|Foamix Announces AMZEEQ™ (minocycline) Achievement of Preferred Status on Express Scripts National Preferred Formulary, One of the Largest Commercial Formularies in the U.S.|
|By: GlobenewsWire - 14 Jan 2020||Back to overview list
Preferred Coverage Effective Immediately on Express Scripts National Preferred, Flex, and Basic Formularies
AMZEEQ is the First FDA Approved Topical Form of Minocycline for the Treatment of Moderate to Severe Acne
REHOVOT, Israel and BRIDGEWATER, N.J., Jan. 14, 2020 (GLOBE NEWSWIRE) -- Foamix Pharmaceuticals Ltd. (Nasdaq: FOMX) (“Foamix” or the “Company”), a specialty pharmaceutical company, today announced a coverage update for its novel AMZEEQTM (minocycline) topical foam, 4%. AMZEEQ 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. AMZEEQ is the first topical minocycline to be approved by the U.S. Food and Drug Administration (FDA) for any condition.
The Company announced that AMZEEQ has achieved preferred coverage effective immediately on the Express Scripts National Preferred, Flex, and Basic commercial formularies. As a preferred medication, AMZEEQ will be available at a lower out-of-pocket cost to the represented Express Scripts plan members compared to acne medications which are non-preferred or excluded.
The Company recently announced that the annual list price of AMZEEQ is $485 per 30-gram canister, a lower per unit cost than that of current brand leaders within the acne prescription market.
“As one of the largest pharmacy benefit managers in the U.S., Express Scripts’ decision to include AMZEEQ as a preferred agent on its national formularies is a significant step toward ensuring access to AMZEEQ for millions of moderate to severe acne patients,” said David Domzalski, Chief Executive Officer of Foamix. “We believe our pricing and overall access strategy prioritizes patients and their healthcare providers by providing a novel, first-of-its-kind acne treatment at pricing designed to help reduce barriers to treatment with AMZEEQ.”
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.
AMZEEQ was approved by the U.S. Food and Drug Administration in October 2019. The Company has previously announced that the product is available in pharmacies nationwide as of January 13th.
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
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:
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
With expertise in topical medicine innovation as a springboard, the Company is working to develop and commercialize solutions that were long thought impossible. Its proprietary Molecule Stabilizing Technology (MST™) is utilized in Amzeeq, the world's first topical minocycline, and in the Company's other products currently in development: FMX103 for the potential treatment of moderate to severe papulopustular rosacea and FCD105 for the potential treatment of moderate-to-severe acne.
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.
Foamix uses its website as a channel to distribute information about Foamix and its product candidates from time to time. Foamix may use its website to comply with its disclosure obligations under Regulation FD. Therefore, investors should monitor Foamix’s website in addition to following its press releases, filings with the Securities and Exchange Commission, public conference calls, and webcasts. For more information, visit www.foamix.com.
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