VYNE Therapeutics Announces FDA Approval of AMZEEQ® (Minocycline) Label Update

AMZEEQ® label update includes new information indicating the low propensity of Propionibacterium acnes (more commonly known as “P. acnes”) to develop resistance to minocycline

BRIDGEWATER, N.J., Feb. 01, 2021 (GLOBE NEWSWIRE) — VYNE Therapeutics Inc. (Nasdaq: VYNE) (“VYNE” or the “Company”), a specialty pharmaceutical company focused on developing and commercializing proprietary therapies to address unmet needs in dermatology, today announced approval by the U.S. Food and Drug Administration (“FDA”) to include new information in the product label for AMZEEQ^® (minocycline) topical foam, 4% referencing the low propensity of P. acnes strains to develop resistance to minocycline, the active ingredient in AMZEEQ. AMZEEQ is indicated for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in adults and pediatric patients 9 years of age and older.

Specifically, the FDA-approved AMZEEQ label now provides that with respect to resistance, P. acnes strains displayed a low propensity for the development of resistance to minocycline, with spontaneous mutation frequencies occurring <10⁻⁸ (or 1 in 100 million) at 2 to 16 times the minimum inhibitory concentration (MIC). The update to the microbiology section in the label further states that although the clinical significance is unknown, the active ingredient in AMZEEQ (minocycline), is proven to be active in vitro against most isolates of P. acnes.

“The risk of antimicrobial resistance is a primary concern for dermatologists or, indeed, any routine prescriber of antibiotics,” said David Domzalski, CEO of VYNE. “We are pleased that the inclusion of this valuable additional information for AMZEEQ will support prescribers in making informed decisions on both their choice of antibiotic and administration route when selecting a treatment for acne.”

The FDA approval was supported by an extensive antimicrobial characterization program by VYNE for both AMZEEQ and minocycline that was published last year in the peer-reviewed journal Anaerobe.¹ The program evaluated the on-target potency of AMZEEQ and minocycline against P. acnes and further evaluated the potential for the development of minocycline-resistant strains that could reduce the potency of AMZEEQ in the treatment of acne.

“Both dermatologists and payors have had keen interest in antimicrobial resistance data as they balance patient care with antibiotic stewardship,” said Matt Wiley, Chief Commercial Officer for VYNE. “We believe theupdate will be well-received.”

About P. acnes and Antibiotic Resistance

P. acnes, recently renamed Cutibacterium acnes, is an anaerobic bacterium that resides within the pilosebaceous unit in the skin and is the primary microbial initiator and propagator in the development of acne. The use of antibiotics to counteract the effect of this bacterium remains a major cornerstone of acne disease management, although concerns over the development of antibiotic-resistant strains are factors in a prescriber’s choice of antibiotic and route of administration. Resistant strains of P. acnes are common although primarily linked to the macrolide and lincosamide class of antibiotic use (erythromycin and clindamycin respectively); there is little evidence of cross-resistance development to the tetracycline class of antibiotics such as minocycline.²

VYNE’s Antimicrobial Characterization Program

Amongst other objectives, the antimicrobial characterization program conducted by VYNE to support this label update evaluated on-target potency of AMZEEQ and minocycline against P. acnes and further evaluated the potential for the development of minocycline-resistant strains that could reduce the potency of AMZEEQ in the treatment of acne. The studies concluded that on-target potency remained consistently high (MIC₉₀ = 0.25µg/ml) when tested in clinical isolates of P. acnes. Further, the prevalence of minocycline-resistant strains as assessed by spontaneous mutation frequency was low (range: <2.7×10^-9 to <1.30×10^-8 colony forming units) when exposed to minocycline at concentrations up to 16-fold higher than the mean minimum inhibitory concentration (MIC).

For a complete copy of the AMZEEQ product label, including the recent update, please see AMZEEQ full Prescribing Information.

Indication
AMZEEQ is a topical form of the antibiotic minocycline for the treatment of pimples and red bumps (non-nodular inflammatory lesions) that happen with moderate to severe acne in adults and children 9 years of age and older. AMZEEQ is available by prescription only.

AMZEEQ should not be used for the treatment of infections. It is not known if AMZEEQ is safe and effective in children under 9 years of age. AMZEEQ is for use on skin only (topical use). AMZEEQ is not for use in the mouth, eyes, or vagina.

Important Safety Information

• AMZEEQ should not be used in people who are allergic to AMZEEQ or any tetracycline medicine. Use of AMZEEQ should be stopped right away if a rash or other allergic symptom occurs.
• AMZEEQ should not be used in women who are pregnant, may become pregnant or are nursing. If a woman becomes pregnant while using AMZEEQ, she should talk to her doctor. Tetracycline medicine when taken by mouth during pregnancy, infancy and/or childhood up to the age of 8 years may permanently discolor teeth (yellow-gray-brown) and may slow the growth of bones.
• AMZEEQ is flammable and fire, flame, and smoking must be avoided when applying and right after applying AMZEEQ.
• People should protect their skin from the sun while using AMZEEQ and avoid sunlight or artificial sunlight such as sunlamps or tanning beds. Use of AMZEEQ should be stopped if skin is sunburned.
• When taken by mouth, minocycline may cause feelings of lightheadedness, dizziness or spinning. People should not drive or operate dangerous machinery if they have these symptoms.

AMZEEQ is a topical foam that contains minocycline, a tetracycline medicine. It is not taken by mouth. However, tetracyclines, when taken by mouth (capsules or tablets), may cause serious side effects, including: diarrhea which may be caused by an infection and can cause watery or bloody stools; loss of appetite; tiredness; yellowing of the skin or eyes (jaundice); bleeding more easily than normal; confusion; sleepiness; vision changes, including blurred vision, double vision, or permanent vision loss; unusual headaches; fever; rash; joint pain; body weakness; discoloration or darkening of the skin, scars, teeth, or gums. People should call their doctor right away if these side effects occur.

The most common side effect of AMZEEQ is headache.

These are not all of the possible side effects with AMZEEQ. People should contact their doctor for medical advice about side effects and be sure to tell their doctor about all of their medical conditions and medicines they take before using AMZEEQ.

People are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

About Acne

Acne is a chronic, inflammatory skin condition that affects the skin’s sebaceous glands and hair follicles. It is characterized by both inflammatory lesions (papules and pustules) and non-inflammatory lesions (open and closed comedones) affecting primarily the face and truncal areas of the body. Acne affects approximately 40 to 50 million people in the U.S. alone, of whom approximately 10 million have moderate to severe disease that may impact self-esteem and quality of life. For most people, acne diminishes over time and tends to disappear or decrease, by age 25. However, some individuals, particularly women, can experience acne much later in life.

About VYNE Therapeutics Inc.

VYNE Therapeutics’ mission is to improve the lives of patients by developing proprietary, innovative and differentiated therapies in dermatology and beyond.

With expertise in topical medicine innovation as a springboard, VYNE is working to develop and commercialize a variety of solutions using its proprietary Molecule Stabilizing Technology (MST)™, and has received FDA approval for AMZEEQ^® (minocycline) topical foam, 4%, the world’s first topical minocycline, and for ZILXI^® (minocycline) topical foam, 1.5%, the first minocycline product of any kind to be approved by the FDA for use in rosacea. For more information about our approved products, please see AMZEEQ’s Full Prescribing Information at amzeeq.com and ZILXI’s Full Prescribing Information at zilxi.com.

For more information about VYNE Therapeutics Inc. or its investigational products, visit www. vynetherapeutics.com or follow VYNE on Twitter. VYNE may use its website to comply with its disclosure obligations under Regulation FD. Therefore, investors should monitor VYNE’s website in addition to following its press releases, filings with the U.S. Securities and Exchange Commission, public conference calls, and webcasts.

Media Relations:
Bridgette Potratz
Zeno Group
312-358-2950
bridgette.potratz@zenogroup.com

Investor Relations:
Joyce Allaire
LifeSci Advisors, LLC
646-889-1200
jallaire@lifesciadvisors.com

Andrew Saik
Chief Financial Officer
VYNE Therapeutics
908-731-6180
Andrew.Saik@vynetx.com

1. Susceptibility of Cutibacterium Acnes to Topical Minocycline Foam. J. Sutcliffe, R. McLaughlin, G. Webster, A. F. Read, K. Drlica, R. Elliot and I. Stuart, Anaerobe, 2020 Apr; 62: 102169.
2. Antimicrobial Susceptibility and Genetic Characteristics of Propionibacterium Acnes Isolated from Patients with Acne. F. Schafer, F. Fich, M. Lam C. C Garate, A Wozniak and P Garcia, Int. J. Derm., 2013; 52(4): 418-425.

Cautionary Statement Regarding Forward-Looking Statements

This release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the development and commercialization of VYNE’s products and product candidates and other statements regarding the future expectations, plans and prospects of VYNE. All statements in this press release which are not historical facts are forward-looking statements. Any forward-looking statements are based on VYNE’s current knowledge and its present beliefs and expectations regarding possible future events and are subject to risks, uncertainties and assumptions that could cause actual results to differ materially and adversely from those set forth or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: the COVID-19 pandemic and its impact on our business operations; adverse events associated with the commercialization of AMZEEQ and ZILXI; the outcome and cost of clinical trials for current and future product candidates; determination by the FDA that results from VYNE’s clinical trials are not sufficient to support registration or marketing approval of product candidates; the outcome of pricing, coverage and reimbursement negotiations with third party payors for AMZEEQ, ZILXI or any other products or product candidates that VYNE may commercialize in the future; whether, and to what extent, third party payors impose additional requirements before approving AMZEEQ and ZILXI prescription reimbursement; the eligible patient base and commercial potential of AMZEEQ, ZILXI or any of VYNE’s other products or product candidates; risks that VYNE’s intellectual property rights, such as patents, may fail to provide adequate protection, may be challenged and one or more claims may be revoked or interpreted narrowly or will not be infringed; risks that any of VYNE’s patents may be held to be narrowed, invalid or unenforceable or one or more of VYNE’s patent applications may not be granted and potential competitors may also seek to design around VYNE’s granted patents or patent applications; additional competition in the acne and dermatology markets; risks related to our indebtedness; inability to raise additional capital on favorable terms or at all; VYNE’s ability to recruit and retain key employees; and VYNE’s ability to stay in compliance with applicable laws, rules and regulations. For a discussion of other risks and uncertainties, and other important factors, any of which could cause VYNE’s actual results to differ from those contained in the forward-looking statements, see the section titled “Risk Factors” in VYNE’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2020, as well as discussions of potential risks, uncertainties, and other important factors in VYNE’s subsequent filings with the U.S. Securities and Exchange Commission. Although VYNE believes these forward-looking statements are reasonable, they speak only as of the date of this announcement and VYNE undertakes no obligation to update publicly such forward-looking statements to reflect subsequent events or circumstances, except as otherwise required by law. Given these risks and uncertainties, you should not rely upon forward-looking statements as predictions of future events.