SCYNEXIS and Amplity Health Announce Agreement to Support the Anticipated U.S. Commercialization of BrexafemmeTM (Ibrexafungerp) for Vaginal Yeast Infections

By Globe Newswire7 days ago

  • Synergistic combination of Amplity's proven commercial sales capabilities and SCYNEXIS' internal medical, marketing, and strategic expertise will maximize Brexafemme's commercial potential while preserving SCYNEXIS' global rights to the drug
  • Amplity to defer a portion of SCYNEXIS' commercial launch expenses for the first two years in exchange for a performance-based success fee
  • Brexafemme, the conditionally FDA-approved brand name for ibrexafungerp for vaginal yeast infections, is on track for anticipated June 2021 approval and H2:2021 launch
  • SCYNEXIS in a strong financial position to execute on its plans with a projected cash runway into 2023

JERSEY CITY, N.J., Feb. 23, 2021 (GLOBE NEWSWIRE) -- SCYNEXIS, Inc. (NASDAQ:SCYX), a biotechnology company pioneering innovative medicines to overcome and prevent difficult-to-treat and drug-resistant fungal infections, today announced it has partnered with Amplity Health in connection with the anticipated U.S. launch of Brexafemme (ibrexafungerp). Amplity, a leading global contract commercialization organization, specializes in designing, implementing, and managing customer facing and inside sales, service, medical and clinical teams. 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.

“We are thrilled to enter into this strategic partnership with Amplity Health, leveraging its commercial capabilities and established infrastructure while preserving cash by deferring a portion of the commercialization costs of Brexafemme until 2023,“ said Marco Taglietti, M.D., President and Chief Executive Officer of SCYNEXIS. “We look forward to working with an Amplity women's health sales force and payer account management team fully dedicated to help realize Brexafemme's blockbuster potential.“

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.

“We have been closely following the development of this novel antifungal and believe it is a differentiated product poised to make a difference in the field of women's health,“ said Mike Griffith, Chief Executive Officer of Amplity Health. “We are excited to partner with SCYNEXIS to support the U.S. commercialization of ...

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