Savient Pharmaceuticals Provides Business Update
Promotional Launch of KRYSTEXXATM (pegloticase) Expected in the First Quarter of 2011
EAST BRUNSWICK, N.J., Jan. 7, 2011 /PRNewswire/ -- Savient Pharmaceuticals, Inc. (Nasdaq: SVNT) today provided an update on its business activities related to the U.S. launch and commercialization of KRYSTEXXA, a PEGylated uric acid specific enzyme indicated for the treatment of chronic gout in adult patients refractory to conventional therapy. Savient continues to believe that it is on track for the promotional launch of KRYSTEXXA in the first quarter of 2011.
The Company announced that:
- KRYSTEXXA became commercially available in the U.S. by prescription on December 1, 2010 with the commencement of sales and shipments by the Company to its network of specialty distributors and to its wholesale distributors.
- The first chronic gout patient received treatment with KRYSTEXXA in December.
- The Company has built out much of its planned sales, marketing, managed care, medical affairs and pharmacovigilance teams, including hiring the full team of six regional business directors and more than 60% of the planned territory sales representatives. As a group, these hires bring additional rheumatology and biologics experience to Savient's commercial team.
- In early December, the Company activated its pharmacovigilance hotline and comprehensive reimbursement support services hotline and internet portal through its third party service providers PPD and Covance.
- To date, several large private managed care organizations have added medical benefits coverage for KRYSTEXXA, and others are actively evaluating medical benefits coverage. The Company has also filed for a temporary "C" code and a permanent "J" code application with the Centers for Medicare & Medicaid Services in December of 2010.
- In support of the commercial launch of KRYSTEXXA, the Company has in inventory at its third party logistics warehouse in the United States, supplies of finished KRYSTEXXA product that is packaged and labeled for distribution and additional supplies of bulk product which are scheduled to be packaged and labeled in the coming months which it believes are, based on the Company's current projections, adequate to supply market demand through the first quarter of 2012.
•The Company has also been advancing its plans to submit a marketing authorization application (MAA) for centralized review in the EU. In this regard, in December 2010 the Pediatric Committee (PDCO) of the European Medicines Agency approved the Company's pediatric investigation plan for the treatment and prevention of hyperuricemia, which is a condition to filing for marketing approval in the EU. While the Company has made significant progress in preparing the MAA for KRYSTEXXA, the Company is revising its projected timing for this filing to the end of the first quarter of 2011.
The Company further announced that its third party contractor manufacturing organizations (CMO) in Israel and Indianapolis, Indiana have commenced regularly scheduled commercial manufacturing campaigns to build inventory of pegloticase and KRYSTEXXA. In connection with this process, the Company's third party CMO in Israel and Merck Biomanufacturing Network, formerly known as Diosynth ("Merck"), which the Company is working to qualify as a secondary contract manufacturer, have experienced some batch failures based on one manufacturing specification. While the Company believes these batch failures are within normal industry failure rates experienced for the commencement of biologic commercial manufacturing, this failure rate is above the level that the Company believes to be acceptable for normal ongoing operations. Savient personnel, assisted by an outside manufacturing and quality consulting firm, have completed a review of these batch failures and believe they have identified the root cause of the batch failures at both the Company's third party CMO in Israel and Merck. Under the Company's direction, the Company's CMO in Israel and Merck are in the process of implementing remediation steps that the Company and its outside consulting firm believe will minimize or eliminate these failures moving forward. Prior to implementing these remediation steps, the Company's CMO in Israel, under the close supervision and direction of the Company, has continued to manufacture pegloticase and has recently manufactured two batches of pegloticase which have met all specifications.
As a result of the batch failures at Merck, the Company has determined that the manufacturing validation campaign at Merck was unsuccessful. The Company plans to repeat its validation campaign batches at Merck in 2011, which the Company expects will result in incremental additional costs of approximately $9 to $10 million over a two-year period.
The Company also announced that it has met all post-marketing and REMS commitments required to be completed to date. The Company believes that it is on schedule to provide the protocol for the post-marketing observational study in February 2011 and to commence the study according to the timeline provided in the September 2010 FDA action letter approving KRYSTEXXA.
ABOUT SAVIENT PHARMACEUTICALS, INC.
Savient Pharmaceuticals, Inc. is a specialty biopharmaceutical company focused on developing and commercializing KRYSTEXXA(TM) (pegloticase), which was approved by the FDA on September 14, 2010 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 manufactures and supplies Oxandrin(R) (oxandrolone tablets, USP) CIII in the U.S.
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 launch of KRYSTEXXA, our recruiting of personnel, reimbursement through managed care and governmental organizations, supply of inventory and market demand for KRYSTEXXA, the remediation of the issues causing batch failures at our manufacturing facilities, the cost of repeating the validation campaign at Merck and the timing of filing for marketing approval in the 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, our ability to commercialize KRYSTEXXA; our ability to retain the personnel whom we have hired and to hire the remaining personnel necessary to complete the build out of our commercial team; our ability to successfully identify a person to serve as chief executive officer, our ability to negotiate an employment agreement with any such person; whether we have identified the root cause of the batch failures at our manufacturing facilities; whether the remediation steps that we have taken will eliminate or minimize these batch failures moving forward; if the remediation steps that we have taken do not reduce our batch failure rate, the risk that the FDA could require us to cease manufacturing KRYSTEXXA until we have been able to reduce our batch failure rate; our reliance on third parties to manufacture, market and distribute KRYSTEXXA; the risk that the market for KRYSTEXXA is smaller than we have anticipated; 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 payors 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.
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SOURCE Savient Pharmaceuticals, Inc.
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