SO-1105 (miconazole Lauriad®) is an antifungal agent, administered as a muco-adhesive buccal tablet for the treatment of oropharyngeal candidiasis in immunocompromised patients. SO-1105 was originally developed by Onxeo (ex-BioAlliance Pharma). It was first approved in October 2006 and has since been registered in 24 European countries, in South Korea, and in the United States.
SO-1105 has the potential to become the first treatment in tablet form for oropharyngeal candidiasis in Japan, to provide an important addition to available treatments, and to enhance patients' compliance and improve their quality of life. Sosei has acquired development and commercialization rights to SO-1105 in Japan from Onxeo.
- 28 Feb 2017
Sosei announces submission of marketing authorization application of SO-1105 for oropharyngeal candidiasis
- 29 Aug 2016
Sosei announces completion of Japanese Phase III clinical study of SO-1105 for oropharyngeal candidiasis and achievement of principal endpoints
- 04 Mar 2014
Sosei signs distribution agreement with FUJIFILM Pharma for commercialization of SO-1105
- 12 Mar 2013
Sosei announces initiation of Phase III study for SO-1105 for the treatment of oropharyngeal candidiasis
- 2 Jul 2012
Sosei announces successful completion of Phase I study for SO-1105 for the treatment of oropharyngeal candidiasis
- 8 Mar 2012
Sosei Announces Initiation of Phase I study for SO-1105
- 11 May 2011
Sosei Acquires Development and Commercialization Rights to Loramyc from BioAlliance Pharma
Fungal infections of the oral mucosa are most frequently caused by Candida species, with C. albicans being the most common species associated with such infections. Oropharyngeal candidiasis is commonly found in immuno-compromised patients, including HIV and cancer patients, and in other chronic disease states such as diabetes. For instance, oropharyngeal candidiasis is the most frequently occurring infection in head and neck cancer patients undergoing radiation therapy. The clinical presentation of oropharyngeal candidiasis is variable with symptoms including soreness, burning, and/or altered taste. The signs of clinical candidiasis usually include white pseudomembraneous plaques and patches (thrush), erythematous lesions or occasionally angular cheilitis. Left untreated, the condition may progress to involve the esophagus or to more serious systemic complications.