REHOVOT, Israel and BRIDGEWATER, N.J., Feb. 26, 2019 (GLOBE NEWSWIRE) -- Foamix Pharmaceuticals Ltd. (FOMX) (“Foamix” or the “Company”), a clinical stage specialty pharmaceutical company focused on developing and commercializing proprietary topical therapies to address unmet needs in dermatology, today announced that it will participate in the American Academy of Dermatology (AAD) Annual Meeting to take place March 1 – 5, 2019 at the Walter E. Washington Convention Center, in Washington D.C.
Clinical data on the Company’s late stage clinical development candidates, FMX101 for moderate to severe acne, and FMX103 for papulopustular rosacea, are expected to be covered in oral presentations by leading clinical dermatologists during the meeting. The Company will also host a medical affairs booth, with medical affairs staff on-site to answer questions on its clinical data as well as on its proprietary foam technology.
The American Academy of Dermatology is one of the largest, non-partisan professional organizations of dermatologists in the world. Each year, AAD convenes an annual meeting to discuss the latest advances and trending topics in dermatology in more than 300 educational sessions across various tracks. Last year’s AAD meeting drew more than 18,750 attendees.
“This is a great opportunity for the medical community to hear some of the most recent clinical study data on our late stage candidates for acne and rosacea,” said David Domzalski, CEO of Foamix. “We submitted our New Drug Application (NDA) for FMX101 to the US FDA late last year, with an anticipated PDUFA date in Q4 2019, and are planning to submit another NDA for FMX103 in rosacea in mid-2019. The combined total body of clinical data supporting these candidates, including positive results from Phase 3 trials, suggests that they have the potential to address significant unmet needs in their respective dermatology indications. Pending regulatory approvals by FDA, Foamix could be in a position to commercialize FMX101 in early 2020 followed by FMX103 in the second half of 2020.”
Medical Affairs Booth:
Booth # 4301
Open: March 1 – 2 from 10am to 5pm; March 3 from 10am to 3pm
Relevant Presentations and Details:
Session: New Emerging Therapies (S003)
Date and Time: Friday March, 1 9:48 a.m., Eastern Time
Location: Ballroom C
Presenter: Dr. Diane Bersen
Presentation: New and Emerging Therapies for Acne and Rosacea
Session: Acne Boot Camp (F005)
Date and Time: Friday March 1, 10:30 a.m., Eastern Time
Location: Ballroom B
Presenter: Dr. Leon Kircik
Presentation: New and Emerging Treatments for Acne
Session: Acne and Rosacea (S043)
Location: Room 207A
Date and Time: Sunday March 3, 1:23 p.m., Eastern Time
Presenter: Dr. Linda Stein Gold
Presentation: Acne: What’s new and What’s on the Horizon?
Date and Time: Sunday March 3, 2:30 p.m., Eastern Time
Presenter Dr. Hilary Baldwin
Presentation Rosacea: What’s New?
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 A/S and others.
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 Foamix’s website in addition to following its press releases, filings with the Securities & Exchange Commission, public conference calls, and webcasts.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the future development plans of FMX101 and FMX103 and the Company’s commercial activities. All statements other than statements of historical facts are forward-looking statements. Any forward-looking statements are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, determination by the FDA that results from clinical trials are not sufficient to support registration or marketing approval of our product candidates; the risk that our product candidates will not be successfully developed, approved or commercialized; unexpected delays in clinical trials or announcement of results; our ability to effectively and timely conduct clinical trials in light of excess costs or unfavorable results of clinical trials; delays or denial in the U.S. regulatory approval process and the risks that the current or planned clinical trials will be insufficient to support future regulatory submissions or to support marketing approval in the United States of our product candidates; additional competition in the acne and dermatology markets; market acceptance by physicians and patients; risks associated with denial of reimbursement by third party payors; our ability to raise additional capital; and our ability to recruit and retain key employees. For a discussion of other risks and uncertainties, and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the section entitled “Risk Factors” in our most recent annual report on Form 10-K, as well as discussions of potential risks, uncertainties, and other important factors in our subsequent filings with the Securities and Exchange Commission. Although we believe these forward-looking statements are reasonable, they speak only as of the date of this release and we undertake no obligation to update this information 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.
Ilan Hadar, CFO & Country Manager
Foamix Pharmaceuticals Ltd.
U.S. Investor Relations
LifeSci Advisors, LLC