monoclonal antibody and the bactericidal/permeability-increasing (BPI) protein are intravenous treatments that can neutralize endotoxins and halt the cascade of inflammatory mediators that cause toxic shock and organ failure.
5 million of pharmaceutical sales, resulting from the recall of prior HA-1A
sales in Europe.
In April, the FDA announced it would not allow Centocor's drug, called HA-1A
, on the market, even though an expert panel convented last September to advise the agency recommended approving the drug.
sales, if any, of its monoclonal antibody HA-1A
, and the companies have agreed to forego all future litigation and administrative proceedings regarding each other's patents and patent applications related to anti-endotoxin monoclonal antibodies.
A committee of outside experts convened by the Food and Drug Administration has endorsed a human antibody, HA-1A
, for the treatment of life-threatening bacterial infections.
Product sales in the first quarter, including HA-1A
European sales of $5.
The new drug, called HA-1A
, consists of antibodies produced by laboratory-reared human cells isolated nearly a decade ago by researchers at Stanford University and the University of California, San Diego.
NASDAQ: CNTO) today announced that the Food and Drug Administration (FDA) has advised the company that there is insufficient evidence of efficacy for approval at this time of HA-1A
By exercising the option, Centocor retains rights to the products developed on behalf of CPII, which are HA-1A
, a human monoclonal antibody directed against the endotoxin of gram negative bacteria, and also certain cancer imaging agents.
, tradenamed Centoxin(R) in Europe, is a human monoclonal antibody directed against the life-threatening endotoxin of gram negative bacteria.
In addition to new product opportunities, Mercia provides Centocor Diagnostics with a European manufacturing base and a strategic link with Centocor's pharmaceutical business, led by HA-1A
, a human monoclonal antibody for the treatment of septic shock and gram negative bacterial infections of the bloodstream.
NASDAQ: XOMA) on uses and sales of HA-1A
(also known as Centoxin) in the United States by Centocor Inc.