Amplity Health Growing its Commercialization Business with SCYNEXIS Agreement

SCYNEXIS, Inc., a biotechnology company pioneering innovative medicines to overcome and prevent difficult-to-treat and drug-resistant fungal infections, recently announced it has partnered with Amplity Health (Amplity) in connection with the anticipated U.S. launch of Brexafemme (ibrexafungerp).

Brexafemme is the expected trade name for ibrexafungerp, an oral antifungal product candidate for the treatment of vulvovaginal candidiasis (VVC), also known as vaginal yeast infection. The New Drug Application (NDA) for Brexafemme is under review by the U.S. Food and Drug Administration (FDA) with a Prescription Drug User Fee Act (PDUFA) action date of June 1, 2021.

If approved, Brexafemme would represent the first novel antifungal class in over 20 years and would be the first and only non-azole treatment for vaginal yeast infections. Difficult-to-treat Vaginal Fungal infections affect millions of women and offer limited available alternatives with only one oral treatment option available.

SCYNEXIS planned U.S. Commercial launch is in the second half of 2021. The company estimates U.S. peak sales of $400-600MM. SCYNEXIS has turned to Amplity, a leading global contract commercialization organization, that specializes in designing, implementing, and managing customer facing and inside sales, service, medical and clinical teams. Amplity is owned by Altamont Capital Partners.

Under the terms of the 5-year agreement, SCYNEXIS will utilize Amplity’s commercial execution expertise and resources for sales force, remote engagement, training, market access and select operations services. Amplity is deferring a portion of its direct service costs in the first two years (2021 and 2022) up to a cap, which SCYNEXIS will repay over three years starting in 2023.

Amplity has the potential to earn a performance-based success fee in the 2023-2025 time frame by exceeding certain revenue targets. SCYNEXIS will maintain full ownership of Brexafemme, control of all strategic aspects of the launch and have the right to terminate the agreement, including upon a change of control.

Takeaway: Amplity believes its partnership with SCYNEXIS to support the U.S. commercialization of Brexafemme with deferred-costs and success fee arrangements will greatly benefit both companies