Confidence grows in mega-blockbuster approval for HGS's Benlysta

For many tracking the biopharma industry, FDA decisions have become harder than ever to predict. But there's very little argument over what's ahead for Human Genome Science's ($HGSI) new lupus drug Benlysta. Just about everyone believes regulators will soon say yes to the NDA, setting off a marketing scramble that will likely push peak sales to around $3 billion or more a year.

Avik Roy, an analyst at Monness Crespi Hardt, is even more bullish. He's projecting peak sales at $5 billion. And he has this to say to Reuters about Human Genome Sciences' future: "You're going to have revenue for a long time from this product. You're going to become one of the big boys."  

HGS has been building a commercial operation to launch its first drug, hiring a sales force of 150. And there's plenty of confidence inside the company that the drug will be a swift hit among patients and doctors.

"2011 will be a game-changing year for us assuming approval and launch of Benlysta," HGS CEO Tom Watkins told the crowd at JP Morgan in January. "We are ready to hit the ground running alongside GlaxoSmithKline following [FDA] approval of Benlysta." GSK is partnered on the drug and both companies expect to see European regulators follow up with an approval in the second half.

- here's the story from Reuters