BRIDGEWATER, N.J., March 20, 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 provided a business update in the context of the developing situation with the COVID-19 (coronavirus) pandemic. At this time, Menlo does not anticipate any changes to key clinical and regulatory milestones in 2020, but is continuing to monitor the situation.
Key Clinical and Regulatory Milestones
Our expectations regarding the timing for announcement of top line data for our two ongoing serlopitant Phase 3 studies in pruritus associated with prurigo nodularis (PN), expected in late March or early April 2020, remain unchanged. Enrollment was completed in both trials in October 2019. All patient visits have been conducted and the Company is now focusing on preparations for analyzing the data. The long‑term safety trial (MTI-107), in which patients are receiving daily treatment doses of 5 mg serlopitant for up to one year, also currently remains on track. Assuming successful completion of the Phase 3 clinical trials, an NDA submission for serlopitant for the treatment of pruritus in PN is planned in the second half of 2020.
Enrollment is also complete in the Phase 2 clinical trial (Study FX2016-40) evaluating the efficacy and safety of FCD105 (topical combination foam which comprises minocycline 3% and adapalene 0.3%) in moderate to severe acne. Topline data from this trial are expected in the second quarter of 2020.
Menlo continues to work with the U.S. Food and Drug Administration (FDA) in the New Drug Application review process for FMX103 (1.5% minocycline foam for the treatment of papulopustular rosacea) which has been assigned a PDUFA action date of June 2, 2020. We have not received any regulatory communication that would require an update to this timeline.
With respect to AMZEEQ™, minocycline topical foam, 4%, for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 9 years of age and older, which the Company launched commercially in the U.S. in January this year – the Company does not anticipate any material disruptions in the supply chain at this time. Company management is in close contact with its primary suppliers and we have not received any indication that the suppliers’ operations have been materially affected by the COVID-19 outbreak. We continue to believe that there is more than sufficient amount of product in the trade and safety stock of raw materials at our contract manufacturer, ASM in Switzerland, to support the expected demand for AMZEEQ.
Sales Representatives and Employees
The Company’s AMZEEQ sales representatives are focused on staying connected with healthcare providers and are taking necessary precautionary steps in their interactions. In areas where face-to-face field activity has been suspended, sales representatives are employing digital tactics and virtual meetings to remain engaged with physicians. Corporate employees in all offices have pivoted to a work-from-home model until further notice.
“Menlo is committed to protecting and supporting the safety of our employees, patients, healthcare provider customers and their families,” said David Domzalski, CEO of Menlo Therapeutics. “We will continue to monitor the developing situation with the COVID-19 pandemic, heed direction provided by the CDC and other federal, state and local public health and administration officials and make adjustments to our policy as the situation evolves and respective directives adjust.”
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.
For more information about Menlo or its investigational products, visit www.menlotherapeutics.com. 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 the anticipated 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, any adverse effects related to the global COVID-19 pandemic, 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, 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; 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.
LifeSci Advisors, LLC