Novartis to Develop and Commercialize Incyte’s Lead JAK1/JAK2
Inhibitor, INCB18424, for Territories Outside the US and Incyte’s cMET
Inhibitor, INCB28060, Worldwide
Incyte May Receive Over $1 Billion in Payments, Including $150
Million Upfront Plus an Immediate $60 Million Development
Milestone in Addition to Future Potential Milestones and Royalties
WILMINGTON, Del.--(BUSINESS WIRE)--Nov. 25, 2009--
Incyte Corporation (NASDAQ: INCY) announced today that it has entered
into a collaboration and license agreement with Novartis for two of its
investigational hematology-oncology therapies: INCB18424, an oral
JAK1/JAK2 inhibitor that is in Phase III development for myelofibrosis,
a serious life-threatening neoplastic condition characterized by varying
degrees of bone marrow failure, splenic enlargement and debilitating
constitutional symptoms, and INCB28060, an oral cMET inhibitor that is
about to enter Phase I development as a potential treatment for multiple
cancers.
Paul A. Friedman, Incyte’s president and CEO, stated, “This agreement
reflects our objective to retain US rights to INCB18424 and puts us in a
strong position to transition Incyte into a successful commercial
company with sufficient resources to continue to advance other promising
compounds in our pipeline. Additionally, the appreciation from Novartis
for INCB18424’s potential to treat the unmet patient need in
myelofibrosis and other cancers, and their proven success in rapidly
commercializing new targeted oncology treatments, were determining
factors in our decision to choose Novartis as our collaborative partner.”
Under the terms of the agreement, Incyte will retain exclusive rights
for the development and potential commercialization of INCB18424 in the
US. Novartis will have responsibility for the future development and
commercialization of INCB18424 in all hematology–oncology indications
outside of the US. Novartis will also be responsible for the future
worldwide development of INCB28060.
Novartis will make an upfront payment of $150 million to Incyte plus an
immediate $60 million milestone payment for the initiation of the
European Phase III trial of INCB18424, COMFORT-II, that began in July of
this year. Novartis will receive ex-US commercialization rights for
Incyte’s lead JAK inhibitor and global commercialization rights for the
cMET inhibitor. Each company will be responsible for costs in their
respective territories for the JAK inhibitor, with costs of
collaborative studies shared equally. Incyte may also be eligible over
time for additional payments of up to approximately $1.1 billion if
future contingent development and commercialization milestones are
achieved. Incyte is also eligible to receive tiered, double-digit
royalty payments on future ex-US INCB18424 sales. Novartis will be
responsible for all costs and activities for the cMET inhibitor after
the Phase I clinical trial. Incyte is eligible to receive royalties on
future sales of INCB28060 and has retained an option to co-develop and
co-promote INCB28060.
About Myeloproliferative Neoplasms (MPNs)
MPNs are a related group of hematological neoplasms characterized by
dysfunction of the bone marrow resulting in either over production of
blood cells or ineffective hematopoiesis leading to production of blood
cells in the spleen and resulting in massive splenomegaly. The three
main MPNs are polycythemia vera (PV), essential thrombocythemia (ET) and
myelofibrosis (MF). Approximately 10 to 20% of patients with PV and ET
progress to MF and MF can also develop without a prior history of PV or
ET. There are no adequately effective therapies to treat these disorders.
About INCB18424
INCB18424 is Incyte's lead internally developed JAK1/JAK2 inhibitor that
has shown positive clinical activity in a number of hematology and
inflammatory conditions. The compound is currently in Phase III for
patients with MF and Phase II for patients with advanced PV and ET.
Incyte has retained rights to develop a topical formulation of INCB18424
which has demonstrated positive clinical results in a recently completed
Phase IIb trial in patients with mild to moderate psoriasis.
About INCB28060
cMET is a validated target with significant potential in multiple major
oncology indications. INCB28060 is a potent cMET inhibitor that has
demonstrated favorable pharmacologic activity in relevant cell and
animal models and has demonstrated in those models that it can be dosed
safely to achieve levels of cMET inhibition that are associated with
tumor regression in multiple solid tumors. The investigational new drug
application has been cleared by the US Food and Drug Administration.
About Incyte
Incyte Corporation is a Wilmington, Delaware-based drug discovery and
development company focused on developing proprietary small molecule
drugs for oncology, inflammation and diabetes. Incyte’s most advanced
compound, INCB18424, is in Phase III development for myelofibrosis. 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
potential to receive up to approximately $1.1 billion in future
contingent milestone payments, plans and timing for INCB28060 to enter
Phase I development as a potential treatment for multiple cancers,
statements regarding being put in a strong position to transition into a
successful commercial company with sufficient resources to continue to
advance other promising compounds in the pipeline, the potential
indications and benefits of INCB18424 and INCB28060, and the potential
benefits from and payments under the agreement, 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 the
parties not to achieve some or all of the commercial and developmental
milestones set forth in the collaboration agreement and that may
otherwise cause Incyte’s actual results and timing to differ materially,
including the high degree of risk and uncertainty associated with drug
development and clinical trials, the uncertainty associated with the
regulatory approval processes, risks related to the timing of and
patient enrollment in clinical trials, risks related to the potential
failure of INCB18424 and INCB28060 to demonstrate safety and efficacy in
clinical testing; risks and uncertainty associated with the therapeutic
and commercial value of INCB18424 and INCB28060; risks relating to
market competition, risks associated with Incyte's dependence on its
relationship with its collaboration partners, 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, 2009. Incyte disclaims any intent or obligation to
update these forward-looking statements.
Source: Incyte Corporation
Incyte Corporation
Pamela M. Murphy
Vice
President, Investor Relations/Corporate Communications
302-498-6944