Petros Pharmaceuticals, Inc. (Nasdaq: PTPI), a leading provider of
therapeutics for men’s health, announces today they will be
pursuing the 505(b)(2) pathway for its investigational agent,
H-100™, a novel, patented, non-invasive topical treatment being
developed for Peyronie’s disease, a condition impacting more than 1
in 10 men in the US. The Company is pursuing this pathway after
discussions with the FDA, and through its exclusive global license
agreement with Hybrid Medical LLC, the developer of H-100.
H-100 has the potential to be the first FDA-approved,
non-invasive topical treatment for Peyronie’s disease. H-100 is
being developed as a topical gel using nanotechnology to
potentially enhance permeation of the medication. It is
hypothesized that this will better address the inflammatory cascade
that leads to the pain, scarring, and penile irregularities
associated with Peyronie’s disease. Currently, Peyronie’s disease
can be treated by invasive surgery, by penile implantation, or by a
series of injections or traction devices.
The 505 (b)(2) regulatory pathway provides manufacturers with
the opportunity to acquire FDA approval by bridging to a decision
previously made by the FDA for that active ingredient, essentially
inheriting a fairly extensive and current array of nonclinical and
clinical data enabling a more efficient development pathway for
Peyronie’s disease. It can be an option for drugs with a new aspect
related to indication, dosage form or regimen, strength,
combination with other products, or other unique
characteristics.
“Petros’s vision continues to provide optimized solutions across
the spectrum of men’s health conditions, and we believe that H-100
represents a much needed therapeutic advancement as potentially the
first non-invasive treatment for a painful and debilitating
condition that currently has few viable options,” commented Fady
Boctor, Petros’ President and Chief Commercial Officer. “We look
forward to working closely with the FDA as we pursue the 505(b)(2)
pathway, significantly shortening the development timeline needed
to bring H-100 to men, and to their partners, living with
Peyronie’s disease.”
About Peyronie’s diseaseThe National Institute
of Diabetes and Digestive and Kidney Diseases reports that the
actual number of men who have Peyronie’s disease in the US is more
than 1 in 10. According to American Urological Association (AUA)
Guidelines, among the current treatments for Peyronie’s disease are
invasive surgeries, injections and implants.1 As a topical
treatment, H-100 has the potential to be approved as the first
non-invasive treatment for the condition. Peyronie's (pay-roe-NEEZ)
disease is a noncancerous condition resulting from fibrous scar
tissue on the penis, causing curved, often painful, erections.
While not necessarily a cause for larger concern, Peyronie's
disease causes an irregularity in the shape of the erection in some
men, which may prevent sexual intercourse or might cause difficulty
in achieving or maintaining an erection (erectile dysfunction).
Penile shortening is another common concern. The condition does not
often naturally abate, and in most cases, will remain as is, or
worsen.2
According to a healthcare advocacy group The Men’s Health
Network, not all irregularly shaped erections or penile bumps are
caused by Peyronie’s disease and the impact goes beyond the
physical symptoms, expanding to include sexual, psychological, and
social effects. Because in Peyronie’s disease the erection shape is
abnormal and sometimes hurts, intercourse can become difficult and
even impossible for some men. Others can become self-conscious
about the appearance and limitations of their erections, causing
them to avoid sex. The Men’s Health Network notes that Peyronie’s
disease can be embarrassing to talk about – even with a partner –
which can lead to relationship difficulties. In one study of 92 men
with Peyronie’s disease, 48% were reported to have had clinical
depression in connection with the condition.3
About Petros PharmaceuticalsPetros
Pharmaceuticals is committed to the goal of becoming a
world-leading specialized 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, hormone health, and substance use
disorders.
Cautionary Note Regarding Forward-Looking
StatementsThis press release includes forward-looking
statements within the meaning of Section 27A of the Securities Act
of 1933, as amended, and Section 21E of the Securities Exchange Act
of 1934, as amended. These forward-looking statements are based
upon Petros Pharmaceuticals, Inc.’s (“Petros,” “we,” “our,” “us” or
the “Company”) management’s assumptions, expectations, projections,
intentions and beliefs about future events. In some cases,
predictive, future-tense or forward-looking words such as “intend,”
“develop,” “goal,” “plan,” “predict”, “may,” “will,” “project,”
“estimate,” “anticipate,” “believe,” “expect,” “continue,”
“potential,” “opportunity,” “forecast,” “should” and similar
expressions, whether in the negative or affirmative, are intended
to identify forward-looking statements, but are not the exclusive
means of identifying such statements. 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, Petros’
ability to execute on its business strategy, including its plans to
develop and commercialize its product candidates; 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 Petros may not be
as anticipated by the merger transactions that resulted in the
Company’s creation; 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’ history of incurring
significant losses; risks related to Petros’ dependence on the
commercialization of a single product, STENDRA®, and on a single
distributor thereof; risks related to the termination of Petros’
commercial supply agreement with Vivus, including the risk that
Petros may not be able to obtain sufficient quantities of STENDRA®
in a timely manner or on commercially viable terms; risks related
to Petros’ ability to obtain regulatory approvals for, or market
acceptance of, any of its products or product candidates; and the
expected or potential impact of the novel coronavirus (“COVID-19”)
pandemic, including the emergence of new variants, such as the
Delta variant, and the related responses of governments, consumers,
customers, suppliers, employees and the Company, on our business,
operations, employees, financial condition and results of
operations. Additional factors that could cause actual results to
differ materially from the results anticipated in these
forward-looking statements are contained in the Company’s periodic
reports and in other filings that the Company has filed, or may
file, with the U.S. Securities and Exchange Commission (the “SEC”)
under the headings “Risk Factors” and “Management’s Discussion and
Analysis of Financial Condition and Results of Operations” and
elsewhere. The Company cautions readers that the forward-looking
statements included in this press release represent our beliefs,
expectations, estimates and assumptions only as of the date of
hereof and are not intended to give any assurance as to future
results. New factors emerge from time to time, and it is not
possible for us to predict all of these factors. Further, the
Company cannot assess the effect of each such factor on our
business or the extent to which any factor, or combination of
factors, may cause actual results to be materially different from
those contained in any forward-looking statement. Accordingly, you
should not unduly rely on any forward-looking statements.
The Company undertakes no obligation to update or revise any
forward-looking statements contained in this press release, whether
as a result of new information, future events, a change in our
views or expectations or otherwise, except as required by federal
securities laws.
CONTACTS:Investors:CORE
IRir@petrospharma.com
Media:Jules AbrahamCORE IR917-885-7378pr@coreir.com
1
https://www.auanet.org/guidelines/guidelines/peyronies-disease-guideline
2
https://www.mayoclinic.org/diseases-conditions/peyronies-disease/symptoms-causes/syc-20353468
3
https://menshealthnetwork.org/peyronies#other%20than%20physical%20symptoms
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