- BREXAFEMME, a one-day, novel, oral treatment for vaginal yeast infection, is the first FDA-approved indication of the ibrexafungerp antifungal development pipeline and the first approved drug from a novel antifungal class in over 20 years
- Commercial launch update call is scheduled for Tuesday, June 29th @ 12pm ET
JERSEY CITY, N.J., June 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 that it will present a commercial launch update for its recently FDA-approved drug, BREXAFEMME® (ibrexafungerp tablets). BREXAFEMME is a triterpenoid antifungal indicated for the treatment of adult and postmenarchal pediatric females with vulvovaginal candidiasis (VVC), or vaginal yeast infections. It is contraindicated during pregnancy and in patients with a history of hypersensitivity to ibrexafungerp.
The webcast on Tuesday, June 29, 2021 at 12pm Eastern Time will feature presentations by the SCYNEXIS management team who will discuss the second half 2021 commercial plan for BREXAFEMME, the first approved drug from a novel antifungal class in over 20 years. Also featured will be Key Opinion Leader, Michael L. Krychman, M.D.C.M., Southern California Center for Sexual Health and Survivorship Medicine, a renowned physician specializing in Obstetrics and Gynecology, who will discuss how BREXAFEMME fits into the yeast infection treatment landscape.
You are required to register in advance for the webcast. Presenters include:
Michael L. Krychman, M.D.C.M., Southern California Center for Sexual Health and Survivorship Medicine
Dr. Krychman is the Executive Director of the Southern California Center for Sexual Health and Survivorship Medicine located in Newport Beach California. He is board certified in Obstetrics and Gynecology. He is the former Co Director of The Sexual Medicine and Rehabilitation Program at Memorial Sloan-Kettering Cancer. He also is a clinical sexologist and has completed his Masters in Public Health and Human Sexuality. Dr Krychman has a degree in Erotology, Sexual Education and Forensic Sexology. Dr Krychman is also an AASECT certified sexual counselor. He is an Associate Clinical Professor at the University of California Irvine, Division of Gynecological Oncology and the Medical Director of Ann’s Clinic, a high-risk program for Breast and Ovarian Cancer Survivors.
Marco Taglietti, M.D., SCYNEXIS President & Chief Executive Officer
Dr. Taglietti has served as Chief Executive Officer of SCYNEXIS since April 2015 and became President of the Company in September 2015. He has been a member of the board since November 2014. He served as Executive Vice President, Research and Development and Chief Medical Officer of Forest Laboratories, Inc. and as President of the Forest Research Institute until its acquisition by Actavis in 2014. Prior to joining Forest Laboratories in 2007, Dr. Taglietti held the position of Senior Vice President, Head of Global Research and Development, at Stiefel Laboratories, Inc., a GSK company, for three years. He joined Stiefel Laboratories after 12 years at Schering-Plough Corporation, where he last held the position of Vice President, Worldwide Clinical Research for Anti-Infectives, Oncology, CNS, Endocrinology and Dermatology. Dr. Taglietti began his pharmaceutical career at Marion Merrell Dow Research Institute. Over the course of his career, he has brought to market 35 different products in the U.S. and internationally. Dr. Taglietti currently serves on the Board of Directors of BioNJ, Inc. and Aquestive Therapeutics, Inc. (Nasdaq: AQST). He received his medical degree and board certifications from the University of Pavia in Italy.
Christine Coyne, SCYNEXIS Chief Commercial Officer
Ms. Coyne joined SCYNEXIS as Chief Commercial Officer in May 2021. She has 30 years of experience in launch and commercialization of products across multiple therapeutic areas. Most recently, Ms. Coyne served as Senior Vice President, Commercial at Paratek Pharmaceuticals, where she was instrumental in launching the company’s first product and adjusting tactics to ensure success, even during external challenges such as the COVID-19 pandemic. Prior to that, Christine led marketing and sales teams in biotech and large pharma companies such as Wyeth-Ayerst Global Pharmaceuticals (now part of Pfizer), Endo, and Auxilium Pharmaceuticals (now part of Endo). Ms. Coyne served as Vice President of Marketing, Sales, and Operations in the United States and globally for specialty pharmaceuticals companies responsible for several approved products. Ms. Coyne holds an M.B.A from Eastern University.
Eric Francois, SCYNEXIS Chief Financial Officer
Mr. Francois joined SCYNEXIS as Chief Financial Officer in November 2015. He previously served as Co-founder and Chief Operating Officer of Topi, Inc., a technology startup, which he helped grow from inception to over 250 clients worldwide. Previously, Mr. Francois spent six years as a Director in the Equity Capital Markets Group at Lazard Ltd. where he led capital raisings and advisory assignments for healthcare and biotechnology companies. He started his career at Cowen and Company in the Equity Capital Markets and Convertible Debt Groups. Mr. Francois holds a B.A. in Economics and Business Administration and an M.A. in Marketing from Pantheon-Sorbonne University.
About Vulvovaginal Candidiasis
VVC, commonly known as a vaginal yeast infection due to Candida, is the second most common cause of vaginitis. Although these infections are frequently caused by Candida albicans, infections caused by fluconazole-resistant and non-albicans Candida strains, such as Candida glabrata, have been reported to be on the rise. VVC can be associated with substantial morbidity, including significant genital discomfort (pain, itching, burning), reduced sexual pleasure and activity, psychological distress (stress, depression, anxiety), embarrassment, reduced physical activity, and loss of productivity. Typical VVC symptoms include pruritus, vaginal soreness, irritation, excoriation of vaginal mucosa and abnormal vaginal discharge. An estimated 70-75% of women worldwide will have at least one episode of VVC in their lifetime, and 40-50% of them will experience multiple episodes.
Currently approved treatments for VVC include BREXAFEMME (ibrexafungerp tablets), several topical antifungals, and oral fluconazole, which is the only other orally administered antifungal approved for the treatment of VVC in the U.S. and which has typically accounted for over 90% of the prescriptions written for this condition every year.
About BREXAFEMME® (ibrexafungerp tablets), for oral use
BREXAFEMME is the trade name for ibrexafungerp, a novel oral antifungal approved for the treatment of vulvovaginal candidiasis (VVC), also known as vaginal yeast infection. Its mechanism of action, glucan synthase inhibition, is fungicidal against Candida species, meaning it kills fungal cells. The New Drug Application (NDA) for BREXAFEMME was approved by the U.S. Food and Drug Administration (FDA) on June 1, 2021. The NDA was supported by positive results from two Phase 3, randomized, double-blind, placebo-controlled, multi-center studies (VANISH-303 and VANISH-306), in which oral ibrexafungerp demonstrated efficacy and a favorable tolerability profile in women with VVC. BREXAFEMME represents the first approved drug in a new antifungal class in over 20 years and is the first and only treatment for vaginal yeast infections which is both oral and non-azole. For more information, visit www.brexafemme.com.
Please click here for full Prescribing Information.
BREXAFEMME® is a triterpenoid antifungal indicated for the treatment of adult and postmenarchal pediatric females with vulvovaginal candidiasis (VVC).
Dosage and Administration
The recommended dosage of BREXAFEMME is 300 mg (two tablets of 150 mg) twice a day for one day, for a total treatment dosage of 600 mg. BREXAFEMME may be taken with or without food.
Important Safety Information
- BREXAFEMME is contraindicated during pregnancy and in patients with a history of hypersensitivity to ibrexafungerp
- BREXAFEMME administration during pregnancy may cause fetal harm based on animal studies. Prior to initiating treatment, verify pregnancy status in females of reproductive potential and advise them to use effective contraception during treatment
- When administering BREXAFEMME with strong CYP3A inhibitors, the dose of BREXAFEMME should be reduced to 150 mg twice a day for one day. Administration of BREXAFEMME with strong CYP3A inducers should be avoided
- Most common adverse reactions observed in clinical trials (incidence ≥2%) were diarrhea, nausea, abdominal pain, dizziness, and vomiting
To report SUSPECTED ADVERSE REACTIONS, contact SCYNEXIS, Inc. at 1-888-982-SCYX (1-888-982-7299) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
SCYNEXIS, Inc. (NASDAQ: SCYX) is a biotechnology company pioneering innovative medicines to help millions of patients worldwide overcome and prevent difficult-to-treat infections that are becoming increasingly drug-resistant. We are developing our lead asset, ibrexafungerp (formerly known as SCY-078), as a broad-spectrum, systemic antifungal for multiple fungal indications in both the community and hospital settings. The New Drug Application (NDA) for BREXAFEMME® (ibrexafungerp tablets) was approved by the U.S. Food and Drug Administration (FDA) on June 1, 2021. For more information, visit www.brexafemme.com. We are also continuing late-stage clinical development of ibrexafungerp for the prevention of recurrent VVC as well as the treatment of life-threatening invasive fungal infections in hospitalized patients. For more information, visit www.scynexis.com.
Statements contained in this press release regarding expected future events or results are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including but not limited to statements regarding: the BREXAFEMME launch update and the second half 2021 commercial plan for BREXAFEMME. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These risks and uncertainties include, but are not limited, to: BREXAFEMME may not be accepted by physicians and patients at the rate SCYNEXIS expects; risks inherent in SCYNEXIS' ability to successfully develop and obtain FDA approval for ibrexafungerp for additional indications; unexpected delays may occur in the timing of acceptance by the FDA of an NDA submission; the expected costs of studies and when they might begin or be concluded; SCYNEXIS’ need for additional capital resources; and SCYNEXIS' reliance on third parties to conduct SCYNEXIS' clinical studies and commercialize its products. These and other risks are described more fully in SCYNEXIS' filings with the Securities and Exchange Commission, including without limitation, its most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q, including in each case under the caption "Risk Factors," and in other documents subsequently filed with or furnished to the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. SCYNEXIS undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
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A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/1ca08c25-c216-4a0d-b5c3-6801b1410df9
BREXAFEMME® (ibrexafungerp tablets), for oral use A novel oral antifungal approved for the treatment of vulvovaginal candidiasis (VVC), also known as vaginal yeast infection