REHOVOT, Israel and BRIDGEWATER, N.J., Oct. 12, 2018 — Foamix Pharmaceuticals Ltd. (NASDAQ: FOMX), (“Foamix”), a clinical stage specialty pharmaceutical company focused on developing and commercializing proprietary topical therapies to address unmet needs in dermatology, today announced that data from its Phase 3 clinical trial, FX2017-22, which investigated FMX101 for the treatment of moderate-to-severe acne, will be presented at the Fall Clinical Dermatology Conference to be held October 18 – 21 at the Wynn Hotel in Las Vegas, Nevada.
The poster, which is entitled “FMX101 4% Topical Minocycline Foam for the Treatment of Moderate-to-Severe Acne Vulgaris: Efficacy and Safety From a Phase 3 Randomized, Double-Blind, Vehicle-Controlled Study” is expected to be presented during several plenary and scientific poster sessions throughout the conference. A copy of the poster will be available on the Foamix corporate website http://foamix.com/, simultaneous with its presentation at the conference.
As the company previously communicated, the Phase 3 study met both co-primary endpoints of (1) absolute change from baseline in inflammatory lesion count at Week 12, and (2) Investigator Global Assessment (“IGA”) treatment success at Week 12, defined as an IGA score of 0 or 1, and at least a 2-grade improvement (decrease) from baseline. Results from both co-primary endpoints demonstrated highly statistically significant results for FMX101 vs vehicle, with p-values <0.0001. The favorable safety profile of FMX101 was consistent with that determined from the two prior Phase 3 studies of FMX101 in acne (FX2014-04 and FX2014-05).
About the Fall Clinical Dermatology Conference® The Fall Clinical Dermatology Conference® Las Vegas is a four-day program designed to provide the practicing dermatologist with a comprehensive update on the diagnosis and treatment of a variety of conditions related to medical, surgical and cosmetic dermatology. For additional information, refer to https://fallclinical.health/conferences/fall-clinical-2018/.
About Foamix Pharmaceuticals Foamix is a specialty pharmaceutical company focused on the development and commercialization of proprietary, innovative and differentiated topical drugs for dermatological therapy. Our leading clinical stage product candidates are FMX101, our novel minocycline foam for the treatment of moderate-to-severe acne and FMX103, our novel minocycline foam for the treatment of rosacea. We continue to pursue research & development of our proprietary, innovative foam technologies for the treatment of various skin conditions. We currently have development and license agreements relating to our technology with various pharmaceutical companies including LEO Pharma and others.
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Foamix uses its website (www.Foamix.com) 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 the Foamix website in addition to following its press releases, filings with the Securities & Exchange Commission (“SEC”), public conference calls, and webcasts.
Forward Looking Statements This release includes forward-looking statements within the meaning of Section 27A of the U.S. Securities Act of 1933, as amended, Section 21E of the U.S. Securities Exchange Act of 1934, as amended, and the safe harbor provisions created by those sections. Forward-looking statements are statements that are not historical facts, such as statements regarding assumptions, expectations, forecasts, beliefs or intentions related to financial results, commercial results, timing and results of clinical trials and U.S. FDA and other regulatory agencies authorizations. Forward-looking statements are based on our current knowledge and our present beliefs and expectations regarding possible future events and are subject to risks, uncertainties and assumptions. Actual results and the timing of events could differ materially from those anticipated in these forward-looking statements as a result of various factors including, but not limited to, unexpected delays in clinical trials or announcement of results, excess costs or unfavorable results of clinical trials, delays or denial in the U.S. FDA approval process, additional competition in the acne and dermatology markets, denial of reimbursement by third party payors or inability to raise additional capital, our ability to recruit and retain key employees and our ability to stay in compliance with applicable laws, rules and regulations. We discuss many of these risks in greater detail in our annual and other periodic filings with the SEC, including under the heading “Risk Factors” in our most recent annual report. Although we believe these forward-looking statements are reasonable, they speak only as of the date of this announcement and Foamix 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.
|Contact:||U.S. Investor Relations|
|Ilan Hadar, CFO||Michael Rice|
|Foamix Pharmaceuticals Ltd.||LifeSci Advisors, LLC|
|[email protected]||[email protected]|
|Elizabeth Tang, PhD|
|LifeSci Public Relations|