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Related content • Eli Lilly stock quote • Eli Lilly company information • Eli Lilly FactFile       Alimta at a glance • Developer: Eli Lilly and Co., licensed from Princeton University. • Conditions for which drug would be approved: mesothelioma and non-small cell lung cancer. • Status: Lilly will finish filing by September for Food and Drug Administration approval, which could come late this year or in 2004. • Sales potential: $1 billion in peak annual sales, according to Lehman Bros.

The experimental cancer drug Alimta worked so well in a study on lung cancer patients that Eli Lilly and Co. said Monday it will ask for federal approval to market the drug for that use, too.

Tapping the large market for lung cancer, which is diagnosed in 175,000 Americans every year, could vastly expand sales possibilities for Alimta. Up to now, Lilly had planned to target the drug only for mesothelioma, a rare cancer of the lung lining caused by asbestos exposure.

Alimta's effectiveness in treating the most common form of lung cancer could amount to "a huge benefit for patients and also for health care," said Dr. Paolo Paoletti, Lilly vice president of clinical research for oncology.

The Indianapolis drug maker revealed the new Alimta findings at the annual meeting of the American Society of Clinical Oncology in Chicago.

In the Lilly-sponsored study, Alimta proved as effective as Taxotere as a second-line treatment for non-small cell lung cancer. Taxotere, made by Aventis and sold since 1999, is the only federally approved drug to treat recurring cases of the common lung cancer in patients who've been unsuccessfully treated with first-line chemotherapy.

Survival was largely the same, at about eight months, for both Taxotere and Alimta patients.

Not only did Alimta match Taxotere in effectiveness, Alimta caused far fewer side effects among the 571 lung cancer patients studied.

Only 5 percent of patients taking Alimta saw a dangerous drop in white blood cells, compared with 40 percent of patients on Taxotere. A low white blood cell count can lead to fever or infection.

In addition, only 10 percent of patients given Alimta suffered serious drug-related adverse events, compared with 24 percent of Taxotere patients.

Fewer side effects should make Alimta a more useful drug for patients and doctors, said Dr. Nasser Hanna, an assistant professor of medicine at Indiana University School of Medicine, who presented the study findings.

Alimta sales geared mainly toward mesothelioma could hit $157 million by 2006, said the investment firm Friedman Billings Ramsey & Co. But last year, the investment firm Lehman Bros. forecast peak annual sales for Alimta of $1 billion, assuming it's used against multiple cancers, a dollar figure that would put Alimta among Lilly's top-selling drugs.

Lung cancer in its most common form typically kills its victims within eight months of diagnosis, so avoiding serious drug-induced side effects during that time is important for patients and their families, Hanna said.

In the study, Alimta was supplemented with vitamin B-12 and folic acid, but Hanna said the vitamins alone didn't account for the fewer side effects.

About a half-dozen drugs are approved as first-line treatments for common lung cancer. They include another Lilly product, Gemzar, and the well-known Taxol, from Bristol-Myers Squibb Co.

But those products often only slow down lung cancer's spread, so new treatments are needed, Hanna said. "This opponent we face is so difficult. Whenever we get another drug, that's exciting."

Lilly will use the new study to ask the Food and Drug Administration to approve Alimta for common lung cancer, as well, which would significantly expand the drug's market.

"That would be my dream. But it's in the hands of the FDA," Paoletti said.

In earlier studies, Alimta proved its worth in lengthening the lives of patients stricken with mesothelioma, which is diagnosed in 10,000 people worldwide annually. No drugs are currently approved in the United States to treat the deadly cancer caused by airborne asbestos. Lilly expects to receive FDA approval late this year or early 2004 to sell Alimta for mesothelioma.

Lilly is filing for approval at a favorable time for what would be its second cancer drug. Under pressure to get new cancer treatments to market, the FDA has speeded up its approval process, approving some drugs even before the last of three stages of human testing is complete.

Alimta came out of the Princeton University labs of Edward C. Taylor, an emeritus professor of organic chemistry. A synthetic compound, Alimta works against cancer by interfering with the way natural folic acid is converted into enzyme co-factors necessary for cancer cell division.

Alimta is given intravenously. In the lung cancer study, patients underwent a 10-minute infusion every three weeks.

Lilly has FDA approval to supply Alimta for free on a compassionate-use basis to more than 600 mesothelioma patients. Lilly makes the drug in Europe.

Call Star reporter Jeff Swiatek at 1-317-444-6483.