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Menlo Therapeutics Provides a Business Update in the

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realfast95 Member Level  Friday, 03/20/20 08:22:27 AM
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Menlo Therapeutics Provides a Business Update in the Context of COVID-19
March 20, 2020 at 8:00 AM EDT

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.

Supply Chain

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.”

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