WASHINGTONA US federal court has granted a preliminary injunction barring Eli Lilly and Company and its sales representatives from promoting its drug Evista (raloxifene ) as effective in reducing the risk of breast cancer.
The injunction was sought by AstraZeneca, a unit of Zeneca, Inc., whose drug Nolvadex (tamoxifen) is approved both for treating breast cancer and for reducing the risk of breast cancer in high-risk women. Evista is approved for use in preventing osteoporosis, and some research has suggested that it may be helpful in preventing breast cancer.
The two drugs are currently being tested for effectiveness in preventing breast cancer in STAR, the Study of Tamoxifen(Drug information on tamoxifen) and Raloxifene(Drug information on raloxifene), which began enrolling the first of 22,000 patients in late May.
AstraZeneca filed for an injunction on Feb. 25, under the Lanham Act, a federal statute dealing with false advertising. The company alleged that Lillys sales force had falsely promoted Evista to physicians as having been shown to reduce the risk of breast cancer.
In a 106-page decision rendered on July 16, Judge John Koeltl, of the US District Court of the Southern District of New York, granted the injunction. He ordered Lilly to cease any claims that Evista has been shown, proven, demonstrated, or established to reduce the risk of breast cancer and to institute a training program for its sales force to ensure that its representatives conform with the courts ruling.
However, Judge Koeltl denied Astra-Zenecas request that the court require Lilly to distribute corrective advertising.
In a statement, Lilly said it was pleased that the court found no evidence to support Zenecas claim that Lilly is promoting Evista as a drug that is approved or indicated by the FDA for the prevention of breast cancer. The company said that although it disagreed with several aspects of the courts decision, it would institute the ordered training program.
The ruling addresses a very narrow issue, said Angela Sekston, a spokeswoman for Lilly at its Indianapolis headquarters. She added that an internal review of material provided to physicians showed that they specifically state that Evista has not been demonstrated to reduce the risk of breast cancer. It appears that our materials are in line with the courts ruling, Ms. Sekston said.