Roche Halts Taspoglutide Dosing in Final Studies

Roche Holding AG told researchers to stop giving its experimental diabetes drug taspoglutide to patients in the final studies needed for approval after side effects such as nausea and vomiting led many to drop out of the trials.

The company, based in Basel, Switzerland, is trying to determine what caused the side effects and see if it can reformulate the medication to reduce the risk, spokeswoman Kristina Becker said in a telephone interview. More details should be available by the end of the year, she said.

The high number of patients who quit taking taspoglutide in the phase 3 trials makes it difficult to determine the drug’s long-term safety, Becker said in an e-mail. Thus, “continuing treatment with the current taspoglutide formulation is not considered to be in the best interest of patients,” she said.

Roche’s setback may benefit San Diego-based Amylin Pharmaceuticals Inc. and its Indianapolis-based partner Eli Lilly & Co., who sell the rival medication Byetta. Novo Nordisk A/S of Copenhagen received U.S. approval for its competing drug Victoza in January. In June, Roche said it was delaying plans to seek approval of taspoglutide next year, pushing back the filing by 12 months to 18 months.

Roche gained less than 1 percent to 144.2 Swiss francs in today’s trading. Amylin gained 49 cents, or 2.3 percent, to $21.99 at 3:26 p.m. New York time in Nasdaq Stock Market composite trading. Lilly gained 33 cents to $35.50 in New York Stock Exchange composite trading.

To contact the reporter on this story: Michelle Fay Cortez in Minneapolis at mcortez@bloomberg.net

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