NASHVILLE, Tennessee – (BUSINESS WIRING) – Harrow Health, Inc. (Nasdaq: HROW), an ophthalmic healthcare company, and Melt Pharmaceuticals, Inc., a clinical stage pharmaceutical company developing first-in-class sedative and analgesic drugs, today announced that Harrow Health has provided Melt Pharmaceuticals with a priority secured loan of 13 , $ 5 million.
Melt Pharmaceuticals plans to use the proceeds to conduct its main Phase 2 efficacy study for the company’s lead drug candidate, MELT-300, a proprietary combination of midazolam and ketamine in a fast dissolving sublingual tablet to provide sedation and pain relief for patients undergoing cataract surgery. … Melt’s IV-Free and Opioid-Free Approach aims to replace the current practice of intravenous sedation and pain relievers, including the use of fentanyl during surgery and other opioids prescribed to treat postoperative pain. Melt plans to dose its first patient in September 2021 and report key clinical results in the spring of 2022. Pending the results of the Phase 2 clinical trial, Melt Pharmaceuticals is awaiting the commencement of a Phase 3 clinical trial comparing MELT-300 to placebo. in the second half of 2022. Melt also plans to file two Investigational New Drugs (IND) applications with the US Food and Drug Administration (FDA) for its MELT-210 and MELT-400 programs in the second half of 2021.
“We are delighted to receive this non-dilutive funding that allows us to complete the Phase 2 clinical trial of MELT-300 and implement our overall clinical strategy, which we expect will generate data that will ultimately support a new drug application (NDA) to the FDA, ”said Larry Dillah, MD, CEO of Melt Pharmaceuticals. “According to the latest estimates, up to 50% of the more than four million cataract surgeries in the United States each year involve patients exposed to opioids during the perioperative period. If approved by the FDA, MELT-300 will become a new surgical protocol that should effectively eliminate the effects of opioids during cataract surgery, partially mitigating the devastating public health impact of the opioid crisis in the United States. As a result of this funding, we will now also be able to advance our goal of using our patented technology in other short-term treatments in medical fields such as pediatrics, dermatology, plastic and women’s health. ”
Mark L. Baum, CEO of Harrow Health, added: “As the largest shareholder in Melt Pharmaceuticals, licensing the potential sales of MELT-300 and based on our experience in commercializing ophthalmic surgical pharmaceutical products, Harrow is pleased to provide capital for the flagship Melt-300 Melt program and to promote other securities. Melts development programs. Dr. Dillah has an impressive 505 (b) (2) track record in drug approval and we strongly believe in his team’s strategy with the MELT-300 program. As for Harrow, I can think of a few upcoming events that could be hugely beneficial, like MELT-300, a multi-patent drug candidate with a billion-dollar annual revenue potential in the burgeoning ophthalmic surgery market. I’m very excited that this is a potential paradigm shift away from opioids and intravenous injections can have clinical implications for patients and ophthalmologists, and financially for Harrow shareholders. ”
The secured senior loan, financed with approximately $ 12.5 million in new cash and approximately $ 1 million in existing amounts due to Harrow Health, has a maturity of one year with no principal and prepayment penalties. The interest rate on the loan is 12.5% per annum, which can be paid in kind in the form of an additional balance of the principal amount of the debt. The loan is secured by nearly all of Melt’s assets, including all US, Australian, Japanese and South Korean patents related to Melt platform technologies. At the same time as the loan agreement, Harrow Health was granted a five-year pre-emptive purchase option related to the third party’s rights to commercialize Melt drug candidates.
Harrow Health owns approximately 44% of Melt Pharmaceuticals, as well as a 5% royalty on MELT-300 sales.
About Melt Pharmaceuticals
Melt Pharmaceuticals, Inc. is a clinical stage pharmaceutical company specializing in the development and commercialization of patented non-intravenous and non-opioid sedative and analgesic drugs for short-term medical procedures in outpatient and inpatient settings. Melt’s core technology is a series of non-opioid sedative combinations that can replace or complement existing sedation techniques for more than 100 million medical procedures in the United States. To find out more about Melt, visit their website. www.meltpharma.com…
About Harrow Health
Harrow Health, Inc. (NASDAQ: HROW) is a medical company specializing in ophthalmology. The company owns and operates ImprimisRx, one of the country’s leading pharmaceutical companies specializing in ophthalmology, and Visionology, a subsidiary of an ophthalmic company specializing in the treatment of chronic eye diseases. Harrow Health also has non-controlling interests Eton Pharmaceuticals, Superficial ophthalmology and Melt Pharmaceuticals, all of which started as subsidiaries of Harrow Health, and are licensed to four clinical stage candidates being developed by Surface Ophthalmics and Melt Pharmaceuticals. For more information on Harrow Health, visit the investor section of the corporate website. www.harrowinc.com…
This press release contains “forward-looking statements” within the meaning of the US Private Securities Litigation Reform Act of 1995. Any statements in this release that are not historical facts may be deemed to be such “forward-looking statements”. Forward-looking statements are based on management’s current expectations and are subject to risks and uncertainties that could 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 the impact of the COVID-19 pandemic and any future health epidemics on our financial condition, liquidity and results of operations; our ability to make our compositions and technologies commercially available in a timely manner or in general; market acceptance of the Company’s wording and the marketing issues of the Company’s wording; risks associated with our prescription pharmacies; our ability to enter into other strategic alliances, including agreements with pharmacies, physicians and healthcare organizations to develop and distribute our formulations; our ability to obtain intellectual property protection for our assets; our ability to accurately assess our costs and expenditures of funds and, if necessary, raise additional funds; risks associated with research activities; the projected size of the potential market for our technologies and formulations; unexpected new data, security and technical problems; regulatory and market changes affecting pharmacies, outsourcing businesses and the pharmaceutical industry; competition; and market conditions. These and additional risks and uncertainties are further detailed in Harrow Health’s filing with the Securities and Exchange Commission, including its Form 10-K Annual Report and Form 10-Q Quarterly Reports. Such documents can be found free of charge on the SEC website at: www.sec.gov… Do not place undue reliance on forward-looking statements that are only valid as of the date they are made. Except as required by law, Harrow Health assumes no obligation to update any forward-looking statements to reflect new information, events or circumstances after the date on which they were made, or to reflect the occurrence of unforeseen events.