Teva Pharmaceutical Industries Ltd. (TEVA) is planning an advanced study of the experimental drug laquinimod as a treatment for a kidney inflammation caused by lupus after the pill showed promise in a smaller trial.
Kidney function improved for lupus nephritis patients who took laquinimod in combination with the available treatments in a mid-stage study of 46 people, according to an abstract posted on the European League Against Rheumatism website ahead of the group’s meeting in Madrid this week.
Teva plans to start a larger study soon, according to a spokesman for the Petach Tikva, Israel-based company. The drug may capture sales of $400 million to $800 million in the broader $4 billion lupus market, said Ronny Gal, a New York-based analyst at Sanford C. Bernstein & Co.
“The drug is clearly active with results in the ‘ballpark’ for a product which will be added on to current therapy,” Gal said in a note to investors. “Our impression is that expectations for laquinimod are minimal and against that benchmark we believe that the results in lupus nephritis are decent.”
Swedish partner Active Biotech AB (ACTI) gained as much as 9.8 percent, the biggest intraday increase since March 6, and traded 6.4 percent higher at 46.50 kronor as of 2:40 p.m. in Stockholm. Teva fell 1 percent to 143.50 shekels at the close in Tel Aviv after saying it will pay Pfizer Inc. $1.6 billion to settle a dispute over Protonix.
Teva and Active, now recruiting for an advanced study of laquinimod in 1,800 multiple sclerosis patients, are exploring whether the pill can also be effective in fighting other disorders of the immune system such as lupus and Crohn’s disease. Success in any of these indications would help Teva broaden its drug portfolio as its best-selling MS injection Copaxone faces new oral competitors.
Lupus nephritis is a kidney inflammation caused by systemic lupus erythematosus, or SLE, a disease in which the immune system attacks the body’s own cells and organs. As many as 60 percent of SLE patients are diagnosed with lupus nephritis, which can lead to serious illness and even death, according to the National Kidney and Urologic Diseases Information Clearinghouse in the U.S.
In the trial to be presented in Madrid, 16 people received 0.5 milligram of laquinimod a day, 15 people received 1 milligram a day, and 15 got a placebo with the standard treatment. There were four serious adverse events in each treatment group, including one patient taking the 1-milligram dose of laquinimod who died of pneumonia and sepsis, according to the abstract. The study wasn’t large enough to definitively establish differences among the treatment groups, the researchers said in the abstract.
“This study is a positive step in the right direction in terms of bringing a much-needed treatment option to this area of significant unmet medical need,” Teva Chief Scientific Officer Michael Hayden said in a statement to Bloomberg. “Teva will work closely with regulatory authorities in defining the next stages of the clinical development program which we hope to be able to commence in the near future.”
Teva would face competition from GlaxoSmithKline Plc (GSK)’s Benlysta, the first drug approved by the U.S. Food and Drug Administration that was developed specifically for lupus. Benlysta is in a late-stage clinical trial for lupus nephritis.
Other companies that have been developing products for this disease include Bristol-Myers Squibb Co. and Roche Holding AG. (ROG) Teva has completed a study of laquinimod in lupus arthritis, which causes pain and swelling in the joints.
“The favorable trends towards laquinimod treatment in the renal end-points, coupled with the safety and tolerability profile, provide a rationale for further Phase III clinical studies,” David Jayne, the researcher who led the trial, said in a statement.
Successful lupus treatments have been elusive, with most therapies, including steroids to ease inflammation, used for other disorders when they were cleared for lupus more than a half-century ago. Teva halted development of Edratide after it failed to achieve a target of reducing lupus activity over a 26-week treatment period in a 2007 study.
Laquinimod has failed in previous trials to beat competing products in reducing the rate at which patients experience MS relapses. The drug was safe in the Bravo trial and the earlier study, Allegro, with no extra incidence of side effects, infections or deaths versus a placebo, while reducing both brain-volume loss and the risk of disability, according to Teva. The Phase III study for MS, dubbed Concerto, may take as long as two years to complete, according to Teva.
“The investment community generally looks at laquinimod as a ’dead drug’ based on the weak initial set of results in MS,” said Gal. “While there is still much to prove, laquinimod be a $1 billion a year plus drug.”
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