For the second time this month, Takeda Pharmaceutical Co has been told by US regulators that a review of one of the Japanese firm’s key late-stage drugs has been delayed.

The Osaka-headquartered group said it received notification from the US Food and Drug Administration that the agency will not be able to complete its review of a New Drug Application of proton pump inhibitor TAK-390MR (dexlansoprazole) by the original Prescription Drug User Fee Act date of October 31. The compound is regarded as a likely successor to Takeda’s blockbuster antiulcerant Prevacid/Takepron (lansoprazole), which faces patent expiry in the USA next year.

Dean Sundberg, senior vice president, regulatory affairs at Takeda Global R&D Center in the USA, said the FDA informed the firm that it will require an additional three months to complete the review of the TAK-390MR NDA. He added that "Takeda has been very responsive to all questions posed during the review cycle” and the FDA “needs this time to review the total package of information contained in the NDA”.

Mr Sundberg went on to say that Takeda is confident dexlansoprazole will be “an important new treatment option for people living with gastroesophageal reflux disease and erosive esophagitis” and there are no safety concerns about the drug itself.

The problem lies with the FDA and the staff shortages it is suffering from. The same problem saw the agency recently tell Takeda it will not be able to complete a review of an NDA for alogliptin, a dipeptidyl peptidase IV inhibitor for type 2 diabetes also known as SYR-322, by October 27.

The delays are bad news for Takeda which is looking to SYR-322 and TAK-390MR to help soften the loss of patent protection on Prevacid and the diabetes blockbuster Actos (pioglitazone), which could face generic competition in the USA in 2011.

Takeda ups earnings estimate
However it was not all doom and gloom as Takeda raised its profit forecasts for the first half of its fiscal year. The firm now expects to post a group operating profit of 85 billion yen for the April-September period, up from a prior estimate of 50 billion yen, helped by the fall of the Japanese currency against the dollar and the euro.

Net income is expected to reach 70 billion yen, up from a previous estimate of 50 billion yen, while sales should come in at 805 billion yen up 45 billion yen. The results will be published on November 4.

However, Takeda left its full-year operating profit estimate unchanged at 280 billion yen on sales of 1.57 trillion yen, pending a further review. The firm also said it would spend up to 50 billion yen to buy back up to 11 million shares.