- BREXAFEMME receives a 5-year extension of exclusivity under the GAIN Act for a total of 10 years of regulatory exclusivity
- BREXAFEMME also protected by a composition patent until 2035
- The call to update the commercial rollout is Tuesday, April 29ththe at 12 p.m. ET
JERSEY CITY, NJ, June 9, 2021 (GLOBE NEWSWIRE) – SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company pioneering innovative drugs to overcome and prevent difficult-to-treat and drug-resistant fungal infections, today announced that it that the US Food and Drug Administration (FDA) granted BREXAFEMME (ibrexafungerp tablets) a five-year extension of exclusivity under the Generating Antibiotic Incentives Now (GAIN) Act. This exclusivity is added to all other applicable exclusivity periods for a combined period of ten years of regulatory exclusivity, e.g. B. to the five years of exclusivity for new chemical entities (NCE). BREXAFEMME is also protected by several patents, including a composition of matter patent covering the ibrexafungerp molecule. With the extension of the patent term, this patent is expected to expire in 2035 and provide 14 years of protection from generic competitors in the United States
“With our first FDA approval behind us, we are delighted to have confirmed BREXAFEMME’s five-year GAIN Act exclusivity for the treatment of vulvovaginal candidiasis,” said Marco Taglietti, MD, President and Chief Executive Officer of SCYNEXIS. “We believe BREXAFEMME is an important treatment option to help patients with often resistant yeast infections and we look forward to educating the medical community about the availability of this exciting new product. We will continue to work hard to take full advantage of this regulatory exclusivity and longstanding patent protection to advance our pipeline of Ibrexafungerp indications. Our vision is to create a permanent antifungal franchise in both hospitals and public institutions. We will have a more comprehensive update on our VVC business plans on June 29ththe. “
As a novel antifungal drug used to treat severe and life-threatening infections, Ibrexafungerp benefited from being labeled as a Qualified Infectious Disease Product (QIDP), which allowed it to obtain the exclusivity of the GAIN Act. This law was passed in 2012 to encourage the development and approval of new antibiotics and antifungal drugs.
About vulvovaginal candidiasis
VVC, commonly known as vaginal yeast infection due to candidate, is the second leading cause of vaginitis. Although these infections are often caused by Candida albicans, Infections caused by fluconazole-resistant and non-Albicans candidate Strains such as Candida glabrata, is said to be on the rise. VVC can be associated with significant morbidity, including significant genital discomfort (pain, itching, burning), decreased sexual desire and activity, psychological distress (stress, depression, anxiety), embarrassment, decreased physical activity, and loss of productivity. Typical VVC symptoms are pruritus, vaginal soreness, irritation, excoriation of the 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 antifungal drugs, and oral fluconazole, the only other orally administered antifungal drug approved in the United States for the treatment of VVC that typically accounts for over 90% of the time There are no recipes issued for this condition every year.
About BREXAFEMME® (Ibrexafungerp tablets), for oral use
BREXAFEMME is the trade name for Ibrexafungerp, a novel oral antifungal drug approved for the treatment of vulvovaginal candidiasis (VVC), also known as vaginal yeast infection. Its mechanism of action, the inhibition of glucan synthase, is antifungal candidate Species, which means that it kills fungal cells. The 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 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. The first approved drug in a new class of antifungal agents in over 20 years, BREXAFEMME is the first and only treatment for vaginal yeast infections that is both oral and non-azole-free. More information is available at www.brexafemme.com.
Please click here for full prescribing information.
BREXAFEMME® is a triterpenoid antifungal agent used to treat adult and postmenarchal pediatric women with vulvovaginal candidiasis (VVC).
Dosage and application
The recommended dose of BREXAFEMME is 300 mg (two 150 mg tablets) twice a day for one day for a total dose of 600 mg. BREXAFEMME can be taken with or without food.
important safety notice
- BREXAFEMME is used during pregnancy and in patients with known hypersensitivity to Ibrexafungerp. contraindicated
- Animal studies have shown that the use of BREXAFEMME during pregnancy can cause fetal damage. Before starting treatment, check the pregnancy status in women with reproductive potential and advise them to use effective contraception during treatment
- When using BREXAFEMME with strong CYP3A inhibitors, the dose of BREXAFEMME should be reduced to 150 mg twice daily for one day. Administration of BREXAFEMME with strong CYP3A inducers should be avoided
- The 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 the FDA at 1-800-FDA-1088 or www.fda.gov / medwatch.
SCYNEXIS, Inc. (NASDAQ: SCYX) is a biotechnology company pioneering innovative drugs to help millions of patients worldwide overcome and prevent difficult-to-treat infections that are becoming more resistant. We are developing our lead product, Ibrexafungerp (formerly known as SCY-078), as a broad spectrum systemic antifungal agent for multiple fungal indications in both 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. More information is available at www.brexafemme.com. In addition, we are 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. More information is available at www.scynexis.com.
Statements made in this press release about 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: Ibrexafungerp’s commercial potential; expected duration of commercial exclusivity; and SCYNEXIS ‘vision to create a long-lasting antifungal franchise in both the hospital and community sectors. Because such statements are subject to risks and uncertainties, actual results could differ materially from those expressed or implied in such forward-looking statements. These risks and uncertainties include, but are not limited to: BREXAFEMME may not be accepted by doctors and patients at the rate SCYNEXIS expects; Risks related to SCYNEXIS ‘ability to successfully develop ibrexafungerp and gain FDA approval for additional indications; there may be unexpected delays in the FDA’s acceptance of an NDA filing; the expected cost of the course and when it could begin or be completed; SCYNEXIS ‘need for additional capital resources; and SCYNEXIS ‘dependence on third parties for conducting clinical studies of SCYNEXIS and marketing its products. These and other risks are more fully described in SCYNEXIS ‘filings with the Securities and Exchange Commission, including, but not limited to, the most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q, including under the heading “Risk Factors” “and in other documents later filed or filed with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date of their publication. SCYNEXIS assumes no obligation to update such statements to reflect events or circumstances that occur after the date of their publication.
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