Breaking News on Contract Research, Manufacturing & Clinical Trials

Roche updates on flu manufacturing; expands US unit

By staff reporter , 26-Apr-2007

Roche gave an update on its manufacturing of influenza drug Tamiflu (oseltamivir) today, saying that while it had reached its target capacity of 400 million doses a year, demand is running much lower.

The Swiss giant ramped up its capacity to make Tamiflu last year via an internal expansion programme and the creation of a network of 19 contract manufacturing partners around the world, prompted by huge orders for the drug from governments wanting to stockpile supplies as part of their pandemic preparedness plans.

 

 

 

Just over a year ago the company said that 100 million of its total capacity could be supplied from outsourcing contracts.

 

 

 

William Burns, CEO of Roche Pharma, said: "To date we have had orders from governments amounting to about 215 million treatments in total."

 

 

 

"We can satisfy significant additional orders from governments and corporations and unless the demand picks up Roche will be tailoring its production schedule accordingly," he added, stressing that the firm will maintain a buffer stock "while remaining in close contact with our manufacturing partners to respond speedily to a surge in demand."

 

 

 

A trigger for an increase in production would be if the World Health Organization finds that human-to-human transmission of bird flu has occurred, which could signal the start of a pandemic.

 

 

 

That aside, the product is still proving an enormous commercial success for Roche on the back of fears that a global flu pandemic may be around the corner. Sales in 2006 soared 68 per cent to 2.63 billion francs (€1.6bn), although the rate of growth slowed to 47 per cent in the first quarter of this year.

 

 

 

Meanwhile. Roche announced various projects to boost the usefulness of Tamiflu in the event of a major flu outbreak, including: preclinical studies to optimise the dose of the drug against different strains of the currently circulating H5N1 bird flu; studying its ability to prevent flu in people exposed to the virus; looking at the safety and effectiveness of a higher dose (300mg versus 150mg/day); and developing new formulations, including a low-dose oral version for children and an intravenous version.

 

 

 

US expansion

 

 

Meanwhile, Roche also said yesterday it had embarked on a $60m (€45m) expansion of its process development and bulk active ingredient manufacturing facility in South Carolina, US, operated by its Roche Carolina subsidiary.

 

 

 

The money will be used to build a new multi-purpose production unit in an existing manufacturing building, and should lead to the creation of 25 to 30 new positions at the facility in Florence, which currently employs around 70 chemists and technicians.

 

 

 

Construction is scheduled to begin in the middle of this year and complete by the end of 2008, said the company.

 

 

 

The investment programme will hike the number of production units at the facility from three to four, operating alongside Roche Carolina's development laboratories, and provide a significant increase in manufacturing capacity. The unit can already handle multi-step organic synthesis from small demonstration lots to metric ton commercial scale production, said the firm.

 

 

 

Roche Carolina focuses on process development for its Swiss parent, as well as the supply of clinical trial materials. It has contributed to the development of manufacturing protocols for a number of Roche's leading brands, including cancer drug Xeloda (capecitabine), Pegasys (peginterferon alfa-2a) for hepatitis, Tamiflu and Xenical (orlistat) for obesity.

Related products

Key Industry Events

Interphex 2014

New York, NY 10001 / Conference and exhibition

Read more

Access all events listing