Petros Pharmaceuticals Expands Program for Novel Investigational Non-Invasive Treatment Formulation for Peyronie's Disease

Company developing H-100 with goal to be the first and only FDA-approved topical treatment for Peyronie's Disease, currently treated predominantly through highly invasive surgery or series of penile Injections

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Petros Pharmaceuticals, Inc.

Nov 08, 2021, 09:15 ET

NEW YORK, Nov. 8, 2021 /PRNewswire/ -- Petros Pharmaceuticals, Inc. (Nasdaq: PTPI), a leading provider of therapeutics for men's health, announces today the expansion of its program for investigational H100, a novel patented non-invasive topical treatment under development for Peyronie's disease. H100 is a topical gel formulated to address the inflammatory cascade that leads to pain, scarring and penile irregularities associated with Peyronie's disease. Through its exclusive global license agreement with Hybrid Medical LLC, developer of H100, Petros furthers its commitment to advancing men's health with a product intended to become the first and only clinically-approved non-invasive topical for the treatment of Peyronie's disease.

"Petros's vision is to provide optimized men's health solutions across the spectrum of conditions that are specific to men, whether they be focused on the male anatomy or of increased risk among men," commented Fady Boctor, Petros' President and Chief Commercial Officer. "We believe that if approved, H-100 may be able to provide the first-ever non-invasive treatment to a confounding and often painful condition for which there have been few viable solutions. Importantly, through further studies, it may demonstrate an established safety and tolerability profile which could facilitate a 505(b)(2) submission. This could significantly shorten the clinical development timeline. We look forward to continuing to drive development around this potential treatment."

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, 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 healthcare advocates, 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, 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. They note that Peyronie's 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, 48% were reported to have had clinical depression connected 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 that address the men's health landscape. The Company's current commercialized portfolio includes patented Stendra® (avanafil), an oral phosphodiesterase 5 (PDE5) inhibitor for the treatment of erectile dysfunction as well as a line of market leading ED therapeutic devices. Topical H-100™gel is the Company's prospective treatment under development for Peyronie's disease. Please see below for Important Safety Information for Stendra.

Petros seeks to establish new foundations for the field of men's health by collaborating with researchers, scientists, medical thought leaders and payers on therapies that restore men's body function to vitality. petrospharma.com

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 erectile dysfunction. STENDRA is not for use in women or children. It is not known if STENDRA is safe and effective in women or children under 18 years of age. (A 100-mg and 200-mg tablet can be taken as early as ~15 minutes before sexual activity. STENDRA only works with sexual stimulation and should not be taken more than once a day. STENDRA can be taken with or without food; do not drink too much alcohol when taking STENDRA (for example, more than 3 glasses of wine or 3 shots of whiskey) as it can increase chances of side effects. Of people enrolled in clinical trials, 1.4%, 2.0%, and 2.0%, respectively, stopped taking STENDRA (50 mg, 100 mg, or 200 mg) due to side effects compared to 1.7% on placebo. 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.

STENDRA Important Risk Information
STENDRA can cause your blood pressure to drop suddenly to an unsafe level if it is taken with certain other medicines. A sudden drop in blood pressure can cause you to feel dizzy, faint, or have a heart attack or stroke.

Do not take STENDRA if you:

take medicines called nitrates, which are used to treat chest pain (angina)
use street drugs called "poppers," such as amyl nitrate and butyl nitrate
take medicines called guanylate cyclase stimulators, which include Adempas^® (riociguat), a medicine that treats pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension
are allergic to avanafil or any of the ingredients in STENDRA

Stop sexual activity and get medical help right away if you have symptoms such as chest pain, dizziness, or nausea during sex. Sexual activity can put an extra strain on your heart, especially if your heart is already weak from a heart attack or heart disease. Discuss your health with your healthcare provider to ensure you are healthy enough for sex.

STENDRA can cause serious side effects.

Uncommonly reported side effects include:

An erection that will not go away (priapism). If you have an erection that lasts more than 4 hours, get medical help right away.
Sudden vision loss in one or both eyes. Sudden vision loss in one or both eyes can be a sign of a serious eye problem called non-arteritic anterior ischemic optic neuropathy (NAION). It is uncertain whether PDE5 inhibitors directly cause vision loss. Stop taking STENDRA and call your healthcare provider right away if you have sudden vision loss in one or both eyes.
Sudden hearing decrease or hearing loss. Some people may also have ringing in their ears (tinnitus) or dizziness.

Before you take STENDRA, tell your healthcare provider if you:

have or have had heart problems such as a heart attack, irregular heartbeat, angina, or heart failure; have had heart surgery within the last 6 months; have had a stroke; have low blood pressure, or high blood pressure that is not controlled; have a deformed penis shape
have had an erection that lasted for more than 4 hours; have problems with your blood cells, such as sickle cell anemia, multiple myeloma, or leukemia; have retinitis pigmentosa, a rare genetic (runs in families) eye disease; have ever had severe vision loss, including an eye problem called non-arteritic anterior ischemic optic neuropathy (NAION); have bleeding problems; have or have had stomach ulcers; have liver problems; have kidney problems or are having kidney dialysis; or have any other medical conditions

Tell your healthcare provider about all of the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. STENDRA may affect the way other medicines work, and other medicines may affect the way STENDRA works, which may cause side effects. Especially tell your healthcare provider if you take any of the following:

medicines called nitrates
medicines called guanylate cyclase stimulators, such as riociguat
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^®)
some types of antibiotics, such as clarithromycin (Biaxin^®), telithromycin (Ketek^®), or erythromycin
medicines called alpha-blockers. These include terazosin (Hytrin^®), tamsulosin HCl (Flomax^®), doxazosin (Cardura^®), prazosin HCl (Minipress^®), alfuzosin HCl (UroXatral^®), dutasteride and tamsulosin HCl (Jalyn^®), or silodosin (Rapaflo^®). Alpha-blockers are sometimes prescribed for prostate problems or high blood pressure. In some patients, the use of STENDRA with alpha-blockers can lead to a drop in blood pressure or fainting
other medicines that treat high blood pressure
other medicines or treatments for ED

Do not drink too much alcohol (for example, more than 3 glasses of wine or 3 shots of whiskey) when taking STENDRA, as this can lead to increased chances of headache, dizziness, increased heart rate, or lowered blood pressure.

STENDRA does not protect against sexually transmitted diseases, including HIV.

The most common side effects of STENDRA are headache, flushing, stuffy or runny nose, sore throat, and back pain.

Tell your healthcare provider if you have any side effect that bothers you or does not go away. These are not all of the possible side effects of STENDRA. For more information, ask your healthcare provider or pharmacist. Call your healthcare provider for medical advice about side effects.

Please see full Prescribing Information and Patient Information

FORWARD-LOOKING STATEMENTS

This press release contains forward-looking statements and forward-looking information within the meaning of applicable securities laws. These statements relate to future events or future performance. All statements other than statements of historical fact may be forward-looking statements or information. Generally, forward-looking statements and information may be identified by the use of forward-looking terminology such as "plans", " expects" or "does not expect", "proposed", "is expected", "budgets", "scheduled", "estimates", "forecasts", "intends", "anticipates" or "does not anticipate", or "believes", or variations of such words and phrases, or by the use of words or phrases which state that certain actions, events or results may, could, would, or might occur or be achieved. Forward-looking statements consist of statements that are not purely historical, including any statements regarding beliefs, plans, expectations or intentions regarding the future. Such forward-looking statements are based on the beliefs of management as well as assumptions made by and information currently available to management. Actual results could differ materially from those contemplated by the forward-looking statements as a result of certain factors, including, but not limited to, Petros Pharmaceuticals' ability to execute on its business strategy, including its plans to develop and commercialize its product candidates; Petros Pharmaceuticals' ability to comply with obligations as a public reporting company; the ability of Petros Pharmaceuticals 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 Pharmaceuticals may not be as anticipated by the merger transactions that resulted in Petros Pharmaceuticals' creation; risks resulting from Petros Pharmaceuticals' status as an emerging growth company, including that reduced disclosure requirements may make shares of Petros Pharmaceuticals common stock less attractive to investors; risks related to Petros Pharmaceuticals' history of incurring significant losses; risks related to Petros Pharmaceuticals' dependence on the commercialization of a single product, Stendra®, and on a single distributor thereof; risks related to Petros Pharmaceuticals' commercial supply agreement with Vivus, including the risk that Petros Pharmaceuticals may not be able to obtain sufficient quantities of Stendra® in a timely manner or on commercially viable terms; risks related to Petros Pharmaceuticals' 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 pandemic, including the emergence of new variants, such as the Delta variant, and the related responses of governments, consumers, customers, suppliers, employees and Petros Pharmaceuticals, on Petros Pharmaceuticals' business, operations, employees, financial condition and results of operations. A discussion of these and other factors, including risks and uncertainties with respect to Petros Pharmaceuticals, and other factors described in Petros Pharmaceuticals' most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K filed with the Securities and Exchange Commission, which can be reviewed at www.sec.gov. Petros Pharmaceuticals disclaims any intention or obligation to revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

[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

SOURCE Petros Pharmaceuticals, Inc.