Celgene Acquires Entremed Inc.'s Rights to Thalidomide
Good news for both sides. The split in rights was always a big concern for me, and now ENMD doesn't have to get duplicate approval for its own version of Thalidomide.
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ROCKVILLE, Md. and WARREN, N.J.--(BUSINESS WIRE)--Dec. 10, 1998--
Collaborative Effort Expedites Drug Development for Cancer Patients
EntreMed Inc. (NASDAQ:ENMD) and Celgene Corp. (NASDAQ:CELG)
Thursday announced the signing of a collaborative sublicensing
agreement for the advancement of thalidomide drug development.
Under the agreement, Celgene has acquired exclusive worldwide
rights to EntreMed's patents and technology for thalidomide, as well
as United States Food and Drug Administration (FDA) orphan drug
designations achieved by EntreMed.
A joint steering committee comprised of scientists and executives
from both companies has been formed to ease the transfer of
sponsorship for ongoing clinical trials of thalidomide in a variety of
cancer indications.
Under a letter of intent with the NCI, EntreMed had recently
broadened the scope of its thalidomide clinical trials to include new
investigational studies in non-small cell lung cancer, metastatic
renal cell cancer, and head and neck cancer which will build upon
current studies in primary brain cancer, prostate cancer, Kaposi's
sarcoma, and breast cancer.
Celgene will now have responsibility for present and future
clinical research on thalidomide and will additionally assume primary
responsibility for the on-going relationship with the National Cancer
Institute (NCI) for clinical trials of thalidomide.
Celgene has been developing THALOMID(TM) (thalidomide) for the
treatment of a number of autoimmune and inflammatory diseases. In July
1998, Celgene received FDA clearance to market and sell THALOMID(TM)
for the treatment of erythema nodosum leprosum (ENL), an inflammatory
complication of leprosy.
Celgene is currently investigating THALOMID(TM) in several
oncological indications, including multiple myeloma, and in
HIV/AIDS-related conditions, and Crohn's disease.
According to Celgene Chairman and Chief Executive Officer, John
Jackson, "This agreement significantly expands the intellectual
property rights Celgene holds on thalidomide to include
antiangiogenesis as well as expanding our outside collaborations and
development of THALOMID(TM) in oncology.
Our agreement with EntreMed will expedite development of this
novel drug as a therapeutic in life-threatening cancers where current
therapy is often inadequate," said Jackson.
Dr. John W. Holaday, EntreMed chairman and chief executive
officer commented on the agreement, "This collaboration is an
extremely positive one with direct and swift benefits to Celgene,
EntreMed and cancer patients throughout the country.
"EntreMed will receive royalty payments beginning immediately and
the revenue produced by this agreement will assist EntreMed in its
development of the antiangiogenic agent Endostatin(TM) protein as we
prepare for initiation of clinical trials in 1999."
It is important to note that thalidomide can cause severe birth
defects or death to an unborn baby if taken during pregnancy. The drug
should never be used by women who are pregnant or who could become
pregnant while taking the drug.
Because of this toxicity and in an effort to make the chance of
fetal exposure to thalidomide as small as possible, THALOMID(TM) must
be accessed through physicians and pharmacies participating in a
program called the System for Thalidomide Education and Prescribing
Safety, or S.T.E.P.S.(TM).
In all patients, thalidomide has the potential to cause nerve
damage that may be permanent, drowsiness/somnolence,
dizziness/orthostatic hypotension, neutropenia, increased viral load
and hypersensitivity reactions.
Celgene Corp., headquartered in Warren, is engaged in the
development of pharmaceuticals and agrochemicals.
Rockville-based EntreMed Inc., The Angiogenesis Company(TM), is a
leader in the field of antiangiogenesis research, which involves the
inhibition of abnormal blood vessel growth recently associated with a
broad range of diseases.
The Company's strategy is to accelerate development of its core
technologies through collaborations and sponsored research programs
with university medical departments, research companies and government
laboratories.
For further information, please visit the EntreMed web site at
www.entremed.com. Statements herein that are not descriptions of
historical facts are forward-looking and subject to risk and
uncertainties.
Actual results could differ materially from those currently
anticipated due to a number of factors, including those set forth in
the Company's Securities and Exchange Commission filings under "Risk
Factors," including risks relating to the early stage of products
under development; uncertainties relating to clinical trials;
dependence on third parties; future capital needs; and risks relating
to the commercialization, if any, of the Company's proposed products
(such as marketing, safety, regulatory, patent, product liability,
supply, competition and other risks).
CONTACT: EntreMed Inc.
Mary P. Sundeen, director of corp. communications
301/738-2490
or
Celgene Corp.
Sol J. Barer, Ph.D., president and COO, 732/271-4153
or
Makovsky & Co.
Ken Lewis, 212/508-
Copyright 1998, Business Wire |
