Human Genome Sciences Inc
The U.S. Food and Drug Administration (FDA) has set an action date of March 10 for the drug.
The company said it is well prepared for the launch of Benlysta and expects to receive European approval for the drug in the second half of 2011.
We believe the company is effectively endorsing the current 2015 consensus revenue estimate of $2.05 billion (for Benlysta), said ISI Group analyst Mark Schoenebaum.
Last month, the U.S. FDA delayed a decision on whether to approve Benlysta to review additional data submitted by Human Genome in mid-November.
Human Genome said its current inventory of Benlysta will be able to meet global market needs for at least one year, and its large-scale manufacturing facility has sufficient capacity to provide worldwide supply for the first two to three years following launch.
Overall, the company's update on their launch and manufacturing capacity plans was in-line with our expectations, said Sanford Bernstein analyst Geoffrey Porges.
Porges expects FDA approval for Benlysta by March 10.
Lupus, a debilitating and sometimes fatal disease, causes the immune system to attack the body's own tissues and organs.
Human Genome shares, which have lost 1 percent since the FDA extended review of the drug on December 3, were up 1.5 percent at $25.71 in late morning trade on Monday on Nasdaq.
(Reporting by Anand Basu in Bangalore; Editing by Gopakumar Warrier)