Aspen to get lion's share in African Tamiflu production
in preparation for a possible avian influenza, Roche has asked
contract manufacturer Aspen Pharmacare to produce finished doses of
Tamiflu (oseltamivir) in Africa.
It is the first time Roche has agreed to share its know-how on Tamiflu with an African manufacturer, so Aspen becomes the first drugmaker in the continent with the capacity to produce the flu drug.
The agreement is non-exclusive and will mean that Roche and other sub-licensees will be able to work on pandemic orders within Africa, which the Swiss company insists it is actively pursuing.
"Roche has been very proactive in seeking manufacturers in Africa to produce Tamiflu, but producing the drug under quality conditions has to be a consideration as well," Roche spokeswoman Roseann Ward told In-PharmaTechnologist.com.
"Roche spoke to over 200 companies last year about such manufacturing deals and if companies are interested to take part in the production we will always consider them."
Under a technology licence agreement, Aspen will benefit from Roche's technical, pre-clinical and clinical data on Tamiflu and will also have its staff trained by Roche.
The drug will be manufactured in Aspen's Port Elizabeth-based Oral Solid Dose (OSD) facility which was approved by the US Food and Drug Administration (FDA) in 2004.
The manufacturing process is expected to take six to twelve months to evolve, starting first from lab batches, moving on to pallets and then to validation batches.
The agreement, whose financial details were not disclosed, also offers Aspen the option of receiving the active pharmaceutical ingredient (API) from Roche.
"More than likely we will get the API from Roche but will we also explore other options, particularly from Asian suppliers," Stavros Nikolaou, a senior executive at Aspen, told In-PharmaTechnologist.com.
"We don't know yet how much of the drug we will be making but the deal allows us to build up a capacity since speed is obviously very important when responding to a pandemic."
While Roche claims it remains on schedule to meet all orders from African governments by early 2007, the collaboration with Aspen, Africa's largest pharmaceutical manufacturer, will certainly further enhance the supply of Tamiflu for Africa.
Roche plans to ramp up its annual production capacity to 400m doses by the end of 2006, generating more and more business for vendors and contract manufacturers.
Since re-emerging in Asia in late 2003, the H5N1 avian influenza virus has spread to more than 40 countries.
It mainly infects birds but has affected 208 people and killed 115 of them.
Despite it being predominantly a bird disease, scientists are warning it could mutate into a form that transmits easily among humans and trigger a pandemic.
