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AMZEEQ is the Aboriginal FDA Accustomed Contemporary Form of Minocycline and the Company’s Aboriginal Bartering Launch
AMZEEQ Offers Adeptness with Low Systemic Absorption
List amount of $485 Competitive Against Accepted Abscess Bazaar Leaders
REHOVOT, Israel and BRIDGEWATER, N.J., Jan. 09, 2020 (GLOBE NEWSWIRE) — Foamix Pharmaceuticals Ltd. (Nasdaq: FOMX) (“Foamix” or the “Company”), a specialty biologic company, today appear that its atypical AMZEEQTM (minocycline) contemporary foam, 4% will be accessible on January 13, 2020 by decree for the analysis of anarchic lesions of non-nodular abstinent to astringent abscess vulgaris in adults and pediatric patients 9 years of age and older. Accustomed by the U.S. Food and Biologic Administration (FDA) in October 2019, AMZEEQ is the aboriginal contemporary minocycline to be FDA accustomed for any action and represents the company’s aboriginal bartering artefact launch. This new once-daily analysis will be accessible in retail, association and specialty pharmacies nationwide.
The Aggregation additionally appear that the anniversary account amount of AMZEEQ will be $485 per 30-gram canister. This is a lower amount per assemblage than that of accepted cast leaders in the abscess decree market, ambience AMZEEQ afar in agreement of its appraisement approach.
Foamix alive a aggregation of experts to advance the Company’s admission for agreeable bartering insurers to action the broadest accessible admission to AMZEEQ for patients and healthcare professionals. The Aggregation will accommodate copay agenda abetment for acceptable commercially insured patients. An cyberbanking account analysis apparatus is additionally accessible through the artefact website, AMZEEQ.com, to abetment healthcare professionals and patients to accept their acceptable allowance advantage and abroad costs.
Foamix has additionally developed a multi-channel adapted business plan to adeptness customers, including a sales force deployment to added than 6,000 acne-treating providers with artefact samples. Foamix will advertisement a promotional apostle affairs for accordant bloom affliction professionals (“HCPs”) nationally on February 13, 2020 to allotment AMZEEQ artefact and prescribing information. In addition, Foamix is deploying a ample ambit of agenda customer beat tactics, including artefact advice and a altered unboxing-style “how to use” video advised to be calmly accepted by an boyish accommodating citizenry and based on AMZEEQ’s instructions for use.
“Moderate to astringent abscess is a arduous and crushing action of abounding sufferers. AMZEEQ is now positioned to become an important apparatus in managing this condition,” said David Domzalski, Chief Executive Officer of Foamix. “We admit that providers and abscess sufferers accept been gluttonous alternatives in abscess treatment, and I’m actual appreciative of the affairs we’ve advised to accommodate ample acquaintance and availability of AMZEEQ for physicians and patients.”
Minocycline, a broad-spectrum antibacterial accepted for its adeptness in alleviative abstinent to astringent acne, has not ahead been accessible as a contemporary analysis due to its alternation in acceptable contemporary formulations. With the development of AMZEEQ, Foamix has leveraged its proprietary Molecule Stabilizing Technology (MST™) belvedere to calmly and finer bear minocycline in a foam-based agent that maintains the adherence of the alive additive while carrying it anon on the skin.
INDICATIONS AND USAGE
AMZEEQ™ (minocycline) contemporary foam, 4% is adumbrated for the analysis of anarchic lesions of non-nodular abstinent to astringent abscess vulgaris in adults and pediatric patients 9 years of age and older.
Limitations of Use: This conception of minocycline has not been evaluated in the analysis of infections. To abate the development of drug-resistant bacilli as able-bodied as to advance the capability of added antibacterial drugs, AMZEEQ should be acclimated abandoned as indicated.
IMPORTANT SAFETY INFORMATION
Warnings and Precautions
Flammability: The propellant in AMZEEQ is flammable. Instruct the accommodating to abstain fire, flame, and smoker during and anon afterward application.
AMZEEQ is a contemporary foam. While systemic assimilation of AMZEEQ is low, and austere adverse reactions were not apparent in analytic studies, the following adverse reactions associated with articulate minocycline should be considered:
To address SUSPECTED ADVERSE REACTIONS, acquaintance Foamix Pharmaceuticals Inc. at 1-844-375-3673 or FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch.
Please see abounding Prescribing Information.
About AcneAcne is a chronic, anarchic bark action that affects the skin’s oil glands and beard follicles. It is characterized by both anarchic lesions (papules and pustules) and non-inflammatory lesions (open and bankrupt comedones) affecting primarily the face and truncal areas of the body. Abscess affects about 40 to 50 actor bodies in the U.S. alone, of whom about 10 actor accept abstinent to astringent ache that may appulse self-esteem and affection of life. For best people, abscess diminishes over time and tends to abandon or decrease, by age 25. However, some individuals, decidedly women, can acquaintance abscess abundant after in life.
About Foamix Pharmaceuticals Foamix is a specialty biologic aggregation alive to break some of today’s best difficult ameliorative challenges in dermatology and beyond.
With adeptness in contemporary anesthetic accession as a springboard, the Aggregation is alive to advance and commercialize solutions that were continued anticipation impossible. Its proprietary Molecule Stabilizing Technology (MST™) is activated in Amzeeq, the world’s aboriginal contemporary minocycline, and in the Company’s added articles currently in development: FMX103 for the abeyant analysis of abstinent to astringent papulopustular rosacea and FCD105 for the abeyant analysis of moderate-to-severe acne.
Foamix is a altered blazon of specialty biologic aggregation by design, apprenticed to see solutions, affected barriers in all aspects of business, and reimagine what’s accessible for altitude with aerial unmet needs.
Foamix uses its website as a approach to administer advice about Foamix and its artefact candidates from time to time. Foamix may use its website to accede with its acknowledgment obligations beneath Regulation FD. Therefore, investors should adviser Foamix’s website in accession to afterward its columnist releases, filings with the Securities and Exchange Commission, accessible appointment calls, and webcasts. For added information, visit www.foamix.com.
Forward-Looking StatementsThis absolution includes advanced statements aural the acceptation of the Private Securities Litigation Reform Act of 1995. All statements in this columnist absolution which are not actual facts are advanced statements, including, but not bound to, statements apropos the approaching expectations, affairs and affairs for Foamix; advancing commercialization affairs of AMZEEQ including the abeyant for AMZEEQ to amusement abstinent to astringent abscess vulgaris in adults and pediatric patients and projected date to be accessible for prescription; and expectations apropos the admeasurement of acceptable accommodating citizenry for AMZEEQ and the advancing accommodating benefit. Advanced statements are based on Foamix’s accepted adeptness and its present behavior and expectations apropos accessible approaching contest and are accountable to risks, uncertainties and assumptions. Actual after-effects and the timing of contest could alter materially from those advancing in these advanced statements as a aftereffect of assorted factors including, but not bound to, adverse contest associated with AMZEEQ; the aftereffect of pricing, advantage and agreement negotiations with third affair payors for AMZEEQ or any added articles or artefact candidates that Foamix may commercialize in the future; whether, and to what extent, third affair payors appoint added requirements afore acknowledging AMZEEQ decree reimbursement; the acceptable accommodating abject and bartering abeyant of AMZEEQ or any of Foamix’s added artefact or artefact candidates; added antagonism in the abscess and dermatology markets; disability to accession added capital; Foamix’s adeptness to recruit and absorb key advisers and its adeptness to break in acquiescence with applicative laws, rules and regulations. Foamix discusses abounding of these risks in greater detail in its alternate filings with the SEC, including beneath the branch “Risk Factors” in its best contempo anniversary address and consecutive annual reports. Although Foamix believes these advanced statements are reasonable, they allege abandoned as of the date of this advertisement and Foamix undertakes no obligation to amend about such advanced statements to reflect consecutive contest or circumstances, except as contrarily appropriate by law. Given these risks and uncertainties, you should not await aloft advanced statements as predictions of approaching events.
Corporate Contact: Ilan Hadar, CFO Foamix Pharmaceuticals Ltd. 972-8-9316233 [email protected]
Media Relations:Rebecca SchechnerZeno Group312-586-3429, [email protected]
U.S. Investor Relations:Joyce AllaireLifeSci Advisors, [email protected]
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