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

TAMPA, Fla., April 16, 2007 /PRNewswire/ -- 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(R). Sirion licensed the rights to Virgan(R) 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 sig ht."

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.

CONTACT: Penny Cobb, +1-813-496-7325 ext. 221, pcobb@siriontherapeutics.com

Web site: http://www.siriontherapeutics.com/

Terms and conditions of use apply
Copyright © 2007 PR Newswire Association LLC. All rights reserved.
A United Business Media Company


'"/>




Related medicine technology :

1. Sirion Therapeutics Announces Clinical Data to be Presented at the 2007 Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting
2. Cell Therapeutics, Inc. Management to Discuss Todays Announcement of Interim Pixantrone Study Results
3. Halozyme Therapeutics Enhanze Technology Large Protein Molecule Therapeutic Clinical Trial Results Presented at the 34th Annual Meeting of the Controlled Release Society
4. CV Therapeutics Identifies Potential Anti-Diabetic Mechanism of Action for Ranexa
5. Fat Kills Cancer: Turning Stem Cells from Fat Tissue into Personalized, Cancer-Targeted Therapeutics
6. A 4-Week Therapy with Transition Therapeutics E1-I.N.T. Leads to Sustained Reductions in Blood Glucose Levels for 6 Months Post-treatment in Type 2 Diabetes Patients
7. Clinical Trial Suggests Bone Marrow Stem Cells Are Useful for Spinal Cord Injury; PrimeCell Therapeutics Provided Pre-Clinical Study
8. Opexa Therapeutics Reports Positive Top-line Data in Phase I/II Extension Trial with Tovaxin for Multiple Sclerosis
9. Orexigen Therapeutics to Present Data on Contrave Impact on Visceral Fat and Insulin Resistance at American Diabetes Association 67th Scientific Sessions in Chicago June 23
10. Allos Therapeutics Reports Results for Phase 3 Enrich Study of Efaproxyn in Women With Brain Metastases Originating From Breast Cancer
11. Trophos Publishes ALS Article in Journal of Pharmacology and Experimental Therapeutics
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/23/2017)... 23, 2017  Genesis Healthcare Services has merged with ... made by Bill Monast , President and CEO ... Nathan Feltman , executives with Home Health Depot, ... This acquisition helps Hospice Cloud maintain ... enabled durable medical equipment (DME) solutions for the hospice ...
(Date:2/23/2017)... Feb. 23, 2017 Nevro Corp. (NYSE: NVRO), a ... for the treatment of chronic pain, today reported financial results ... 2016. 2016 Accomplishment & Highlights: ... 2016, an increase of 228% as reported, over the prior ... an increase of 612% over the prior year ...
(Date:2/23/2017)... 2017 Research and Markets has announced the ... 2016" report to their offering. ... The latest research Fibromyalgia Drugs Price Analysis ... the global Fibromyalgia market. The research answers the following ... for Fibromyalgia and their clinical attributes? How are they positioned in ...
Breaking Medicine Technology:
(Date:2/24/2017)... ... ... Fiber Network (IFN) President and CEO Kelly C. Dyer recently announced that he will ... the Management Committee when IFN was originally formed in 2002 where he was ultimately ... of the business plan. He became the first paid employee of IFN in ...
(Date:2/24/2017)... MI (PRWEB) , ... February 24, 2017 , ... ... in Charlevoix, once again hosted their Military Wedding Giveaway, with the winning ... hosted by Castle Farms with services generously donated from local vendors: A Matter ...
(Date:2/23/2017)... FL (PRWEB) , ... February 23, 2017 , ... ... non-profit organization devoted exclusively to funding innovative lymphoma research and serving the lymphoma ... – will return to the La Gorce Country Club in Miami Beach to ...
(Date:2/23/2017)... ... 2017 , ... Hamlin Dental Group and Dr. Hamid Reza, dentist in ... the month of February, patients who visit Hamlin Dental Group will receive a ticket ... two at the Cheesecake Factory. , Tickets are available for routine dental visits ...
(Date:2/23/2017)... ... ... Dr. David Mahon leads Siena Dental, a comprehensive dental practice located at 10075 ... Patient Rated Henderson Dentist by Find Local Doctors earlier this year. ... who have earned high ratings and superior patient reviews from multiple credible sources. , ...
Breaking Medicine News(10 mins):