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August 10, 2011

Additional Indication Application for Synthesized Penicillin "PASETOCIN®"

Tokyo, Japan, August 10, 2011 --- Kyowa Hakko Kirin Co., Ltd. ("Kyowa Hakko Kirin") announced today that it has submitted an additional indication application in the public domain within Japan for changes in the maximum dosages (Refer to "Product Overview and Application Details") of its synthetic penicillin "PASETOCIN® Capsules 125," "PASETOCIN® Capsules 250," "PASETOCIN® Fine Granules 10%," and "PASETOCIN® Tablets 250" (Generic name: amoxicillin hydrate, "PASETOCIN") for use in treatment of pediatric infectious diseases.

As a result of a review by the "Review Committee on Unapproved Drugs and Indications with High Medical Needs" conducted in December 2010 for the uses of PASETOCIN in pediatric applications, the Ministry of Health, Labor and Welfare submitted a request to Kyowa Hakko Kirin for development of new dosages of PASETOCIN. In light of this request, Kyowa Hakko Kirin submitted an official indication of its desire to submit an application in the public domain on January 24, 2011 for an additional indication of PASETOCIN. Thereafter, the indication was evaluated as an application in the public domain by the "Review Committee on Unapproved Drugs and Indications with High Medical Needs" in June 2011. Furthermore on August 1, 2011 the Second Committee of the "New Drugs of the Pharmaceutical Affairs and Food Sanitation Council" determined that an application in the public domain would be allowed based on its own preliminary evaluations.

Cases of difficulties in treating otitis media (tympanitis) and other pediatric infectious diseases are on the rise due to the increasing incidence of the likes of penicillin-resistant Streptococcus pneumoniae (PRSP). This medicine is a broad spectrum antibiotic that, when administered in higher doses, promises to be effective against various bacterial strains. As such, having also considered factors such as the approval status of the medicine overseas, we have filed "Application Based on Evidence in the Public Domain" regarding a change in the maximum daily applied dose with respect to indicated strains and indications that have already been approved.

We will be a Japan-based Global Specialty Pharmaceutical Company contributing to human health and well-being worldwide through innovative drug discovery and global commercialization.




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