Incyte Corporation (Nasdaq:INCY) will announce today at the 27th Annual
JPMorgan Healthcare Conference its 2009 corporate objectives, including
its decision to focus on clinical programs with the greatest near-term
value.
These programs include:
-
Janus kinase (JAK) inhibitor program for:
- myelofibrosis
(MF),
- polycythemia vera (PV) & essential thrombocythemia (ET),
-
rheumatoid arthritis (RA) and
- psoriasis
-
11beta-HSD1 (HSD1) inhibitor program for type 2 diabetes
-
Sheddase inhibitor program for breast cancer
Paul Friedman, M.D., Incyte's President and CEO, stated, "Our most
important clinical priority is to complete our planned pivotal trials
for our lead product candidate, INCB18424, in myelofibrosis. With our
special protocol assessment for myelofibrosis recently submitted to the
FDA, we remain on track to initiate registration trials, one in the U.S.
and one in Europe, during the first half of 2009.
Our decision to focus on clinical programs with the greatest likelihood
of creating near-term value supports our goal to spend less in 2009 than
we spent in 2008. Additionally, given the challenging economic
environment, a second financial objective in 2009 is to establish
partnerships for a number of programs including our lead metabolic
program, HSD1. A third objective for this year is to reduce and/or
restructure our debt.”
Incyte intends to provide formal 2009 guidance during its year-end / 4th
quarter press release and conference call in February.
Programs that will not receive funding in 2009 include:
-
JAK inhibitor for multiple myeloma and hormone refractory prostate
cancer
-
HM74a agonist for type 2 diabetes
-
CCR2 inhibitor for multiple sclerosis
-
CCR5 inhibitor for HIV
Partnership Objectives
In addition to partnering HSD1, Incyte is looking to establish alliances
for several other programs and/or indications that require extensive
development and commercial resources or are outside the core focus of
the Company in oncology and inflammation.
New Oncology Programs
Two new oncology programs involving oral inhibitors of c-MET and
indoleamine 2, 3-dioxygenase (IDO) have been cleared by the U.S. Food
and Drug Administration (FDA) to begin clinical trials. Dr. Friedman
will describe the c-MET program during his presentation. The IDO
inhibitor program will be discussed at a future date.
The initiation of Phase I trials for these compounds in 2009 depends
upon partnering one or more of Incyte’s other programs.
Clinical Objectives
JAK Inhibitor Program
INCB18424 (MPDs)
-
Secure agreement with the FDA regarding the special protocol
assessment (SPA) for approval in MF
-
Initiate registration trials in MF during the first half of 2009
-
Complete and present results from Phase II trial in PV/ET patients in
the second half of 2009
INCB18424 (psoriasis)
-
Complete and present results from the ongoing three-month Phase IIb
trial with the topical formulation in mild to moderate psoriasis
patients in the second half of 2009
INCB18424 and INCB28050 (rheumatoid arthritis)
-
Select lead compound to advance into Phase II program during the first
quarter of 2009
11beta-HSD1 Inhibitor Program
-
Complete and present results from the three-month Phase IIb trial in
type 2 diabetes in mid-2009
-
Secure partnership
Sheddase Inhibitor Program
-
Complete and present results from the Phase II breast cancer trial in
combination with Herceptin(R) in the second half of the year
The Incyte presentation at the JPMorgan Healthcare Conference will be
webcast live today at 6:30 pm Eastern Time / 3:30 pm Pacific Time and
can be accessed at www.incyte.com
under Investor Relations, Events and Webcasts. A replay of the
presentation will be available for 30 days. Investors interested in
listening to the live webcast should log on before the start time in
order to download any required software.
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 I and Phase II development for oncology,
inflammation and diabetes.
Forward-Looking Statements
Except for the historical information contained herein, the matters set
forth in this press release, including statements with respect to
Incyte’s decision to focus on clinical programs with the greatest
near-term value; Incyte remaining on track to initiate registration
trials for INCB18424 in MF in the U.S. and Europe during the first half
of 2009; Incyte’s financial goals to spend less in 2009 than in 2008, to
establish partnerships for a number of programs including its lead
metabolic program, HSD1, and other programs and/or indications that
require extensive development and commercial resources or are outside
the Company’s core focus in oncology and inflammation, and to reduce
and/or restructure its debt; Incyte’s intent to provide formal 2009
guidance during its year-end / 4th quarter press release and
conference call in February; Incyte’s clinical objectives for INCB18424
(MPDs) to secure agreement with the FDA regarding the special protocol
assessment for approval in MF, initiate registration trials in the first
half of 2009, complete and present results from the Phase II trial in
PV/ET patients during the second half of 2009; Incyte’s clinical
objective for INCB18424 (psoriasis) to complete and present results from
the ongoing three-month Phase IIb trial in mild to moderate psoriasis
patients in the second half of 2009; Incyte’s clinical objective for
INCB18424 and INCB28050 (rheumatoid arthritis) to select a lead compound
to advance into a Phase II program during the first quarter of 2009;
Incyte’s clinical objectives for its HSD1 inhibitor program to complete
and present results from the three-month Phase IIb trial in type 2
diabetes in mid-2009 and secure a partnership; Incyte’s clinical
objectives for its Sheddase inhibitor program to complete and present
results from the Phase II breast cancer trial in combination with
Herceptin in the second half of the year, 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
associated with drug development and clinical trials, the uncertainty of
the FDA and European approval process, results of further research and
development, the impact of competition and of technological advances and
the ability of Incyte to compete against parties with greater financial
or other resources, Incyte's ability to enroll a sufficient number of
patients for its clinical trials, 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
September 30, 2008. Incyte disclaims any intent or obligation to update
these forward-looking statements.