Lonza has scored a manufacturing contract to help Bristol Myers-Squibb (BMS) meet anticipated demand of its newly approved drug that will offer a new treatment option for rheumatoid arthritis, a disease that afflicts more than two million Americans.
The new drug, Orencia (abatacept), was approved by the US Food and Drug Administration (FDA) at the end of December and is expected to be commercially available by the end of February 2006.
In order to increase production capacity and meet expected long-term demand for the drug, >BMS has enlisted Switzerland's >Lonza to share the manufacturing until the company builds a second manufacturing facility to cope with the output on its own.
A supplemental biologics license application (sBLA) has now been submitted by BMS to the FDA to allow a third party (Lonza) to manufacture the drug.
Initial batches will be manufactured by BMS's existing manufacturing facility however, as soon as the FDA approves the sBLA, Lonza will step in and ramp up production capacity.
No further details of the deal could be provided by BMS.
Rheumatoid arthritis is a chronic inflammatory disease, marked by swelling, stiffness and pain in the linings of the joints. The linings become inflamed after the body's immune system acts against them.
Treatments for rheumatoid arthritis typically involve immunosuppressants, however, Orencia is the first in a new class of drugs called selective T-cell co-stimulation modulators. The drug uses a new mechanism and acts by blocking the activation of T-cells. When T-cells proliferate, they play a role in the body's immune response.
"There is clearly a need for more therapies for rheumatoid arthritis, and Orencia has the potential to help many people with this serious disease," said Peter Dolan, chief executive officer, BMS.