Roche files application in Europe for Tamiflu 30 and 45 mg capsules
Alternative to suspension for seasonal and pandemic use in children
Basel, 16. February, 2007 - Roche has filed an application with regulatory authorities in Europe requesting an extension of the current Tamiflu license to include smaller capsules of 30 mg and 45 mg in addition to the 75 mg capsule already registered. These lower dosage strengths have been developed mainly for use in children for seasonal and pandemic influenza, as an alternative to the suspension formulation. Tamiflu small capsules would also be useful in the elderly or other adults that have difficulty swallowing the 75 mg capsule. Roche has been granted an accelerated review and is optimistic that EMEA will complete their evaluation by mid-year.
An application will also be filed with the Food and Drug Administration (FDA) in the US shortly.
The application was filed based on information already available for the 75 mg capsule. The method of manufacturing will remain the same and the only change will be the size of the capsule and the amount of the active ingredient, oseltamivir, filled into the capsule.
As well as being used to manage seasonal influenza, the 30 mg and 45 mg capsules will be an important component in government pandemic preparedness. They provide:
* A better option for stockpiling for paediatric use, given the longer shelf life compared to paediatric suspension.
* Easier and more convenient dosing by parents. These unit dosing capsules could also allow accurate preparation of an extemporaneous formulation (the contents of the capsules can be used for oral dosing of a solution).
A number of governments have stockpiled Active Pharmaceutical Ingredient (API) as an option, particularly for children, in the event of a pandemic. However the preparation of the API into a drinking solution is logistically more challenging and time consuming than distributing capsules. Therefore, Roche is now in the process of offering additional services for encapsulating existing API stockpiles, particularly with the new formulations. A number of countries are in discussion regarding this exchange and Finland has already exchanged all of its API for capsules.
Tamiflu, an oral neuraminidase inhibitor, is designed to be active against all clinically relevant influenza viruses. It works by blocking the action of the neuraminidase enzyme on the surface of the virus. When neuraminidase is inhibited, the virus is not able to spread to and infect other cells in the body.
Flu’s Impact on Children
Influenza is particularly dangerous for the most vulnerable and this includes young children and infants. Children younger than two years old are as likely as those over age 65 to be hospitalized because of influenza. It is estimated that children are three times more likely to get sick with the flu – on average, one in 10 adults is affected by influenza annually, compared with one in three children.
About Tamiflu (oseltamivir)
* 38 percent reduction in the severity of symptoms
* 67 percent reduction in secondary complications such as bronchitis, pneumonia and sinusitis in otherwise healthy individuals
* 37 percent reduction in the duration of influenza illness
* Tamiflu was shown to provide up to 89 percent overall protective efficacy against clinical influenza in adults and adolescents who had been in close contact with influenza-infected patients
* In children, Tamiflu delivers:
* 36 percent reduction in the severity and duration of influenza symptoms
* 44 percent reduced incidence of associated otitis media as compared to standard care
Roche’s efforts to support government pandemic stockpiling
The World Health Organization (WHO) advises that stockpiling antivirals in advance is presently the only way to ensure that sufficient supplies are available in the event of a pandemic. Roche has been working closely with WHO and national governments to ensure governments are aware of the importance of stockpiling antivirals in the event of a pandemic situation. Roche has received and fulfilled pandemic orders for Tamiflu from more than 75 countries worldwide. The magnitude of these orders varies with some countries, France, Finland, Iceland, Ireland, Luxembourg, Netherlands, New Zealand, Norway, Switzerland and UK stockpiling or intending to stockpile adequate Tamiflu to cover 20-40% of their population. Roche has also donated 5.125 million courses of Tamiflu treatment to the WHO for international rapid response and regional response to a pandemic influenza strain.
Roche and Gilead
Tamiflu was invented by Gilead Sciences and licensed to Roche in 1996. Roche and Gilead partnered on clinical development, with Roche leading efforts to produce, register and bring the product to the markets. Under the terms of the companies’ agreement, amended in November 2005, Gilead participates with Roche in the consideration of sub-licenses for the pandemic supply of oseltamivir. To ensure broader access to Tamiflu for all patients in need, Gilead has agreed to waive its right to full royalty payments for product sold under these sub-licenses.
Headquartered in Basel, Switzerland, Roche is one of the world’s leading research-focused healthcare groups in the fields of pharmaceuticals and diagnostics. As a supplier of innovative products and services for the early detection, prevention, diagnosis and treatment of diseases, the Group contributes on a broad range of fronts to improving people’s health and quality of life. Roche is a world leader in diagnostics, the leading supplier of drugs for cancer and transplantation and a market leader in virology. In 2006 sales by the Pharmaceuticals Division totalled 33.3 billion Swiss francs, and the Diagnostics Division posted sales of 8.7 billion Swiss francs. Roche employs roughly 75,000 people in 150 countries and has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai. Additional information about the Roche Group is available on the Internet at www.roche.com.
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- Contact Information
- Katja Prowald
- Head R&D Communications
- Roche Group
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