Eyeing the outskirts of blockbuster land with its newly minted antifungal, Jersey City's Scynexis is hitting the gas with a drug launch into a massive and largely deserted field.
The new drug, Brexafemme, will land on pharmacy shelves in August at a U.S. wholesale acquisition cost of $475 per course, Scynexis’ chief commercial officer Christine Coyne said on a call with analysts Tuesday. The company has built out its sales team with commercial partner Amplity Health, and it's also started payer negotiations.
Scynexis is also getting ready to roll with branded and unbranded campaigns to spread awareness in a wide-open market the company predicts is worth billions.
Not widely known before Brexafemme’s approval to treat vaginal yeast infection, Scynexis now finds itself the “loudest and only voice” in the field, CEO Marco Taglietti said on the call. The company is confident it can smash through the generics-led market, too, thanks to Brexafemme’s myriad advantages over azole drugs like Pfizer’s Diflucan, which have dominated treatment for more than 20 years.
Scynexis is eyeing peak U.S. sales of $400 million to $600 million for the drug, though there could be "upside scenarios," Eric Francois, chief financial officer, said on the call.
Some analysts agree. Brexafemme’s one-day oral dosing, plus its ability to kill the fungal cells behind vaginal yeast infections—where azoles fall short—and an “increasing interest by large pharma in the antifungal space,” could see the med reach blockbuster territory with more than $1 billion in annual sales, Cantor Fitzgerald analysts wrote in a note to clients earlier this month.
While there’s massive over-the-counter demand for products to treat vaginal yeast infection, also known as vulvovaginal candidiasis (VVC), Scynexis plans to initially focus on the prescription realm, Coyne said. Doctors wrote 15.9 million fluconazole scripts alone last year, not to mention another 1 million or so for topical VVC treatments, she said. But doctors and patients alike are clamoring for something better.
Of more than 1,000 healthcare practitioners Scynexis questioned in a survey, 84% said they’d prescribe Brexafemme to a patient on request, Coyne said. Those doctors have specific patients in mind, such as women who’ve endured more than one yeast infection or those with severe symptoms.
With a sales team of 70, Scynexis is setting its sights on marketing to doctors in 60 sales territories covering 89% of the market, Coyne said. Sixty of those reps will be on the ground, with another 10 held back as part of the “inside” team. The commercial field crew is fully hired and in the onboarding process.
Elsewhere on the marketing front, the company is rolling out digital, journal and search advertising, plus promotional webinars. It’s also planning appearances at certain medical conferences this year.
The $475 wholesale price covers one treatment course of four tablets. The drug is designed to work after a single course.
To get Brexafemme on shelves, the company has teamed up with commercial juggernauts Walgreens, CVS, Rite Aid, Walmart and Kroger. It will also offer prior authorization services and a copay card at launch, plus a telehealth channel on its website, Coyne said. Payer negotiations are ongoing.
The company isn’t offering revenue guidance until next year, but it’s currently looking at a “long cash runway into 2023,” Francois said. Scynexis had more than $92 million on hand as of March 31 and drew a $60 million term loan facility with Hercules Capital in May.
Meanwhile, the company has forged a licensing pact with Hansoh Pharma to develop and sell Brexafemme in the greater China region, which could see it pocket up to $112 million in regulatory and commercial milestones, plus royalties