Rigel slumps on rheumatoid arthritis drug results

NEW YORK -- Shares of Rigel Therapeutics Inc. lost more than a third of their value Friday on mixed results from a late-stage clinical trial of a rheumatoid arthritis drug the company helped develop.

Rigel's partner AstraZeneca PLC said Friday that fostamatinib met one of its two goals in the study: patients who took the experimental drug and methotrexate, a standard treatment for rheumatoid arthritis, had a bigger improvement in symptoms like joint swelling and tenderness than patients who took methotrexate and a placebo. However, the drug did not meet a second goal related to bone erosion and reductions in joint space.

Rigel doesn't have any approved products, and fostamatinib is its most advanced experimental drug. The company licensed fostamatinib to AstraZeneca in 2010 in a deal that could be worth more than $1 billion if the drug is approved and meets sales targets.

Citi Investment Research analyst Yaron Werber said fostamatinib doesn't compare favorably to existing rheumatoid arthritis drugs or to others in clinical development.

Rigel stock lost $2.56, or 34 percent, to $4.97. Earlier the stock fell to $4.71, its lowest price in almost four years.

The late-stage trial included 923 patients who had not been helped by previous treatment with methotrexate. The results are based on 24 weeks of treatment. AstraZeneca said it expects to report results from two other studies of fostamatinib during the second quarter.

Rigel Pharmaceuticals is based in South San Francisco, Calif. AstraZeneca, which is based in London, is one of the world's largest drug companies. The British company licensed fostamatinib from Rigel in February 2010, paying $100 million upfront.

Werber said fostamatinib doesn't seem to be as effective as biotech treatments like AbbVie Inc.'s Humira and other potential rheumatoid arthritis drugs.

"The outlook for fostamatinib is becoming more challenging given these results and the fact that the arthritis market will be getting very competitive with several oral and biologic drugs in development," he wrote.

U.S.-listed shares of AstraZeneca rose 26 cents to $50.39 in morning trading.

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Pfizer's rheumatoid arthritis drug OK'd in Japan

Drugmaker Pfizer Inc. said Monday that its new rheumatoid arthritis drug, Xeljanz, has been approved for use in Japan.

The Japanese Ministry of Health, Labor and Welfare approved the twice-a-day pill for use in patients whose symptoms have not improved after using at least one other disease-modifying drug. Those drugs are meant to slow worsening of the disabling autoimmune disorder, rather than just relieve joint pain and inflammation.

In rheumatoid arthritis, the immune system mistakenly attacks tissue in the body, primarily the joints, limiting mobility and sometimes leaving fingers bent at uncomfortable angles. It can also attack the lungs, heart, eyes, skin, blood and nerves. It's a chronic disease that generally worsens over time, but that progression can be slowed down by early, aggressive treatment.

Xeljanz, known chemically as tofacitinib, is the first approved pill in a new class of medicines called Janus kinase inhibitors, or JAK inhibitors for short.

The drug from New York-based Pfizer works inside cells, inhibiting the Janus kinase enzyme's signaling pathways. Those pathways are involved in the inflammation caused by rheumatoid arthritis.

Injectable biologic drugs such as Enbrel and Remicade, grown in living cells from genetically engineered proteins, work outside the body's cells to slow progression of the disorder by broadly suppressing the immune system. They are expensive, must be injected or infused, and can cause significant side effects. Those range from persistent fevers and flu-like illness to susceptibility to infections and flare-ups of dormant diseases such as tuberculosis.

Pfizer, the world's largest drugmaker by revenue, said that initially, Xeljanz will be made available in Japan to medical institutions participating in a program monitoring the progress of all patients.

Xeljanz, which was approved in the U.S. in November, is viewed as a potential big seller for Pfizer.

"RA is a serious and disabling disease and there is a need for new treatment options, as a significant number of patients do not adequately respond to current therapies," Mark Swindell, head of Pfizer's specialty care business in Japan, said in a statement.

Rheumatoid arthritis affects about 750,000 people in Japan and 23.7 million people worldwide. Up to one-third of patients don't respond adequately to current therapies, and about half stop using a particular disease-modifying treatment within five years, according to Pfizer.

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Follow Linda A. Johnson on Twitter at http://twitter.com/LindaJ_onPharma

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Lilly stops rheumatoid arthritis treatment study

INDIANAPOLIS -- Drug developer Eli Lilly and Co. is stopping clinical testing of an experimental rheumatoid arthritis treatment because it wasn't working.

The Indianapolis company said Thursday it will continue studying the potential drug, tabalumab, as a possible treatment for a form of the autoimmune disorder lupus and the bone marrow cancer multiple myeloma.

Lilly said in December it stopped a late-stage study of tabalumab due to a lack of effectiveness. The company announced Thursday that it decided to end additional mid- and late-stage research after further analyzing data. It said the decision was not based on safety concerns.

Late-stage studies are generally the last and most expensive phase of testing a drug undergoes before the developer asks regulators to approve it.

Rheumatoid arthritis is a major area of research for drug companies because it is a chronic condition, meaning patients will likely take the drugs regularly for a long time. In November, the Food and Drug Administration approved a new treatment for the disease, Pfizer Inc.'s twice-a-day pill Xeljanz.

Lilly shares fell 46 cents to $53.47 in morning trading.

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