Last updated on April 21, 2014 at 5:21 EDT

Sosei Announces Successful Completion of Phase I Study for SO-1105 for the Treatment of Oropharyngeal Candidiasis

July 1, 2012

TOKYO, July 2, 2012 /PRNewswire/ –

Sosei Group Corporation (“Sosei”; TSE Mothers Index: 4565), the biopharmaceutical
company, today announces that its wholly owned Japanese subsidiary, Sosei Co., Ltd., has
successfully completed a Japanese Phase I trial for SO-1105 for the treatment of
oropharyngeal candidiasis. SO-1105 was originally developed by a French pharmaceutical
company, BioAlliance Pharma, which received its first marketing authorization for SO-1105
in France in October 2006. SO-1105 has since been registered in 26 European countries, in
South Korea, and in the United States, under the trade names Loramyc(R)/Oravig(R).

The clinical study was conducted in a single study centre in Japan, and was designed
to evaluate the pharmacokinetics and safety of SO-1105 in healthy Japanese adults.

SO-1105, a once daily muco-adhesive buccal tablet containing 50 mg of miconazole
administered to the buccal mucosa in 12 healthy volunteers provided a 24-hours sustained
high concentration in saliva and on the infection site (upper surface of the tongue). In
addition, low plasma concentration indicates that no serious systemic adverse events can
be expected. Results from the Phase I study also showed that SO-1105 had a good overall
safety profile, and that usability and compliance were good.

SO-1105 has the potential to become the first long-acting, sustained-release treatment
in tablet form for oropharyngeal candidiasis in Japan that could enhance patients’
compliance and quality of life.

Shinichi Tamura, CEO of Sosei Group Corporation, commented: “This is an important step
forward in development of SO-1105. We will continue our efforts to bring this widely used
drug to the Japanese market as quickly as possible.”

Notes for Editors:

About Oropharyngeal Candidiasis

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

About Sosei

Sosei is an international biopharmaceutical company anchored in Japan with a global
reach. It practises a reduced risk business model by acquiring compounds from, and
bringing compounds into, Japan through exploitation of its unique position within global

For further information about Sosei, please visit http://www.sosei.com.

About BioAlliance Pharma

Dedicated to cancer and supportive care – cancer related pathologies, chemotherapy and
radiotherapy-induced complications and opportunistic infections in immunocompromised
patients – BioAlliance conceives and develops innovative products, especially in the
hospital setting and for orphan or rare diseases.

For more information, visit the BioAlliance Pharma web site at


SOURCE Sosei Group Corporation

Source: PR Newswire