BRIDGEWATER, N.J., Sept. 23, 2020 (GLOBE NEWSWIRE) — VYNE Therapeutics Inc. (Nasdaq: VYNE) (“VYNE” or the “Company”) today announced that the Company will host a physician symposium on AMZEEQ® and ZILXI™ on Thursday, October 1, 2020 from 12pm – 3pm ET.
The webinar will feature presentations by Key Opinion Leaders (KOLs) Ted Lain, M.D. (Sanova Dermatology), Julian Moore, FAAD (Hollywood Dermatology) and Linda Stein Gold, M.D. (Henry Ford Health System), who will discuss the current treatment landscape and unmet medical needs in treating patients with acne vulgaris and rosacea. Drs. Lain and Moore will discuss their experiences treating acne patients with AMZEEQ® (minocycline) topical foam, 4% and Dr. Stein Gold will discuss ZILXI™ (minocycline) topical foam, 1.5% and her expectations of how the product will be used to treat rosacea patients in her practice. In addition, VYNE management will discuss the commercial progress and plans for these two products. There will be a Q&A session following the formal presentations.
To register for the symposium, please click here.
Ted Lain, MD is a board-certified Dermatologist and Chief Medical Officer specializing in diagnosis and treatment of disorders of the hair, skin and nails. He also specializes in minimally-invasive cosmetic and laser skin rejuvenation procedures. Dr. Lain is a Physician Trainer for Allergan whereby he trains other physicians and medical professionals how to correctly and safely inject BOTOX® Cosmetic, JUVÉDERM®, and JUVÉDERM VOLUMA®. After graduating with highest honors from the University of Texas he obtained his joint medical/masters in business administration degrees from Baylor College of Medicine and Rice University in Houston, Texas. He moved to Little Rock, Arkansas where he completed his internship in Internal Medicine and his specialized training in Dermatology.
Julian O’Neil Moore, FAAD is a board-certified dermatologist at Hollywood Dermatology and Cosmetic Surgery Specialists in Hollywood, Florida and the Assistant Director of the Larkin/Nova Southeastern University Dermatology Residency Training Program. Dr. Moore specializes in skin conditions, such as acne, eczema and psoriasis, as well as skin cancer detection and treatment. He also treats conditions affecting the hair and nails. Dr. Moore received his undergraduate degree in Biology with honors from the State University of New York at Stony Brook Health Sciences Center. He received his Doctorate in Medicine from the New York College of Osteopathic Medicine in 2001 followed by a medical internship at St. Barnabas Hospital in the Bronx, New York. Dr. Moore later completed his Post-Doctoral NIH Fellowship in Dermatology and Cutaneous Malignancy at Mount Sinai Icahn School of Medicine in both the Department of Dermatology and Department of Radiation Oncology in New York City. Dr. Moore completed his residency in Dermatology at Nova Southeastern University / Broward General Medical Center Fort Lauderdale.
Dr. Moore is a member of many professional associations, including the American Academy of Dermatology, American Osteopathic College of Dermatology, the American Society of Dermatologic Surgery, the Society for Investigative Dermatology and the American Cancer Society. He is the recipient of numerous awards such as the 2005 American Cancer Society/New York State Dept. of Health Clinical Investigators Fellowship Award and the 2010 Daniel Koprince National Dermatology Award for Outstanding Dermatology Resident Presentation. He has authored many peer reviewed publications in dermatology and dermatologic research.
Linda Stein Gold, MD is Director of Dermatology Clinical Research at Henry Ford Health System in Detroit, Michigan, as well as Division Head of Dermatology at Henry Ford Health System in West Bloomfield, Michigan. Dr. Stein Gold earned her undergraduate degree at the Wharton School of the University of Pennsylvania and her medical degree from the University of Pennsylvania School of Medicine in Philadelphia and completed her residency in dermatology at Henry Ford Hospital in Detroit.
Dr. Stein Gold is very active in clinical research on a variety of dermatologic conditions, including the treatment of chronic plaque-type psoriasis, actinic keratosis, atopic dermatitis, acne vulgaris, seborrheic dermatitis, and rosacea. She has published articles in journals such as the Journal of the American Academy of Dermatology, Cutis and the Journal of Drugs in Dermatology, among others. She is a frequent national and international lecturer on acne, rosacea, psoriasis, actinic keratosis, alopecia, viral infections, atopic dermatitis, and fungal infections, at grand rounds and medical society meetings. She is also the treasurer of the National Acne and Rosacea Society and a member of the National Psoriasis Foundation Medical Board.
Indications
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 in children.
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 or AMZEEQ should not be used in people who are allergic to ZILXI, AMZEEQ, or any tetracycline medicine. Use of ZILXI or AMZEEQ should be stopped right away if a rash or other allergic symptom occurs.
- ZILXI or AMZEEQ should not be used in women who are pregnant, may become pregnant or are nursing. If a woman becomes pregnant while using ZILXI or 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.
- ZILXI and AMZEEQ are flammable and fire, flame, and smoking must be avoided when applying and right after applying ZILXI or AMZEEQ.
- People should protect their skin from the sun while using ZILXI or AMZEEQ and avoid sunlight or artificial sunlight such as sunlamps or tanning beds. Use of ZILXI or 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.
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 AMZEEQ.
AMZEEQ’s Full Prescribing Information at amzeeq.com and ZILXI’s Full Prescribing Information at zilxi.com.
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
312-755-5462, x5516
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
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.