NEW YORK and MANALAPAN TOWNSHIP, N.J., Dec. 2, 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 the
completion of their previously announced merger following the
satisfaction of all closing conditions required by the amended
merger agreement (the "Merger Agreement"). Neurotrope
shareholders also approved the spin-off of substantially all of
Neurotrope's existing assets, operations and liabilities, except
for certain cash retained in accordance with the terms of the
Merger Agreement, into a separately traded public company.
In connection with the completed merger and pursuant to the
terms of the Merger Agreement, Neurotrope and Metuchen have merged in an all-stock
transaction forming a newly traded holding company named Petros
Pharmaceuticals, Inc. ("Petros"). Petros' shares will
commence trading on the Nasdaq Global Market on December 2, 2020, under the ticker symbol "PTPI".
Neurotrope shareholders will initially own approximately 49% of the
combined company and Metuchen
shareholders will initially own approximately 51% of the combined
company. Pursuant to the terms of the Merger Agreement,
Metuchen shareholders also may
receive additional shares of Petros common stock issuable upon the
achievement of certain milestones. Petros' lead commercial asset is
Stendra® (avanafil), a U.S. Food and Drug Administration
("FDA")-approved erectile dysfunction ("ED") treatment (See
indications and important safety information below.)
Petros is currently exploring the potential to convert
Stendra® from prescription-only status to
non-prescription status. Petros will be led by Fady Boctor, Chief
Commercial Officer of Metuchen,
who has been named President and CCO.
"We are excited to complete this merger and create two publicly
traded companies, Petros Pharmaceuticals, Inc. and Neurotrope
Bioscience, Inc. ("NBI"), each with the potential to create
long-term value for our stakeholders," said Josh Silverman, a Director of the newly formed
Petros and Chairman of Neurotrope and NBI. "This transaction
provides a unique opportunity to participate in the upside
potential of Stendra®, a distinct, FDA approved ED
therapy. I am especially encouraged by Petros' partnership with
Foundation Consumer Healthcare, a world leading OTC company, as we
develop strategies to bring our FDA approved ED therapy to
consumers on a non-prescription basis."
"The closing of this merger transaction marks the beginning of a
new chapter for Petros," said Mr. Boctor. "With this merger, Petros
will now have the opportunity to advance the commercial
distribution of Stendra® in the ED space and build a
pipeline of other therapeutic products to improve men's health,
including a topical treatment H100™ for Peyronie's disease ("PD"),
as well as pursue innovative treatment options in other high-value
disease areas."
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. 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.
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 investigational product for
Peyronie's disease. In its current formulation, in a pilot
study, H-100™ demonstrated 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.
About Stendra® (avanafil)
Stendra® (avanafil) is approved in the U.S. by the
FDA for the treatment of ED. 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.
Indications and Important Safety Information
Stendra® (avanafil) is prescribed to treat 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 ED
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 Petros Pharmaceuticals, Inc.
Petros 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 ED, endothelial dysfunction, psychosexual and
psychosocial ailments, Peyronie's disease (acute and chronic),
hormone health and substance use disorders.
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 U.S. Food and Drug
Administration 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.
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 and other
matters. Words such as "could," "may," "expects," "anticipates,"
"projects," "intends," "plans," "believes," "seeks," "estimates,"
"will," "predicts," and variations on such words, and similar
expressions that reflect current views with respect to future
events and operational, economic and financial performance are
intended to identify such forward-looking statements. These
forward-looking statements are only predictions and are subject to
risks and uncertainties and other influences, many of which Petros,
Neurotrope and Metuchen have 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 risks and uncertainties,
including, without limitation, those described in the sections
entitled "Risk Factors" and "Management's Discussion and Analysis
of Financial Condition and Results of Operations" in the joint
proxy/prospectus Petros has filed with the Securities and Exchange
Commission, as updated from time to time in Petros' subsequent
filings with the Securities and Exchange Commission. These factors
include, but are not limited to, the success of the combined
company as a result of the merger among Petros, Metuchen and Neurotrope, including Petros'
ability to execute on its business strategy, including its plans to
develop and commercialize its product candidates; the market
price of shares of Petros common stock; Petros' ability to comply
with obligations as a public reporting company; the ability of
Petros to timely and effectively implement controls and procedures
required by Section 404 of the Sarbanes-Oxley Act of 2002; the risk
that the financial performance of the combined company may not be
as anticipated by Metuchen and
Neurotrope; risks resulting from Petros' status as an emerging
growth company, including that reduced disclosure requirements may
make shares of Petros common stock less attractive to investors;
risks related to Petros' ability to continue as a going concern;
risks related to Petros' dependence on the commercialization of a
single product, Stendra®, and on a single distributor
thereof; risks related to Petros' commercial supply agreement with
Vivus; and risks related to Petros' ability to obtain regulatory
approvals for, or market acceptance of, any of its products or
product candidates.
New factors emerge from time to time and it is not possible for
us to predict all such factors, nor can we assess the impact of
each such factor on the business or the extent to which any factor,
or combination of factors, may cause actual results to differ
materially from those contained in any forward-looking statements.
Forward-looking statements included in this release are based on
information available to Petros as of the date of this release.
Petros disclaims any obligation to update such forward-looking
statements, except as required by applicable law.
Contact information:
Investors and Media – Petros Pharmaceuticals
Deirdre Walsh
Abernathy MacGregor
dlw@abmac.com
212-371-5999
Investor and Media – NBI
Robert Weinstein
Chief Financial Officer – NBI
rweinstein@neurotrope.com
973.242.0005 x101
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SOURCE Neurotrope, Inc.
