NYMOX Announces Expanded Marketing Plans
July 02 2018 - 9:30AM
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
DanielsenNymox Pharmaceutical
Corporation1-800-93NYMOXwww.nymox.com
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