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Harrow Health Forms Stowe Pharmaceuticals Subsidiary to Develop Broad Spectrum Anti-Microbial Ophthalmic and Otic Therapeutics

1025 Days ago

First in class Zian™ molecule has shown promising pre-clinical results in treating infections caused by multi-resistant bacteria, molds, fungi and viruses

NASHVILLE, Tenn., Aug. 02, 2019 (GLOBE NEWSWIRE) -- Harrow Health, Inc. (NASDAQ: HROW) today announced that its newly formed subsidiary, Stowe Pharmaceuticals, Inc., has entered into an agreement with TGV Health to acquire worldwide rights to the Zian™ anti-microbial molecule for ophthalmic and otic uses.  Zian™ is a patented small molecule that is water soluble, colorless and odorless, and was developed to treat various complex bacterial, fungal, and viral infections, including in the eye and ear.  The initial primary indication for Stowe’s initial drug candidates is expected to be adenoviral conjunctivitis, with secondary indications for mixed bacterial-viral infections, keratitis, endophthalmitis, and corneal ulcers. 

“Currently, there is a large unmet need – globally – for a single medication that can treat various types of microbial ocular and otic infections.  For example, there are no FDA approved drugs for use in the management of acanthamoeba keratitis and adenoviral Epidemic Keratoconjunctivitis (EKC),” said George Tets, MD, PhD, co-inventor of the Zian™ molecule.  “In pre-clinical ophthalmic studies, our initial drug candidate based on the Zian™ molecule – STE-006 – successfully killed broad spectra of bacteria and inactivated ranges of viruses, including enveloped and non-enveloped viruses, within 15 seconds.  We believe that if FDA-approved, STE-006 could potentially become a ‘one-stop-shop’ solution to quickly fight ophthalmic bacteria, fungi, and viruses, having sight-saving implications for people worldwide.”

Harrow Health board member and ophthalmologist Richard L. Lindstrom, MD, commented, “Serious sight threatening infections like acanthamoeba, fungal and bacterial keratitis, viral infections of the cornea and conjunctiva and endophthalmitis need better treatments.  In many cases, if left untreated, these types of infections can and often do lead to blindness and other complications.  Ocular infections are on the rise worldwide and anti-bacterial resistant pathogens are showing up in national headlines with increasing frequency.  STE-006 has the potential to be an important weapon in our armamentarium against these threats.”

Harrow Health CEO, Mark L. Baum, added, “The development of Zian™ for ophthalmic and otic uses is one of the most exciting and potentially impactful opportunities we’ve seen.  The performance of STE-006 in rabbit keratitis, rabbit adenoviral keratoconjunctivitis, and anti-biofilm models – which included a comparison against many of the leading current therapies – was incredibly impressive.  It is our belief that Stowe could develop several first-in-class medications that could affect millions of people in the U.S. and worldwide.  We look forward to our new subsidiary, Stowe Pharmaceuticals, pursuing the full potential for this first-in-class therapeutic in U.S. markets that we estimate to be well north of $2 billion per year.”

About Drug Candidate STE-006

STE-006 is a patented small molecule topical drug candidate intended to treat various bacterial, fungal, and viral infections in the eye.  In initial preclinical models, STE-006 was shown to be significantly more effective compared to current conventional therapies against numerous bacterial and viral pathogens, including strains of MRSA and herpes simplex virus.  STE-006 has several patents issued in the U.S. and globally, covering matter of composition, methods of production, methods of use and molecule, which are valid until 2038.  STE-006 is expected to pursue FDA approval via the 505(b)(1) pathway as a New Chemical Entity.

About Harrow Health

Harrow Health, Inc. (NASDAQ: HROW) owns a portfolio of healthcare businesses, including one of the nation’s leading ophthalmology pharmaceutical businesses, ImprimisRx.  The company holds large equity positions in Eton Pharmaceuticals (NASDAQ: ETON), Surface Pharmaceuticals, Melt Pharmaceuticals, Mayfield Pharmaceuticals, Radley Pharmaceuticals, and Stowe Pharmaceuticals, Inc. all companies founded as subsidiaries of Harrow Health.  The Company also owns royalty rights in certain 505(b)(2) drug candidates being developed by 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 Patton

Source:  Harrow Health, Inc.

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