The Swiss pharmaceutical giant Roche said on Tuesday that it was now ready to allow other companies or governments to produce Tamiflu, a drug considered a first line of defence against a potential flu pandemic.
It also announced that it would go ahead with a new facility to produce the drug in the United States.
”We are prepared to discuss all the available options, including granting sub-licences, with any government or private company, who approach us to manufacture Tamiflu, or collaborate with us in its manufacturing,” said William Burns, head of Roche’s drugs division.
Just days after the Swiss-based group had signalled its reluctance to loosen its grip on an exclusive licence, Roche said discussions could include secondary licensing arrangements in the event of a flu pandemic.
However, it insisted that any partner must be able to ”realistically produce substantial amounts of the medicine for emergency pandemic use” and meet quality, safety and regulatory requirements.
The group has repeatedly warned that the production process is complex and costly.
Roche, which has had trouble satisfying booming demand for the drug despite racking up output, announced that the US Federal Drug Administration had given it approval for a new production facility for the drug in the United States.
The Swiss group has now received orders for national stockpiles from 40 countries. It has also donated enough Tamiflu to treat three million people to the World Health Organisation, and is facing demand from anxious private customers.
The spread of the human H5N1 strain of avian flu in birds migrating from Asia to Europe in recent weeks has prompted a rush for the drug in pharmacies.
Roche was aiming to raise output eight to tenfold over 2003 levels within 18 months on its own. The new US facility will be part of a network of 12 production centres.
A spokesperson for Roche told Agence France Presse that the government of Taiwan had contacted the group to look at ways of increasing production of Tamiflu.
She said: ”We received a letter from the Taiwanese government yesterday [Monday] and we are studying it.”
She said that so far this was the first approach by a country offering to collaborate in production of the anti-viral treatment.
The Financial Times reported last week that the Indian pharmaceutical manufacturer Cipla planned to produce a generic version of Tamiflu.
”We will sell it in many countries where there are no patents,” notably in Africa, the Middle East, Latin America and Asia,” Cipla’s joint managing director Amar Lulla told the newspaper.
Roche has exclusive commercial rights for the basic flu drug oseltamivir from US laboratory Gilead.
Until now, the Swiss company has refused to grant secondary licences, saying that it preferred to retain control of production to ensure quality control.
Burns, said on Tuesday that the top priority now was to increase production capacity quickly.
Some stages of the production process are already sub-contracted to partners. – AFP
