UPDATED: Loss of Actos weighs heavily on Takeda

Japan's largest drugmaker now has FDA approval of Nesina to fill some gaps
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Takeda Pharmaceutical last week nailed down FDA approval for three new diabetes drugs--DPP-4 inhibitors--and it was none too soon, as today's earnings report makes crystal clear.

Japan's largest drugmaker reported that its operating profit plunged 53% and net profit was down 14% in the 9 months that ended Dec. 31, The Wall Street Journal reports.

The drugmaker has been racing to get the new treatments approved against the loss of patent on its foundation product, the diabetes treatment Actos. The drug has accounted for more than half of Takeda's U.S. revenue and 18% of its overall sales. Actos brought in more than $16 billion in U.S. sales over its brand-name lifetime. But it tipped over the patent cliff in August, which means the worst is yet to come. To prepare, Takeda has been slashing jobs while making clear that it expects profit to retreat through 2015.

Approval in the U.S. last week of Nesina and two combination pills will help it face that muted future. Nesina is already approved in Japan. Because the FDA had withheld their entry into the U.S. to closely evaluate safety issues, the drugs arrive facing some established rivals. Merck's ($MRK) Januvia group leads with $3 billion-plus in annual sales. There's also Onglyza, the Bristol-Myers Squibb ($BMY) and AstraZeneca ($AZN) drug. There is also Galvus, from Novartis ($NVS), which is approved in Europe. Nesina and its kin did not get that approval free of any strings. The FDA told the company that it must conduct some postmarketing safety studies, including one of cardiovascular effects.

The potential for Nesina to help, however, was evident in today's report, the WSJ points out. Sales of Nesina in Japan helped lift global revenue 5.5% to $12.8 billion. Sales of its cancer drug Velcade in the U.S. also contributed to that bit of good news.

- read the WSJ piece (sub. req.)

Special Report: Takeda Pharmaceutical - 10 Largest U.S. Patent Losses

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Editor's Note: Story updated to clarify that Galvus is approved in Europe but not the U.S.