BOSTON, Oct. 08, 2019 (GLOBE NEWSWIRE) -- Mayfield Pharmaceuticals, the women’s health-focused subsidiary of Harrow Health, Inc. (HROW), today announced its Chief Executive Officer, Melissa Bradford-Klug, will discuss Mayfield’s advancements in developing new anti-infective medications such as its MAY-66 drug candidate for recurrent bacterial vaginosis, as well as Mayfield’s programs for dyspareunia and interstitial cystitis, at the SVB Leerink New Treatments Focused on Women’s Health Conference on October 10th, 2019 at 3:45 p.m. ET at the SVB Leerink offices in New York, NY. Bradford-Klug will be available to meet with attendees who may contact their SVB Leerink representative to arrange for a meeting.
Mayfield is focused on making a difference in women’s lives by being a voice for women and, in turn, developing branded pharmaceutical products that address their significant unmet healthcare needs.
Mayfield’s drug candidate pipeline includes:
- MAY-66, which is a first-in-class new chemical entity drug candidate intended to prevent recurrent 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 and high reoccurrence rates of BV are an ongoing need. Complications of BV, if left untreated, include increased risk of acquiring and transmitting HIV, increased risk of preterm birth and reduction in fertility during IVF therapy. The addressable market for MAY-66 is estimated at $1 billion annually in the U.S.
- MAY-44, which is being developed for the temporary relief of dyspareunia in breast cancer survivors and pre-menopausal 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 34 million American women for whom dyspareunia is common. The dyspareunia indication Mayfield will seek approval for is an estimated $2.1 billion annual U.S. market opportunity.
- MAY-88, which is a patent-pending oral suspension that Mayfield will develop for the treatment of moderate to severe interstitial cystitis (IC). Mayfield believes the IC drug market, currently estimated at $400 million annually, is highly underserved and in need of new treatment options for an estimated 8 million U.S. patients who chronically suffer from IC. Mayfield’s MAY-88 is initially pursuing an orphan population within the IC market.
About Mayfield Pharmaceuticals
Mayfield Pharmaceuticals, Inc. is a pharmaceutical company focused on the development of branded solutions that address the unmet needs of women. Mayfield intends to seek regulatory approval for its drug candidates through the U.S. Food and Drug Administration’s 505(b)(1) and 505(b)(2) regulatory pathways. Mayfield’s current drug candidates will pursue indications for recurrent bacterial vaginosis, dyspareunia, and interstitial cystitis, which are collectively estimated to present an addressable market opportunity that exceeds $3 billion annually in the U.S.
About Harrow Health
Harrow Health, Inc. (HROW) owns a portfolio of healthcare businesses, including ImprimisRx, the nation’s leading ophthalmology outsourcing facility and pharmaceutical compounding business. The company holds large equity positions in Eton Pharmaceuticals, Surface Pharmaceuticals, Melt Pharmaceuticals, Mayfield Pharmaceuticals, Stowe Pharmaceuticals and Radley Pharmaceuticals, all companies founded as subsidiaries of Harrow Health. The Company also owns royalty rights in certain drug candidates being developed by Surface, Melt, Mayfield and Radley. Harrow intends to create, invest in and grow paradigm shifting healthcare businesses that put patients first. For more information about Harrow Health, please visit the Investor Relations section of the corporate website by clicking here.
This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Any statements in this release that are not historical facts may be considered such "forward-looking statements." Forward-looking statements are based on management's current expectations and are subject to risks and uncertainties which may cause results to differ materially and adversely from the statements contained herein. Some of the potential risks and uncertainties that could cause actual results to differ from those predicted include our ability to make commercially available our compounded formulations and technologies in a timely manner or at all; physician interest in prescribing our formulations; risks related to our compounding pharmacy operations; our ability to enter into other strategic alliances, including arrangements with pharmacies, physicians and healthcare organizations for the development and distribution of our formulations; our ability to obtain intellectual property protection for our assets; our ability to accurately estimate our expenses and cash burn, and raise additional funds when necessary; risks related to research and development activities; the projected size of the potential market for our technologies and formulations; unexpected new data, safety and technical issues; regulatory and market developments impacting compounding pharmacies, outsourcing facilities and the pharmaceutical industry; competition; and market conditions. These and additional risks and uncertainties are more fully described in Harrow Health’s filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Such documents may be read free of charge on the SEC's web site at www.sec.gov. Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made. Except as required by law, Harrow Health undertakes no obligation to update any forward-looking statements to reflect new information, events or circumstances after the date they are made, or to reflect the occurrence of unanticipated events.
Source: Mayfield Pharmaceuticals, Inc. and Harrow Health, Inc.