GSK and HGS put the 'us' in lupus, ahead of Benlysta FDA decision

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GSK and HGS put the 'us' in lupus, ahead of Benlysta FDA decision
GSK and HGS put the 'us' in lupus, ahead of Benlysta FDA decision

GlaxoSmithKline and Human Genome Sciences launched a patient community for lupus sufferers and their friends and family, in anticipation of an FDA decision on Benlysta in March.

Located online at usinlupus.com, the website - built by Euro RSCG Tonic - includes personal stories about living with lupus, information about symptoms, and coping strategies for managing the disease. Visitors are asked to join by registering on the site, to receive tips and advice, as well as information from GSK and Human Genome Sciences. Online registrants can check or uncheck boxes giving the companies permission to “market or advertise to you about lupus,” or “market or advertise to you about medicines that treat lupus.”

A direct response print ad in WebMD the Magazine's January/February 2011 issue, which has a tear-off business reply mailer for enrollment, asks respondents to rate their healthcare professional in terms of competency “when it comes to managing my lupus,” in addition to other questions about symptoms and diagnosis. The print ad acknowledges that “some people featured in ‘the us in lupus' are paid spokespeople for Human Genome Sciences and GlaxoSmithKline.” Lupus patients can also enroll in the community by telephone, at 1-855-USINLUPUS.

Though it's not guaranteed, analysts and company executives expect a thumb's up on Benlysta (belimumab) from FDA regulators around March 10, after a 13-2 advisory committee vote in favor of approval last November. The drug was designated for priority review by FDA last August, with a target decision date set for December 9, but FDA extended the review for three months after requesting more information, which the companies have submitted. If approved, the drug has blockbuster potential, analysts have said. 

“Based on the opportunities we have in hand and our expectation of US and European regulatory approvals of Benlysta, we believe HGS will achieve sustainable multi-billion dollar revenues by 2015,” said Thomas Watkins, president and CEO, HGS, at the JPMorgan Healthcare Conference on January 10.

HGS brokered a deal with GSK to retain equal ownership on Benlysta, and the companies will target an initial 200,000 patients in the US, according to Watkin's presentation at the conference. HGS and GSK will launch the drug in the US with a sales force of roughly 150, managed by three area directors and 10 district managers. Reps hired for the job have “significant experience with rheumatology biologics, including Remicade, Rituxan, Orencia, Enbrel and Actemra,” according to Watkins' slides. Pricing for Benlysta has not been announced.

If approved, Benlysta would represent the first FDA-approved medication for lupus in over 50 years, or “since Dwight D. Eisenhower was president,” said Sandra Raymond, president and CEO of the nonprofit Lupus Foundation of America, in a statement congratulating HGS and GSK on Benlysta's progress.

Calls to HGS and GSK for comment on the us in lupus campaign were not immediately returned.

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