Menlo Therapeutics Announces Covered Status for AMZEEQ® (minocycline) topical foam, 4%, on Additional Commercial Formulary
Coverage Effective Immediately on One of the Largest Payor Networks in the U.S.
AMZEEQ® is the First FDA Approved Topical Form of Minocycline for the Treatment of Moderate to Severe Acne
BRIDGEWATER, N.J., May 27, 2020 (GLOBE NEWSWIRE) -- Menlo Therapeutics Inc. (Nasdaq: MNLO) ("Menlo" or the "Company"), a specialty pharmaceutical company focused on developing and commercializing proprietary therapies to address unmet needs in dermatology, today announced that its novel AMZEEQ® (minocycline) topical foam, 4%, 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, has been added to the prescription drug formulary of one of the largest payors in the U.S. AMZEEQ was approved by the U.S. Food and Drug Administration in October 2019.
“We are pleased with the continued expansion of our national coverage for AMZEEQ. With this additional plan under contract, we now have coverage for up to 60% of the total commercial lives in the United States,” said David Domzalski, Chief Executive Officer of Menlo. “This is great news as it allows for AMZEEQ to be more broadly accessible to millions of moderate to severe acne patients.”
Minocycline, a broad-spectrum antibiotic known for its efficacy in treating moderate to severe acne, has not previously been available as a topical treatment due to its instability in traditional topical formulations. In AMZEEQ, Foamix has leveraged its proprietary Molecule Stabilizing Technology (MST™) platform to deliver minocycline in a foam-based vehicle that maintains the stability of the active ingredient while delivering it directly on the skin.
INDICATIONS AND USAGE
AMZEEQ®(minocycline) topical foam, 4% 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.
Limitations of Use: This formulation of minocycline has not been evaluated in the treatment of infections. To reduce the development of drug-resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, AMZEEQ should be used only as indicated.
IMPORTANT SAFETY INFORMATION
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, 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 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.
Please see full Prescribing Information.
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 Menlo Therapeutics
Menlo Therapeutics Inc. recently combined with Foamix Pharmaceuticals Ltd. (“Foamix”) to form a different type of biopharmaceutical company working to solve some of today’s most difficult therapeutic challenges in dermatology and beyond. Foamix is now a wholly-owned subsidiary of Menlo.
With expertise in topical medicine innovation as a springboard, the Company is working to develop and commercialize a variety of solutions using its proprietary Molecule Stabilizing Technology (MST™), and has received FDA approval for the world’s first topical minocycline, AMZEEQ® (minocycline) topical foam, 4%.
For more information about Menlo or its investigational products, visit www.menlotherapeutics.com. Menlo may use its website to comply with its disclosure obligations under Regulation FD. Therefore, investors should monitor Menlo’s website in addition to following its press releases, filings with the U.S. Securities and Exchange Commission, public conference calls, and webcasts.
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 Menlo’s products and product candidates and other statements regarding the future expectations, plans and prospects of Menlo. All statements in this press release which are not historical facts are forward-looking statements. Any forward-looking statements are based on Menlo’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, any adverse effects related to the global COVID-19 pandemic, the achievement of certain expected cost synergies from Menlo’s recent combination with Foamix; the outcome of any legal proceedings related to the merger; the outcome and cost of clinical trials for current and future product candidates; determination by the FDA that results from Menlo’s clinical trials are not sufficient to support registration or marketing approval of product candidates; adverse events associated with the commercialization of AMZEEQ; the outcome of pricing, coverage and reimbursement negotiations with third party payors for AMZEEQ or any other products or product candidates that Menlo may commercialize in the future; whether, and to what extent, third party payors impose additional requirements before approving AMZEEQ prescription reimbursement; the eligible patient base and commercial potential of AMZEEQ or any of Menlo’s other product or product candidates; risks that Menlo’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 Menlo’s patents may be held to be narrowed, invalid or unenforceable or one or more of Menlo’s patent applications may not be granted and potential competitors may also seek to design around Menlo’s granted patents or patent applications; additional competition in the acne and dermatology markets; inability to raise additional capital on favorable terms or at all; Menlo’s ability to recruit and retain key employees; and Menlo’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 Menlo’s actual results to differ from those contained in the forward-looking statements, see the sections titled “Risk Factors” in Menlo’s most recent quarterly report on Form 10-Q as well as discussions of potential risks, uncertainties, and other important factors in Menlo’s subsequent filings with the U.S. Securities and Exchange Commission. Although Menlo believes these forward-looking statements are reasonable, they speak only as of the date of this announcement and Menlo 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.
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