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Teva Targets Roche’s Rituxan in Biosimilar Drug Trial
May 25 (Bloomberg) -- Teva Pharmaceutical Industries Ltd. is testing a copy of Roche Holding AG’s second-biggest-selling drug Rituxan in what may be the first U.S. generic version of a monoclonal antibody, a protein-based medicine used to treat diseases ranging from arthritis to cancer.
Teva this month began recruiting patients with rheumatoid arthritis for a clinical trial comparing its biosimilar copy, TL011, with the Roche drug, sold outside the U.S. as MabThera, according the U.S. National Institutes of Health website. The trial was posted on the website on May 11. Roche also sells Rituxan as a cancer treatment.
“Teva confirms that we are in clinicals,” Yossi Koren, a company spokesman, said in an e-mail, adding that the trial shows Teva is progressing according to plan and “positions us well in the biosimilars race.”
The health-care overhaul law signed by President Barack Obama earlier this year permits U.S. regulators to approve copies of biological medicines like Rituxan, creating a new market and stirring up competition. U.S. sales of biosimilars may reach $10 billion in the next decade, according to Ronny Gal, an analyst for Sanford C. Bernstein in New York. The drug copies could save Americans $6.6 billion over 10 years, according to a Congressional Budget Office report, with most of the savings coming after 2013.
Teva Shares Gain
Teva climbed as much as 5.2 percent in Tel Aviv, the biggest intraday gain since November 2008. The stock rose 8.7 shekels, or 4.2 percent, to 218.3 shekels at 1:16 p.m. Roche fell 3.4 Swiss francs, or 2.2 percent, to 153.2 francs in Zurich.
In the European Union, where the first biosimilar product was approved in 2006, the medicines aren’t considered to be interchangeable with brand-name drugs, meaning they can’t be automatically substituted.
The world’s biggest maker of generic drugs joined forces with the top drug-ingredient producer, Switzerland’s Lonza Group AG, last year to develop lower-priced copies of biotechnology treatments. Spokesmen for both companies declined to say whether Rituxan is the partnership’s first target.
Teva and Lonza are focusing on monoclonal antibodies, and aim to gain regulatory approval for their first product by the end of 2014, Lonza spokesman Michael Frizberg said in a telephone interview.
First Product
Teva and Lonza began clinical trials on their first product in the first half of this year, Frizberg said, declining to be more specific. Lonza shares fell 1.4 francs, or 1.8 percent, to 74.65 francs.
A telephone message seeking comment from Roche’s press office wasn’t immediately returned.
Biosimilars will be “an important future growth engine” for Teva, Chief Executive Officer Shlomo Yanai told investors at the Petah Tikva, Israel-based company’s first-quarter earnings this month. The company sells a biosimilar copy of Amgen Inc.’s Neupogen, used to boost infection-fighting white blood cells in chemotherapy patients, in Europe and sought U.S. approval in December.
Approved to treat non-Hodgkin’s lymphoma and leukemia as well as rheumatoid arthritis, Rituxan generated 6.09 billion Swiss francs ($5.24 billion) in sales last year. Roche asked U.S. regulators last month to expand use of the medicine as a maintenance therapy for people with advanced lymphoma, which the company said could add 300 million francs to 400 million francs in sales.
Indian Generic
Indian generic-drug maker Dr. Reddy’s Laboratories Ltd. began selling a new version of Rituxan in India in 2007. The drug had 199 million rupees ($4.2 million) in sales there in the 2009 fiscal year, according to the company’s annual report.
Patients in the Teva trial will get two infusions of Rituxan or two infusions of the biosimilar copy, at a two-week interval, according to the NIH website. The trial’s primary goal is to compare the biosimilar copy of Rituxan with the original version after one year, according to the website. The study is also measuring the drug’s safety.
Teva declined to comment further on the design and aims of the trial.
Rheumatoid arthritis occurs when the immune system attacks the joints, causing swelling, pain and damage that can lead to deformity and disability. The disease afflicts about 1.3 million Americans, according to the NIH.
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