Japanese firm to make modified Tamiflu dry syrup
of Roche's Tamiflu (oseltamivir) in a dry syrup formulation which
can be stored at room temperature after the bottle is opened,
allowing for more storage capacity as fears of a possible bird flu
pandemic spread.
The construction of the manufacturing facilities for this dry syrup is in the initial phase and if the work is completed as scheduled, production of the modified version of Tamiflu is expected to start for the 2009-2010 influenza season.
The decision to produce the modified version of Tamiflu is based on the difference between Europe, the US and Japan in how prescriptions are dispensed.
Normally in Europe and the US a medical organisation or a pharmacy will add water to a bottle of Tamiflu dry syrup and give it in liquid form to the patient.
In Japan, however, Tamiflu 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, so 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 10C) to avoid the influence of temperature or humidity.
To supply Tamiflu 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.
Moreover, taking into account that Tamiflu 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 bulk substances, while the formulation process for Tamiflu Dry Syrup will take place domestically at Chugai.
The company said it will continue to import Tamiflu Capsule 75 in finished formulation from Roche, and market it after packaging also at Chugai.
Chugai is prepared to supply a total of 12m treatments of Tamiflu 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 12m for the next season, the same volume as this past season.
Tamiflu, a neuraminidase inhibitor, reduces the severity and spread of traditional flu and is recommended by the World Health Organisation (WHO) as a front line treatment for bird flu.
In March, Roche expanded its external contractors to fifteen in nine different countries, as its needs for intermediates and finished product increased and companies such as Albemarle, Ampac, API Corporation, Clariant, DSM, FIS, Martek Biosciences, Novasep/Dynamit Nobel, PHT International, PPG Industries, Sanofi-Aventis, Shaanxi Jiahe Phytochem and Siegfried are now all involved in contributing to the overall production of Tamiflu.
Under further pressure in May to ensure cheap supplies of Tamiflu in Africa, Roche took a leap of faith and for the first time shared its know-how on Tamiflu with an African manufacturer, asking Aspen Pharmacare to produce finished doses of Tamiflu for the continent.
