Incyte Corporation (Nasdaq:INCY) announced today that based on recent
input from the U.S. Food and Drug Administration (FDA) regarding
Incyte’s request for a Special Protocol Assessment (SPA) for INCB18424
for patients with primary myelofibrosis (PMF), post-polycythemia vera
myelofibrosis (PPV-MF) and post-essential thrombocythemia myelofibrosis
(PET-MF), it is clear that the most appropriate single primary endpoint
for Incyte’s U.S. Phase III trial is the proportion of treated patients
achieving a 35% reduction in spleen volume as compared to patients
receiving placebo.
Paul A. Friedman, M.D., President and CEO of Incyte, stated, "Because
INCB18424 is a first-in-class compound and there has never been a
registration trial for this disease conducted in the U.S., it has taken
a couple of iterations on the SPA request to establish that reduction in
spleen volume is the most appropriate primary endpoint to support
approval of a new treatment for myelofibrosis.”
Dr. Friedman added, "Although resubmitting our request will cause a
modest delay in starting the Phase III study, we still anticipate
completion of the study in a time frame that will allow for filing a New
Drug Application in late 2010 or early 2011 assuming positive results
are achieved. This time frame is consistent with prior guidance
provided.”
Based on the aforementioned interaction with the FDA, Incyte expects to
begin enrollment of COMFORT-I (COntrolled MyeloFibrosis
Study with ORal JAK Inhibitor Treatment) in August 2009.
The Phase III European trial, COMFORT-II, is scheduled to begin
enrollment in June 2009. COMFORT-II is an open-label study designed to
evaluate the efficacy, safety and tolerability of INCB18424 as compared
to the best-available therapy in 150 patients with PMF, PPV-MF or
PET-MF. This trial is expected to involve approximately 70 clinical
sites in 10 European countries and has been designed based on scientific
advice from the European Medicines Agency. The primary efficacy endpoint
in COMFORT–II is the proportion of patients achieving at least 35%
reduction in spleen volume from baseline to week 48.
About Myelofibrosis
Myelofibrosis is a serious neoplastic condition for which there are no
approved therapies in the U.S. It is characterized by varying degrees of
bone marrow failure, splenic enlargement and debilitating constitutional
symptoms resulting in a significant loss in quality of life and reduced
life-span. Myelofibrosis is part of a related group of hematological
neoplasms called myeloproliferative disorders that includes
myelofibrosis, polycythemia vera and essential thrombocythemia.
Approximately 10 to 20% of patients with polycythemia vera and essential
thrombocythemia progress to myelofibrosis. Myelofibrosis can also
develop without a prior history of polycythemia vera and essential
thrombocythemia.
About Special Protocol Assessments
The SPA is a process that allows for official FDA evaluation of the
clinical protocols of a Phase III clinical trial intended to form the
primary basis for an efficacy claim and provides trial sponsors with a
binding written agreement that the design and analysis of the trial are
adequate to support a marketing application submission if the trial is
performed according to the SPA. The SPA agreement may only be changed
through a written agreement between the sponsor and the FDA, or if the
FDA becomes aware of a substantial scientific issue essential to product
efficacy or safety. For more information on Special Protocol Assessment,
please visit http://www.fda.gov/cder/guidance/3764fnl.htm.
About Incyte
Incyte Corporation is a Wilmington, Delaware-based drug discovery and
development company focused on developing proprietary small molecule
drugs to treat serious unmet medical needs. Incyte's pipeline includes
multiple compounds in Phase II clinical trials for oncology,
inflammation and diabetes. For additional information on Incyte, visit
the Company's web site at www.incyte.com.
Forward-Looking Statements
Except for the historical information contained herein, the matters set
forth in this press release, including statements with respect to
the anticipated completion of the Phase III clinical trial in patients
with myelofibrosis and timing of filing of a New Drug Application for
INCB18424 assuming positive results are received, the expected times to
begin enrollment of patients in COMFORT-I and COMFORT-II, and the
expected number of clinical sites and countries for COMFORT-II, are all
forward-looking statements within the meaning of the "safe harbor"
provisions of the Private Securities Litigation Reform Act of 1995.
These forward-looking statements are subject to risks and uncertainties
that may cause actual results to differ materially, including the high
degree of risk and uncertainty associated with drug development and
clinical trials, the uncertainty of the regulatory approval processes,
including uncertainty regarding the nature and timing of the FDA’s
response to Incyte's revised request for SPA and the timing of
submission of Incyte's revised request, uncertainty regarding the timing
of commencement of the COMFORT-I trial based in part on uncertainty
regarding the timing and nature of the FDA's response to Incyte's
revised request for SPA, Incyte's ability to enroll a sufficient number
of patients for the COMFORT-I and COMFORT-II clinical trials in a timely
manner or at all, unanticipated developments in the efficacy or safety
of INCB18424, and other risks detailed from time to time in Incyte's
filings with the Securities and Exchange Commission, including
its Quarterly Report on Form 10-Q for the quarter ended March 31, 2009.
Incyte disclaims any intent or obligation to update these
forward-looking statements.
