Foamix and Menlo announce approval of merger

Shareholders of Foamix Pharmaceutical Ltd. and Menlo Therapeutics Inc. voted to approve all stockholder and shareholder proposals in order to complete the merger between the two companies on Feb. 6.

The proposed plans for the merger will have Menlo’s wholly-owned subsidiary, Giants Merger Subsidiary Ltd, absorb into Foamix. All the while, Foamix will become a wholly-owned subsidiary of Menlo following the approval of closing conditions and the conclusion of the 30-day waiting period mandated by Israeli law.¹

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“The combination of Menlo with Foamix will accelerate our progression in becoming a leading dermatology-focused company with several late-stage assets that can leverage the commercialization infrastructure we have created to support the launch of AMZEEQ,” says David Domzalski, CEO of Foamix.

Included in the merger are a variety of treatments and therapies including the first topical formulation for minocycline (AMZEEQ, Foamix), FCD105 (Foamix),  FMX103 (Foamix), serlopitant (Menlo) and Molecule Stabilizing Technology (MST) developed by Foamix.

Recently, Foamix released positive results from two phase 3 clinical trials investigating FMX103, a 1.5% minocycline foam for the treatment of moderate-to-severe papulopustular rosacea. Results showed the drug met all primary endpoints and displayed superiority over vehicle.² This new data followed the Oct. 17, 2019 announcement from the U.S. Food and Drug Administration (FDA) of approval of the New Drug Application (NDA) for FMX103. The Prescription Drug User Fee Act (PDUFA) date is set for June 2, 2020.³

FCD105, Foamix’s 3% minocycline and 0.3% adapalene foam for treatment of moderate-to-severe acne vulgaris, completed its enrollment of 400 participants 12 years and older in November 2019 for the company’s upcoming phase 2 clinical trial.⁴ Also, Foamix’s 4% minocycline foam, AMZEEQ, was approved by the FDA for treatment of inflammatory lesions of non-nodular moderate-to-severe acne vulgaris in pediatric patients and adults on Oct. 18, 2019.5

Additionally, the merger will include MST, a propriety foam vehicle without surfactants that features natural oils and is designed to work with the oils found in human skin.

As for Menlo, the company will bring serlopitant to the table, an oral NK1 receptor antagonist for treatment of pruritus. The company is currently working on three indications of the drug: a phase 3-ready clinical trial investigating the drug’s effect on pruritus associated with psoriasis; a phase 2 clinical trial examining serlopitant on chronic pruritus of unknown origins; and two phase 3 clinical trials examining the safety and efficacy of the drug’s treatment for pruritus associated with prurigo nodularis.¹

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“The combined company will be well positioned to develop and commercialize therapies to address the needs of patients with dermatologic conditions. We believe that together we have the potential to generate long-term, sustainable value for stockholders and superior solutions and choices for patients,” says Steve Basta, CEO of Menlo.

According to the press release announcing the vote approval, the merger is set to be completed by March 2020 following each company separately filing final voting results from the general and special meetings to the U.S. Securities and Exchange Commission.

References:

1. Foamix and Menlo Announce Shareholder Approval of Proposed Merger. Foamix Pharmaceuticals Ltd. http://www.foamix.com/news-releases/news-release-details/foamix-and-menlo-announce-shareholder-approval-proposed-merger. Published February 6, 2020. Accessed February 12, 2020.

2. Foamix Announces Publication of Phase 3 Studies Evaluating FMX103 for the Treatment of Papulopustular Rosacea in Journal of the American Academy of Dermatology. Foamix Pharmaceuticals Ltd. https://www.foamix.com/news-releases/news-release-details/foamix-announces-publication-phase-3-studies-evaluating-fmx103. Published February 6, 2020. Accessed February 12, 2020.

3. Foamix Announces FDA Acceptance of its New Drug Application for FMX103 Minocycline Foam for the Treatment of Moderate-to-Severe Papulopustular Rosacea. Foamix Pharmaceuticals Ltd. https://www.foamix.com/news-releases/news-release-details/foamix-announces-fda-acceptance-its-new-drug-application-fmx103. Published October 17, 2019. Accessed February 12, 2020.

4. Foamix Announces Enrollment Completion of Phase 2 Acne Clinical Trial for FCD105 Minocycline 3% and Adapalene 0.3% Combination Foam. Foamix Pharmaceuticals Ltd. https://www.foamix.com/news-releases/news-release-details/foamix-announces-enrollment-completion-phase-2-acne-clinical. Published November 18, 2019. Accessed February 12, 2020.

5. Foamix Pharmaceuticals Ltd. Foamix Receives FDA Approval of AMZEEQ™ Topical Minocycline Treatment for Millions of Moderate to Severe Acne Sufferers. Foamix Receives FDA Approval of AMZEEQ™ Topical Minocycline Treatment for Millions of Moderate to Severe Acne Sufferers. https://www.prnewswire.com/il/news-releases/foamix-receives-fda-approval-of-amzeeq-topical-minocycline-treatment-for-millions-of-moderate-to-severe-acne-sufferers-300941412.html. Published October 18, 2019. Accessed February 12, 2020.