New Erectile Dysfunction Treatment Likely to Face Stiff Competition If Approved

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The treatment of erectile dysfunction (ED) has helped literally tens of millions of men in America alone. The number of drugs treating ED has grown substantially over the years, and each drug tends to have a different target market within the community of those suffering from ED.

Now that Viagra and Cialis are facing generic competition, the total pool of dollars spent on treating ED after the Big Pharma patent cliffs expired is expected to drop ahead. Still, there are many newer and upcoming drugs that targeting subsets of patients with new issues around ED.

A relatively new and unheard of company called Aquestive Therapeutics Inc. (NASDAQ: AQST) has a decision on the U.S. approval of AQST-119 (tadalafil oral film) for ED coming up shortly. This company just came public in the summer of 2018. Wedbush Securities, which rates Aquestive with an Outperform rating and $34 target (versus a $17.91 prior close) sees it receiving FDA approval on or before the PDUFA date of November 18, 2018.

The question now is just how much a new ED treatment is needed for the market, as well as how much a new entrant can really make off of a new ED treatment now that Viagra is over 20 years old and with generics and lower-priced competition on the market. Wedbush posted a 90:10 probability of approval on Aquestive’s ED treatment, and it listed the following data sets in its report:

  • 1,800,000 estimated eligible patients
  • Price per patient of $3,726
  • Gross peak sales of $62.9 million
  • Peak sales year of 2024

These numbers may be great for a company with a mere $450 million market cap like Aquestive. Unfortunately, it’s a small subset of the ED market as a whole, and the total global pie treating ED is still worth hundreds of millions to billions of dollars as a whole.

The demand for drugs to treat ED has risen to meet the needs of an aging population and to help combat disease-related ED from issues around kidney disease, hypertension-related issues, chronic disorders, hormonal issues, diabetes complications and neurological disorders. Again, the dollar amounts being generated around ED is dropping due to stiff competition from generics.

Some other broader news has been around in the larger ED treatments in 2018 and in 2017 shown below.

In September of 2018, Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) announced the exclusive first-to-file launch of a generic version of Cialis tablets in the United States. Eli Lilly and Co. (NYSE: LLY) tadalafil tablets are a phosphodiesterase 5 (PDE5) inhibitor for the treatment of erectile dysfunction. The Teva release showed that Cialis had annual sales of more than $1.9 billion in the United States as of July 2018. That said, due to generics and competition, Cialis sales may drip under $1 billion in 2019 or shortly thereafter.

Pfizer Inc. (NYSE: PFE) enjoyed billions of dollars in sales of its Viagra for ED, but Viagra went generic in late 2017. Pfizer makes its own generic version, as do companies like Teva, Aurobindo and Cambia.

Bayer also had Levitra, but this was a distant number-three drug behind leader Viagra and then behind Cialis.

A site called Sharecare suggests that more than 30 million men in America have a form of ED. Now think about how many more millions of men have had it who have died, and how many millions of men will have it in the future but do not yet. Does the market need yet another treatment for ED? Maybe the answer really depends on whom you ask.