TOKYO - U.S. FDA has moved back its PDUFA date on yet another Takeda drug - this time dipeptidyl peptidase-4 inhibitor SYR-322 (alogliptin) - making it the third Takeda drug facing FDA delays this year, Takeda President Yasuchika Hasegawa told a Nov. 4 earnings conference.

Developed by Takeda San Diego, a Takeda subsidiary created by the company's acquisition of U.S. bioventure company Syrrx, Takeda also applied for new drug approval for the diabetes drug Sept. 29 with Japan's Ministry of Health, Labor and Welfare. The application is worth watching because it was submitted without conducting a domestic Phase III trial in Japan. If approved, Takeda expects alogliptin to be the third major diabetes drug from the company after Actos (pioglitazone) and Basen (voglibose).

Takeda, which linked the delay to FDA resource constraints, said a revised PDUFA date has not been set (Also see "Takeda’s Alogliptin Falls Prey To U.S. FDA Slowdown" - Scrip, 12 October, 2008.).

The Osaka-based company has two other drugs pending before U.S. FDA, which have been delayed.

The firm was notified a few weeks ago that its PDUFA date was also pushed back another three months for its proton pump inhibitor TAK-390MR for gastroesophageal reflux disease and other serious acid-related problems. (PharmAsia News, Oct. 27, 2008). Hasegawa told the conference that FDA said it will complete the review by Jan. 31.

After two rounds of "approvable" letters, the firm's gout drug febuxostat will be reviewed by U.S. FDA Arthritis Drugs Advisory Committee on Nov. 24. Under their earlier U.S. joint venture, TAP Pharmaceutical Products, Takeda and Abbott developed the oral, once-daily non-purine selective xanthine oxidase inhibitor for management of hyperuricemia in patients with chronic gout. Takeda took control of the compound, along with heartburn and GERD drug Prevacid (lansoprazole), when it purchased 100 percent of TAP earlier this year (Also see "Japanese Takeda Buys Abbott’s Stake In TAP Joint U.S. Venture" - Scrip, 20 March, 2008.).

"Depending on the results of this advisory committee, we believe that we'll be able get the approval by Jan. 18," Hasegawa said. ""But this will be depending upon the outcome of this advisory committee."

Yen Appreciation Means Lower Profits

The yen's sharp appreciation, weaker than expected demand for its key products, and negative contributions from its acquired companies have forced Takeda to lower its fiscal 2008 profit forecasts.

The Osaka-based company made downward revisions to its July forecast in releasing its half-year business results ended in September: revenues for the full year will shrink from ¥1.57 trillion to ¥1.56 trillion ($15 billion). Operating income fell 36.2 percent from ¥280 billion to ¥270 billion.

It will be the first time in 17 years, since the year ended in March 1992, that Takeda would incur operating income contraction.

In the latest half-year reporting period ended Sept. 30, Takeda reported revenues of ¥807.1 billion, up 13.9 percent; operating income ¥85 billion, down 67.9 percent, and net income ¥71.8 billion, down 67.1 percent from the same year-ago period.

"We are experiencing long head winds," Takeda spokesman Hisashi Tokinoya, said during the earnings report, blaming, among many factors, the yen's sharp appreciation against the U.S. dollar and the euro and the global financial woes.

Takeda had projected that Millennium would yield operating income in the latest period but in reality, it ended up making a negative ¥137.7 billion contribution to net income - reflecting in part the adverse impact of the U.S. economic slowdown, Tokinoya said. TAP contributed a positive ¥29 billion contribution to net income, he said.

Takeda's earlier earnings forecast was also dogged by weaker-than-expected sales of its leading products: the firm's global distribution diabetes treatment Actos' sales shrank 1.9 percent from the same year-ago period, with the company forecasting a single digit sales rise for the full year instead of double-digit sales.

Prevacid global sales jumped 92.2 percent to ¥71.5 billion. Hypertension agent candesartan rose 5.8 percent to ¥119 billion and leuprorelin for prostate and breast cancer and endometriosis, was up 0.9 percent to ¥65 billion.

Overall pharmaceutical revenues rose 15.5 percent to ¥760.3 billion in the half-year period while operating income plummeted 69 percent to ¥80.1 billion.

In oncology and urology, three out of six products in development registered advances: Velcade (bortezomib) for multiple myeloma received U.S. FDA marketing approval (Also see "Analyst Says FDA First-Line Approval Of Takeda/Millennium’s Velcade No Surprise" - Scrip, 24 June, 2008.); TAP-144-SR for prostate cancer in Austria and Germany for marketing approval; and Vectibix (panitumumab) for colon and return cancer completed Phase III trials and is pending approval in Japan.

Entering Phase I clinical trials are TAK-448 for prostate cancer and Lu AA21004 for mood and anxiety disorders in Japan.

In addition, NE-58095 for Paget's bone disease was approved for distribution in Japan.

Takeda announced Oct. 17 that the company has decided to halt developing GVAX , a prostate cancer vaccine jointly developed with the U.S. biopharmaceutical company Cell Genesys (PharmAsia News, Oct. 23, 2008).

- Toshio Aritake (pharmasia@elsevier.com)

Takeda Copes With FDA Delays, Yen Appreciation and Acquisition Drags in 2008

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