Key Products Key Products
Antivirals
ARYS-01 (Sorivudine), An Antiviral for Treatment of Herpes zoster (Shingles)
aRigen is developing sorivudine formulated in a topical cream (ARYS-01 Cream), of which tablets were once approved in Japan for the treatment of herpes zoster. Sorivudine is highly and selectively active against a number of herpes viruses such as herpes simplex virus type 1 and varicella-zoster virus (VZV) compared with existing anti-herpesviral agents. Particularly, the activity against VZV was the most potent among tested compounds. Therefore, ARYS-01 Cream is expected for clinical application to herpes zoster, for which only a few useful drugs are available.
The initial IND of ARYS-01 Cream, 3% was submitted with the US FDA, in March, 2005, and the Phase I study was completed in the same year. aRigen announced in December, 2006, results of clinical Phase II study of ARYS-01 Cream in the US targeting immunocompetent adult zoster patients. Results of the study have revealed preliminary clinical efficacies of improvement of zoster rash and early reduction of zoster-　associated pain, safety in patients, and local skin tolerability. In addition, drug absorption was clarified and any drug effect was not seen on reduction of the DPD activity, the 5-FU catabolizing key enzyme of peripheral blood mononuclear cells of patients below the normal range. Therefore, undesirable adverse effects of orally administered sorivudine which are observed when combined with 5-FU are not likely to occur with ARYS-01 Cream. A Phase II/III study of ARYS-01 Cream is in process.
In July, we concluded a License agreement with Centaur Pharmaceuticals Pvt. Ltd. regarding our product ARYS-01 and granted the rights to them exclusively for India, Sri Lanka and Nepal　Bhutan.