Roche says unsure why Japan warned against Tamiflu
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Swiss drugmaker Roche Holding AG said on Thursday it was unsure why the Japanese government had warned that influenza drug Tamiflu should not be given to teenagers.
No definite link had been established between Tamiflu, seen as effective against a possible pandemic triggered by bird flu, and reports of young people injured by jumping from buildings after taking the drug, Roche spokeswoman Martina Rupp said.
“Roche does not really understand the rationale for the actions taken by the Japanese government,” Rupp said. “There is no causal relationship established between Tamiflu and these reports.”
Japan’s Health Ministry has told importers of Tamiflu to warn doctors not to prescribe it to those aged 10 to 19.
The ministry has said it would carry out a detailed investigation of the cases of abnormal behaviour.
Roche has said new data from the United States and Japan showed there was no established causal link between Tamiflu and neuropsychiatric symptoms.
“You’ve seen the new data, that’s actually showing in the U.S. database that psychiatric symptoms are even lower in patients treated with Tamiflu compared to those who did not get drug,” Rupp said. “And I think that the scientific data that we have is quite strong and really shows that there is no established causality.”
It is unclear whether the warning will affect sales of Tamiflu in Japan, Rupp said.
But the warning is unlikely to hit Roche’s future earnings profile, said Helvea analyst Andrew Fellows, who has a buy rating on Roche stock.
“Tamiflu sales at Roche have received an enormous boost following the panic over bird flu, with sales of over 2 billion Swiss francs ($1.65 billion) generated in 2006 and likely in 2007, compared to a normalised annual rate of around 400 million Swiss francs,” Fellows said in a note.
Pandemic sales will continue into 2008 but at a lower rate, Fellows said, and will gradually be replaced by higher margin cancer drugs, boosting Roche’s gross margins.
“Tamiflu is irrelevant to our investment case,” he said.
Roche shares were up 1.5 percent at 221.20 Swiss francs at 1408 GMT.
Roche’s Rupp said the company was not planning any specific actions in response to the Japanese warning.
“There are 45 million people who took Tamiflu worldwide up to date (and the number affected) is really very small,” she said.
“We do take this very seriously and we will continue to monitor this and to study this but you have to be aware that rare cases of neuropsychiatric events have also been reported in patients who were not taking Tamiflu.”
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