Glaxo Sees Promise in Study of Breast Cancer Drug

Drug maker GlaxoSmithKline said Monday that its experimental cancer pill Lapatinib was effective as a first-line breast cancer treatment but regulatory approval would not be sought before late 2006 or early 2007 after more data were collected.

London-based Glaxo said interim results from a mid-stage trial of the drug in 40 women with advanced breast cancer showed that 35% had their tumors shrink by at least 30%.

Lapatinib is an oral drug designed to block two biological switches involved in cancer growth.

The trial -- whose findings thus far were presented at a meeting of the American Society of Clinical Oncology in Florida -- tests the drug as a therapy for breast cancer patients whose tumors involve a protein called HER-2.

Genentech Inc.’s Herceptin, a monoclonal antibody administered by intravenous infusion, also works through its effect on HER-2.

Patients in the Lapatinib trial were not previously treated with Herceptin, said Dr. Paolo Paoletti, Glaxo’s senior vice president of oncology medicine development.

In the mid-stage trial, another 35% of patients saw their disease stabilize, the company said. The trial is continuing, and 130 patients will be enrolled.

Side effects of Lapatinib included itching, rash, diarrhea, acne and dry skin, but none were high grade and there was no observed cardiotoxicity, Paoletti said.

Glaxo said it now planned to seek regulatory approval of the drug in late 2006 or early 2007, using data from trials that were underway. Previously, the company had considered filing late this year on the basis of mid-stage trials in patients with advanced cancer who had failed other treatment options.

In other drug industry news:

* An experimental dual-action pill has produced promising results in fighting lung cancer in a mid-stage clinical trial, its developer, AstraZeneca, said Monday.

Success for the product, known as ZD6474, could help Europe’s third-largest drug maker recover some of the ground lost last year when Iressa, the company’s marketed lung cancer treatment, failed to show overall survival benefits.

Results of a Phase 2 study found that ZD6474 increased the amount of time patients remained alive without their disease getting worse.

* Schering-Plough Corp.’s combination treatment for hepatitis C was more effective in eliminating the virus than Roche Holding’s better-selling similar combination, according to a small study described Monday.

The study analyzed how patients treated for hepatitis C at the Cleveland Clinic fared from 2001 to 2004.

Clinic officials said a higher percentage of patients who received Schering-Plough’s therapy, especially those who were obese, eliminated the virus after treatment than those taking Roche’s therapy.

Complete data from the informal retrospective study were available on 28 obese patients and 58 non-obese patients, all of whom were white and had been infected with the hardest-to-treat genotype 1 strain of the virus. None of the patients had previously been treated.

Dr. Nizar Zein said he reviewed the patient records because no formal head-to-head trials of the two leading therapies had been completed. Schering-Plough is conducting such a trial, but its results will not be known until 2007.

Schering-Plough’s combination consists of an injectable interferon called Peg-Intron that is given along with an antiviral pill called ribavirin for 48 weeks. Roche’s treatment includes an interferon called Pegasys, which is also paired with ribavirin for the same duration.

The dosage of Schering-Plough’s interferon is based on a patient’s body weight.

Zein said the virus was eliminated in 53% of obese patients getting the weight-based Schering-Plough interferon, similar to the 48% of non-obese patients receiving it.

By contrast, 18% of obese patients receiving the fixed-dose Roche interferon cleared the virus from their bloodstreams. That was significantly lower than the 28% of non-obese patients taking the same therapy who eliminated the virus.

* Teva Pharmaceutical Industries Ltd. said Monday that U.S. regulators had approved its bid to make a generic version of Abbott Laboratories Inc.’s blood-fat-reducing drug Tricor.

The Food and Drug Administration gave Israel-based Teva final approval to sell versions of the drug, known generically as fenofibrate, Teva said.

Teva and Abbott Laboratories are in a legal battle over rights to make the drug, which is used to reduce high levels of cholesterol and triglycerides in the blood.

Last week, a U.S. District Court granted a summary judgment in Teva’s favor on certain patent claims.

Abbott currently sells a slightly altered version of the drug, which brings in annual sales of about $800 million, Abbott spokeswoman Jennifer Smoter said.

Teva contends that Abbott is trying to avoid a generic competitor by tinkering with the drug’s formulation.

The newer form can be taken with or without food, Smoter said.

Teva said it was seeking damages for potential profit lost during the dispute.