ALIMTA Receives Positive Opinion From CHMP as Continuation Maintenance Therapy for a Fatal Form of Lung Cancer

INDIANAPOLIS, September 26, 2011 -

Eli Lilly and Company (NYSE: LLY) announced today that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for the use of ALIMTA® (pemetrexed for injection) as continuation maintenance therapy in patients with advanced nonsquamous non-small cell lung cancer (NSCLC). Positive opinions from the CHMP are reviewed by the European Commission, which then decides on whether to grant marketing authorization in Europe.

Maintenance therapy is a relatively new concept in lung cancer treatment in which patients start maintenance therapy immediately following their first-line treatments to try to maintain disease control.  No chemotherapies are currently approved in the “continuation maintenance” setting, in which one of the same medicines used in first-line treatment is continued as maintenance therapy. Currently approved maintenance therapies in lung cancer use different medicines in the first-line and maintenance phases of treatment.

“Lung cancer is one of the most difficult cancers to treat and new therapy options are much needed,” said Allen Melemed, M.D., M.B.A., senior medical director with Lilly Oncology. “If approved, pemetrexed would be the first tailored treatment option that can potentially extend lives beginning in first-line treatment and continuing through maintenance in advanced nonsquamous non-small cell lung cancer.”

The CHMP’s opinion was based on results from PARAMOUNT, a randomized double-blind Phase III study presented in June 2011 at the American Society of Clinical Oncology Annual Meeting.(1)

In the EU and U.S., pemetrexed is already approved in the first-line; switch maintenance and second-line settings for treatment of patients with advanced nonsquamous NSCLC.  

For full licensed indications of ALIMTA please see the SPC that can be accessed via link below.

www.medicines.org.uk/emc/medicine/15513/SPC   

Notes to Editor

About Non-Small Cell Lung Cancer (NSCLC)

Globally, lung cancer is the most common form of cancer and the biggest killer, causing 1.4 million cancer deaths annually.(2)  About 85 - 90 percent of all lung cancers are NSCLC.(3)  The liver, bones and brain are potential targets if the cancerous cells enter the bloodstream.

NSCLC comprises a group of histologies or tumor types differentiated by cellular structure. Nonsquamous histology includes adenocarcinoma and large cell carcinoma, which account for more than half of all NSCLC diagnoses,(3) as well as histologies classified as ‘other.’

About Lilly Oncology, a Division of Eli Lilly and Company  

For more than four decades, Lilly Oncology, a division of Eli Lilly and Company, has been dedicated to delivering innovative solutions that improve the care of people living with cancer.  Because no two cancer patients are alike, Lilly Oncology is committed to developing novel treatment approaches.  

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 product 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.

(1)  Paz-Ares LG, De Marinis F, et.al. PARAMOUNT: Phase III study of maintenance pemetrexed (pem) plus best supportive care (BSC) versus placebo plus BSC immediately following induction treatment with pem plus cisplatin for advanced nonsquamous non-small cell lung cancer (NSCLC). J Clin Oncol 29: 2011 (suppl; abstr CRA7510).

(2)  World Health Organization, Gender in Lung Cancer and Smoking Research, Department of Gender, Women and Health, 2008, www.who.int/gender/documents/en/lungcancerlow.pdf, (July 25, 2011).

(3)  American Cancer Society, “What Is Non-Small Cell Lung Cancer?,” December 16, 2010, American Cancer Society, www.cancer.org/Cancer/LungCancer-Non-SmallCell/DetailedGuide/non-small-cell-lung-cancer-what-is-non-small-cell-lung-cancer, (July 25, 2011).

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Caroline Harkness, +44(0)1256-775201(Office), +44(0)7889-718648 (mobile), harknessca at lilly.com; Grainne Maguire, TogoRun, +44(0)207-554-1813 (office), +44-754-0002-009 (mobile), g.maguire at togorun.net