LONDON The first new treatment for lupus in a half-century was recommended for approval in Europe on Friday, offering a new option for patients and underpinning multibillion-dollar sales expectations for its makers.
The companies said the European Medicines Agency had backed use of Benlysta, discovered by Human Genome Sciences and developed with GlaxoSmithKline, to combat the disease that causes the immune system to attack joints and organs.
Decisions by the London-based drugs watchdog are normally endorsed by the European Commission within two or three months. The green light for Benlysta had been expected, following its approval in the United States in March.
It will take time for sales of Benlysta to ramp up in Europe, as the companies will have to negotiate reimbursement in many countries.
"We would not anticipate meaningful sales until mid-2012," said Mark Schoenebaum, a biotechnology analyst at ISI Group.
Still, Schoenebaum said shares in HGS could rise around $1 on news of the European green light, since some investors had worried that EU approval could be denied, based on the perception that the drug has modest efficacy.
Benlysta's annual global sales are expected to reach $3.55 billion in 2015, according to Thomson Reuters Pharma consensus forecasts. Some analysts predict sales as high as $5 billion in later years.
Moncef Slaoui, head of research at GSK, said the European recommendation was a major milestone in the clinical development program for Benlysta. Other regulatory applications are under review in Canada, Australia, Switzerland, Russia, Brazil, the Philippines, Israel and Colombia.
GSK and HGS will split profits and work together to market the drug. Thomas Watkins, chief executive of HGS, said his company was "well along" the way in building its own team to commercialize the medicine in Europe.
Lupus causes a range of symptoms including arthritis, kidney damage, chest pain, skin rashes, severe fatigue and other problems. Symptoms often wax and wane. The organ damage can be fatal.
An estimated 5 million people worldwide have the disease. Current drugs often fail to help, or cause harsh side-effects, such as severe bone loss from steroids.
One company-funded study showed 43 percent of patients given a high Benlysta dose with standard therapies felt relief, and had no further organ damage after one year of treatment.
That compared with nearly 34 percent with a placebo and standard therapies, which typically include immunosuppressant drugs such as Roche's CellCept and steroids such as prednisone.
Benlysta, known generically as belimumab, is given once a month by intravenous infusion.
In the United States, the drug costs an average of $35,000 per patient a year.
The manufacturers have yet to set a price in Europe but Schoenebaum said he was assuming it would be around $23,000. Costly modern biotech medicines are often priced lower in Europe than in the United States.
Benlysta has revived Human Genome, a company that struggled to capitalize on excitement about the mapping of the human genome.
Several of the company's drugs failed in clinical trials, and investors largely wrote off Benlysta after mixed early data. Its shares fell below 50 cents in March 2009 but jumped later that year when the first encouraging Benlysta data was released.
Now the company is an industry star and some analysts think it could eventually be a takeover target for partner GSK or other big drugmakers.
(Editing by Paul Sandle and David Hulmes)