Harrow Health Subsidiary, Mayfield Pharmaceuticals, Inc., Acquires Patented Dyspareunia Drug Candidate and Other Intellectual...
07 Febrero 2019 - 6:00AM
Harrow Health, Inc. (NASDAQ: HROW), today announced that its
subsidiary, Mayfield Pharmaceuticals, Inc., has acquired drug
formulation assets and intellectual property, including three
recently issued patents, from Elle Pharmaceutical, LLC, for MAY-44,
a drug candidate for the treatment of dyspareunia, or pain
experienced by women during sexual intercourse.
“Dyspareunia is a common condition significantly affecting the
quality of life of millions of women, but is often unacknowledged,
undiagnosed, and untreated,” said Lauren J. Oshry, MD, Chief
Medical Officer of Elle. “As a physician, it is gratifying to
work with Mayfield to bring attention to this condition and expand
women’s options with this novel treatment that is non-hormonal and
which, through my clinical experience with lidocaine-based topical
preparations, that were the cornerstone of developing our patented
formulation, have provided exceptional clinical benefits.”
Harrow Health CEO, Mark L. Baum, commented, “The MAY-44 drug
development program, including the patents and other assets
Mayfield acquired in this transaction, will require minimal Harrow
investment because they are advanced to the point of having
clinical trial material successfully built and shown to be
stable. We also have accumulated considerable market
research, positive anecdotal evidence of the clinical value of
compounded lidocaine-based gel formulations, and we’re in
negotiations with experienced candidates to join the Mayfield team
in key leadership positions. We look forward to advancing the
Mayfield business, including the MAY-44 program and other assets
that are now a part of Mayfield. I anticipate we will be
speaking more about this exciting women’s health focused company
throughout 2019.”
ABOUT MAY-44
MAY-44 is a non-estrogen topical analgesic gel containing a
patented pH-balanced formulation of 3.75% lidocaine and other
essential excipients designed for use on mucosal surfaces. If
FDA-approved, MAY-44 could become the first topical
non-estrogen-based product indicated for this large underserved
medical need. Anecdotal evidence has shown topical lidocaine,
which only needs to be applied immediately prior to intercourse,
can be highly effective (90%) for moderate to severe dyspareunia1,
2. In a 46-patient randomized, controlled, double-blinded
trial, users of 4% aqueous lidocaine reported significantly less
pain during intercourse compared to a control group (median score
of 1.0 compared to 5.3 on a 0-10 scale for pain,
respectively)1.
ABOUT DYSPAREUNIA
There are an estimated 32 million women in the U.S. who suffer
from moderate-to-severe dyspareunia, and 64 million post-menopausal
women in the U.S. for whom dyspareunia is common3. Other
estimates suggest dyspareunia affects greater than one in ten
women4. In a proprietary market research report completed in
December 2017, a survey of OB/GYN practices estimated that one in
every four patients complained of some level of dyspareunia each
month. It was also estimated that two-thirds of women
complaining of dyspareunia are post-menopausal and one-third are
pre- or peri-menopausal.
ABOUT HARROW HEALTH
Harrow Health, Inc. (NASDAQ: HROW) owns a
portfolio of healthcare businesses, including the nation’s leading
ophthalmology pharmaceutical compounding business,
ImprimisRx. The company holds large equity positions in Eton
Pharmaceuticals, Surface Pharmaceuticals, Melt Pharmaceuticals,
Mayfield Pharmaceuticals and Radley Pharmaceuticals, all companies
founded as subsidiaries of Harrow Health. The Company also
owns royalty rights in certain 505(b)(2) drug candidates being
developed by Eton, Surface, Melt, Mayfield and Radley. Harrow
intends to create, invest in and grow paradigm shifting health care
businesses that put patients first. For more information
about Harrow Health, please visit the Investor Relations section of
the corporate website by clicking here.
SAFE HARBOR
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.
Investor Contact:Jon
Pattonjpatton@harrowinc.com858-704-4587
References:
- Goetsch M, et al. (2015, October). A Practical Solution
for Dyspareunia in Breast Cancer Survivors: A Randomized Controlled
Trial. Journal of Clinical Oncology, 33(30), 3394-3400.
- Harvard Health Publishing. (2012, May). When sex gives more
pain than pleasure. Retrieved December 27, 2018 from
https://www.health.harvard.edu/pain/when-sex-gives-more-pain-than-pleasure
- Wysocki S, et al. (2014). Management of Vaginal Atrophy:
Implications from the REVIVE Survey. Clinical Medicine
Insights: Reproductive Health, 8, 23-30.
- Mitchell KR, et al. (2017, October). Painful sex (dyspareunia)
in women: prevalence and associated factors in a British population
probability survey. BJOG An International Journal of
Obstetrics and Gynaecology, 124(11), 1689-1697.
Source: Harrow Health, Inc.
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