Healthcare Industry News:  non-small cell lung cancer 

Biopharmaceuticals Oncology Regulatory

 News Release - September 20, 2007

Lilly Files for European Approval of ALIMTA(R) (pemetrexed for injection) for First-Line Treatment of Non-Small Cell Lung Cancer

INDIANAPOLIS, Sept. 20 (HSMN NewsFeed) -- Eli Lilly and Company (NYSE: LLY ) today announced that it has submitted an application with the European Medicines Agency (EMEA) for centralised review of ALIMTA® (pemetrexed for injection), in combination with cisplatin, for the first-line treatment of advanced non-small cell lung cancer (NSCLC).

ALIMTA is currently indicated in more than 85 countries as a second-line, single agent for the treatment of patients with locally advanced or metastatic NSCLC after prior chemotherapy, and is also indicated, in combination with cisplatin, for the treatment of patients with malignant pleural mesothelioma (MPM) whose disease is unresectable or who are otherwise not candidates for curative surgery.

The EMEA submission is based on a study which evaluated ALIMTA plus cisplatin versus GEMZAR® (gemcitabine HCl for injection) plus cisplatin. The study met its primary endpoint of non-inferiority relative to overall survival in a first-line NSCLC setting.

"As non-small cell lung cancer is the leading cause of cancer death worldwide, it is important that doctors have a range of treatments for this devastating illness," said Richard Gaynor, M.D., vice president of cancer research and global oncology platform leader for Lilly. "In this clinical study, ALIMTA plus cisplatin demonstrated similar efficacy to GEMZAR plus cisplatin, a widely used regimen for first-line NSCLC, while providing a more favorable toxicity profile and greater convenience. We look forward to the outcome of the EMEA review."

In September 2004, the EMEA approved ALIMTA as a single agent, second-line treatment for patients suffering from advanced NSCLC, as well as in combination with cisplatin for the treatment of patients with MPM.

In the U.S., ALIMTA was approved by the FDA as a second-line therapy for locally advanced or metastatic NSCLC in August 2004, as well as in combination with cisplatin as a first-line treatment for MPM in February 2004.

Notes to Editor:

About non-small cell lung cancer (NSCLC)

NSCLC is the most common type of lung cancer and represents 75 to 80 per cent of all lung cancers.(i) NSCLC has five-tier staging, starting at 0 and rising to the severity of stage IV.(ii) NSCLC can spread through the lymphatic system, penetrating the chest lining, ribs and the nerves and blood vessels that lead to the arm. The liver, bones and brain are potential targets if the cancerous cells enter the blood stream.

According to the World Health Organization (WHO) Cancer Report, lung cancer is the world's most common cancer and the leading cause of cancer death for both men and women. More than one million people die from lung cancer each year.(iii)

About Lilly Oncology, a Division of Eli Lilly and Company

For more than four decades, Lilly Oncology has been collaborating with cancer researchers to deliver innovative treatment choices and valuable programs to patients and their physicians. Inspired by courageous patients living with cancer, Lilly Oncology is providing treatments that are considered global standards of care and developing a broad portfolio of novel targeted therapies to accelerate the pace and progress of cancer care. To learn more about Lilly's commitment to cancer, please visit

About Eli Lilly and Company

Lilly, a leading innovation-driven corporation, is developing a growing portfolio of first-in-class and best-in-class pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Ind., Lilly provides answers - through medicines and information - for some of the world's most urgent medical needs.

ALIMTA® (pemetrexed for injection), Lilly

GEMZAR® (gemcitabine HCl for injection), Lilly

This press release contains forward-looking statements about the potential of ALIMTA for the treatment of non-small cell lung cancer and reflects Lilly's current beliefs. However, as with any pharmaceutical products under development, there are substantial risks and uncertainties in the process of development, commercialization, and regulatory review. There is no guarantee that the product will receive additional regulatory approvals. There is also no guarantee that the product will continue to be commercially successful. For further discussion of these and other risks and uncertainties, see Lilly's filings with the United States Securities and Exchange Commission. Lilly undertakes no duty to update forward-looking statements.

Source: Eli Lilly

Issuer of this News Release is solely responsible for its content.
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