US authorities recommended last week Japan’s biggest drug maker halt high-dose trials of experimental TAK-475 -- previously seen as major earner for the company once it loses US patent protection for Actos in 2011. They also requested more clinical data before a new drug application.
TAK-475’s unclear future has turned up the pressure on Takeda to use its $10 billion war chest to acquire new drugs and companies but the company also said little that was positive on its acquisition outlook.
Takeda President Yasuchika Hasegawa said that buying a European firm to bolster the company’s sales presence there had proved tough. The company has also made no progress in talks with Abbott Laboratories about buying out the US firm in their North American joint venture.
Hasegawa acknowledged that there was no doubt that earlier expectations earnings from TAK-475 would have to be significantly revised down.
TAK-475 is a squalene synthase inhibitor, a type of cholesterol-cutting drug that has yet to be successfully developed. If it did make it to the market, it would go up against Merck & Co. Inc’s and Schering-Plough Corp’s Zetia and Vytorin.
When asked if there was chance that development of the drug could be dropped completely, Takeda executives said only they had reached no conclusion but would take into account such factors as the timing of Zetia’s patent expiry.
Takeda said on Monday it now expects net profit for the year to end-March to climb 18 percent to 395 billion yen ($3.5 billion) driven by Actos after safety concerns hit rival drug Avandia, the second-biggest medicine for GlaxoSmithKline.
That is 4 percent higher than an earlier estimate but falls short of a consensus figure of 407 billion yen from 21 analysts polled by Reuters Estimates.
It lifted its full-year dividend projection to 168 yen from 160 yen.
First-half net profit was 218 billion yen, up 37 percent from a year earlier while sales climbed 10 percent to 708 billion yen.
Sales of Actos have jumped while sales of Avandia have tumbled since it was linked to heart attack risk in a US study in May. Actos sales were up 29 percent in first-half.
‘Obviously this kind of growth can’t go on forever,’ Hasegawa told a news conference. ‘But still we are hoping for double-digit growth in the next business year.’
In other pipeline news, Takeda said its experimental drug TAK-442, to prevent blood-clotting, had moved into mid-stage or phase II trials in the United States and Europe.
Its stock closed down 0.8 percent at 7,100 yen after the earnings results. It has fallen 12 percent since the news was announced on Tuesday. For the year to date, it is down 13 percent compared with a 10 percent decline for the pharmaceutical subindex
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