30 April 2009 23:15 [Source: ICIS news]
NEW YORK (ICIS news)--Swiss pharmaceutical major Roche is ready to ramp up production of Tamiflu, a company official said on Thursday, as pharmaceutical chemical companies respond to the swine flu outbreak.
Chemical manufacturers associated with Tamiflu, one of only two anti-virals known to be effective against the current flu, could see a demand windfall if nations around the world move to deepen stockpiles of the drugs.
The World Health Organization (WHO) on Wednesday raised its assessment of the outbreak to phase 5, indicating widespread human infection and one level short of declaring a pandemic. As of Thursday, 11 countries had officially reported 257 cases of swine flu – or influenza A (H1N1) – infection, including eight deaths, according to the WHO.
Although many national stockpiles of Tamiflu (oseltamivir) were established after the 2003 avian flu pandemic, fears are mounting that the quantities now available of Tamiflu and another antiviral, GlaxoSmithKline’s Relenza, will not be sufficient.
David Reddy, Roche’s global pandemic preparedness leader, sought to relieve worries.
“Roche’s 3m treatment courses donated to the WHO in 2006 are ready on 24-hour standby to be deployed to areas of need as determined by the WHO,” he said. “We will be working through the night to do all we can to respond in a rapid, timely and responsible manner for patients in need,” he said.
Roche donated 5m treatment courses of Tamiflu in 2006 - a 2m treatment course “regional stockpile” and a 3m treatment course “rapid response” stockpile. The regional stockpiles are held by the WHO at locations around the world.
Roche said that it had fulfilled government orders for a total of 220m Tamiflu treatments.
Roche also said that it had been in contact with WHO since the UN agency’s pandemic alert was elevated.
If the outbreak spreads widely, existing quantities may not be sufficient.
The WHO has previously recommended that governments prepare for pandemics by stockpiling enough treatments for half the population. Most countries are nowhere near that level, although some EU members come close.
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India, with a population over 1bn, has a stockpile of just 1m treatments, according to Dow Jones International News. East Asian nations are reportedly better prepared, having been devastated by the avian flu. Many African countries have none.
However, time may be on the side of public health. On Wednesday, a team of researchers at Northwestern University released a computer simulation of the current outbreak that projected a worst-case scenario of only 1,700 cases in the US in four weeks, by which point production could be well under way.
Roche has the capacity to produce 70m additional treatments over six months, a fine chemicals consultant said.
Roche could call on the global network of over 17 fine chemical contractors that the drug company established after the 2003 avian flu pandemic to meet demand for stockpiling Tamiflu. Among the members of this network are Groupe Novasep, Clariant, PHT International, Albemarle and AMPAC Fine Chemicals.
Hyderabad, India-based Hetero Drugs has also been producing a generic version authorised by Roche, which has also authorised Chinese producers Shanghai Pharmaceutical Group and HEC Group to provide pandemic supplies in
Indian drugmakers Cipla and Ranbaxy have been producing generic versions for sale into markets where Tamiflu does not have patent protection. Cipla could produce 1.5m treatments within 4-6 weeks, according to a company official quoted by
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