EAST BRUNSWICK, N.J., Jan. 6, 2012/PRNewswire/ --Savient Pharmaceuticals, Inc. (NASDAQ: SVNT) today announced that a product-specific billing code, or permanent J-code, for KRYSTEXXA® (pegloticase) became available on January 1, 2012. The new J-code, J2507, was assigned by the Centers for Medicare and Medicaid Services (CMS) and will help simplify the billing and reimbursement process for prescribers of KRYSTEXXA, the first and only U.S. Food and Drug Administration (FDA) approved treatment for refractory chronic gout (RCG).
"The availability of a permanent J-code for KRYSTEXXA is a significant step toward ensuring that healthcare providers and their patients with severe and debilitating gout, or RCG, have access to the first and only product for RCG," said John H. Johnson, Chief Executive Officer and President of Savient Pharmaceuticals.
Comprehensive support and financial assistance programs for KRYSTEXXA are available through KRYSTEXXA Connexxions. To access KRYSTEXXA Connexxions, call 1-877-633-9521 or visit .
ABOUT KRYSTEXXA®
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. KRYSTEXXAbecame commercially available in the
U.S. by prescription on December 1, 2010and 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
hyperuricemia.
IMPORTANT SAFETY INFORMATION ABOUT TREATMENT WITH
KRYSTEXXA®
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 therapy.
Possible side effects of KRYSTEXXA include:
- Anaphylaxis 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.
- Infusion 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.
- As 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.
ADVERSE REACTIONS
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 .
ABOUT REFRACTORY CHRONIC GOUT
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.
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 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"). Dukedeveloped the
recombinant uricase enzyme and MVP developed the PEGylation
technology used in the manufacture of KRYSTEXXA. MVP and
Dukehave 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 manufactures and supplies Oxandrin®
(oxandrolone tablets, USP) CIII in the U.S. For more
information, please visit the Company's website at .
FORWARD-LOOKING STATEMENTS
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®,
status of our KRYSTEXXA marketing efforts and additional
plans related thereto, market demand and reimbursement for
KRYSTEXXA, our view of the refractory chronic gout (RCG)
market size, and our market expansion plans including our
MAA filing before the EMA 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,
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 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.
SVNT- G
Contacts: | |
Investor Relations | Media Relations |
Mary Coleman | Lindsay Rocco |
Savient Pharmaceuticals, Inc. | Rx Mosaic Health |
(732) 418-9300 | (862) 596-1304 |
SOURCE Savient Pharmaceuticals, Inc.
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