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
'"/>




Page: 1 2

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:
(Date:5/29/2015)... , May 28, 2015 Research and ... the "North America MRI Market - Growth, Trends ... offering. The North American MRI systems market ... in 2014 to $1.58 billion by 2020 with a ... are of three types namely, the open system, closed ...
(Date:5/29/2015)... N.J. , May 29, 2015 Actinobac ... companies originally funded with investments from Foundation Venture Capital ... at Bio International 2015 as part of the Start-Up ... announced FVCG President James M. Golubieski . ... the biotechnology industry, will be held in ...
(Date:5/29/2015)... Eli Lilly and Company (NYSE: LLY ... Healthcare Conference on Tuesday, June 9, 2015. Jeffrey ... Health, will participate in a fireside chat at 2:20 ... audio webcast will be available on the "Webcasts & ... . A replay of the fireside chat will be ...
Breaking Medicine Technology:North America MRI Market - Growth, Trends And Forecasts 2014-2019 with GE, Hitachi Medical, Philips Healthcare, Siemens Healthcare & Toshiba Medical Systems Dominating 2Foundation Venture Capital Group Portfolio Companies to be Highlighted at Bio International in June 2Foundation Venture Capital Group Portfolio Companies to be Highlighted at Bio International in June 3Lilly to Participate in Goldman Sachs Global Healthcare Conference 2
(Date:5/30/2015)... 30, 2015 AVT, the world leader ... is joining forces with leading proofing solutions provider Global ... worldwide printing market. , Under the agreement, ... engine for its offline inspection solutions, which are customized ... and its varying production workflow setups and printing applications. ...
(Date:5/30/2015)... Thousands of aesthetic industry professionals converged in ... the American Society for Aesthetic Plastic Surgery (ASAPS). ... the parent company of one of the fastest expanding ... growth, the one-of-a-kind device just sold its 2 millionth ... in the news for gaining the FDA’s stamp of ...
(Date:5/30/2015)... One of the pervasive problems plaguing ... options available. Often, the ruralness of a location can ... rural areas feeling the crunch of a strained healthcare ... of paying high premiums and copays, Online USA ... physicians via the power of the internet. , ...
(Date:5/30/2015)... May 30, 2015 ProIntro Magnify contains 30 ... and animations. Instantly add an elegant opening title to any ... a range of clean design layouts. ProIntro Magnify is created ... is extremely easy to use. Simply drag a preset into ... on-screen-controls and parameters in the Inspector window then watch as ...
(Date:5/30/2015)... Minnesota (PRWEB) May 30, 2015 ... acquired the Disability Income Associate (DIA) designation to ... The DIA designation is designed for insurance advisors, ... to further their knowledge and expertise associated with ... Earning the DIA designation is only the latest ...
Breaking Medicine News(10 mins):Health News:AVT and Global Vision Collaborate to Offer Cutting-edge Offline Inspection Solutions for Printing Industry 2Health News:AVT and Global Vision Collaborate to Offer Cutting-edge Offline Inspection Solutions for Printing Industry 3Health News:Dr. Paul Vitenas Meets with Zeltiq President and CEO in Montreal 2Health News:Dr. Paul Vitenas Meets with Zeltiq President and CEO in Montreal 3Health News:Online USA Doctors Brings Healthcare to the Masses with New E-Consults 2Health News:Online USA Doctors Brings Healthcare to the Masses with New E-Consults 3Health News:Announcing the release of ProIntro Magnify from Pixel Film Studios. 2Health News:Secura Consultants Expands Disability Insurance Expertise 2
... Studies conducted on the health effects of tea and alcohol ... while the latter can increase the chances of committing a ... effects of green tea, which is claimed to have numerous ... leukemia patients who drank the beverage had an improved clinical ...
... smokers who suffer from withdrawal symptoms at the Queensland's public ... inpatients of all the // public hospitals in the country ... cost, from 1 January 2006. ,As many ... year. ,Nicotine is capable of creating blood ...
... study has indicated that the use of short wide glasses ... to 30% more. This has been published in the ... small glasses than in the narrow tall glasses of the ... by professional bartenders. ,The study involved 198 ...
... Report of the rising rates of infection with C.difficile ... the mutation of the microorganism into a more virulent ... only manifest in individuals with resistance to antibiotics. ... among non-hospitalized patients has created much panic among the ...
... Merck & Co, known as MSD India, has entered into ... to conduct studies on the former's investigational cervical cancer drug, ... development in India. Under the agreement, clinical trials will be ... cervical cancer. ,The vaccine that has been developed by ...
... has revealed that there is no evidence which proves that ... billion by way of lost wages as a result of ... the British Medical Journal recommends moderation while drinking to prevent ... based product, tropisetron, fructose, tolfenamic acid, artichoke, prickly pear, and ...
Cached Medicine News:Health News:Rising Rates Of C.Difficile Infection Among Non-Hospitalized Patients 2Health News:Merck, ICMR to conduct joint trials on cervical cancer vaccine 2
... PelviSoft® Acellular Collagen BioMesh, provides ... tissue together with the porosity of ... for use in pelvic floor reconstruction. ... and cystocele prolapse, where plication alone ...
... Allograft meets the demanding ... floor reconstructive procedures, and ... suture pull-through, demonstrating long-term ... a structural support for ...
The High Pure Viral RNA Kit is intended for general laboratory use and is designed to purify viral RNA from serum or plasma. Viral RNA is used for RT-PCR analysis directly after elution in nuclease-f...
... The QIAamp Viral RNA Mini ... nucleic acids from cell-free fluid ... acids that can be isolated ... are not limited to, RNA ...
Medicine Products: