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.