Pharmaceutical News

Osaka, Japan, May 11, 2012 – Takeda Pharmaceutical Company Limited (“Takeda”, “the Company”) is implementing the “Transformation into a new Takeda,” guided by its corporate Vision of achieving Growth through Innovation and Culture, in order to realize a new start as a truly global pharmaceutical company.

OSAKA, Japan, May 11, 2012--- Takeda Pharmaceutical Company Limited (TSE:4502) today announced top-line results from the international, randomized, placebo-controlled, double-blind GEMINI II pivotal phase 3 trial. The trial evaluated vedolizumab in 1,115 patients with moderately to severely active Crohn’s disease who have failed at least one conventional therapy, including TNFα antagonists. Many of the patients included in the study had failed two or more TNFα antagonists. Patients received a year of vedolizumab (MLN0002) or placebo treatment, starting with six weeks of induction therapy. In both phases of the trial, induction and maintenance, vedolizumab demonstrated statistically significant improvement in the primary endpoint of clinical remission compared to placebo. Additionally, vedolizumab provided a numerically higher rate of enhanced response, the other primary end point in the induction phase, although not statistically significant.

Osaka, Japan, May 7, 2012 – On April 6, 2012, Takeda Pharmaceutical Company Limited (“Takeda”) received notice*1 that the Osaka Regional Tax Bureau (“ORTB”) had concluded its reinvestigation with respect to the 2006 correction notice*2 on transactions of Prevacid, a drug for the treatment of peptic ulcers, between Takeda and TAP Pharmaceutical Products Inc. (“TAP” *3), a 50/50 joint venture between Takeda and Abbott Laboratories. The ORTB concluded with a decision to reduce the original assessment amount of ¥122.3 billion in taxable income, by the amount of ¥97.7 billion.

Deerfield, Ill., April 25, 2012, and Osaka, Japan, April 26, 2012 – Takeda Pharmaceutical Company Limited (Takeda) and its wholly-owned subsidiary, Takeda Global Research & Development Center, Inc. today announced that the company received a complete response letter from the United States (U.S.) Food and Drug Administration (FDA) regarding New Drug Applications (NDAs) for alogliptin and fixed-dose combination (FDC) alogliptin and pioglitazone.

Palo Alto, Calif. – April 24, 2012, and Osaka, Japan – April 25, 2012 – Affymax, Inc. (Nasdaq:AFFY) and Takeda Pharmaceutical Company Limited (TSE:4502), today announced that OMONTYS® (peginesatide) Injection is now available only for use in treating anemia due to chronic kidney disease (CKD) in adult patients on dialysis. OMONTYS is the only once-monthly erythropoiesis-stimulating agent (ESA) for anemia available to the dialysis patient population in the United States. OMONTYS is co-marketed by Affymax and Takeda Pharmaceuticals U.S.A (TPUSA) and distributed by TPUSA. See below for Full Indication, Limitations of Use and Important Safety Information including Boxed WARNINGS.

London, UK, April 20, Osaka, Japan, April 23 and Lexington, MA, USA April 20 – Takeda Pharmaceutical Company Limited (Takeda) and AMAG Pharmaceuticals, Inc. today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion for ferumoxytol, a new intravenous (IV) iron therapy with a proposed indication for the treatment of iron deficiency anaemia (IDA) in adult patients with chronic kidney disease (CKD).

Deerfield, Ill., Osaka, Japan, and PHILADELPHIA, April 11, 2012, – Takeda Pharmaceutical Company Limited (Takeda) and URL Pharma, Inc. (URL Pharma) jointly announced today that Takeda’s wholly-owned subsidiary, Takeda America Holdings, Inc. and URL Pharma have entered into a definitive agreement to acquire URL Pharma – a privately-held pharmaceutical company headquartered in Philadelphia, Pennsylvania, for an upfront payment of $800 million and future performance-based contingent earn out payments. Upon completion of the acquisition, URL Pharma will be managed by Takeda Pharmaceuticals U.S.A., Inc. The acquisition will contribute significantly to Takeda’s revenues, operating income, and free cash flow beginning in fiscal year (FY) 2013. Pending the satisfaction of customary closing conditions, the deal is expected to close within 60 days.

Osaka, Japan, April 6, 2012 – Takeda Pharmaceutical Company Limited (“Takeda”) announced today a milestone in its transfer pricing dispute with respect to certain transactions of Prevacid, a drug for the treatment of peptic ulcers. The subject transactions were between Takeda and TAP Pharmaceutical Products Inc.*1 (“TAP”). In November 2011, Takeda re-opened a suspended reinvestigation process*2 concerning the correction notice*3 received in 2006 from the Osaka Regional Tax Bureau (“ORTB”) on the Prevacid transactions. The original reinvestigation process had previously been placed on hold so that Takeda could seek relief through the Mutual Agreement Procedure (“MAP”), however, the MAP did not result in any agreement between the tax authorities of Japan and the United States. Takeda has been asserting the legitimacy of the Takeda position to the ORTB.