HASBROUCK HEIGHTS, N.J., July 02, 2018 (GLOBE NEWSWIRE) -- Nymox Pharmaceutical Corporation (NASDAQ:NYMX) announced today that following the recently announced increased manufacturing capabilities, the Company has formally decided to expand its European marketing plans for Fexapotide Triflutate (FT) to all countries in the European Community.
Earlier this month Nymox announced that it had successfully accomplished important milestones relating to manufacturing scale-up for FT. Consequently, the Company is now in the enhanced position to have sufficient manufacturing capacities in place to be able to realistically meet anticipated physician demand for FT upon approval.
Dr. Suresh Kalbag, Nymox Head of Manufacturing Operations, commented: “Validated FT active pharmaceutical ingredients in quantities of 50 grams per batch (equivalent to approximately 18,000 to 20,000 units of 2.5 mg per batch) has been achieved. In addition, sterile processing of similar sized batches (>16,000 units per batch) of filled and finished drug product vials has also been accomplished. The scaled up sterile injectable FT (finished product) is manufactured as a lyophilized powder which has excellent shelf life when stored at room temperature, frozen or refrigerated. The active pharmaceutical ingredient (contained in the finished product) can be stored frozen in bulk and is also highly stable”. Marketing requires approvals from regulatory authorities, which has not yet been granted.
The Company has initiated the process and is taking the necessary steps to submit an expanded application for FT to the European Medicines Agency for approval. The prior application in the EU will be replaced by the new expanded application. The expanded application upon marketing approval will also greatly facilitate the overall drug-distribution logistics as well as the annual post-marketing safety filing requirements in Europe.
Dr. Paul Averback, CEO and President of Nymox commented, "Management is excited by the opportunity to expand the application leading to full EU market access. We believe FT will now become available to patients across Europe earlier than in our previously projected plans. The increased manufacturing capacity will be necessary to meet the anticipated demand across all European jurisdictions and worldwide. We all look forward to continue to update our shareholders on our progress going forward”.
The Company held a pre-NDA meeting with FDA earlier in 2018 and expects to file for approval in the US later in 2018.
Nymox has recently announced 18.25 million USD in funding from long-term shareholders.
Nymox's Fexapotide has been shown to produce long-term improvements in lower urinary tract symptoms associated with benign prostatic hyperplasia (BPH), a problem that afflicts an estimated 100 million or more men in the world. Fexapotide does not cause the annoying side effects and risks found with available treatments for BPH and has also been shown to lower the occurrence of surgery for BPH. Fexapotide is also in development for low grade prostate cancer. Fexapotide has been shown in 9 clinical trials and numerous long-term extension studies involving over 1700 injections, to be very safe and well tolerated.
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, 2017, and its Quarterly Reports.
For Further Information Contact:
Erik Danielsen
Nymox Pharmaceutical Corporation
1-800-93NYMOX
www.nymox.com