Harrow Health Announces Launch of Mayfield Pharmaceuticals

Harrow Health has filed a Form 8-K with the Securities and Exchange Commission containing a corporate presentation for its subsidiary, Mayfield Pharmaceuticals. Mayfield is focused on making a difference in women’s lives by developing branded pharmaceutical products that address significant unmet needs within the women’s health marketplace. Once funded, Harrow expects Mayfield to be led by Melissa Bradford-Klug.

As CEO of Mayfield, Bradford-Klug will be charged with the development of Mayfield’s drug candidate pipeline:

MAY-66, a patented new chemical entity drug candidate intended to treat bacterial vaginosis (BV). MAY-66 has produced extraordinarily promising data in what we believe is a translatable pre-clinical model. Approximately 21 million women in the U.S. are estimated to suffer from BV, with 4 million treated annually, and high reoccurrence rates of BV are an ongoing need. In addition, pregnant women currently have no safe treatment options for this type of infection. The addressable market for MAY-66 is estimated at $1 billion annually in the U.S.

MAY-44, which was acquired by Mayfield in February, will be developed through the 505(b)(2) clinical pathway for the treatment of dyspareunia in pre and post-menopausal women. MAY-44 is protected by three issued patents and could become the first FDA-approved topical non-estrogen-based product to address a market of as many as 38 million American women for whom dyspareunia is common. The dyspareunia indication Mayfield will seek approval for is an estimated $1.5 billion annual U.S. market opportunity.

MAY-88 is a patent-pending oral suspension that Mayfield will develop for the treatment of interstitial cystitis (IC) via the 505(b)(2) clinical pathway. An estimated 8 million U.S. patients chronically suffer from IC, with the existing IC drug market in the U.S. estimated at $400 million annually.

"I am excited to co-found and lead an exciting and needed women’s health focused company with such a promising pipeline. MAY-66, our lead first in class molecule for bacterial vaginosis – based on early data generated – has the potential to be a breakthrough product in a very large underserved market," Melissa Bradford-Klug said. "Feedback from FDA during our recent Pre-IND meeting for our patented MAY-44 drug candidate was instructive and we have important clarity about the development pathway for what we believe is a potentially high impact program. MAY-88 could finally change the treatment landscape for the millions of American women who chronically suffer from interstitial cystitis."

"Melissa is a visionary and extremely competent biopharma leader with a record of developing and commercializing pharmaceutical women’s health products that have improved the lives of millions of American women," Harrow Health CEO, Mark L. Baum, said. "As Mayfield’s CEO, Melissa will leverage her 20+ year career – as a scientist, in business development, and in executive leadership – at some of the leading U.S. and global pharmaceutical companies. Beyond her impressive experience, Melissa has a deep reservoir of determination to drive innovation in the women’s health space. I’m excited to be working with her and am confident that under her leadership, Mayfield investors and shareholders, including Harrow, will have the opportunity to not only generate great economic returns, but to also commercialize products that will uniquely benefit the sisters, daughters, mothers, aunts and grandmothers in our country and around the world."

Harrow expects Mayfield will follow a similar template of its previous subsidiaries Eton Pharmaceuticals, Surface Pharmaceuticals, and Melt Pharmaceuticals, by pursuing a Series A financing and being separately managed and funded from Harrow.

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