SVNT- People kept bidding up the stock thinking it was a sure thing after the AC.
Savient Pharmaceuticals Receives Complete Response Letter from U.S. Food and Drug Administration for KRYSTEXXA(TM)
Savient to Host Conference Call on Monday, August 3, 2009 at 8:00am
EAST BRUNSWICK, N.J., Aug. 2 /PRNewswire-FirstCall/ -- Savient Pharmaceuticals, Inc. (Nasdaq: SVNT - News) today announced that the Company has received a complete response letter from the U.S. Food and Drug Administration (FDA) stating that the FDA can not at this time approve the Company's Biologics License Application (BLA) for KRYSTEXXA(TM) (pegloticase) as a treatment for chronic gout in patients refractory to conventional therapy.
The complete response letter from the FDA cites deficiencies with the chemistry, manufacturing and controls (CMC) section of the BLA and also provided the current draft of the proposed labeling and further guidance regarding a Risk Evaluation and Mitigation Strategy (REMS) (Medication Guide and Communication Plan). The Company intends to immediately request a meeting with the FDA to discuss and clarify the issues raised in the complete response letter. Under FDA regulations, the Company believes that this meeting is deemed a "Type A" meeting, meaning that the FDA would meet with the Company within 30 days of its receipt of the meeting request.
One of the issues raised by the FDA in the complete response letter addresses a change made by the Company in the proposed process for manufacturing KRYSTEXXA for commercial use. The FDA has concluded that the comparability data submitted for the material manufactured using the proposed commercial manufacturing process was not adequate to demonstrate that it was representative of the material used to establish the safety and efficacy of KRYSTEXXA in its Phase 3 clinical trials. The FDA stated that the Company has the option of either reverting to and validating the manufacturing process used to produce KRYSTEXXA for the Phase 3 clinical trials or conducting additional comparability clinical trials to support the use of KRYSTEXXA manufactured using the proposed commercial manufacturing process. The Company currently expects that it will seek to address this issue by reverting to and revalidating the manufacturing process used to produce KRYSTEXXA for the Phase 3 clinical trials.
The complete response letter also stated that the FDA has determined that a REMS is necessary for KRYSTEXXA consisting of:
* A Medication Guide to ensure the safe and effective use of KRYSTEXXA by patients,
* A Communication Plan directed to healthcare providers likely to prescribe KRYSTEXXA to support the dissemination of information about the risks of severe infusion reactions and possible anaphylaxis, the risk of severe adverse reactions in administering KRYSTEXXA to patients with glucose-6-phopshate dehydrogenase (G6PD) deficiency and major cardiovascular events, and
* An Assessment Plan to monitor and assess the effectiveness of the Medication Guide and Communication Plan in communicating to patients and physicians an understanding of the risks of KRYSTEXXA treatment.
The complete response letter included additional CMC comments focused on tightening manufacturing parameters and narrowing analytical specifications associated with commercial production. The Company was also informed that its resubmission to the FDA in response to the complete response letter must include an update of safety data from all on-going studies. Additionally, the Company's drug substance manufacturer BTG-Israel has already provided a work plan to remediate observations arising from the FDA pre-approval inspection of BTG-Israel's manufacturing facility and a satisfactory inspection report is required prior to the approval of KRYSTEXXA.
"While our timeline for resubmission to the FDA is subject to a number of uncertainties, we currently believe that we can target completion of our resubmission for early 2010. We hope to have more clarity on the expected timeline after we meet with the FDA to discuss the complete response letter," stated Paul Hamelin, President of Savient Pharmaceuticals. "While we believe we have made substantial progress toward the potential final approval of KRYSTEXXA, we also have more work to do with the FDA to resolve these open issues. We are committed to work diligently to address these issues with a goal of obtaining final approval for KRYSTEXXA so we can provide this therapy to those chronic gout patients who are suffering from this crippling, debilitating disease and have no other treatment options."
The Company believes that its resubmission will respond to all of the deficiencies cited in the compete response letter and would lead to a new Prescription Drug User Fee Act expected action date of either two or six months after the date of the Company's resubmission, depending on the FDA's classification of the resubmission.
ABOUT KRYSTEXXA(TM)
KRYSTEXXA(TM) (pegloticase) is a PEGylated uricase enzyme intended for the treatment of chronic gout in patients refractory to conventional therapy. Gout refractory to conventional therapy occurs in patients who have failed to normalize serum uric acid and whose signs and symptoms are inadequately controlled with xanthine oxidase inhibitors at the maximum medically appropriate dose or for whom these drugs are contraindicated.
Conference Call Information
Savient will host a live webcast to discuss the approval of KRYSTEXXA on August 3, 2009 at 8:00 a.m. Eastern Time. Both the live and archived webcast can be accessed from the Investor Relations page of Savient's Website at savient.com. A digital recording of the webcast will be available within one hour following the conclusion of the call and will be available for 14 days. To access the recording, use the dial-in number and the Conference ID listed below.
Dial: 888-203-1112 (domestic) or 719-457-0820 (international)
Conf ID: 9640146 |
