SAN DIEGO and OSAKA, Japan, March 4,
2014 /PRNewswire/ -- TRACON Pharmaceuticals (TRACON) and
Santen Pharmaceutical Co., Ltd. (Santen) announced today that they
have entered into an exclusive agreement for the development and
global commercialization of TRACON's anti-endoglin antibodies,
including TRC105, in ophthalmology. Pre-clinical and clinical data
from TRACON's ongoing development of TRC105 in combination with
anti-VEGF products in oncology indicate inhibiting both the
endoglin and VEGF pathways has the potential to show advantages
over inhibiting VEGF alone in the treatment of conditions such as
wet age-related macular degeneration (wet AMD).
Under the terms of the agreement, Santen will make a
$10 million upfront payment and
certain milestone payments to TRACON in the development phase, and
will pay commercialization milestones and tiered royalties on
global sales of TRC105 in ophthalmology. Santen will fund
100% of all global development, and commercialization activities,
including the initiation of IND-enabling studies. TRACON will
continue ongoing Phase 2 development of TRC105 in a number of
oncology indications, and will retain global rights on applications
of its anti-endoglin antibody portfolio outside of
ophthalmology.
"TRC105 has the potential to help patients suffering from
serious and debilitating eye diseases who do not benefit from
current treatment," said Charles
Theuer, M.D., Ph.D., President and CEO of TRACON. "The
experience TRACON has gained in the development of TRC105 in
oncology, by combining TRC105 with bevacizumab and other inhibitors
of the VEGF pathway, reinforces our belief that development of
TRC105 in serious angiogenesis-driven eye diseases is an
outstanding product development opportunity. Santen is a global
leader in the development and commercialization of ophthalmic
products. We look forward to working with Santen as they develop
TRC105."
"Santen is a global pharmaceutical company specialized in the
field of ophthalmology, and it is committed to delivering novel
medicines for the treatment of high unmet need ophthalmic
conditions on a global basis. TRC105 is an antibody that inhibits a
novel target, endoglin, a key mediator of resistance to VEGF
inhibitor treatment in angiogenesis-driven diseases.
Currently, treatment options for retinal disease, including wet AMD
are limited, and thus, Santen is pleased to gain access to novel
compounds such as TRC105, so that Santen can contribute to
improving the quality of life of patients suffering from retinal
disease such as wet AMD," said Akira
Kurokawa, President and CEO of Santen.
The TRC105 oncology development program includes two ongoing
randomized Phase 2b studies with bevacizumab in renal cell
carcinoma and glioblastoma, and combination studies with axitinib
in renal cell carcinoma, with pazopanib in advanced soft tissue
sarcoma and with sorafenib in hepatocellular carcinoma.
Impact on Santen's earning forecast for fiscal year 2013, ending
on March 31st, 2014, is considered to
be limited.
About TRC105
TRC105 is a novel, first-in-class, clinical stage antibody to
endoglin (CD105), an endothelial cell receptor that is essential
for the process of new blood vessel formation called angiogenesis.
TRC105 is currently being studied in multiple clinical trials in
cancer patients, sponsored by both TRACON and the National Cancer
Institute (NCI) Cancer Therapy Evaluation Program (CTEP) and is
expected to complement VEGF inhibitor therapies. TRC105 is also
expected to complement VEGF inhibitor treatments in age-related
macular degeneration. For more information about the clinical
trials, please visit TRACON's website at
http://www.traconpharma.com/clinical_trials.php.
About Santen
Founded in 1890, Santen is a global company headquartered in
Osaka, Japan. Santen researches,
develops and markets ophthalmic products for physicians worldwide.
Among prescription ophthalmic pharmaceuticals, Santen holds the top
share within the Japanese market and is one of the leading
ophthalmic companies worldwide. Tokyo Stock Exchange code
4536. For more information, visit www.santen.com.
About TRACON
TRACON Pharmaceuticals develops targeted therapies for people
with cancer and age-related macular degeneration. The current
pipeline includes two clinical-stage product candidates, each
addressing a unique cellular process, that are expected to
complement currently available therapies. TRACON aims to develop
effective and well-tolerated treatments for underserved populations
with the ultimate goal of enhancing survival and quality of life.
To learn more about the company and its products, visit TRACON's
website at www.traconpharma.com.
Santen Forward-looking
Statements
Information provided in this press release contains so-called
"Forward-looking Statements". The realizations of these forecasts
are subject to risk and uncertainty from various sources.
Therefore, please note that the actual results may differ
significantly from the forecasts. Business performance and
financial condition are subject to the effects of change in
regulations made by the governments of Japan and other nations concerning medical
insurance, drug pricing and other systems, and to fluctuations in
market variables such as interest rates and foreign exchange
rates.
SOURCE TRACON Pharmaceuticals