Experienced Team to Advance Ocular Surface Disease Care by Seeking FDA-Approval for Three Branded Drug Programs Through FDA's 505(b)(2) Development Pathway
SAN DIEGO, Oct. 24, 2017 /PRNewswire/ -- Imprimis Pharmaceuticals, Inc. (IMMY), an ophthalmology-focused pharmaceutical company, today announced it has filed a Form 8-K with the SEC which contains a corporate presentation for its subsidiary, Surface Pharmaceuticals, Inc. The Surface presentation is also available at www.SurfacePharma.com.
Surface Pharmaceuticals intends to advance state of the art treatments for ocular surface diseases by seeking FDA approval for three drug candidates for up to five indications. Surface's drug candidates were formulated using technology covered by two issued patents and three pending patent applications. Certain Surface drug formulations have been prescribed as compounded drugs and have demonstrated considerable anecdotal human clinical success. The markets for Surface's drug candidates include dry eye disease and blepharitis, both of which exceed 1 billion dollars in annual U.S. pharmaceutical sales.
Imprimis intends to follow the template of the Eton Pharmaceuticals spin-off it completed in June of 2017, with Surface being separately managed and funded outside of Imprimis. Once funded, Imprimis expects that Kamran Hosseini, MD, PhD, an executive and scientist with a proven track record of developing and achieving FDA approval for ophthalmic drugs, will become the CEO of Surface. The Surface Board will be chaired by renowned ophthalmologist and businessman Richard L. Lindstrom, MD and will also include ophthalmology leader, businesswoman and former CEO of Santen, Inc., Adrienne Graves, PhD, as well as Louis Drapeau, former CFO of InSite Vision and Nektar Therapeutics, and former CEO and CFO of BioMarin Pharmaceuticals.
ABOUT DRY EYE DISEASE
Dry Eye Disease is estimated to affect up to 30 million Americans and is commonly characterized by irritated, gritty, scratchy or burning eyes, blurred vision, and feeling particles in the eye when there are none. Advanced Dry Eye Disease may damage the front surface of the eye and ultimately impair vision. The Imprimis Cyclosporine-based formulations, which are made from FDA-approved drug components and compounded in FDA-inspected facilities, require a patient specific prescription and may be customized according to patients' individual needs.
According to the Mayo Clinic, Blepharitis is inflammation of the eyelids. Blepharitis usually involves the part of the eyelid where the eyelashes grow and affects both eyelids. Blepharitis commonly occurs when tiny oil glands located near the base of the eyelashes become clogged. This leads to irritated and red eyes. Several diseases and conditions can cause Blepharitis. Blepharitis is often a chronic condition that is difficult to treat. Blepharitis can be uncomfortable and may be unsightly, although it usually doesn't cause permanent damage to eyesight, and is not contagious.
ABOUT IMPRIMIS PHARMACEUTICALS
Imprimis Pharmaceuticals, Inc. (IMMY) is an ophthalmology-focused pharmaceutical company that produces and dispenses high quality innovative medications in all 50 states. Imprimis is dedicated to patient access and affordability to many critical medicines. Headquartered in San Diego, California, Imprimis produces and dispenses from both California and New Jersey. Imprimis is the largest shareholder of Eton Pharmaceuticals, Inc. (www.etonpharma.com), a company it spun out in 2017. For more information about Imprimis, please visit the corporate website at www.ImprimisRx.com.
ABOUT SURFACE PHARMACEUTICALS
Surface Pharmaceuticals, Inc. is focused on development and commercialization of innovative therapeutics for ocular surface diseases utilizing the U.S. Food and Drug Administration's 505(b)(2) regulatory pathway. Its current drug pipeline consists of three proprietary product candidates. Its patent-pending preservative-free topical eye drop product candidates, SURF-100 and SURF-200, utilize a patented delivery vehicle known as Klarity DropsTM that was invented by Surface's chairman of the board and renowned ophthalmologist Richard L. Lindstrom, MD. Klarity DropsTM are designed to protect and rehabilitate the ocular surface pathology for patients with dry eye disease. SURF-300 is a patent-pending oral capsule that targets patients also suffering from DED signs & symptoms. Surface is a subsidiary of Imprimis Pharmaceuticals, Inc.
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; whether Imprimis or Surface are able to secure funding to support Surface's product development efforts, whether Surface is able to establish or maintain an executive management team and board of directors in accordance with its expectations; 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 Imprimis' 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, Imprimis 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.
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