Roche has received a positive opinion from EU regulators recommending the approval of low-dose capsules of the blockbuster flu drug Tamiflu (oseltamivir), providing a more convenient dosage form for children.
The new 30mg and 45mg capsules were approved in the US earlier this month, and if approved in the EU will offer a much more user-friendly alternative to the syrup formulation currently used to treat children.
The new dose capsules will be available in time for the upcoming flu season, assuming there are no problems with the EU approval.
The lower dose capsules will follow the same administration routine as the currently available 75mg adult dose, but the exact regimen will depend on the weight of the child, for example a combination of the 30mg and 45mg capsules could be required to achieve an appropriate dose in some children.
The current treatment routine for the 75mg capsule in adults is one capsule twice a day for five days for treatment of flu, one capsule daily for ten days for post-exposure prophylaxis, and one capsule every day for up to six weeks to protect against seasonal influenza.
Roche will continue to manufacture the syrup formulation for use in patients for whom the capsules are inappropriate.
The low-dose capsules have a considerably longer shelf-life than the suspension formulation, five years as opposed to two, and require much less storage space - significant advantages in terms of stockpiling to protect against a pandemic outbreak.
The capsules themselves will be smaller than the 75mg version, with less of the active ingredient filled in the capsule, but will require the same drawn out manufacturing process as the existing formulations.
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 two or three years to be able to produce the treatment on a large scale if they started from scratch.
As such, the company is sitting in an enviable position, with Tamiflu currently the drug of choice among governments seeking to protect their countries against the threat of pandemic flu.
Roche ramped up production capacity for Tamiflu following bulk orders and high demand for the drug in the wake of warnings about the threat of flu pandemics and scares resulting from cases of avian flu in humans.
Between 2004 and 2006, the company increased production capacity 15 fold, upping capacity to 400 million doses through a global manufacturing network involving 19 partner companies in 10 different countries, as well as other third party manufacturers.
However, earlier this year, the company realised that production was well in excess of demand, having received government orders to date totalling around 220 million courses. With these orders all about to be fulfilled, the company decided to scale back production in line with current demand, though continues to maintain a buffer stock of intermediates and active ingredient oseltamivir in order to respond rapidly should an increase in production be required.
Tamiflu itself is a member of the neuraminidase class of drugs, active against all clinically relevant influenza viruses. It is the only such drug to be approved for use in treatment and prevention of influenza in children aged one to five years, according to the company.
While the 2006/2007 flu season was relatively mild, resulting in lower demand for Tamiflu for seasonal use, sales of the drug in the first half of 2007 were still impressive. Roche's figures showed a 39 per cent increase (in local currencies) in sales of Tamiflu over the first half, coming in at around CHF1.3bn (€0.8bn).
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).