Rexahn and BioSense Global Announce Collaboration and License Agreement for RX-3117 in Greater China
April 16 2019 - 8:00AM
Rexahn Pharmaceuticals, Inc. (NYSE American: RNN), a clinical
stage, biopharmaceutical company focused on oncology, and BioSense
Global LLC, a New Jersey- and Suzhou, China-based biopharmaceutical
company, today announced a collaboration and license agreement to
advance the development and commercialization of RX-3117 for
pancreatic cancer and other cancers in Greater China.
Under the agreement, Rexahn will grant BioSense an exclusive
license to develop and commercialize RX-3117 in Greater China.
Rexahn will receive an upfront payment and will be eligible to
receive additional development, regulatory and commercial
milestones up to a total of $226 million contingent on achieving
regulatory and commercial goals related to pancreatic cancer and
additional indications. Rexahn will also be eligible to receive
tiered royalties in the low double digits to mid teens on annual
net sales in the territory. The companies will collaborate to
develop RX-3117 for pancreatic cancer and other indications.
BioSense will fund all activities related to the development and
commercialization of RX-3117 in Greater China and will initiate a
Phase 2 study to evaluate the drug candidate in up to three
additional indications not previously studied by Rexahn.
“Rexahn is focused on developing novel therapies for people with
difficult-to-treat cancers. This partnership will enable us to
extend the development of RX-3117 to patients in Greater China and
also to evaluate RX-3117 in additional indications in collaboration
with BioSense,” said Douglas Swirsky, President and CEO of Rexahn.
“We are excited to work with the experienced regulatory and
development team at BioSense to advance the development of RX-3117
towards regulatory approval in Greater
China.”
Andy Li, PhD, President and CEO of BioSense Global, added,
“We are delighted to partner with Rexahn to develop RX-3117 for the
Greater China markets. Cancer is the leading cause of death in
China with over four million new diagnoses and almost three million
deaths per year. Prognosis is poor for certain cancers and
treatment options are limited. Despite the significant success of
immunotherapy, chemotherapy will remain a critical component of
treatment regimens for many cancers. With its unique
tumor-targeting mechanism, we believe RX-3117 could become a safer,
more efficacious yet affordable treatment option to patients and
doctors. We are excited to advance the development of RX-3117 for
cancers that are especially prevalent among Chinese patients.”
Additional information on the collaboration and license
agreement can be found in the Current Report on Form 8-K being
filed by Rexahn today with the Securities and Exchange
Commission.
About RX-3117
RX-3117 is a novel, investigational, oral, small molecule
nucleoside compound. Once intracellularly activated
(phosphorylated) by UCK2, it is incorporated into the DNA or RNA of
cells and inhibits both DNA and RNA synthesis, which induces
apoptotic death of tumor cells. Due to the high level of over
expression of UCK2 in cancer cells, RX-3117 offers the potential
for a targeted anti-cancer therapy with an improved efficacy and
safety profile. RX-3117 is currently being studied in a Phase 2a
clinical trial in combination with Abraxane® (paclitaxel
protein-bound particles for injectable suspension) in first line
metastatic pancreatic cancer patients and a Phase 2a clinical trial
in patients with advanced or metastatic bladder cancer. It has
received Orphan Drug designation for the treatment of pancreatic
cancer. Additional information on RX-3117 can be found
at: https://rexahn.com/cms/portfolio/rx-3117/.
Abraxane is a registered trademark of Abraxis Bioscience, LLC, a
wholly owned subsidiary of Celgene Corporation.
About Rexahn Pharmaceuticals, Inc.
Rexahn Pharmaceuticals, Inc. (NYSE American: RNN) is a clinical
stage biopharmaceutical company developing innovative therapies to
improve patient outcomes in cancers that are difficult to treat.
The Company’s mission is to improve the lives of cancer patients by
developing next-generation cancer therapies that are designed to
maximize efficacy while minimizing the toxicity and side effects
traditionally associated with cancer treatment. Rexahn’s product
candidates work by targeting and neutralizing specific proteins
believed to be involved in the complex biological cascade that
leads to cancer cell growth. Preclinical studies show that several
of Rexahn’s product candidates may be effective against multiple
types of cancer, including drug resistant cancers,
difficult-to-treat cancers and others, may augment the
effectiveness of current FDA-approved cancer treatments. The
Company has two oncology product candidates, RX-3117 and RX-5902,
in Phase 2 clinical development and additional compounds in
preclinical development, including RX-0301. For more information
about the Company and its oncology programs, please visit
www.rexahn.com.
About Biosense Global LLC
BioSense is an emerging biotech company established to address
the business needs of the global biopharmaceutical market with a
focus on China, Europe, and the U.S. The company is based in New
Jersey (US) and Suzhou (China). The organization’s mission is to
bridge the gap between undercapitalized biopharmaceutical projects,
resources and markets to add value to its stakeholders and address
significant unmet medical needs and bring affordable treatment
options to patients. BioSense’s expert team of international
biopharma executives and seasoned investors has extensive
experience in developing, registering and commercializing some of
the most successful products in key markets, including, US, Europe
and China, plus the business management and cross-cultural
knowledge. www.biosensegloballlc.com.
Safe Harbor
To the extent any statements made in this press release deal
with information that is not historical, these are forward-looking
statements under the Private Securities Litigation Reform Act of
1995. Such statements include, but are not limited to, statements
regarding expectations and intentions with respect to Rexahn’s
relationship with Biosense, the potential effectiveness and safety
of Rexahn’s product candidates, including RX-3117, Rexahn’s plans,
objectives, expectations and intentions with respect to future
operations and products, the path of clinical trials and
development activities, and other statements identified by words
such as “will,” “potential,” “could,” “can,” “believe,” “intends,”
“continue,” “plans,” “expects,” “anticipates,” “estimates,” “may,”
and other words of similar meaning or the use of future dates.
Forward-looking statements by their nature address matters that
are, to different degrees, uncertain. Uncertainties and risks may
cause Rexahn’s actual results to be materially different than those
expressed in or implied by Rexahn’s forward-looking statements. For
Rexahn, particular uncertainties and risks include, among others,
understandings and beliefs regarding the role of certain biological
mechanisms and processes in cancer; drug candidates being in early
stages of development, including clinical development; the ability
to initially develop drug candidates for orphan indications to
reduce the time-to-market and take advantage of certain incentives
provided by the U.S. Food and Drug Administration; the ability to
transition from our initial focus on developing drug candidates for
orphan indications to candidates for more highly prevalent
indications; the availability and access to capital; and the
expected timing of results from our clinical trials. More detailed
information on these and additional factors that could affect
Rexahn’s actual results are described in Rexahn’s filings with the
Securities and Exchange Commission, including its most recent
annual report on Form 10-K. All forward-looking statements in this
news release speak only as of the date of this news release. Rexahn
undertakes no obligation to update or revise any forward-looking
statement, whether as a result of new information, future events or
otherwise.
Investor Contact:ir@rexahn.com
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