head of the
Rheumatology department at the Lariboisière Hospital in Paris, France.
"KRYSTEXXA addresses a significant unmet medical need and represents an
important development for healthcare professionals and European patients
suffering from this debilitating disease."
"European approval of KRYSTEXXA demonstrates our ongoing commitment to this
underserved population by offering a much needed treatment option to these
patients and marks a significant milestone for the Company," said Lou Ferrari,
President and Chief Executive Officer of Savient. "We continue to establish
relationships with clinicians and key opinion leaders in Europe, and we
anticipate product launch in the region by mid-2013."
The European Commission's approval decision was based upon safety and efficacy
data from Savient's two pivotal Phase III studies, and a long-term open label
extension study of KRYSTEXXA, as well as non-clinical and chemistry,
manufacturing and control information.
Until the product becomes commercially available in the EU, Savient will
continue to provide KRYSTEXXA to patients through the established Named
Patient Programme (NPP).
ABOUT CHRONIC TOPHACEOUS GOUT
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." In cases of severe
debilitating chronic tophaceous gout, these symptoms have a major influence on
patient health due to the frequency and severity of episodes.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 US in September 2010. KRYSTEXXA is indicated in
the US for the treatment of chronic gout in adult patients refractory to
conventional therapy. KRYSTEXXA is not recommended for the treatment of
IMPORTANT SAFETY INFORMATION
The following information is provided in both the US and European prescribing
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 US 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.
ABOUT SAVIENT PHARMACEUTICALS, INC.
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 US and foreign patents disclosing
and claiming the licensed technology and, in addition, Savient owns or co-owns
US 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 US For more information, please visit
the Company's website at www.savient.com.
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 US and
additional plans related thereto both in the US and EU, market demand and
reimbursement for KRYSTEXXA, our view of the market size in the US and EU, and
our market expansion plans outside the US 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.
Savient Pharmaceuticals, Inc.
John P. Hamill
Senior Vice President and Chief Financial Officer
SOURCE Savient Pharmaceuticals, Inc.
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