Showing posts with label Sirion Therapeutics. Show all posts
Showing posts with label Sirion Therapeutics. Show all posts

Monday, April 16, 2007

Sirion Therapeutics Receives Orphan Drug Designation for Ophthalmic Drug to Treat Viral Eye Infection

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

Monday, April 9, 2007

Sirion Therapeutics Completes $45 Million Series B Financing

Sirion Therapeutics, Inc., an ophthalmic-focused biopharmaceutical company, announced today that it has raised $45 million in a Series B private equity financing led by Aisling Capital. In addition to Aisling, the financing included new investors Investor Growth Capital, Atlas Venture, Advent International and Bear Sterns Healthcare Value Partners. Previous Series A investor NovaQuest also participated in the Series B round.

Andrew Schiff, MD, Managing Director of Aisling Capital commented, "Sirion's experienced management team has put together an impressive portfolio of products. We are pleased with the company's progress to date. It is extraordinary to have achieved so much in such a short period of time and we appreciate the opportunity to support them at a crucial time in the company's development."

Curt LaBelle, MD, Vice President of Investor Growth Capital, Inc. added "IGC is pleased to make this investment in Sirion. We think ophthalmology is an exciting area and the management team at Sirion has the experience to continue building an excellent ophthalmic company."

Barry Butler, President and CEO of Sirion Therapeutics, said that the proceeds from this raise will be used to advance the company's pipeline of products. "We are obviously delighted to be partnered with such high caliber investors and appreciate their confidence in our technology, management team and strategic direction. This investment will allow us to reach critical milestones in several of our development programs."

Sirion currently has four products in various stages of development:

ST-601. ST-601 is a potent ophthalmic steroid emulsion for the treatment of steroid responsive inflammatory diseases. A Phase III program was initiated in January 2007.

ST-602. ST 602 is a product aimed at reducing the accumulation of lipofuscin in the eye by inhibiting the formation of serum retinol. It is theorized that the accumulation of lipofuscin in the eye is responsible for vision loss in such diseases as dry age-related macular degeneration, geographic atrophy and Stargardt's disease. A Phase II trial commenced in December 2006.

ST-603. ST-603 is a topical preparation of cyclosporine A in the patented Sophisen ophthalmic delivery system. A clinical program commenced in Q1 2007.

ST-605. ST-605 is a topical ophthalmic gel containing ganciclovir for the treatment of certain viral and superficial eye infections. The product is currently marketed by Laboratoires Thia in Europe under the brand name of Virgan®.

About Sirion Therapeutics, Inc. Sirion Therapeutics is a Tampa, FL based biopharmaceutical company, with additional offices in La Jolla, California, dedicated to the development and commercialization of innovative ophthalmic products. For more information regarding Sirion, please visit Sirion's website at http://www.siriontherapeutics.com