UPDATE 1-Novartis apologises for not disclosing side-effects of leukaemia drugs sooner

Thu Jul 31, 2014 6:17am EDT

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(Updates with company statement)

TOKYO, July 31 (Reuters) - The Japanese unit of Novartis AG apologised on Thursday for nfailing to report to authorities in a timely manner side-effects of its leukaemia drugs, in the company's latest scandal in the country.

Novartis Pharma KK, the Swiss drugmaker's wholly owned local subsidiary, said Japan's Ministry of Health, Labour and Welfare ordered the company to improve its practices after the company did not report side-effects of its Gleevec and Tasigna leukaemia treatments until around April.

The ministry said serious side-effects must be reported within a month of discovery. Media reports said such side-effects had been known between April 2013 and January 2014.

"We deeply regret that we have allowed this situation to arise, and offer our deepest apologies to our patients, their families, medical professionals, as well as the public," the company said in a statement.

"We take it very seriously, that side-effects, which should be extremely important to any pharmaceutical company, were not reported appropriately."

Earlier in July, Tokyo prosecutors said they would charge the unit and a former employee in connection with allegations of data manipulation to promote its best-selling blood pressure drug Diovan.

The prosecutors office in June arrested Nobuo Shiraishi on allegations that he gave false data to researchers whose work was used for advertising. (Reporting by Ritsuko Ando; Editing by Chris Gallagher and Ryan Woo)

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