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.
HASBROUCK HEIGHTS, N.J., Oct. 21, 2019 (GLOBE NEWSWIRE) -- 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 Danielsen
Nymox Pharmaceutical Corporation
1-800-93NYMOX
www.nymox.com
