REHOVOT, Israel and BRIDGEWATER, N.J., Oct. 21, 2019 (GLOBE NEWSWIRE) -- Foamix Pharmaceuticals Ltd. (FOMX) (“Foamix” or the “Company”), a specialty pharmaceutical company, today announced that, together with LEO Pharma A/S (“LEO Pharma”) it has entered into a settlement and license agreement with an affiliate of Teva Pharmaceuticals Industries Ltd. (“Teva”) to resolve pending patent litigation involving Finacea® Foam. Details of the settlement agreement are confidential, and the settlement agreement is subject to the review of the Federal Trade Commission and the U.S. Department of Justice.
This settlement comes after the settlement in April 2019 with affiliates of Perrigo Company plc relating to Finacea® Foam.
“Together with LEO Pharma, we are pleased to have now also settled the outstanding litigation with Teva,” said David Domzalski, Chief Executive Officer of Foamix. “We will continue to vigorously defend our patents and explore opportunities to further expand our intellectual property portfolio around our proprietary foam products and technologies.”
Foamix is the owner of patents that have been licensed to LEO Pharma to market Finacea® Foam, a topical prescription medicine used to treat the inflammatory papules and pustules of mild to moderate rosacea. Foamix’s recently approved product AMZEEQ™ (minocycline) topical foam, 4% for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris, and its product candidates FMX103 and FCD105, are based on a different foam technology platform and different patents than those listed in the Orange Book for the foam technology used in Finacea® Foam.
Patent infringement litigation related to Finacea® Foam continues against Taro Pharmaceuticals U.S.A., Inc. and Taro Pharmaceutical Industries, Ltd.
About Foamix Pharmaceuticals
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 AMZEEQ and in the Company’s 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.
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 review of the settlement agreement by the U.S. Federal Trade Commission and the U.S. Department of Justice and the Company’s ability to obtain, expand, maintain and defend its intellectual property portfolio. 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 the Company’s product candidates; the risk that the Company’s 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; risks that the Company’s intellectual property rights, such as patents, may fail to provide adequate protection, may be challenged and one or more claims may be revoked or interpreted narrowly or will not be infringed; risks that any of the Company’s patents may be held to be narrowed, invalid or unenforceable or one or more of the Company’s patent applications may not be granted and potential competitors may also seek to design around the Company’s granted patents or patent applications; 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 the Company’s product candidates; additional competition in the acne and dermatology markets; risks associated with denial of reimbursement by third party payors; the Company’s ability to raise additional capital; and the Company’s ability to recruit and retain key employees. For a discussion of other risks and uncertainties, and other important factors, any of which could cause the Company’s 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 the Company’s 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 the Company 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.