Petros Pharmaceuticals to Pursue 505(B)(2) Pathway for H-100, Company’s Novel Topical Investigational Treatment for Peyronie’s Disease Which Impacts More Than 1 in 10 Men in the US

Rhea-AI Summary

Petros Pharmaceuticals is pursuing the 505(b)(2) pathway for its investigational agent H-100, potentially the first FDA-approved non-invasive topical treatment for Peyronie’s disease, affecting over 10% of men in the US. Developed using nanotechnology, H-100 aims to enhance medication permeation and tackle the disease's inflammatory cascade. The 505(b)(2) pathway offers an efficient development route by leveraging existing FDA data. Petros aims to provide a much-needed alternative to current invasive treatment options.

Positive

• H-100 could be the first non-invasive topical treatment for Peyronie's disease.
• The use of nanotechnology may enhance medication effectiveness.
• The 505(b)(2) regulatory pathway could speed up FDA approval.

Negative

• Dependence on FDA approval for H-100 introduces regulatory risks.
• -

Company Is Developing H-100 as Potentially the First FDA-Approved, Nanoparticle-Based Topical Treatment Designed to Provide Improved and Sustained Local Medication Permeation Against Peyronie’s Disease, Which is Currently Predominantly Treated Surgically, or by a Series of Injections

NEW YORK, May 03, 2022 (GLOBE NEWSWIRE) -- 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 disease
The 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 Pharmaceuticals
Petros 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 Statements
This 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 IR
ir@petrospharma.com

Media:
Jules Abraham
CORE IR
917-885-7378
pr@coreir.com

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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

 

FAQ

What is H-100 and its purpose?

H-100 is a novel, non-invasive topical treatment being developed by Petros Pharmaceuticals for Peyronie’s disease.

How does Petros Pharmaceuticals plan to obtain FDA approval for H-100?

Petros Pharmaceuticals is pursuing the 505(b)(2) pathway, which allows for a more efficient approval process by leveraging existing FDA data.

What is the prevalence of Peyronie's disease in the US?

Peyronie’s disease impacts more than 1 in 10 men in the United States.

What are the current treatment options for Peyronie's disease?

Current treatments primarily involve invasive surgeries, penile implants, and injections.

What is the significance of the 505(b)(2) regulatory pathway?

It allows for more efficient drug development by utilizing existing FDA data related to the active ingredient.