Nymox Reports on Newly Issued Patents and Corporate Developments
October 21 2019 - 09:30AM
Nymox Pharmaceutical Corporation (NASDAQ: NYMX) is pleased to
report very positive fundamental news, that the Company has
received several new additional United States, European, and other
jurisdictional formal patent issuances covering Fexapotide
Triflutate and its use for prostate and urinary tract disorders.
The effective coverage for the treatments has now been extended to
18 years into 2037 and later in the major global regions. These new
patents are fully assigned to the Corporation and are the property
of Nymox shareholders.
Dr. Paul Averback CEO of Nymox commented, "Our
team has been working diligently for many years and these
intellectual property extensions are some of the fruits of our
labors. For our shareholders this effectively is a major increase
in the conventionally recognized timeline of proprietary rights,
and thus the market exclusivity of our products and long-term
valuations if approved. It is work that requires persistence, but
good things normally take their time to be done properly. The best
quality companies plan for and execute long-term. Nymox has strong
shareholders who have provided our team with the patient support
and capital needed to make these important advances."
Nymox also reported today that its efforts
involved in the upcoming filings for approval for Fexapotide in the
US and in Europe have steadily been moving forward. The Company had
its pre-filing Chemistry Manufacturing and Controls meeting with
FDA in April 2019 which was successful. The Company is currently
preparing to seek similar formal clarification from the authorities
on data formatting and standardization for the filings which is a
necessary step and which it expects to receive in the near future.
After the latter, the Company expects to be able to report to
shareholders with further precision about expected timelines for
the two filings. Because the data involved in the program has
extended over a very long time period (which is a positive), it has
also generated additional requirements of data formatting updates
and other specific procedures for the filings.
Management continues to work extremely hard and
diligently towards completing the preparatory work necessary for
submitting the applications for marketing approval both in the US
(NDA) and in Europe (MAA). Significant time and efforts – working
with external expert teams – has been put into the extremely
important critical tasks involved in bringing all aspects of the
applications current with all the required regulations and
requirements in the two different applications. Amongst
others, these additional efforts by the teams have included
intensive work in the areas of updated computer coding of
databases, updated formatting of data and required terminologies
for drug effects and longer-term effects, shelf-life documentation,
auditing documentation, quality assurance and control systems, and
a variety of other updating activities needed to fully comply with
all the current regulations.
Dr. Averback said, "We reiterate to our
shareholders that the Company has engaged several outside
contractor groups with extensive relevant experience and
established expertise. These experts are actively and collectively
managing key aspects of our preparatory regulatory work. With $9.1M
in the bank last quarter, we have the necessary financial resources
to complete the preparatory work for filing our two current
marketing applications in Europe and US, and also to complete the
required procedures during the regulatory review processes for the
first two applications. Management is completely focused towards
assuring that when our regulatory submissions are made, the Company
will have done everything conceivable to achieve the highest
quality standards for our submissions, which we strongly believe is
in the very best interest of all shareholders of Nymox."
Nymox is further pleased to report that two new
peer review manuscripts concerning the Fexapotide investigations
have recently been prepared and which are in the process of being
submitted for publication. The Company looks forward to reporting
further on these and other exciting developments in the near future
at the appropriate time.
In addition to many well-received presentations
of Fexapotide data and clinical trial results at American
Urological Association meetings and other public forums in the
field in the past two years, there have been two prestigious
publications of extensive data and results of Fexapotide studies
published in the peer-review medical literature. The first in 2018
was "Fexapotide triflutate: results of long term safety and
efficacy trials of a novel injectable therapy for symptomatic
prostate enlargement”. World Journal of Urology 2018;36(5):801-9
authored by Drs N. Shore, R. Tutrone, M. Efros, M. Bidair, B.
Wachs, S. Kalota, S. Freedman, J. Bailen, R. Levin, S. Richardson,
J. Kaminetsky, J. Snyder, B. Shepard, K. Goldberg, A. Hay, S.
Gange, and I. Grunberger. The second in 2019 was “Efficacy and
safety of fexapotide triflutate in outpatient medical treatment of
male lower urinary tract symptoms associated with benign prostatic
hyperplasia”. Therapeutic Advances in Urology. 2019;11:1-16."
authored by Drs N. Shore, R. Tutrone, and C. Roehrborn.
For more information please
contact info@nymox.com or 800-936-9669.
Forward Looking Statements
To the extent that statements contained in this
press release are not descriptions of historical facts regarding
Nymox, they are forward-looking statements reflecting the current
beliefs and expectations of management made pursuant to the safe
harbor provisions of the Private Securities Litigation Reform Act
of 1995, including statements regarding the need for new options to
treat BPH and prostate cancer, the potential of Fexapotide to treat
BPH and prostate cancer and the estimated timing of further
developments for Fexapotide. Such forward-looking statements
involve substantial risks and uncertainties that could cause our
clinical development program, future results, performance or
achievements to differ significantly from those expressed or
implied by the forward-looking statements. Such risks and
uncertainties include, among others, the uncertainties inherent in
the clinical drug development process, including the regulatory
approval process, the timing of Nymox's regulatory filings, Nymox's
substantial dependence on Fexapotide, Nymox's commercialization
plans and efforts and other matters that could affect the
availability or commercial potential of Fexapotide. Nymox
undertakes no obligation to update or revise any forward looking
statements. For a further description of the risks and
uncertainties that could cause actual results to differ from those
expressed in these forward-looking statements, as well as risks
relating to the business of Nymox in general, see Nymox's current
and future reports filed with the U.S. Securities and Exchange
Commission, including its Annual Report on Form 20-F for the year
ended December 31, 2018, and its Quarterly Reports.
For Further Information
Contact:Erik DanielsenNymox Pharmaceutical
Corporation1-800-93NYMOXwww.nymox.com
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