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Petros Pharmaceuticals Welcomes Dr. Mohit Khera to Steering Committee to Expand into Non-Rx Status for Stendra® (avanafil)

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Petros Pharmaceuticals (NASDAQ: PTPI) announced the appointment of Dr. Mohit Khera to its steering committee to enhance patient access for STENDRA® (avanafil), a treatment for erectile dysfunction (ED). Dr. Khera, a Urology Professor at Baylor College of Medicine, aims to explore potential over-the-counter availability for STENDRA® in the U.S., reflecting on successful non-prescription models in other countries. This initiative is part of Petros's strategy to bolster the relaunch of STENDRA®, which generated approximately $30 million in revenue in 2019.

Positive
  • Dr. Mohit Khera's expertise may enhance strategic initiatives for STENDRA®.
  • Potential for STENDRA® to achieve non-prescription status could increase market access.
  • STENDRA® generated approximately $30 million in gross revenues in 2019, indicating prior market success.
Negative
  • Petros is heavily reliant on STENDRA® for revenue, posing risks if market changes occur.
  • Dependence on a single distributor for STENDRA® may limit operational flexibility.

NEW YORK, Feb. 18, 2021 /PRNewswire/ -- Petros Pharmaceuticals, Inc. ("Petros" or "the Company") (NASDAQ: PTPI), a leading provider of therapeutics for men's health, today announces that Mohit Khera, M.D., M.B.A., M.P.H. has joined the company's steering committee to develop expanded patient access initiatives for STENDRA® (avanafil) product, an oral medication used in the treatment of erectile dysfunction (ED). 

Mohit Khera, M.D., M.B.A., M.P.H., specializes in male infertility, male and female sexual dysfunction, and testosterone replacement therapy. Dr. Khera has dedicated his clinical and research efforts to three main areas:  testosterone, erectile dysfunction, and Peyronie's disease.  Soon after completing my fellowship he started the Laboratory for Andrology Research. His laboratory focuses on basic science research on testosterone and its effects on the prostate, stem cells to treat erectile dysfunction, the effects of finasteride on sexual function, and genetic markers of hypogonadism. In his laboratory he has had the opportunity to train many residents and research fellows. In addition to his basic science research, he has initiated numerous FDA approved clinical trials. His basic science and clinic experiences have allowed him to thus far give over 250 lectures at scientific meetings, publish over 100 articles in peer reviewed journals, complete 15 book chapters, and edit and write two books all in the field of sexual medicine. Dr. Khera freely shares his time and knowledge with the general public. He has been voted one of Houston's Best Doctors numerous times by Health and Sport Fitness Magazine and by Houstonia Magazine and is a frequent guest on such TV programs as Fox News' "Ask the Doctor." He also writes a blog on Men's Health for the Houston Chronicle Newspaper.

"I believe there is considerable opportunity to expand the access of erectile dysfunction medication beyond what we currently see in the United States. We have seen other medications go over-the-counter in other countries and I believe that an approach is possible to create a non-Rx scenario in the near future," said Dr. Khera. "This steering committee provides the opportunity to forge a strategic path forward to improve the lives of men with ED by potentially allowing them to access medication without a prescription."

Dr. Khera is the Professor of Urology and Director of the Laboratory for Andrology Research at the McNair Medical Institute at Baylor College of Medicine. He is also the Medical Director of the Executive Health Program at Baylor. Dr. Khera earned his undergraduate degree at Vanderbilt University. He subsequently earned his Master's in Business Administration and his Master's in Public Health from Boston University. He received his MD from The University of Texas Medical School at San Antonio and completed his residency training in the Scott Department of Urology at Baylor College of Medicine. He then went on to complete a one-year Fellowship in Male Reproductive Medicine and Surgery.

"We are honored to welcome a key opinion leader of Dr. Khera's stature to our steering committee, as he brings a combination of unparalleled expertise in men's sexual health, considerable experience in working with landmark therapeutic innovations, and business acumen, all of which make him an important component in the development of our path forward," commented Fady Boctor, Petros Pharmaceutical's President and Chief Commercial Officer. "We look forward to Dr. Khera's contributions to the steering committee's activities."

About 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. The Company recently undertook a relaunch of Stendra®, generating gross revenues of approximately $30 million in 2019. 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.

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," "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' 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. 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.

Cision View original content:http://www.prnewswire.com/news-releases/petros-pharmaceuticals-welcomes-dr-mohit-khera-to-steering-committee-to-expand-into-non-rx-status-for-stendra-avanafil-301230597.html

SOURCE Petros Pharmaceuticals, Inc.

FAQ

What is Petros Pharmaceuticals' recent announcement regarding STENDRA (PTPI)?

Petros Pharmaceuticals announced the appointment of Dr. Mohit Khera to its steering committee to enhance patient access to STENDRA (avanafil), potentially exploring an over-the-counter option.

Who is Dr. Mohit Khera and what is his role with Petros Pharmaceuticals?

Dr. Mohit Khera is a respected urology expert and has joined Petros Pharmaceuticals' steering committee to develop initiatives for expanding access to STENDRA (avanafil).

What revenues did STENDRA generate in 2019?

STENDRA generated approximately $30 million in gross revenues in 2019, reflecting its market potential.

Why is the potential OTC status of STENDRA important?

Achieving over-the-counter status for STENDRA could significantly increase its market access and sales opportunities.

Petros Pharmaceuticals, Inc.

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