Rexahn Pharmaceuticals Announces Teva will not Exercise its Option to License RX-3117
August 28 2013 - 9:00AM
Business Wire
Rexahn Pharmaceuticals (NYSE MKT: RNN) announced today that Teva
Pharmaceutical Industries has decided, for strategic reasons, not
to exercise its option to license RX-3117 from Rexahn. As a result,
the Research and Exclusive License Option (RELO) Agreement for
RX-3117 between Rexahn and Teva has been terminated and Rexahn will
retain all the global development and commercialization rights to
RX-3117, a novel DNA and RNA synthesis inhibitor for the treatment
of solid cancer tumors.
In July 2013, pursuant to the RELO agreement, Teva submitted an
Investigational New Drug (IND) application to the US Food and Drug
Administration (FDA) for RX-3117 which has now cleared the FDA’s 30
day review period. Under the RELO agreement, Teva had 45 days from
the filing of the IND to exercise the option to exclusively license
RX-3117.
According to Teva, "RX-3117 appears to have potential in various
indications, but does not align with Teva’s new Oncology
strategy."
Rexahn will continue to advance the clinical development of
RX-3117 and expects to finalize the timeline for initiating a Phase
I clinical study in cancer patients within the next three
months.
"Rexahn looks forward to advancing the clinical development of
RX-3117," Peter D. Suzdak, Ph.D., Rexahn’s Chief Executive Officer
commented. "RX-3117 has already demonstrated safety and oral
bioavailability in cancer patients, and has the potential to treat
a wide variety of solid cancer tumors. We will explore potential
partnering opportunities with oncology focused pharmaceutical
companies for this compound, as we continue to make progress in the
clinical development of RX-3117."
RX-3117 is a novel small molecule anti-metabolite compound that
inhibits DNA and RNA synthesis and induces apoptotic cell death of
tumor cells. Preclinical studies have shown RX-3117 to be effective
in both inhibiting the growth of various human cancer xenograft
models, including colon, lung, renal and pancreatic, as well as
overcoming chemotherapeutic drug resistance. In August 2012, Rexahn
reported the completion of an exploratory Phase I clinical trial of
RX-3117 in cancer patients conducted in Europe. The clinical trial
demonstrated that RX-3117 is orally bioavailable with no adverse
events reported over the dose range tested.
About Rexahn Pharmaceuticals, Inc.
Rexahn Pharmaceuticals is a clinical stage biopharmaceutical
company dedicated to developing best-in-class therapeutics for the
treatment of cancer. Rexahn currently has three clinical stage
oncology candidates, Archexin®, RX-3117, and SupinoxinTM (RX-5902)
and a robust pipeline of preclinical compounds to treat multiple
types of cancer. Rexahn has also developed proprietary drug
discovery platform technologies in the areas of Nano-Polymer-Drug
Conjugate Systems (NPDCS), nano-medicines, 3D-GOLD, and TIMES. For
more information, please visit www.rexahn.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
about Rexahn’s plans, objectives, expectations and intentions with
respect to future operations and products and other statements
identified by words such as “will,” “potential,” “could,” “can,”
“believe,” “intends,” “continue,” “plans,” “expects,”
“anticipates,” “estimates,” “may,” 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, the difficulty of developing
pharmaceutical products, obtaining regulatory and other approvals
and achieving market acceptance; the marketing success of Rexahn’s
licensees or sublicensees; the success of clinical testing; and
Rexahn’s need for and ability to obtain additional financing. 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 and subsequent quarterly reports
on Form 10-Q. 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.
Rexahn Pharmaceuticals, Inc. (AMEX:RNN)
Historical Stock Chart
From Oct 2024 to Nov 2024
Rexahn Pharmaceuticals, Inc. (AMEX:RNN)
Historical Stock Chart
From Nov 2023 to Nov 2024