Un autre point commun....
William B. White, MD
Dr. White has indicated that he served as a consultant for Astellas
Pharma, Inc., Gilead Sciences, Inc., NicOx
, Roche Laboratories Inc.,
Pharmaceuticals, Inc., Pharmaceuticals, Inc., and Takeda
Pharmaceuticals North America, Inc. He served on the Speaker’s Bureau
for Boehringer Ingelheim Pharmaceuticals, Inc., Forest Laboratories,
Inc. He also received grants/research support from National Institutes
of Health, Novartis Pharmaceuticals Corporation.
In late November 2008, the Company engaged an experienced
independent panel of clinical experts, headed by Dr. William B. White,
Professor of Medicine, Calhoun Cardiology Center, School of Medicine,
to perform a formal blinded and unblinded post-hoc adjudication of all
cardiovascular events included in reports of Serious Adverse Events,
Infusion Reactions and Severe Infusion Reactions from the Phase 3
pegloticase trials. The primary event evaluation was predicated on the
Anti-Platelet Trialist Collaborative (APTC) assessment criteria. This
is a standardized approach that the FDA has widely accepted as a method
of evaluating cardiovascular risk. APTC cardiovascular events include
deaths, nonfatal myocardial infarction or nonfatal stroke. Dr. White
and his panel concluded that:
In addition to the work of Dr. White and his team, a separate
external panel of experts performed an additional analysis by reviewing
"all cause" mortality in the Phase 3 trials and Open Label Extension
study. It is important to note that in the Phase 3 trials, there was a
2:2:1 randomization used, meaning that 4 times as many patients were on
drug than placebo. However, in the Open Label Extension study virtually
all patients were on drug with only 2 going on observation. The panel
determined the following:
Upon review of these amendments, the FDA determined that the
additional information contained in these submissions constituted a
major amendment to the pegloticase BLA, which allowed the FDA under the
Prescription Drug User Fee Act (PDUFA) regulations to extend the review
period. In order to allow the agency time to consider these amendments,
the FDA has notified the Company that the pegloticase BLA priority
review PDUFA action date has been extended by three months to July 30,
2009. Given the extended action date, the FDA has also notified the
Company that the Advisory Committee meeting previously scheduled for
March 5, 2009 will be rescheduled. Savient will provide additional
details regarding the rescheduling of the Advisory Committee meeting
when a specific date and time have been determined.
"While we are eager to move the process forward as quickly as
possible, the change in schedule does not impact our planning related
to commercialization. The Company has always had a commercialization
launch plan that parallels the FDA review process and that will be
adjusted to meet the new PDUFA date," said Hamelin.
Krystexxa as a tradename was found to be acceptable by both the FDA and The European Medicines Agency (EMEA).
The Company will host a conference call and webcast today, Thursday,
February 12, 2009, 2009 at 7:00 PM ET to discuss the status of the BLA
and the amendments filed with the FDA. A question and answer period
will follow the Company's prepared remarks. Both the live and archived
web cast can be accessed from the Investor Relations page of Savient's website at http://www.savient.com.
A digital recording of the web cast will be available within two
hours 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) 802-8577 (U.S. participants) or (973) 935-8754 (International participants).
Conf ID: 85467097
Krystexxa (pegloticase) (formerly referred to as Puricase(R)) 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. Savient has licensed exclusive worldwide rights to the
technology related to Krystexxa (pegloticase) from and Mountain View
Pharmaceuticals, Inc. Puricase(R) is a registered trademark of Mountain
View Pharmaceuticals, Inc.
t'as d'autres suspects Marino ?