Petros Pharmaceuticals Establishes Steering Committee to Expand into Non-Rx Status for Stendra® (avanafil)

Company taps key industry leaders for expanded access strategies for Stendra, including Over the Counter

February 4, 2021 8:30 AM EST

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NEW YORK, Feb. 4, 2021 /PRNewswire/ -- Petros Pharmaceuticals, Inc. (Petros or the Company) (Nasdaq: PTPI), a leading provider of therapeutics for men's health, today announced that it has formed a steering committee to develop expanded patient access initiatives, including non-prescription or Over the Counter (OTC) status strategies, for its STENDRA® (avanafil) product, an oral medication used in the treatment of erectile dysfunction (ED).  The committee will build upon more than 2 years of work conducted by the Company to pursue direct to consumer self-care mechanisms for increased engagement and control over their erectile health.

The initial members of the steering committee include Greg Bradley, member of the Petros board of directors and president and CEO of Foundation Consumer Healthcare, which has an industry leading portfolio of differentiated OTC products, including the #1 OB-GYN recommended Plan B One-Step emergency contraception, its flagship product and #1 selling SKU in the U.S.; Paul Wardle, founder and principal of Beacon Associates, LLC and a former pharmaceutical executive with extensive experience in Rx to OTC switch, including the Viagra OTC switch in the United Kingdom; Fady Boctor, the Company's Chief Commercial Officer; and Tania King an operating advisor to Petros with significant experience in retail, sales and marketing, supporting various brands with their OTC initiatives, including working with Mr. Bradley on achieving Plan B One-Step's OTC status.

"The large number of men silently suffering from erectile dysfunction provides an incredible opportunity to encourage men to take care of their health while maintaining the discretion that men naturally seek.  Exploring the feasibility and path forward for an ED medication to minimize additional steps and still provide excellent care is an attractive possibility for a market segment that is traditionally underserved based on reticence to interact with physicians. We are looking forward to exploring the possibilities available to facilitate access to Stendra while differentiating it in the market.  We look forward to providing updates as we progress," said Mr. Boctor.

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 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," "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-establishes-steering-committee-to-expand-into-non-rx-status-for-stendra-avanafil-301222109.html

SOURCE Petros Pharmaceuticals, Inc.



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