Menlo Announces Settlement to Conclude Finacea Foam Litigation and Announces that Partner, LEO Pharma A/S, Remedies Finacea Foam Supply Issues

BRIDGEWATER, N.J., April 02, 2020 (GLOBE NEWSWIRE) -- Menlo Therapeutics Inc. (Nasdaq: MNLO) (“Menlo” or the “Company”), a biopharmaceutical company focused on developing and commercializing proprietary therapies to address unmet needs in dermatology, today announced that its wholly-owned subsidiary, Foamix Pharmaceuticals Ltd. (“Foamix”) has entered into a settlement and license agreement to resolve the remaining 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.

Foamix is the owner of patents that have been licensed to LEO Pharma A/S (“LEO Pharma”) to market Finacea® Foam, a topical prescription medicine used to treat the inflammatory papules and pustules of mild to moderate rosacea. This settlement concludes the litigation relating to Finacea® Foam and comes after the settlements in October 2019 with an affiliate of Teva Pharmaceutical Industries Ltd. and in April 2019 with affiliates of Perrigo Company plc.

Expected Resupply of Finacea Foam

Menlo further announces that LEO Pharma has remedied the supply chain issues related to Finacea Foam that Foamix previously disclosed in April 2019. Pursuant to the license agreement between Foamix and LEO Pharma, Foamix is entitled to the payment of royalties based on the net sales of Finacea Foam. This week, LEO Pharma informed Menlo that it has remedied its supply issues and expects to resupply batches of Finacea Foam for commercial sales in the U.S. in the coming weeks. Following the resupply, we anticipate that our royalty payments for Finacea Foam will increase. 

About Menlo Therapeutics 

Menlo Therapeutics Inc. recently combined with Foamix Pharmaceuticals Ltd. (“Foamix”) to form a different type of biopharmaceutical company working to solve some of today’s most difficult therapeutic challenges in dermatology and beyond. Foamix is now a wholly-owned subsidiary of Menlo.

With expertise in topical medicine innovation as a springboard, the Company is working to develop and commercialize a variety of solutions using its proprietary Molecule Stabilizing Technology (MST™), and has received FDA approval for the world’s first topical minocycline, AMZEEQ™ (minocycline) topical foam, 4%. In addition, the Company is focused on the development of serlopitant, a once-daily oral NK-1 receptor antagonist, as a novel potential treatment option for pruritus associated with prurigo nodularis. AMZEEQ uses a different foam technology platform, and is supported by different patents, than Finacea Foam.

For more information about Menlo or its investigational products, visit Menlo may use its website to comply with its disclosure obligations under Regulation FD. Therefore, investors should monitor Menlo’s website in addition to following its press releases, filings with the U.S. Securities and Exchange Commission, public conference calls, and webcasts.

Cautionary Statement Regarding Forward-Looking Statements

This release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding expectations with respect to anticipated royalties from licensed products or the announcement of results of Menlo’s clinical trials for pruritus associated with prurigo nodularis, statements regarding the development and commercialization of Menlo’s products and product candidates and other statements regarding the future expectations, plans and prospects of Menlo. All statements in this press release which are not historical facts are forward-looking statements. Any forward-looking statements are based on Menlo’s current knowledge and its present beliefs and expectations regarding possible future events and are subject to risks, uncertainties and assumptions that could cause actual results to differ materially and adversely from those set forth or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, Menlo’s ability to successfully integrate the two companies; the achievement of certain expected cost synergies; the outcome of any legal proceedings related to the merger; the outcome and cost of clinical trials for current and future product candidates, including those for serlopitant; determination by the FDA that results from Menlo’s clinical trials are not sufficient to support registration or marketing approval of product candidates; adverse events associated with the commercialization of AMZEEQ™; the outcome of pricing, coverage and reimbursement negotiations with third party payors for AMZEEQ™ or any other products or product candidates that Menlo may commercialize in the future; whether, and to what extent, third party payors impose additional requirements before approving AMZEEQ™ prescription reimbursement; the eligible patient base and commercial potential of AMZEEQ™ or any of Menlo’s other product or product candidates; risks that Menlo’s intellectual property rights, including those of any subsidiary, 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 Menlo’s patents may be held to be narrowed, invalid or unenforceable or one or more of Menlo’s patent applications may not be granted and potential competitors may also seek to design around Menlo’s granted patents or patent applications; additional competition in the acne and dermatology markets; risks and uncertainties associated with pandemics; inability to raise additional capital on favorable terms or at all; Menlo’s ability to recruit and retain key employees; and Menlo’s ability to stay in compliance with applicable laws, rules and regulations. For a discussion of other risks and uncertainties, and other important factors, any of which could cause Menlo’s actual results to differ from those contained in the forward-looking statements, see the sections titled “Risk Factors” in (i) Menlo’s most recent annual report on Form 10-K, (ii) Foamix’s most recent annual report on Form 10-K and (iii) Menlo’s definitive joint proxy statement/prospectus filed with the U.S. Securities and Exchange Commission under Rule 424(b)(3) on January 7, 2020, as well as discussions of potential risks, uncertainties, and other important factors in Menlo’s subsequent filings with the U.S. Securities and Exchange Commission. Although Menlo believes these forward-looking statements are reasonable, they speak only as of the date of this announcement and Menlo 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.

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Vusi Moyo

Zeno Group

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LifeSci Advisors, LLC

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