REHOVOT, Israel and BRIDGEWATER, N.J., April 29, 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 it will present two late-breaking posters relating to its topical product candidate FMX101, a 4% minocycline foam being developed for the treatment of moderate-to-severe acne, at the 77th Annual Meeting of the Society for Investigative Dermatology to be held May 8-11, 2019, in Chicago, Illinois. Foamix previously announced that the U.S. Food & Drug Administration (FDA) has accepted the filing of a New Drug Application for FMX101 for the treatment of inflammatory lesions of non-nodular moderate-to-severe acne vulgaris in patients nine years of age and older and the FDA has set an action date of October 20, 2019 under the Prescription Drug User Fee Act (PDUFA).
Poster Presentation Details:
Title: The Impact of FMX101 on the Physical Properties of Human Sebum: Comparison of an Oil-Based Formulation vs an Oil-in-Water Emulsion
Poster Number: LB1118
Authors: Yohan Hazot; Lenny Margulis, PhD; Shay Burban; Russell Elliott, PhD; Iain Stuart, PhD
Poster Session I; Thursday May 9, 2019; 10:45 am – 12:45 pm Central Time
Location: Late-breaking posters LB 1046 – LB 1144
Title: Assessing Bacterial Susceptibility of FMX101 4% Topical Minocycline Foam
Poster Number: LB1117
Authors: Joyce Sutcliffe, PhD; Robert McLaughlin, PhD; James Del Rosso, DO; Jonathan Weiss, MD; Hilary Baldwin, MD; Guy Webster, MD PhD; James Leyden, MD; Xilin Zhao, PhD; Andrew Read, PhD; Karl Drlica, PhD; Russell Elliott, PhD; Iain Stuart, PhD
Poster Session II; Friday, May 10, 2019; 11:15 am – 1:15 pm Central Time
Location: Late-breaking posters LB 1047 – LB 1143
Members of the Foamix R&D team will be on-site at the conference to present the research in these sessions. Research abstracts will also be published in the Journal of Investigative Dermatology this fall and will be available as handouts at the SID 2019 meeting.
About the Society for Investigative Dermatology (SID) and the SID Annual Meeting
The Mission of the Society for Investigative Dermatology (SID) is to advance and promote scientific evidence relevant to skin health and disease through education and scholarly exchange of scientific information, with the intent to foster improvement in the competence (abilities, skills and strategies) of dermatology researchers and clinicians.
The 77th Annual Meeting of the SID is a forum in which a diverse community of scientists comes to exchange information on the latest advances. The SID Annual Meeting draws a diverse group of senior researchers and clinicians, as well as hundreds of clinical trainees including dermatology residents. These healthcare professionals and basic researchers are on the frontline for recognizing systemic disease (including many types of cancer) with a skin-related association. For additional information, visit https://www.sidannualmeeting.org/.
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 being developed for the treatment of moderate-to-severe acne and FMX103, our novel minocycline foam being developed for the treatment of rosacea. We continue to pursue research & development of our proprietary, innovative topical technologies for the treatment of various skin conditions. We currently have development and license agreements relating to our technology with various pharmaceutical companies.
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 Company's expectations regarding the review, potential regulatory approval and commercial launch of FMX101, including the potential timing of FDA review of the Company's NDA seeking approval of FMX101, and statements regarding the clinical development of the Company's other product candidates including FMX103. 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 the Company's clinical trials are not sufficient to support registration or marketing approval of its product candidates; the risk that its product candidates will not be successfully developed, approved or commercialized; unexpected delays in clinical trials or announcement of results; the Company's ability to effectively and timely conduct clinical trials in light of excess costs or unfavorable results of clinical trials; additional competition in the dermatology markets; risks associated with denial of reimbursement by third party payors; expectations regarding the Company's commercialization efforts and the sufficiency and availability of funding to support its business strategy and operations. 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 the Company's most recent annual report on Form 10-K, as well as discussions of potential risks, uncertainties, and other important factors in its subsequent filings with the Securities and Exchange Commission. Although the Company believes these forward-looking statements are reasonable, they speak only as of the date of this release and it undertakes 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.
Contact: U.S. Investor Relations
Ilan Hadar, CFO & Country Manager Michael Rice
Foamix Pharmaceuticals Ltd. LifeSci Advisors, LLC
+972-8-9316233 646-597-6979
ilan.hadar@foamix.com mrice@lifesciadvisors.com
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