Domestic Manufacturing Of A Modified Version Of The Anti-Influenza Drug Tamiflu(R) Dry Syrup 3%
The construction of the manufacturing facilities for Tamiflu(R) Dry Syrup is in the initial phase at Chugai Pharma Manufacturing Co., Ltd. ("CPMC"), Chugai's wholly-owned subsidiary. If the work is completed as scheduled, production of the modified version of Tamiflu(R) Dry Syrup is expected to start for the 2009-2010 influenza season.
The decision to produce the modified version of Tamiflu(R) Dry Syrup is based on the difference between Europe/US and Japan in how prescriptions are dispensed. Normally, in Europe and the US a medical institution or a pharmacy will add water to a bottle of Tamiflu(R) Dry Syrup and give it in liquid form to the patient. In Japan, however, Tamiflu(R) Dry Syrup is measured out according to the patient's weight, and then the patient receives the drug as divided powder dry syrup. In some cases, the remaining powder dry syrup is stored for a long period after opening. Therefore, if the opened Tamiflu Dry Syrup bottle is to be stored for longer than four weeks, it must be kept in a refrigerator or cool place (under ten degrees centigrade) to avoid the influence of temperature or humidity.
To supply Tamiflu(R) Dry Syrup in a way appropriate with Japan's actual prescription setting by changing some of the formulation ingredients, Chugai decided to domestically develop and manufacture the product as a modified version which can be stored at room temperature after the bottle is opened. Additionally, taking into account that "Tamiflu(R) Dry Syrup" may be stored until the next influenza season, Chugai plans to extend the expiry date from the current two years to a longer period of time.
No changes will be made in the production of Tamiflu(R) bulk substances, while the formulation process for Tamiflu(R) Dry Syrup will take place domestically at CPMC. Chugai will continue to import Tamiflu(R) Capsule 75 in finished formulation (capsule) from Roche, and market it after packaging also at CPMC. Supply Plan of "Tamiflu(R) for the 2006-2007 Influenza Season.
Chugai is prepared to supply a total of 12 million treatments of Tamiflu(R) in capsule and dry syrup formulations, which would be required in the event of an influenza season on the scale of the largest outbreak in the last ten years, based on fixed-point surveillance. Chugai plans to supply 12 million for the next season, the same volume as this past season.
Tamiflu(R) is a trademark of F. Hoffmann-La Roche Ltd., Basel, Switzerland.
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