Benlysta, Yervoy Enter Market
Two drugs approved by FDA this month last year have made successful debuts. One of them was Benlysta (belimumab), a systemic lupus erythematosus (SLE) treatment developed by Human Genome Sciences (HGS) and GlaxoSmithKline (GSK). Benlysta finished 2011 with $52 million in sales, accounting for about 40% of HGS’ total sales of $131 million last year.
HGS and GSK co-developed Benlysta under a 2006 agreement. The companies shared equally in Phase III/IV development costs, sales, and marketing expenses as well as profits. Sales growth has been steady, from $8 million in Q2 to $18 million in Q3, to $26 million in Q4, helped in part by EC’s sanction of Benlysta last May. More importantly, Benlysta’s success positions HGS toward profitability for the first time since it was founded in 1992.
“HGS remains committed to achieving profitability in 2014,” CEO H. Thomas Watkins told analysts February 27 on a conference call. During that call, Barry Labinger, evp and chief commercial officer with HGS, trumpeted a new market study that found in part that three-quarters of patients treated with Benlysta showed improvement in at least one aspect of the disease.
Benlysta’s March 9, 2011, approval came on the back of two Phase III studies involving 1,684 patients showing that the drug reduced SLE activity. Still, the agency limited its indication by not recommending Benlysta for patients with severe active lupus nephritis or severe active central nervous sytem lupus, or in combination with other biologics or intravenous cyclophosphamide.
Also finding success over the past year was Bristol-Myers Squibb’s mAb therapeutic Yervoy for late-stage metastatic melanoma. Two Phase III studies—one completed after approval—showed a significant overall survival benefit. The drug also won EC approval in July, after which it was launched in Germany and some other countries on the continent, “while we are working through the process of access and reimbursement in the rest of the region,” Lamberto Andreotti, BMS’ CEO, told analysts on a January 26 conference call. Charlie Bancroft, BMS’ CFO, said on the call that the firm expects Yervoy will be commercially available and reimbursed in most of its top eight countries by mid-2012 and in almost all EU countries by the end of 2012.
In Europe as in the U.S., Yervoy is indicated for previously-treated patients whose tumors had spread or could not be surgically removed. Yervoy will need to generate sales overseas, since the U.S. accounted for $118 million of the total $144 million racked up.
“We continue to be encouraged by the performance of Yervoy,” Bancroft said. “Until the introduction of Yervoy and [late stage skin cancer drug] Zelboraf last year, no new agent has been approved for metastatic melanoma in over a decade. The market is now in a state of transition as physicians become more familiar with these new medicines.”