Roche has received approval from EU authorities for the child-size, lower strength version of its blockbuster flu treatment Tamiflu (oseltamivir). Smaller strength capsules provide convenient alternative for management of seasonal and pandemic influenza in children
Roche is the world leader in in-vitro diagnostics and drugs for cancer and transplantation, a market leader in virology and active in other major therapeutic areas such as autoimmune diseases, inflammation, metabolic disorders and diseases of the central nervous system. On 20th September 2007, the European Commission – Committee for Medicinal Products for Human Use (CHMP) has approved smaller child sized Tamiflu (oseltamivir) capsules of 30 mg and 45 mg doses.
Until now, Tamiflu was available in capsules containing a 75 mg dose of oseltamivir and as a powder for oral suspension for use in children. The new lower dose capsules provide a convenient alternative for the treatment and prevention of influenza types A and B in children one year and older. Furthermore, since the smaller capsules have a longer shelf life than the suspension formulation (five years vs. two years), they also offer an improved option for government pandemic stockpiling. The lower dose Tamiflu capsules were approved by the U.S. Food and Drug Administration (FDA) in July.
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.
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. Tamiflu is the only member of the neuraminidase class of drugs approved for use in treatment and prevention of influenza in children 1 to 5 years of age.
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. There is a high need for influenza treatments for children as they are more severely affected by seasonal influenza compared to adults.
- 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
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 totalling 215million treatments from more than 80 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.
Few governments to date have stockpiled paediatric antiviral formulations. 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.
In addition the WHO has recently updated their guidance on the clinical management of human infection with H5N1 virus with Tamiflu as the only antiviral strongly recommended for treatment of H5N1 infected patients.
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. The production process for Tamiflu is complicated, involving 10 main steps including complex processes such as azide chemistry. Manufacturing takes around six to eight months once the raw materials are in place, but according to Roche it would take any company starting from scratch two or three years to be able to produce the treatment on a large scale.
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.
Tamiflu represented 7 per cent of sales in Roche's pharmaceutical division, and was one of the unit's highest sellers, coming in fourth under MabThera/Rituxan (rituximab), Herceptin (trastuzumab) and Avastin (bevacizumab).