KrystexxaTreatment for Gout
Update: Krystexxa (pegloticase) Now FDA Approved - September 14, 2010
Savient Announces New Date for FDA Arthritis Advisory Panel Review of Krystexxa for Treatment Failure Gout
EAST BRUNSWICK, N.J., May 7 /PRNewswire-FirstCall/ -- Savient Pharmaceuticals, Inc. today announced that its biologics license application (BLA) for Krystexxa (pegloticase), a novel biological drug for treatment failure gout (TFG) patients, will be reviewed by the Arthritis Advisory Committee appointed by the U.S. Food and Drug Administration (FDA) on June 16, 2009.
In December, the FDA accepted the Company's BLA for Krystexxa and granted priority review status, which is a designation assigned to drugs that are deemed by the FDA to have the potential to provide an important advancement in treatment or provide a treatment for a disease or condition for which there is no adequate therapy available.
In January, the Company submitted to the FDA several key amendments for the Krystexxa BLA to further strengthen and clarify the overall BLA application. The FDA reviewed and accepted the amendments and determined that the additional information contained in the submissions constituted major amendments. In an effort to include the amendments as part of the review, the FDA elected to extend the BLA review period and assigned a revised PDUFA date of August 1, 2009.
Krystexxa (pegloticase) is a pegylated recombinant mammalian urate oxidase in development to control hyperuricemia and its clinical consequences in patients for whom conventional therapy is contraindicated or has been ineffective. The two Phase 3 pivotal trials assessed the safety and efficacy of a six-month course of pegloticase therapy in patients with treatment failure gout, under the auspices of an SPA from the FDA. Krystexxa was granted orphan drug indication by the FDA in 2001. Savient's Krystexxa BLA filing includes data from both the six-month placebo-controlled Phase 3 pivotal trials, as well as data from the open label extension study.
About Savient Pharmaceuticals, Inc.
Savient Pharmaceuticals, Inc. is a specialty biopharmaceutical company focused on developing and marketing pharmaceutical products that target unmet medical needs in both niche and broader specialty markets. Savient's product development candidate, Krystexxa (pegloticase) for treatment failure gout has reported positive Phase 1, 2 and 3 clinical data. The Krystexxa Phase 3 clinical studies were completed in October 2007; the BLA was filed with the FDA in October 2008 and the FDA granted priority review status in December 2008. The Company submitted amendments to the BLA to the FDA in January 2009 and the FDA extended the review period by three months, revising the PDUFA date to August 1, 2009. Savient has exclusively licensed worldwide rights to the technology related to Krystexxa, formerly referred to as Puricase(R), from Duke University and Mountain View Pharmaceuticals, Inc. Savient also manufactures and supplies Oxandrin(R) (oxandrolone tablets, USP) CIII in the U.S. Puricase is a registered trademark of Mountain View Pharmaceuticals, Inc.
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 help identify forward-looking statements, although not all forward-looking statements contain these identifying words. In particular, any statements regarding the efficacy and safety of Krystexxa (pegloticase), our BLA filing with the FDA, the Advisory Committee, approval of the BLA, preparation for commercialization of Krystexxa, and the market for Krystexxa, 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, our Phase 3 clinical data and on 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, the delay or failure in completing development of Krystexxa and developing other product candidates; our stock price and market conditions; varying interpretations of our clinical and CMC data by the FDA; delay achieving or failure to achieve FDA approval of Krystexxa; inability to manufacture commercial quantities of our products; inability to gain market acceptance sufficient to justify development and commercialization costs if our products are approved for marketing; our continuing to incur substantial net losses for the foreseeable future; difficulties in obtaining financing; potential development of alternative or more effective products by competitors; reliance on third parties to manufacture, market and distribute many of our products; economic, political and other risks associated with foreign operations; risks of maintaining protection for our intellectual property; risks of an adverse determination in ongoing or future 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 to shareholders. 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.
Posted: May 2009
- FDA Approves Krystexxa (pegloticase) for Gout - September 15, 2010
- Savient Announces Krystexxa Resubmitted BLA Accepted for Review by the FDA - March 30, 2010
- Savient Resubmits Biologics License Application for Krystexxa (pegloticase) for the Treatment of Chronic Gout in Patients Refractory to Conventional Therapy - March 19, 2010
- Savient Provides Update on Meeting with U.S. Food and Drug Administration for Krystexxa - September 19, 2009
- Savient Pharmaceuticals Receives Complete Response Letter from U.S. Food and Drug Administration for Krystexxa - August 4, 2009
- FDA Appointed Arthritis Advisory Committee Recommends U.S. Food and Drug Administration Approval for Krystexxa for Refractory Chronic Gout - June 17, 2009
- Savient Provides Update on Pegloticase BLA - February 12, 2009
- Savient Announces FDA's Advisory Panel to Review Pegloticase for Treatment-Failure Gout Patients - January 28, 2009
- Pegloticase BLA Filing Accepted for Priority Review by FDA - December 30, 2008
- Savient Submits Biologics License Application (BLA) for Pegloticase - October 31, 2008