SAN DIEGO, CA, UNITED STATES - Mar 4, 2014 - 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
"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
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.
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.
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
companies worldwide. Tokyo Stock Exchange code 4536. For more
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.