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Roche ready to discuss Tamiflu sub-licences

Increased criticism of Roche's refusal to waive its patent on antiviral treatment Tamiflu amid fears of a global avian flu pandemic has overshadowed promising pipeline results for the Swiss drugmaker

Today, Roche reacted to the mounting pressure for it to allow other companies to manufacture antiviral treatment Tamiflu by vowing to step up production of the drug, as fears escalate about a global avian flu pandemic.

In a statement, the company also hinted that it is willing to discuss all options ìwith governments and other manufacturers on the production of Tamiflu for emergency pandemic useî. It said the options include granting sub-licences to companies that ìcan realistically produce substantial amounts of the medicine for emergency pandemic use, in accordance with appropriate quality specifications and safety and regulatory guidelinesî.

ìFor Tamiflu, the key need today is the rapid expansion of production capacity,î said William Burns, chief executive of Roche's pharmaceuticals division.

One Indian generic company, Cipla, has said it intends to start supplying governments who are building stockpiles of the drug. A spokeswoman for Roche confirmed it had not been approached by Cipla or any other generic company about production of Tamiflu.

Previously, Roche had said that it would take generic companies 2-3 years to produce Tamiflu from scratch due to the complexity of the production process.

Roche has received approval from the US Food and Drug Administration to build a new plant in the US, which it says would be one of more than a dozen Tamiflu production facilities worldwide.

The bird flu virus, which originated in Asia, is being carried west by migratory birds and has now reached Greece, Turkey and Romania. A deadly strain of the virus, H5N1, has killed more than 60 people in Asia.

There have been calls from both the United Nations and the World Health Organisation to remove commercial obstacles in the trade and licensing areas such as drug patents protecting Tamiflu so that production can be ramped up.

Roche, which rule out waiving patents for Tamiflu, has agreed to donate 3m treatments to the WHO, for rapid distribution to countries as and when the body sees fit, and has also donated 20,000 packs to Turkey and 2,400 to Romania.

Tamiflu, which was first discovered by US firm Gilead, is not a cure for the virus but experts say it can lessen the symptoms of flu if taken shortly after they first appear.

Roche is currently locked in a legal dispute with Gilead over the rights to the drug, with the US firm claiming Roche has failed to market and produce the drug effectively.

Analysts said that positive pipeline news for Roche was a bigger boost for the company than the surge in demand for Tamiflu. New data has shown the potential of two of its drugs, Rituxan (MabThera in the US) and experimental drug MRA in treating rheumatoid arthritis (RA).

Deutsche Bank analysts said details from scientific abstracts to be presented at a US medical conference next month showed MRA had ìextraordinary efficacyî while a separate study showed Rituxan appeared as effective as Bristol-Myers Squibb's new drug Orencia in treating patients with severe arthritis on whom other therapies had failed.

Kepler Equities analyst Denise Anderson said RA could be the next big thing for Roche.

ìThere has not been enough appreciation for the fact that they have two phase III drugs in arthritis,î she said.

In a recent research note, she predicted that both Rituxan and MRA, which was developed by Roche's partner Chugai Pharmaceutical, could see annual sales in excess of $1bn as treatments for RA.

30th September 2008

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