Sirion Therapeutics, Inc., an ophthalmic-focused biopharmaceutical company, announced today that it has received orphan drug designation from the Food and Drug Administration (FDA) for its anti-viral therapy, ganciclovir, for the treatment of acute herpetic keratitis. The product is currently marketed by Laboratoires Thea in Europe under the brand name of Virgan®. Sirion licensed the rights to Virgan® for the United States from Laboratoires Thea in January 2007.Orphan drug designation is a special status for diseases or conditions affecting fewer than 200,000 patients in the United States, granted by FDA upon request by a sponsor. Drugs that receive orphan drug designation obtain seven years of marketing exclusivity from the date of drug approval as well as tax credits for clinical trial costs, marketing application filing fee waivers and assistance from the FDA in the drug development process.
"We are pleased to receive orphan drug designation from the FDA for ganciclovir," said Christine Miller, Sirion's Vice President of Regulatory Affairs. "Topical ganciclovir has been available in Europe for the treatment of ocular viral infections for over 10 years. This product has the potential to advance medical treatment of herpes simplex keratitis in the U.S. Herpes simplex keratitis is a leading cause of corneal blindness in the United States."
According to data published in the journal Archives of Ophthalmology, herpes simplex keratitis affects approximately 50,000 people annually in the United States, arising as acute primary disease in 20,000 people and recurrent disease in an additional 28,000.
Adds Barry Butler, Sirion's President and CEO, "Sirion is pleased to be able to offer ophthalmologists an important tool to battle this blinding disease. It is gratifying to know that our work has the potential to help patients preserve their sight."
About Sirion Therapeutics, Inc.
Sirion Therapeutics is an ophthalmic biopharmaceutical company poised to compete in the $4 billion U.S. prescription ophthalmic market segment. Sirion is dedicated to the development and commercialization of innovative products to address unmet clinical needs. The company is currently developing a portfolio of product candidates that includes therapies in the areas of inflammatory diseases and conditions, allergy, dry eye, herpetic keratitis and dry age-related macular degeneration. Sirion is focused on growth through in- licensing, acquisition and geographic expansion. For more information regarding Sirion, please visit Sirion's website at http://www.siriontherapeutics.com
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