News Releases

Feb. 12, 2002

Dainippon Licenses Out an Antianxiety, Antidepressant Agent

February 12, 2002 --- Dainippon Pharmaceutical Co., Ltd. (President: Kenjiro Miyatake) announced today that Dainippon had concluded an agreement to license out the Dainippon developed antianxiety/antidepressant agent "AC-5216" (development code; generic name as yet undecided) to Novartis Pharma AG, headquartered in Basel, Switzerland.

Under this agreement, Novartis Pharma receives the exclusive rights to develop and market "AC-5216" globally excluding Japan, China, Korea and Taiwan.

"AC-5216" is an antianxiety/antidepressant drug with an innovative mechanism that is different from existing benzodiazepine type anti-anxiety agents. Unlike most of the currently available antianxiety agents that belong to the benzodiazepine type, AC-5216 is an agonist for mitochondrial benzodiazepine receptors and promotes the production of neurosteroids, which act on the GABAA receptors.

Pre-clinical study data of "AC-5216" demonstrated that even at a low dose it produces anxiolytic-like and antidepressant-like effects. None of the adverse effects that are usually observed with existing benzodiazepine type drugs (i.e., muscle relaxation, amnesia and potentiation of the effects of ethanol and barbiturates) were observed. Preparations for Phase I clinical trials are currently underway in Japan.

Dainippon anticipates "AC-5216" will become one of its global strategic products and to this end intends to work closely with Novartis Pharma to promote the development of the agent on a worldwide basis, which will also enhance the efficiency of domestic development.