VCBeat (WeChat Official Account: vcbeat) has learned that Harrow Health and its subsidiary, Melt Pharmaceuticals, recently entered into a definitive stock purchase agreement. Under this agreement, Melt Pharmaceuticals secured $11 million in Series A financing from Harrow Health. The proceeds will be used to advance the development of MELT-100, Melt Pharmaceuticals’ patented flagship 505(b)(2) candidate drug. MELT-100 is designed to provide moderate conscious sedation for patients undergoing cataract surgery and other outpatient procedures, without the need for intravenous administration or opioids. It is formulated for sublingual delivery, where the drug dissolves under the tongue for absorption into the bloodstream.
Upon completion of this financing round, Melt Pharmaceuticals will spin out from Harrow Health, with Harrow retaining an approximately 44% ownership interest in Melt, including 3.5 million shares of common stock. In addition, Harrow holds a 5% royalty on all circulating drug assets of Melt Pharmaceuticals (including MELT-100), which is expected to generate significant value for shareholders.
Mark L. Baum, CEO of Harrow Health, stated, “It is as if we have established a new company, assembled an experienced and dedicated management team, and secured third-party capital to fund the development of FDA-approved drug candidates.”
Concurrent with the financing round, Greg Madison was appointed Chief Executive Officer of Melt Pharmaceuticals. Most recently, Mr. Madison served as CEO of Keryx Biopharmaceuticals, where he led the company’s transition from a development-stage enterprise to a fully integrated commercial organization and drove revenue growth by expanding the market reach of its flagship product. Prior to his tenure at Keryx, he served as Chief Business Officer of AMAG Pharmaceuticals, a specialty pharmaceutical company, and spent 12 years at Genzyme (a Sanofi company) in Waterford, ultimately serving as Vice President and General Manager of the Renal Division.
Madison commented, “Our mission is to bring innovative non-opioid, non-intravenous therapies for conscious sedation and pain management to market. The market opportunity for sublingual administration in conscious sedation and pain relief is substantial, as there are numerous procedures where this technology could serve as a potential alternative to traditional intravenous therapies. Given that approximately 4.4 million cataract surgeries are performed annually in the United States, our initial goal is to position the product for use prior to cataract surgery. As a non-opioid alternative, this formulation can help address one of today’s most pressing challenges—opioid addiction and overdose.”
Madison concluded, “Our meeting with the FDA two weeks ago to discuss the clinical development plan for MELT-100 yielded satisfactory outcomes. We believe that the Series A financing is sufficient to advance the MELT-100 program to Phase 3. Meanwhile, we expect to submit our Investigational New Drug (IND) application in 2020 and initiate patient enrollment in clinical trials thereafter.”
Melt Pharmaceuticals is a pharmaceutical company whose core technology consists of a series of non-opioid sedative formulations, capable of replacing or supplementing the sedation methods currently used in over 100 million medical procedures in the United States. Currently, Melt Pharmaceuticals is seeking FDA approval for its proprietary technology under the 505(b)(2) regulatory pathway.
Melt Pharmaceuticals’ vision is to become the preferred supplier of non-opioid, non-intravenous sedation and analgesia medications for medical procedures in hospitals, outpatient centers, and offices.
Harrow Health (NASDAQ: HROW) operates a portfolio of healthcare businesses, including ImprimisRx, a leading national compounding pharmacy specializing in ophthalmic medications. The company holds significant equity stakes in Eton Pharmaceuticals, Surface Pharmaceuticals, Melt Pharmaceuticals, Mayfield Pharmaceuticals, and Radley Pharmaceuticals, all of which are subsidiaries of Harrow Health. Currently, Harrow Health’s healthcare operations are undergoing a transformation.
(Compiled by Ning Chen)