About Alimta

Wall Street Journal (Dow Jones), May 21, 2002
"Asbestos-Related Lung Cancer Slowed by Eli Lilly Chemo Drug"

Eli Lilly & Co.'s experimental chemotherapy drug Alimta showed positive results in treating people suffering from a April 6, 2005sbestos. Results from a clinical trial showed that patients with malignant pleural mesothelioma treated with Alimta lived longer, endured less pain and breathed easier than patients treated with standard chemotherapy. Alimta is the first drug shown to prolong the life expectancy of patients suffering from what is an especially fatal form of cancer that has been resistant to treatment. The disease results in tumors, usually caused by asbestos fibers lodged in the lung, which attach to the lung lining and chest wall.

The study was presented at the American Society of Clinical Oncology's annual meeting here. "This is the first time we have ever documented an improvement in mesothelioma survival," said lead investigator Nicholas Vogelzang, director of the University of Chicago Cancer Research Center, during a news conference. Life expectancy for patients treated with a combination of Alimta and the commonly used chemotherapy drug cisplatin increased 25% to 30% compared with patients treated with just cisplatin, according to study results. The study tested 448 patients, 226 of whom received a combination of Alimta and cisplatin. The remaining 222 patients were treated with cisplatin alone. Patients treated with Alimta survived a year, while patients taking cisplatin alone survived for nine months.

Tumors shrank in 41% of the patients treated with Alimta, compared with 17% of the patients treated with cisplatin. Lung function improved in Alimta patients and declined in patients taking cisplatin alone. Pain also decreased for patients treated with Alimta, but began to rise near the end of the study. Researchers have no illusions that Alimta will become a cure for the disease. Rather, it is intended to prolong a patient's life and alleviate symptoms. "It is not a cure, true, but it does offer patients hope," said Paul Bunn, president-elect of the American Society of Clinical Oncology. Lilly is negotiating with the U.S. Food and Drug Administration to gain fast-track approval for Alimta as a treatment for mesothelioma.

It is expected to come to market next year. The drug also is being tested as a possible treatment for lung, pancreatic and colorectal cancer. Mesothelioma is rare; the Centers for Disease Control recorded just 706 cases in the U.S. in 1980. But the numbers are rising. A conservative estimate is that an average of 2,500 to 3,500 new cases are reported every year. Some studies April 6, 2005 who handled asbestos in the 1960s and 1970s are being diagnosed 20 to 40 years later. Alimta is important to Lilly's pipeline.

The company recently lowered its financial projections for this year, citing delays in the release of two new drugs and slow sales of the sepsis drug Xigris. Lilly had expected to release Cialis, for male erectile dysfunction, and atomexetine, for attention-deficit hyperactivity disorder, this year. Lilly now expects the two drugs to be released in 2003. Like many cancer therapies, Alimta is designed to prevent cancer cells from growing by blocking the enzymes that allow the cell's DNA and RNA to replicate. But while other drugs block just one enzyme, Alimta blocks all three.

Financial Times, May 21, 2002
"Eli Lilly boosted by drug success"

Researchers yesterday hailed the first effective treatment for mesothelioma, the incurable lung cancer caused by inhaling asbestos. Alimta, a new type of cancer treatment being developed by Eli April 6, 2005crease the length of survival and ameliorate the symptoms of the disease.

The trial, one of the largest against the fatal disease, was presented at the annual meeting of the American Society of Clinical Oncologists. Hilary Calvert, a cancer specialist from the University of Newcastle-upon-Tyne who took part in the trial, hailed the results as the first significant breakthrough against mesothelioma. But he said it was unlikely the drug would cure the disease, which usually suffocates its victims by destroying the lining of their lungs. "It is very unlikely that it will cure them. What it will do is prolong their life and reduce the chest pain and shortness of breath," Prof Calvert said.

The disease is rare, causing about 10,000 deaths a year worldwide, compared with 125,000 lung cancer deaths in the US alone. But the figure is rising. The widespread use of asbestos was only banned in Europe and the US in the 1980s, but mesothelioma usually lies dormant for 20-40 years. Once diagnosed, few patients live longer than a year. Some patients in earlier trials of Alimta were still alive after three years, Prof Calvert said. Eli Lilly plans to seek US and European approval based on the trial data this year. Approval could be rapid because of the lack of alternative treatments but the launch is likely to be delayed until 2003 due to complications in formulating the treatment. Alimta works by attacking folic acid - a vitamin that is essential for dividing cancer cells. Analysts forecast sales of more than $500m a year if Lilly, which controls a 12 per cent share of the $1.6bn lung cancer market, can win approval for other conditions.

It has already shown success against pancreatic cancer. Before asbestos was linked with mesothelioma, it was widely used in construction and shipbuilding for insulation and as a fire retardant. The World Trade Center attacks have raised fears over the health of the survivors. The collapse of the twin towers released a cloud of potentially deadly asbestos fibres. Experts believe even a brief exposure to the dust can be fatal. Concerns over asbestos liabilities challenge some of corporate America's biggest names and could cost UK insurers billions of pounds following recent court rulings on both sides of the Atlantic. Lilly shares were up 0.25 per cent at $65.15 in New York yesterday.

The New York Times, May 21, 2002
"Report Suggests Prostate Screening Tests Less Frequently for Some Patients National Desk" (only parts of article included here)

... The largest study ever of malignant mesothelioma, a rare type of lung cancer, showed that an experimental drug, Alimta (pemetrexed), improved survival and shrunk the cancers more often than standard therapy

... In the largest study of malignant mesothelioma, the group that took Alimta combined with cisplatin (a standard cancer drug) survived a year on average, compared with nine months for those who took only cisplatin. The mesothelioma shrank in 41 percent of the Alimta group that took Alimta compared with 17 percent in the cisplatin group. There were 456 patients in the study.
Alimta improved the symptoms of many patients by reducing pain, improving lung function and easing breathing.
Malignant mesothelioma, which usually develops about 20 years after exposure to asbestos, is rare and difficult to treat. At least 2,500 cases are diagnosed each year in the United States, but some experts predict that the number will rise in coming years.

Associated Press, May 21, 2002
"Study finds Lilly cancer drug lengthens patients' lives"

A drug developed by Eli Lilly and Co. to treat a rare cancer linked to asbestos exposure lengthened the lives of patients who took the drug in clinical trials, researchers said Monday. The findings involving the new drug, Alimta, heartened cancer researchers because pleural mesothelioma has proven resistant to treatment and no drugs are approved in the United States to treat it. "This is an historic day. Patients and their families who deal with this disease now have a clear path forward," said Dr. Nicholas J. Vogelzang, director of University of Chicago Cancer Research Center.

The clinical trial results were presented during a meeting of oncology researchers in Orlando, Fla. Alimta is in the last of three phases of human testing for mesothelioma. The dramatic results came in the largest-ever patient study for mesothelioma patients. The study of 456 patients showed that those given Alimta, plus a commonly used chemotherapy drug and vitamins, lived for 13 months after diagnosis of the cancer. That compared with seven months for those who received only the standard chemotherapy cisplatin and vitamins. "That is a very, very striking difference for a disease considered hopeless," Vogelzang said. Patients taking Alimta during the yearlong study also suffered less pain and had fewer breathing difficulties, said Dr. Paolo Paoletti, a Lilly researcher who is leading Lilly's development of Alimta.

Lilly plans to file in 2003 for approval from the U.S. Food and Drug Administration to market Alimta for the lung cancer. It could win approval as early as next year. Mesothelioma is diagnosed in only 2,500 Americans and 5,000 Europeans a year, but its prevalence is rising as more people are found to be exposed to the once commonly sold asbestos that causes the cancer. Most people die within nine months of diagnosis.

The Indianapolis Star, May 21, 2002
"Asbestos-Induced Lung Cancer Responds to Eli Lilly Experimental"

An experimental Eli Lilly and Co. drug lengthened the lives of patients with cancer of the lung lining that's mainly caused by asbestos. The study finding, released Monday, heartened cancer researchers because the deadly cancer has proven resistant to treatment and no drugs are approved in the United States to treat it. "This is an historic day. Patients and their families who deal with this disease now have a clear path forward," said Dr. Nicholas J. Vogelzang, director of the University of Chicago Cancer Research Center.

The dramatic results came in the largest-ever patient study for cancer of the lung lining, called pleural mesothelioma. The study of 456 patients showed that those given the Lilly drug Alimta, plus a commonly used chemotherapy drug and vitamins, lived for 13 months after diagnosis of the cancer. That compared to seven months for those who received only the standard chemotherapy cisplatin and vitamins. "That is a very, very striking difference for a disease considered hopeless," Vogelzang said. Patients taking Alimta during the yearlong study also suffered from less pain and had fewer breathing difficulties, said Dr. Paolo Paoletti, a Lilly researcher who is team leader for Alimta's development at Lilly's Indianapolis labs.

Alimta could be on the market next year. Lilly plans to file in 2003 for approval from the U.S. Food and Drug Administration to market Alimta for the lung cancer. Alimta is in the last of three phases of human testing for that cancer. Cancer of the lung lining is rare, diagnosed in only 2,500 Americans and 5,000 Europeans a year, but its prevalence is rising as more people are found to be exposed to the once commonly sold asbestos that causes the cancer. Most people die within nine months of diagnosis. Lilly also is testing Alimta on other cancers, including that of the pancreas, where Alimta shows early promise.

When Alimta was combined with the marketed Lilly drug Gemzar and given to patients with pancreatic cancer, a third of them were alive after one year, a new Lilly study shows. That compares to an 18 percent one-year survival rate generally among pancreatic cancer patients treated with Gemzar alone, Lilly said.

The molecule that is Alimta came to Lilly from a Princeton University researcher. It works like three or more cancer drugs in one, by targeting multiple enzymes that cancer cells need to take up folic acid and multiply.