Full Press Release Details
VYNE Therapeutics Announces ZILXI
(minocycline) topical foam, 1.5%
Available in Pharmacies Nationwide on October 1st
ZILXI is the First FDA Approved Minocycline
Product for the Treatment of Inflammatory
Lesions of Rosacea in Adults
ZILXI Offers Efficacy with Low Systemic
BRIDGEWATER, N.J., Oct. 1, 2020 - VYNE Therapeutics
Inc. (Nasdaq: VYNE) ("VYNE" or the "Company") today announced
that its novel ZILXI (minocycline) topical foam, 1.5% will be available on
October 1, 2020 by prescription for the treatment of inflammatory lesions of rosacea in adults. Approved by the U.S. Food
and Drug Administration (FDA) in May 2020, ZILXI is the first minocycline product of any form to be approved by the FDA for
use in rosacea, 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). This new once-daily therapy will be available in retail, community and
specialty pharmacies nationwide.
"Patients and physicians have been seeking new treatment
options for rosacea, a condition that can be difficult to treat, leaving many patients dissatisfied and, in some cases, switching
treatments multiple times or discontinuing altogether," said David Domzalski, Chief Executive Officer of VYNE. "By
combining a unique topical delivery system for minocycline with strong efficacy and tolerability, ZILXI is positioned to address
a very challenging skin condition in a way that could change treatment considerations for rosacea."
The Company also announced that the
annual list price of ZILXI will be $485 per 30-gram canister, in parity with the wholesale price of AMZEEQ (minocycline)
topical foam, 4%, the Company's topical minocycline 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. The Company is working to align contracts with
commercial insurers, expanding efforts previously undertaken for AMZEEQ, to offer the broadest possible access to ZILXI for patients
and healthcare professionals.
VYNE has also developed a multi-channel tactical marketing plan to reach customers, including
deployment of the existing sales force to targeted rosacea-treating providers.
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 and AMZEEQ Important Safety
ZILXITM (minocycline) topical foam, 1.5% is for the
treatment of adults with pimples and bumps caused by a condition called rosacea. It is not known if ZILXI is safe and effective
AMZEEQ (minocycline) topical foam, 4% is for
the treatment of pimples and red bumps (non-nodular inflammatory lesions) that happen with moderate to severe acne in patients
9 years age and older. It is not known if AMZEEQ is safe and effective in children under 9 years of age or older.
ZILXI and AMZEEQ are both topical forms of the antibiotic minocycline
and are available by prescription only. ZILXI and AMZEEQ are for use on skin only (topical use). ZILXI and AMZEEQ are not for
use in the mouth, eyes or vagina.
ZILXI and AMZEEQ should not be used for the treatment of infections.
Important Safety Information
ZILXI and AMZEEQ are both topical foams that contain minocycline,
a tetracycline medicine. They are not taken by mouth. However, tetracyclines, when taken by mouth (capsules or tablets),
may cause serious side effects, including: diarrhea, including watery or bloody stools; loss of appetite; tiredness; yellowing
of the skin or eyes; 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. The most common
side effect of AMZEEQ is headache.
These are not all of the possible side effects for ZILXI or
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 ZILXI or 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.
Please see full Prescribing Information for ZILXI and
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