NEW YORK and MANALAPAN
TOWNSHIP, N.J., Sept. 30, 2020
/PRNewswire/ -- Neurotrope, Inc. (Nasdaq: NTRP) and Metuchen
Pharmaceuticals, L.L.C., a privately held biopharmaceutical
company focused on innovative therapeutics for men's health
conditions ("Metuchen"), today announced that they have entered
into an amendment to their definitive merger agreement ("Amended
Merger Agreement") under which the consideration due to Neurotrope
stockholders will increase to 49% of the combined company on a
pro forma basis and based upon the final Neurotrope common stock
share count at close (Under terms of the Merger Agreement dated
July 23, 2020, Neurotrope
stockholders were to own approximately 22.5% of the combined
company.) Neurotrope and Metuchen previously announced their intent
to merge in an all-stock transaction resulting to form a
NASDAQ-traded holding company to be named Petros Pharmaceuticals,
Inc. ("Petros"). As part of the Amended Merger Agreement,
Neurotrope shareholders currently representing 34% of the Company's
outstanding shares have signed a shareholder rights agreement in
support of the merger.
Consistent with the original Merger Agreement, under terms of
the Amended Merger Agreement, upon closing of the transaction,
Neurotrope Bioscience Inc.'s ("NBI") current lead asset,
Bryostatin-1 to treat neurodegeneration, and substantially all of
its existing assets, operations and liabilities, except for cash
retained by Petros in accordance with the terms of the Amended
Merger Agreement, will be spun-out into a new, separately traded
company. The Amended Merger Agreement has been approved by the
boards of directors of both companies.
"With this amendment, Neurotrope investors are being offered
nearly half ownership in Petros while retaining full interest in
NBI, with both companies expected to be publicly traded," said Mr.
Silverman. "We believe this provides a far more compelling stake in
two distinct opportunities, one continuing the exciting clinical
development of Bryostatin-1 in an NIH-supported study in
Alzheimer's disease, and the other building on a commercial asset
in Stendra® with substantial upside potential."
As part of the strategy of enhancing value to its existing drug
portfolio, Petros will be led by a streamlined management team and
will focus on its two core assets: Stendra®, a
phosphodiesterase-5 (PDE-5) inhibitor and the only oral, patented
erectile disfunction (ED) product on the market, as well as H-100,
an innovative, non-invasive topical treatment candidate for
Peyronie's disease (PD). Petros will be led by Fady Boctor, Chief
Commercial Officer of Metuchen, who will be named President and
CCO. Mr. Boctor has extensive industry experience in men's
health, particularly in the areas of ED and PD. A new board
of directors will be installed and John
Shulman, Founder and Managing Partner of Juggernaut Capital
Partners ("JCP"), a leading private equity firm with over
$1 billion in capital commitments,
will become Executive Chairman of the Board. In line
with Petros' more focused strategy, Charles S. Ryan, J.D., Ph.D., Neurotrope's Chief
Executive Officer, will transition to a senior consulting role to
Petros.
Petros will explore the potential to convert Stendra® from
prescription-only status to non-prescription status. Stendra®
is a distinct oral prescription therapeutic that may be taken as
early as approximately 15 minutes prior to intimate engagement,
with or without food, and has a clinically proven safety profile,
including a discontinuation rate due to adverse events comparable
to placebo. Petros will partner with Foundation Consumer
Healthcare ("FCH") in this effort. FCH is a long-time
portfolio investment of JCP and is one of the largest pure-play
Over-the-Counter ("OTC") companies in the U.S. FCH is
dedicated to improving consumers' lives by developing and growing a
portfolio of differentiated OTC products, including the single
highest selling SKU in the OTC category: Plan B One Step®. The
company is led by President and CEO Greg
Bradley, who has deep industry experience within the OTC
healthcare landscape in senior roles at GlaxoSmithKline Consumer
Healthcare (GSK) and other organizations.
"Erectile dysfunction is a condition that affects 30 million men
in the U.S., and yet only 25% of men have accessed ED therapies,"
said Mr. Boctor. "OTC availability has a long track record of
increasing access to well-tolerated and effective medicines.
We look forward to exploring this opportunity for Stendra® together
with Foundation Consumer Healthcare."
Neurotrope plans to hold a special meeting of stockholders to
approve the pending transaction mid-fourth quarter 2020. The
transaction is expected to close shortly thereafter, subject to
customary closing conditions, including approval of the amended
Merger Agreement by Neurotrope stockholders.
Lead Asset Stendra® (avanafil)
Stendra® (avanafil), originally launched by
Auxilium Pharmaceuticals prior to that company's sale to Endo
Pharmaceuticals, is an oral phosphodiesterase 5 (PDE5) inhibitor
for the treatment of ED that can be dosed as early as ~15 minutes
before sexual activity, can be taken with or without food, and is
well tolerated, with a rate of discontinuation (2.0%) comparable to
placebo (1.7%) in clinical trials. Stendra® was
designed and developed expressly for erectile dysfunction. Metuchen
recently undertook a relaunch of Stendra®, following
Juggernaut's acquisition of a majority position in Metuchen in
2018, generating gross revenues of approximately $30 million in 2019. Upon closing of the merger,
Petros intends to accelerate the relaunch of
Stendra® with a well-funded commercial organization
and refocused strategy. Currently, Stendra® is
covered for 75% of commercially insured lives, with a co-pay as low
as $0.
Lead Pipeline Program H100™
Metuchen's lead pipeline program includes the recently
in-licensed drug candidate H-100, a non-invasive, compounded,
topical treatment for Peyronie's disease (PD). In its current
formulation, H-100 demonstrated positive efficacy and tolerability
in a 22 patient prospective, randomized, double-blind,
placebo-controlled study in patients with PD. Metuchen intends to
optimize manufacturing and the patented formulation of H-100, then
seek FDA guidance on the studies necessary to achieve approval and
labeling of the product. PD is a progressive, wound-healing
disorder of the penis involving the formation of plaques and the
subsequent development of penile curvature or indentations. The
current non-surgical standard of care in PD, an injectable, was
granted Orphan Designation by the FDA in 1996.
"As a topical treatment, we believe H-100 can have a
transformative effect on the management of a disease that causes
pain, anxiety and psychological distress," said Fady Boctor, Chief
Commercial Officer of Metuchen. "Our goal is to deliver on this
promise rapidly and cost effectively with a proprietary, clinically
validated therapeutic."
About STENDRA® (avanafil)
STENDRA® (avanafil) is approved in the U.S. by
the FDA for the treatment of erectile dysfunction. Metuchen
Pharmaceuticals LLC has exclusive marketing rights to
STENDRA® in the U.S., Canada, South
America and India.
STENDRA® is available through retail and mail
order pharmacies.
For more information about STENDRA®, please
visit www.STENDRA.com.
Important Safety Information
STENDRA® (avanafil) is prescribed to treat
erectile dysfunction (ED).
Do not take STENDRA® if you take nitrates, often
prescribed for chest pain, as this may cause a sudden, unsafe drop
in blood pressure.
Discuss your general health status with your healthcare provider
to ensure that you are healthy enough to engage in sexual activity.
If you experience chest pain, nausea, or any other discomforts
during sex, seek immediate medical help.
STENDRA® may affect the way other medicines
work. Tell your healthcare provider if you take any of the
following; medicines called HIV protease inhibitors, such as
ritonavir (Norvir®), indinavir (Crixivan®), saquinavir (Fortavase®
or Invirase®) or atazanavir (Reyataz®); some types of oral
antifungal medicines, such as ketoconazole (Nizoral®), and
itraconazole (Sporanox®); or some types of antibiotics, such as
clarithromycin (Biaxin®), telithromycin (Ketek®), or
erythromycin.
In the rare event of an erection lasting more than 4 hours, seek
immediate medical help to avoid long-term injury.
In rare instances, men taking PDE5 inhibitors (oral erectile
dysfunction medicines, including STENDRA®) reported a
sudden decrease or loss of vision. It is not possible to determine
whether these events are related directly to these medicines or to
other factors. If you experience sudden decrease or loss of vision,
stop taking PDE5 inhibitors, including STENDRA®, and
call a doctor right away.
Sudden decrease or loss of hearing has been rarely reported in
people taking PDE5 inhibitors, including STENDRA®. It is
not possible to determine whether these events are related directly
to the PDE5 inhibitors or to other factors. If you experience
sudden decrease or loss of hearing, stop taking
STENDRA® and contact a doctor right away. If you
have prostate problems or high blood pressure for which you take
medicines called alpha blockers or other anti-hypertensives, your
doctor may start you on a lower dose of STENDRA®.
Drinking too much alcohol when taking
STENDRA® may lead to headache, dizziness, and lower
blood pressure.
STENDRA® in combination with other treatments
for ED is not recommended.
STENDRA® does not protect against sexually
transmitted diseases, including HIV.
The most common side effects of STENDRA® are
headache, flushing, runny nose and congestion.
Please see full patient prescribing information for
STENDRA® (50 mg, 100 mg, 200 mg) tablets.
About Neurotrope Bioscience, Inc.
NBI is a clinical-stage biopharmaceutical company that has
historically worked to develop novel therapies for
neurodegenerative diseases. NBI has conducted clinical and
preclinical studies of its lead therapeutic candidate,
Bryostatin-1, in Alzheimer's disease, and preclinical studies for
rare diseases and brain injury, including Fragile X syndrome,
multiple sclerosis, stroke, Niemann-Pick Type C disease, Rett
syndrome, and traumatic brain injury. The FDA has granted Orphan
Drug Designation to NBI for Bryostatin-1 as a treatment for Fragile
X syndrome. Bryostatin-1 has already undergone testing in more than
1,500 people in cancer studies, thus creating a large safety data
base that will further inform clinical trial designs.
Additional information about Neurotrope may be found on its
website: www.neurotrope.com.
About Metuchen Pharmaceuticals
Metuchen pharmaceuticals is committed to becoming the world's
leading men's health company by identifying, developing, acquiring,
and commercializing innovative therapeutics for men's health issues
including, but not limited to erectile dysfunction, endothelial
dysfunction, psychosexual and psychosocial ailments, Peyronie's
disease (acute and chronic), hormone health and substance use
disorders.
No Offer or Solicitation
This communication shall not constitute an offer to sell or the
solicitation of an offer to sell or the solicitation of an offer to
buy any securities, nor shall there be any sale of securities in
any jurisdiction in which such offer, solicitation or sale would be
unlawful prior to registration or qualification under the
securities laws of any such jurisdiction. No public offer of
securities shall be made except by means of a prospectus meeting
the requirements of Section 10 of the Securities Act of 1933, as
amended.
Important Additional Information Will be Filed with the
SEC
In connection with the proposed transaction between
Petros, Neurotrope and Metuchen, Petros intends to file relevant
materials with the SEC, including a registration statement that
will contain a proxy statement and prospectus. BEFORE MAKING ANY
VOTING OR INVESTMENT DECISION, INVESTORS AND STOCKHOLDERS ARE URGED
TO READ THE PROXY STATEMENT/PROSPECTUS (INCLUDING ANY AMENDMENTS OR
SUPPLEMENTS THERETO) AND ANY OTHER RELEVANT DOCUMENTS THAT
NEUROTROPE MAY FILE WITH THE SEC WHEN THEY BECOME AVAILABLE BECAUSE
THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED
TRANSACTIONS. Stockholders may obtain, free of charge, copies of
the definitive proxy statement/prospectus and any other documents
filed by Petros with the SEC in connection with the proposed
transactions at the SEC's website
(www.sec.gov), at Neurotrope's
website: www.neurotrope.com, or by
directing written request to: Neurotrope,
Inc., 1185 Avenue of the Americas, 3rd Floor,
New York, New York
10036, Attention: Robert
Weinstein.
Participants in the Solicitation
Petros, Neurotrope, Metuchen and their respective directors and
executive officers may be deemed to be participants in the
solicitation of proxies from the stockholders of Neurotrope in
connection with the proposed transaction. Information regarding the
special interests of these directors and executive officers in the
merger will be included in the proxy statement/prospectus referred
to above. Additional information regarding the directors and
executive officers of Neurotrope is also included in Neurotrope's
Annual Report on Form 10-K for the year ended December 31, 2019, filed with the SEC on
March 13, 2020. This document is
available free of charge at the SEC web site (www.sec.gov), at
Neurotrope's website, or by directing a written request to
Neurotrope as described above.
Cautionary Note Regarding Forward-Looking Statements
Any statements contained in this press release that do not
describe historical facts may constitute forward-looking
statements. These forward-looking statements include statements
regarding Petros, Neurotrope, Metuchen, the combined company, the
proposed transaction and other matters. Such forward-looking
statements are subject to risks and uncertainties and other
influences, many of which Neurotrope has no control over. Actual
results and the timing of certain events and circumstances may
differ materially from those described by the forward-looking
statements as a result of these risks and uncertainties, including,
without limitation: the risk that the conditions to the closing of
the proposed transactions are not satisfied, including the failure
to obtain stockholder approval for the proposed transactions in a
timely manner or at all; uncertainties as to the timing of the
consummation of the proposed transactions and the ability of each
of Petros, Neurotrope and Metuchen to consummate the proposed
transactions; risks related to Petros' initial listing on The
Nasdaq Capital Market at the closing of the proposed transactions;
risks related to Neurotrope's ability to correctly estimate its
operating expenses and its expenses associated with the proposed
transactions; the ability of Neurotrope or Metuchen to protect
their respective intellectual property rights; competitive
responses to the transaction; unexpected costs, charges or expenses
resulting from the proposed transactions; potential adverse
reactions or changes to business relationships resulting from the
announcement or completion of the proposed transactions; and
legislative, regulatory, political and economic developments;
expectations regarding the industry and business operations of
Petros. The foregoing review of important factors that could cause
actual events to differ from expectations should not be construed
as exhaustive and should be read in conjunction with statements
that are included herein and elsewhere, including Neurotrope's
filings with the Securities and Exchange Commission, including
Neurotrope's Annual Report on Form 10-K for the year ended
December 31, 2019, Quarterly Reports
on Form 10-Q and Current Reports on Form 8-K filed with the
SEC. Neurotrope can give no assurance that the conditions to
the proposed transactions will be satisfied. Except as required by
applicable law, Neurotrope does not undertake to update these
forward-looking statements.
Contact information:
Investors and Media
Lisa Sher
Argot Partners
petros@argotpartners.com
212-600-1902
Juggernaut/Metuchen
Deirdre Walsh
Abernathy MacGregor
dlw@abmac.com
212-371-5999
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SOURCE Neurotrope, Inc.