Harrow (Nasdaq: HROW), a leading U.S. eyecare pharmaceutical company, today announced the appointment of Mark Mannebach, Ph.D., R.Ph. as Head of Regulatory Affairs and Pharmacovigilance, responsible for overseeing and managing all regulatory related submissions and strategy related to the Company’s portfolio of new and existing products. Dr. Mannebach’s successful 30-year career in the pharmaceutical industry, much of which was focused in ophthalmology, includes leadership roles in regulatory affairs, quality assurance, program management and pharmaceutical product development.
“Dr. Mannebach brings to Harrow decades of regulatory and clinical expertise and leadership –specifically in ophthalmology – that we believe will be invaluable as we continue to execute on our strategic plan to expand our branded ophthalmic product portfolio,” said Mark L. Baum, Chairman and Chief Executive Officer of Harrow. “We believe Mark’s deep industry knowledge, extensive experience interfacing with U.S. regulatory agencies, and his long history of developing and implementing effective regulatory processes to comply with FDA guidelines and applicable federal laws, will greatly benefit Harrow as we launch IHEEZO™, leverage our recent product acquisitions, and pursue new product acquisition and development opportunities.”
Dr. Mannebach added, “I am pleased to join the Harrow management team and be a part of the transformational events that are underway. I look forward to using my expertise and experience to strengthen Harrow’s regulatory and compliance commitments and to facilitate productive interactions with the FDA to best ensure that Harrow advances the standard of ophthalmic care and ultimately provides eyecare professionals and their patients with access to Harrow’s innovative pharmaceutical products.”
In addition to acting as a regulatory and compliance consultant to various start-up biotech companies, Dr. Mannebach’s previous roles included serving as the Vice President of Global Regulatory Affairs at both Mallinckrodt Pharmaceuticals and then Santen Pharmaceuticals. Earlier in his career, Dr. Mannebach held roles of increasing responsibility at Sanofi, Pharmacia, Baxter, and Pfizer.
Harrow (Nasdaq: HROW) is a leading U.S. eyecare pharmaceutical company engaged in the discovery, development, and commercialization of innovative ophthalmic prescription therapies that are accessible and affordable. Harrow owns U.S. commercial rights to ten FDA-approved ophthalmic pharmaceutical products. Harrow also owns and operates ImprimisRx, the leading U.S. ophthalmic‑focused pharmaceutical compounding business, which also serves as a mail-order pharmacy licensed to ship prescription medications in all 50 states. Harrow has non-controlling equity positions in Surface Ophthalmics, Inc. and Melt Pharmaceuticals, Inc., companies that began as subsidiaries of Harrow. Harrow also owns royalty rights in four late-stage drug candidates being developed by Surface and Melt.
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 the continued impact of the COVID-19 pandemic and any future health epidemics on our financial condition, liquidity and results of operations; our ability to make commercially available our FDA‑approved products and compounded formulations and technologies in a timely manner or at all; market acceptance of the Company’s products and challenges related to the marketing of the Company’s products; risks related to our 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 products; 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 products; 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’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 website at 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 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.
Jamie Webb, Director of Communications and Investor Relations