Astellas shares fall as FDA rejects latest tacrolimus drug

January 28, 2007

1/24/2007

Shares at Japanese drugmaker

Astellas have fallen over 5% on the news that the FDA

has issued a non-approvable letter over a new once-daily formulation of its

immunosuppressant drug Prograf for heart

transplantation.

The company also received a setback from the agency which has asked for

additional information on the new treatment, FK506MR (tacrolimus)

in two other indications, in the case of organ rejection in kidney and liver

transplant patients. Astellas

gave few details about the FDA's communication and simply stated that it is

" internally reviewing the comments outlined in the action letters "

and is working with the agency to address any issues they have raised.

The US patent on Astellas'

twice-daily version of Prograf runs out in 2008,

and the firm had hoped to extend the lifecycle of the drug by getting the green

light for this new formulation. Astellas

estimates Prograf sales to hit 170 billion yen ($1.4

billion) for the fiscal year which ends in March, and the drug currently

contributes around a fifth of the firm's revenues. In the USA, it is currently used in 80% of kidney

transplants, more than 90% of liver transplants and

60% of heart transplants.

Still, not all hope is lost for FK506MR and Hiroshi Tanaka, a senior analyst at

Mizuho Securities, said that " as long as they get approval for kidney and

liver transplants, even if they don't get approval for heart transplants, then

it shouldn't be that much of a problem. "

Antibody deal with Kirin

Meantime, Astellas also announced that it has signed

an agreement with fellow Japanese firm Kirin to develop

and market an immunosuppressive fully human monoclonal antibody.

The firms said that the anti-CD40 antibody had shown strong immunosuppressive

activity in preclinical studies and is also expected to be used for certain

autoimmune diseases. Astellas

will pay Kirin up to 5.8 billion yen if all milestones

are reached.

Barb in Texas - Together in the Fight, Whatever it

Takes!

Son Ken (32) UC 91 - PSC 99 Listed 7/21 @ Baylor Dallas

Recommended Posts