Axonyx (NASDAQ:AXYX)
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From Jun 2019 to Jun 2024
Axonyx Inc. (NASDAQ: AXYX) announced today that it has
granted to Daewoong Pharmaceutical Company Ltd. (Daewoong) an
exclusive license for the use of Phenserine in the South Korean
market. Under the terms of the agreement Daewoong, at its own costs,
undertakes to pursue the product development and regulatory work
necessary for a New Drug Application (NDA) (or its equivalent) in
South Korea with respect to Phenserine for the treatment of
Alzheimer's disease (AD).
The financial terms of the deal are confidential, but include
royalty payments to Axonyx based on sales of Phenserine by Daewoong in
the South Korean market.
This license arrangement is part of the Company's previously
announced strategy to identify partners that are able and willing to
commit the necessary financial resources to Phenserine's further
development and marketing approval.
"We are excited about this license agreement which is our first
for Phenserine. We expect Daewoong to build on the significant
clinical data we have generated as they continue the development of
Phenserine," stated Gosse Bruinsma, M.D., President and CEO of Axonyx.
About Axonyx
Axonyx Inc. is a U.S.-based biopharmaceutical company engaged in
the acquisition and development of proprietary pharmaceutical
compounds for the treatment of Central Nervous System disorders. The
Company currently has three compounds in development for Alzheimer's
disease, namely Phenserine - a potential symptomatic and disease
progression treatment of mild to moderate Alzheimer's disease (AD),
Posiphen(TM) - a potential disease progression treatment for AD now in
Phase I, and BisNorCymcerine (BNC) - a potential symptomatic treatment
of severe AD now in pre-Investigational New Drug (IND) stage.
About Daewoong Pharmaceutical Company Ltd.
Daewoong Pharmaceutical is the leading pharmaceutical company in
the Korean prescription drug market which has a solid network in the
sales and marketing field. Daewoong has 9 products of which sales is
over $10 million, meaning the company with the largest number of
Korean blockbuster products.
Daewoong group also deals with OTC, raw material and IT related
business through its subsidiaries. For the fiscal year ended March 31,
2005, Daewoong pharmaceutical generated revenues of over $350 million,
while the Daewoong group generated revenues of over $500 million.
In 2001, Daewoong has succeeded to develop and launch Easyef
(Epidermal Growth Factor), the first bioengineering product in Korea,
indicated for the diabetic foot ulcer. Additional clinical trial are
being conducted for the extension of indication into the general wound
healing area. In 2003, Daewoong is succeeded to synthesis of the
Coenzyme Q10 at the second time in the world and exporting raw
material to all over the world. Daewoong is also developing an early
stage of several new chemical entities.
The company is headquartered in Seoul, South Korea.
This press release may contain forward-looking statements or
predictions. These statements represent our judgment to date, and are
subject to risks and uncertainties that could materially affect the
Company, including those risks and uncertainties described in the
documents Axonyx files from time to time with the SEC, specifically
Axonyx's annual report on Form 10-K. Specifically, with respect to our
drug candidates Phenserine, Posiphen(TM) and BisNorCymcerine, Axonyx
cannot assure that: any preclinical studies or clinical trials,
whether ongoing or conducted in the future, will prove successful, and
if successful, that the results can be replicated; safety and efficacy
profiles of any of its drug candidates will be established, or if
established, will remain the same, be better or worse in future
clinical trials, if any; pre-clinical results related to cognition and
the regulation of beta-APP will be substantiated by ongoing or future
clinical trials, if any, or that any of its drug candidates will be
able to improve the signs or symptoms of their respective clinical
indication or slow the progression of Alzheimer's disease; any of its
drug candidates will support an NDA filing or its equivalent, will be
approved by the FDA or its equivalent, or if approved, will prove
competitive in the market; or that Axonyx will have or obtain the
necessary financing to support its drug development programs. Axonyx
cannot assure that it will be successful with regard to identifying a
(sub-) licensing partner for any of its compounds, or that any such
partner will successfully develop or commercialize any such compound.
Axonyx undertakes no obligation to publicly release the result of any
revisions to such forward-looking statements that may be made to
reflect events or circumstances after the date hereof or to reflect
the occurrence of unanticipated events.