NEW YORK and MANALAPAN
TOWNSHIP, N.J., May 18, 2020
/PRNewswire/ -- Neurotrope, Inc. (Nasdaq: NTRP) and Metuchen
Pharmaceuticals, L.L.C., a privately held biopharmaceutical
company ("Metuchen"), focused on identifying, developing,
acquiring, and commercializing innovative therapeutics for men's
health conditions, today announced that the two companies have
entered into a definitive merger agreement under which Metuchen and
Neurotrope, Inc. ("Neurotrope") will merge in an all-stock
transaction resulting in a newly formed holding company to be
renamed Petros Pharmaceuticals, Inc. ("Petros"). Petros is expected
to become a Nasdaq traded company focused solely on men's health
conditions. Petros' cornerstone product would be Metuchen's
Stendra® (avanafil) for erectile dysfunction
("ED"). Petros' pipeline would include Metuchen's recently
in-licensed product H-100 for Peyronie's disease, and it would
include a business development program exploring various men's
health products, including endothelial dysfunction, prostate
cancer, psychosexual and psychosocial ailments, hormone health and
substance use disorders.
Upon completion of the proposed merger, based on certain
assumptions, it is anticipated that existing Neurotrope
shareholders will own approximately 20% and Metuchen shareholders
will own approximately 80% of the combined company, in each case on
a pro forma basis and based upon the final Neurotrope common stock
share count at close. The transaction has been approved by the
boards of directors of both companies. Metuchen's principal
investor is Juggernaut Capital Partners, a leading private equity
firm with over $1 billion in capital
commitments. Funding for Petros is expected to include
approximately $20 million of
Neurotrope's available cash and cash equivalents (subject to
adjustment) as well as revenue from sales of Metuchen's U.S. Food
and Drug Administration ("FDA")-approved erectile dysfunction
treatment, Stendra® (avanafil). The merger is expected
to close during the third quarter of 2020, subject to customary
closing conditions, including approval of the merger agreement by
the shareholders of Neurotrope.
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 merger agreement, will be spun-out
into a new, separately traded company. NBI is expected to retain
approximately $14 million which
includes cash plus the recently awarded National Institutes of
Health ("NIH") clinical trial grant. Stakeholders of Neurotrope
prior to the merger will own all of the shares of NBI. As
previously announced, NBI will conduct a Phase 2 clinical study
focused on patients with moderate-severity Alzheimer's disease
("AD"), which it expects the spun-off entity to initiate
shortly. In addition to continuing work on AD, Neurotrope
plans to continue pursuing other indications using bryostatin such
as Multiple Sclerosis and Fragile X syndrome. Daniel Alkon, M.D., who will remain NBI's
President and Chief Scientific Officer and become a Director,
stated, "I am encouraged that Neurotrope Bioscience will continue
its original focus, and potentially expand its plans to treat
neurodegeneration."
Charles S. Ryan, J.D., Ph.D.,
Chief Executive Officer of Neurotrope, will be President, Chief
Executive Officer and a Director of Petros. Four members of
the Board of Directors of Neurotrope will be directors of Petros,
including Ivan Gergel, M.D., who
served, among other prior roles, as Chief Scientific Officer and
Executive Vice President, Research & Development of Endo Health
Solutions, Inc, a company focused on urology and men's health as
well as other therapeutic areas. Neurotrope Director
Bruce Bernstein and Chairman
Josh Silverman will also be on the
Board of Petros. John Shulman,
Founder and Managing Partner of Juggernaut Capital and Executive
Chairman of Metuchen will also join the Board of Petros along with
four additional directors to be identified by Metuchen prior to the
merger.
"Following an extensive review of strategic alternatives,
Neurotrope's Board of Directors believes that a merger with
Metuchen and the formation of Petros offers shareholders the most
compelling opportunity for a new direction to further enhance
long-term value," said Dr. Ryan. "Petros provides a platform to
create the first publicly traded biopharmaceutical company focused
exclusively on FDA-approved treatments for men's health conditions,
an underserved area of healthcare with significant growth
potential. We believe Petros will be well positioned financially
and strategically to potentially accelerate the commercial growth
of Stendra®, as well as advance its pipeline programs
and opportunities."
"Stendra® is a unique asset in the ED space, and its
distinct features enable it to compete in an area dominated by
generic drugs," said Mr. Shulman. "This merger will enable Petros
to dramatically accelerate the commercial relaunch of
Stendra® and build a pipeline of other therapeutic
products to improve men's health including a topical treatment H100
for Peyronie's disease. At Juggernaut, we look forward
to supporting Petros to deliver on its mission of bringing value to
patients within the men's health space by investing in
Stendra® and the many opportunities that lie ahead."
"We are delighted to offer our investors an investment in two
companies, Petros Pharmaceuticals, Inc. and the spin-out company
Neurotrope Bioscience, Inc.," said Mr. Silverman. "With financial
support from the NIH and certain existing NBI assets, we look
forward to beginning a new Phase 2 trial of Bryostatin-1 and
working towards treating neurodegeneration. Separately, Petros will
be positioned to grow its cornerstone product, Stendra®,
within a market of approximately 500,000 new class prescriptions
per month, or approximately 25% of the total ED market of up to 30
million men, while simultaneously developing a disruptive pipeline
addressing a number of underserved and unmet conditions in men's
health."
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, PC served as
legal counsel to Neurotrope and NBI and Morgan, Lewis & Bockius
served as legal counsel to Metuchen with respect to the
transaction.
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%) equivalent 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
Marketing 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
Definitive Proxy Statement on Schedule 14A relating to the 2019
Annual Meeting of Stockholders, which was filed with the SEC on
June 5, 2019. 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. 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 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.
