HGS expects FDA ruling on lupus drug
Rockville biotech received preliminary OK
Company officials, investors, analysts and patients are eagerly awaiting word from the Food and Drug Administration this week as to whether it will approve Human Genome Sciences' lupus drug, potentially worth billions to the Rockville biotech.
Regulators on Thursday are expected to either back or reject the recommendation of an FDA advisory panel that in November voted 13-2 to OK marketing Benlysta, which would be the first approved drug for lupus in more than 50 years.
The FDA was originally expected to announce a decision in early December, but it delayed a ruling until Thursday.
The FDA typically follows the recommendations of its advisory committees, but not always, said Erica Jefferson, spokeswoman for the FDA.
"The panel is advisory in nature so we don't have to follow it," she said. Jefferson also said she could not comment on an actual date for the announcement, although HGS anticipates Thursday.
Benlysta has undergone phase 3 clinical trials involving more than 2,000 patients with lupus. The trials met their primary endpoints, but the advisory panel had some concerns in ensuring the drug was properly labeled to explain it had not been fully tested as a treatment for severe, life-threatening lupus, plus concerns that long-term side effects be monitored. The panel also raised questions about Benlysta's effectiveness among black patients and the risks of combining the drug with other immunosuppressive agents.
"We all feel positive about how things will turn out, but you can never project with these things," HGS spokesman Jerry Parrott said today.
The company is developing the drug with partner GlaxoSmithKline of the U.K., which has applied for marketing approval in Europe.
"Based on the opportunities we have in hand and our expectation of U.S. and European regulatory approvals of Benlysta, we believe HGS will achieve sustainable multibillion-dollar annual revenues by 2015," CEO H. Thomas Watkins told investors and analysts at the 29th annual JPMorgan Healthcare Conference in San Francisco in January, according to a prepared statement. "2011 will be a game-changing year for us assuming approval and launch of Benlysta.
"HGS has systematically hired and carefully trained a specialized commercial team that we believe is second to none in their experience and familiarity with rheumatology, biologics and infused products," Watkins said. "We are ready to hit the ground running alongside GlaxoSmithKline following [FDA] approval of Benlysta." The company has hired about 150 sales employees for marketing Benlysta in the U.S.
HGS spent a total of $196.4 million in 2010 and $173.7 million in 2009 on research and development, according to its 2010 annual report, but did not break down how much of that was for Benlysta.
"With more than $933 million in cash and investments, HGS has the financial strength required to support a world-class launch of Benlysta while continuing to advance and broaden our research and development pipeline," David Southwell, executive vice president and CFO, said in a statement released with the company's annual report.
Throughout last year, the company has significantly increased its investment in the commercial infrastructure, expertise and product manufacture required to launch and support Benlysta, according the statement. If the drug is approved, both HGS and GlaxoSmithKline will work together closely to market Benlysta to rheumatologists and other physicians. The companies also plan to support patients with reimbursement and access programs, according to company information.
HGS believes it has inventory available 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, according to the statement.