AMZEEQ is the First FDA Approved Topical Form of Minocycline and the Company's First Commercial Launch
AMZEEQ Offers Efficacy with Low Systemic Absorption
List price of $485 Competitive Against Current Acne Market Leaders
REHOVOT, Israel and BRIDGEWATER, N.J., Jan. 09, 2020 (GLOBE NEWSWIRE) -- Foamix Pharmaceuticals Ltd. (NASDAQ:FOMX) ("Foamix" or the "Company"), a specialty pharmaceutical company, today announced that its novel AMZEEQTM (minocycline) topical foam, 4% will be available on January 13, 2020 by prescription 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. Approved by the U.S. Food and Drug Administration (FDA) in October 2019, AMZEEQ is the first topical minocycline to be FDA approved for any condition and represents the company's first commercial product launch. This new once-daily therapy will be available in retail, community and specialty pharmacies nationwide.
The Company also announced that the annual list price of AMZEEQ will be $485 per 30-gram canister. This is a lower price per unit than that of current brand leaders in the acne prescription market, setting AMZEEQ apart in terms of its pricing approach.
Foamix employed a team of experts to develop the Company's approach for engaging commercial insurers to offer the broadest possible access to AMZEEQ for patients and healthcare professionals. The Company will provide copay card assistance for eligible commercially insured patients. An electronic benefit verification tool is also available through the product website, AMZEEQ.com, to assist healthcare professionals and patients to understand their likely insurance coverage and out-of-pocket costs.
Foamix has also developed a multi-channel tactical marketing plan to reach customers, including a sales force deployment to more than 6,000 acne-treating providers with product samples. Foamix will broadcast a promotional speaker program for relevant health care professionals ("HCPs") nationally on February 13, 2020 to share AMZEEQ product and prescribing information. In addition, Foamix is deploying a broad range of digital consumer outreach tactics, including product information and a unique unboxing-style "how to use" video designed to be easily understood by an adolescent patient population and based on AMZEEQ's instructions for use.
"Moderate to severe acne is a challenging and burdensome condition of many sufferers. AMZEEQ is now positioned to become an important tool in managing this condition," said David Domzalski, Chief Executive Officer of Foamix. "We recognize that providers and acne sufferers have been seeking alternatives in acne treatment, and I'm very proud of the program we've designed to provide broad awareness and availability of AMZEEQ for physicians and 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. With the development of AMZEEQ, Foamix has leveraged its proprietary Molecule Stabilizing Technology (MST™) platform to conveniently and effectively deliver minocycline in a foam-based vehicle that maintains the stability of the active ingredient while delivering it directly on the skin.
About AMZEEQ™
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
Contraindications
- Persons who have shown hypersensitivity to any of the tetracyclines or any other ingredient in AMZEEQ.
Warnings and Precautions
Flammability: The propellant in AMZEEQ is flammable. Instruct the patient to avoid fire, flame, and smoking during and immediately following application.
AMZEEQ is a topical foam. While systemic absorption of AMZEEQ is low, and serious adverse reactions were not seen in clinical studies, the following adverse reactions associated with oral minocycline should be considered:
Adverse Reactions
- The most common adverse reaction reported during clinical trials of AMZEEQ was headache.
To report SUSPECTED ADVERSE REACTIONS, contact Foamix Pharmaceuticals Inc. at 1-844-375-3673 or FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch.
Please see full Prescribing Information.
About Foamix Pharmaceuticals
Foamix is a specialty pharmaceutical company working to solve some of today's most difficult therapeutic challenges in dermatology and beyond.
Foamix is a different type of specialty pharmaceutical company by design, driven to see solutions, overcome barriers in all aspects of business, and reimagine what's possible for conditions with high unmet needs.
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