HGS ready to sell lupus drug if FDA approves it

BETHESDA, VA. OCT.28.. Tom Watkins, CEO of Human Genome Sciences at a Bio-Tech conference in Bethesda, MD on Oct. 28, 2010 ( Photograph by Jeffrey MacMillan )
BETHESDA, VA. OCT.28.. Tom Watkins, CEO of Human Genome Sciences at a Bio-Tech conference in Bethesda, MD on Oct. 28, 2010 ( Photograph by Jeffrey MacMillan ) (Jeffrey Macmillan - Jeffrey Macmillan For Washington)
By Steven Overly
Monday, November 22, 2010

From top executives to clerical workers, much of the staff at Human Genome Sciences took pause last Tuesday to watch a Food and Drug Administration advisory panel deliberate over the company's flagship drug candidate, and ultimately signal its endorsement..

The committee's 13 to 2 vote in favor of Benlysta bodes well for the first treatment designed for systemic lupus in more than 50 years as it goes to federal regulators for final consideration. The FDA does not have to follow the panel's recommendation, but often does. The agency is slated to rule by Dec. 9.

Benlysta would be the Rockville-based biotech's first drug to reach the commercial market, and the company has been busy for months manufacturing the drug and gearing up to market and sell it in anticipation of a positive response from regulators.

"We're waiting but we're certainly busy as we're waiting because of all the ramp-up activities that have been going here for, I think it's fair to say, 18 months," said chief executive H. Thomas Watkins.

The company began building a marketing team while Benlysta was still in clinical trials and the results were not yet known. And though there was no indication the drug would ever come to market, executives took cautious steps in case it did.

The company has now amassed a sales force of about 70 in only a few months; combined with the team at drug partner GlaxoSmithKline, that will mean about 150 representatives could be deployed as soon as the FDA gives the go-ahead.

They will educate physicians on the drug and how to pursue reimbursement for its use. They will also act as a kind of customer service team for patients who have questions about the drug or need to take part in a financial assistance program.

"The Dec. 9 date that we're working toward with the FDA for approval is a deadline that's every bit as strong for the people on the commercial side of the business who need to be ready to get the product out there," said Barry Labinger, executive vice president and chief commercial officer.

But you can't sell vials of a drug if they don't yet exist. So for months the company's manufacturing plant in Rockville has been humming day and night to create a stockpile. Curran Simpson, senior vice president of operations, said the facility is operating at full capacity to produce Benlysta and will continue to do so throughout the holidays.

"We started out fairly slowly because obviously you're not trying to over-produce, because you don't know if this drug has a future or not at that point," he said. "We started to add staff and we've started to run faster, and now we're in 24/7 operation."

The drug was produced at the $290 million facility, completed in 2005, for clinical trials. Simpson said that made it easy to scale up to constant production, which takes about 60 days for each batch of Benlysta.

"All of the work that would be required to have a smooth launch to fill our distribution channels, that has all been set in motion months ago for us to be ready," Simpson said. He added that the company will be prepared to act as soon as he drug's label is finalized and an approval letter is in hand.

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