Forest Laboratories and Daiichi Sankyo have terminated their co-promotion agreement for AZOR (amlodipine and olmesartan medoxomil), Daiichi Sankyo's fixed-dose combination of two antihypertensives, the calcium channel blocker amlodipine besylate and the angiotensin receptor blocker olmesartan medoxomil. Daiichi Sankyo will receive a one-time payment of $44.1 million from Forest Labs related to the termination. Beginning July 1, 2008, Daiichi Sankyo will be responsible for the promotion of AZOR.
   
A second agreement between the two companies, under which Forest co-promotes Benicar and Benicar HCT, has been extended to end on May 31, 2008. Also, there will be a residual period where Forest will continue to receive income from Benicar and Benicar HCT profits, which is not set to expire until March 31, 2014.
   
Howard Solomon, chairman and chief executive officer of Forest, commented, "We have enjoyed a very fruitful partnership with Daiichi Sankyo since our initial collaboration of Benicar, which began in 2002. Our decision to reallocate resources to our currently marketed products causes us to forego the opportunity to continue to participate in the promotion of Daiichi Sankyo's excellent product AZOR."
   
Daiichi Sankyo president and chief executive officer, Joseph P. Pieroni said, "Our first co-promotion agreement with Forest provided us with important additional resources to build our franchise of Benicar and Benicar HCT into significant products in the antihypertensive market while we built our own sales force. Our second co-promotion collaboration for AZOR allowed us to quickly and comprehensively educate the medical community about this new combination antihypertensive. Now we can take over full responsibility for the continued success of these brands."

Takeda  FY Results (April 1, 2007 – March 31, 2008)

FY Revenues: $13.9 billion (+5%)

FY Earnings: $3.6 billion (+6%)

Comments: FY growth was driven by Actos sales of $4.0 billion (+18%) and Candesartan/Blopress sales of $2.2 billion (+8%). Lansoprazole sales were $1.5 billion (-1%). Leuprorelin sales were $1.3 billion (-3%). Operating income was $4.1 billion (-8%). R&D expenses were up 43% due to enhancement of R&D activities, in-licensing and alliance activities, including the termination of a license agreement with Amgen.

Takeda Global R&D Center and Affymax achieved positive 12-month data from their ongoing Phase II trial evaluating the safety and tolerability of Hematide, an investigational drug in development for the treatment of anemia associated with chronic kidney disease (CKD). Preliminary trial data showed that Hematide administered once every four weeks was well tolerated and maintained mean hemoglobin levels between 11 and 12 g/dL in patients with CKD, both pre-dialysis and hemodialysis, over a 12-month period.  
   
The companies also announced the results of two other Hematide studies. One assessed safety and tolerability of the compound in CKD, for patients already on hemodialysis, and the other studied Hematide in CKD patients with Pure Red Cell Aplasia (PRCA), a rare but serious condition in which the body produces antibodies to erythropoiesis stimulating agents (ESAs) and the patient’s endogenous erythropoietin. Patients who develop PRCA are usually transfusion-dependent. In this study, treatment of these patients with Hematide resulted in maintenance of hemoglobin levels within target in the absence of transfusions.
   
Dr. David Recker, senior vice president, Clinical Sciences at Takeda said, “The focus for Takeda and Affymax are the needs of patients, which is at the forefront of drug development. Together, we are working to bring this novel potential treatment option to patients with CKD-induced anemia and to the physicians who treat them.”