Full Press Release Details
Announces Covered Status for ZILXI (minocycline) with Express Scripts
Effective October 2, 2020 on Express Scripts National Preferred, Flex, and Basic Formularies
BRIDGEWATER, N.J., Oct. 7,
2020 - VYNE Therapeutics Inc. (Nasdaq: VYNE) ("VYNE" or the "Company") today
announced a coverage update for its novel ZILXI (minocycline) topical
foam, 1.5%. ZILXI is the first minocycline product of any form to be FDA approved for use in rosacea for the treatment of inflammatory
lesions in adults and is just recently available in pharmacies nationwide.
Express Scripts, one of the nation's
leading pharmacy benefit managers (PBMs), has elected to cover ZILXI effective October 2, 2020 on Express Scripts' National
Preferred, Flex, and Basic commercial formularies, representing millions of additional covered lives in the U.S. that follow these
"The addition of Express Scripts to our national coverage
for ZILXI is a significant milestone as it represents a large portion of the U.S. commercial coverage patient population,"
said David Domzalski, Chief Executive Officer of VYNE. "We are pleased that our contract provides access to this important
new option for physicians and patients who have not previously had the rosacea treatment outcomes they are seeking."
The annual list price
of ZILXI is $485 per 30-gram canister. ZILXI was approved by the U.S. Food and Drug Administration in May 2020.
Minocycline is one of several broad-spectrum antibiotics known
as tetracyclines with anti-inflammatory properties; their use in some patients is limited due to systemic side effects when taken
orally. In ZILXI, VYNE has once more leveraged its proprietary Molecule Stabilizing Technology (MST ) platform to effectively
deliver minocycline in a foam-based vehicle that contains naturally moisturizing ingredients, such as coconut and soybean oil,
and is free of surfactants and drying agents.
ZILXI Important Safety Information
ZILXITM (minocycline) topical foam, 1.5% is
a topical form of the antibiotic minocycline for the treatment of adults with pimples and bumps caused
by a condition called rosacea. ZILXI is available by prescription only.
ZILXI should not be used for the treatment of infections. It
is not known if ZILXI is safe and effective in children. ZILXI is for use on skin only (topical use). ZILXI is
not for use in the mouth, eyes or vagina.
Important Safety Information
ZILXI 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 ZILXI is diarrhea.
These are not all of the possible side effects with ZILXI. 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 ZILXI.
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.
Please see full Prescribing Information for ZILXI.
Rosacea is a diverse skin condition
that most commonly presents with symptoms such as deep facial redness, spider veins (telangiectasia) and acne-like inflammatory
lesions (papules and pustules). It can create psychosocial burdens, such as embarrassment, anxiety and low self-esteem that can
adversely affect quality of life1. Rosacea is most frequently seen in adults between 30 and 50 years of age. It affects
more than 16 million people in the United States; up to 28% of these sufferers have rosacea with inflammatory lesions2.
About VYNE Therapeutics Inc.
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.
LifeSci Advisors, LLC
Chief Financial Officer
Cautionary Statement Regarding Forward-Looking
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.
COM-ZIL-US-200045 9/2020