Struggling Daiichi stumbles with vaccine production again

As if Daiichi Sankyo didn't have trouble enough, the struggling Japanese drugmaker, which is laying off thousands of employees to cut costs, is again having issues with its vaccine production.

The drugmaker issued a recall on Friday for two lots of its freeze-dried live attenuated measles, vaccine "Kitasatodaiichisankyo" and 6 lots of its measles and rubella combined vaccine "Kitasatodaiichisankyo." It said the recalls were initiated after stability testing indicated the vaccines might fall below the specifications for shelf-life time. The drugmaker said it also is testing two more lots of the combo vax to make sure it meets shelf-life specs.

The drugmaker said at this point there have been no reports of "any impact to efficacy and safety" of the vaccines. The drugmaker apologized to the "medical professionals and the families of children who received or are targeted for inoculation."

The recall came about 10 days after the Japanese company announced it would whack up to 1,200 jobs in the U.S., about half its workforce in its stateside subsidiary. Earlier in the year, it said it was cutting 16% of its commercial headquarters staff and planned to cut its field force as it lost patent protection on the diabetes and cholesterol drug Welchol, a $500 million-plus seller for Daiichi. It also will soon lose the exclusivity on its best-selling med, blood pressure drug Benicar.

Vaccines is one of the areas that the drugmaker has focused on to build revenue and in August said it would invest ¥10 billion ($79.7 million) to add a new building at its Kitasato Daiichi Sankyo Vaccine's main production site in Saitama Prefecture to make some new vaccines. But its vaccine manufacturing stumbled last year when it was unable to meet a promised federal goal for the number of doses it would manufacture of its H5N1 avian influenza vaccine. It discovered diminishing yields during zonal ultracentrifugation and final filtering. It tracked the problem back to suboptimal process conditions during ultracentrifugation and the clogging of vaccine on the filter, it said at the time.

- here's the recall notice

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