Foamix Pharmaceuticals Ltd. recently announced results from an integrated efficacy analysis on the two pivotal Phase 3 clinical trials for FMX103 (minocycline, 1.5% foam) currently under review by the US FDA for the treatment of moderate-to-severe papulopustular rosacea in adults. The new data have been presented at the 17^th Annual South Beach Symposium in Dermatology held on February 6-9, 2020 in Miami, FL.

Foamix previously announced that the FDA has accepted the filing of a New Drug Application for FMX103 for the treatment of moderate to severe papulopustular rosacea in adults with the action date set for June 2, 2020, under the Prescription Drug User Fee Act (PDUFA).

Integrated Summary of Efficacy Highlights

-The integrated efficacy analysis compared FMX103 to vehicle from 2 identical Phase 3 studies (FX2016-11 and FX2016-12) with 1,522 subjects (1,009 subjects received FMX103 and 513 subjects received vehicle) after 12 weeks of once daily application.

•  In the combined analysis of both pivotal Phase 3 studies, FMX103 demonstrated statistically significant benefit compared to vehicle foam on both co-primary endpoints
• • Significantly greater reduction of inflammatory lesion counts from Baseline to Week 12 for FMX103 compared to vehicle (-18.0 vs. -14.9; p<0.001), respectively.
  • Significantly greater number of subjects receiving FMX103 achieved IGA treatment success defined as an IGA score of 0 (clear) or 1 (almost clear) and at least a 2-grade improvement at Week 12, (50.6% vs. 41.0%; p<0.001), respectively.
  • Statistical superiority of FMX103 when compared to vehicle was observed for both co-primary endpoints for all supporting sensitivity analyses.

    In a subgroup analysis of disease severity, FMX103 demonstrated statistically significant efficacy over vehicle in both Baseline severity groups: IGA 3 (“moderate”) and IGA 4 (“severe”).

• For subjects assessed as having severe papulopustular rosacea (IGA 4) at Baseline in each study:
  • The FMX103 integrated treatment group demonstrated a significantly higher reduction of inflammatory lesions compared to the vehicle integrated treatment group from Baseline to Week 12, (-26.0 vs. -15.1; p<0.001), respectively.
  • The FMX103 integrated treatment group demonstrated a significantly higher proportion of subjects achieving IGA treatment success compared to the vehicle integrated treatment group at Week 12, (36.8% vs. 14.9%; p=0.003), respectively.
• The integrated efficacy analysis further demonstrated the effect of FMX103 treatment on disease improvement as early as week 4.

Since 2002, South Beach Symposium has served as a central and comprehensive forum for advanced clinical and aesthetic dermatology education. In its mission to advance new standards of dermatological care, South Beach Symposium has emerged as a leading educational source for the latest therapies, technologies, procedures, and practice guidelines in clinical and aesthetic medicine. With a dual focus on both clinical and aesthetic dermatology, SBS has championed and disseminated a transformative approach to effectively address growing demands for dermatological care. https://www.southbeachsymposium.org/about-us.html

Papulopustular rosacea is a chronic skin disease causing inflammatory lesions (papules and pustules) on the nose, cheeks, chin and forehead.  It can create psychosocial burdens, such as embarrassment, anxiety and low self-esteem that can adversely affect quality of life.  Rosacea is most frequently seen in adults between 30 and 50 years of age. It affects more than 16 million people in the United States (JAAD (2015) 72:749-758). There is no known cure for rosacea. Mild papulopustular rosacea is treated by topical antimicrobials (metronidazole, clindamycin and ivermectin), azelaic acid or retinoids, while the mainstay for the treatment of moderate to severe papulopustular rosacea are oral antibiotics such as doxycycline and, less frequently, tetracycline and off-label use of oral minocycline (Drugs (2014) 74:1457-1465).

Foamix is a specialty pharmaceutical company working to solve some of today’s most difficult therapeutic challenges in dermatology and beyond. With expertise in topical medicine innovation as a springboard, the Company is working to develop and commercialize solutions that were long thought impossible, including the world’s first topical minocycline, AMZEEQ. Its proprietary Molecule Stabilizing Technology (MST™) is utilized in the Company’s dermatology products and in 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 the 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.