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Lilly to Unveil More Than 30 Studies at Premier Lung Cancer Meeting
Date:7/27/2009

INDIANAPOLIS, July 27 /PRNewswire-FirstCall/ -- Eli Lilly and Company continues to lead the way in advancing lung cancer treatment. On the heels of new FDA and European Commission approvals for ALIMTA((R)) (pemetrexed for injection) as a treatment for nonsquamous non-small cell lung cancer (NSCLC) in the maintenance setting, the company will release findings from more than 30 lung cancer studies at the 13th World Conference on Lung Cancer (WCLC) in San Francisco, Calif., from July 31 to Aug. 4, 2009. WCLC is sponsored by the International Association for the Study of Lung Cancer. Data will feature Lilly's ALIMTA and GEMZAR((R)) (gemcitabine HCl for injection).

"Our goal is - and has always been - to improve treatment options for individual patients," said Richard Gaynor, M.D., Lilly vice president, cancer research and global oncology platform leader. "In lung cancer in particular, histology provides us with one way to tailor treatment with ALIMTA for patients living with nonsquamous NSCLC."

ALIMTA, launched in 2004, continues to be evaluated in a number of NSCLC treatment settings. At WCLC, the company will share data involving ALIMTA-based regimens in combination with radiation for inoperable stage IIIA/B NSCLC.

Globally, lung cancer impacts more than 3 million people and is one of the most common cancers worldwide, accounting for 1.2 million new cases annually.(i)

Studies of note for ALIMTA include:

  • B2.6: Oral Presentation: Aug. 2, 2009, 3:30 p.m. PDT
    • Pemetrexed is more effective* in patients with nonsquamous non-small cell lung cancer (NSCLC) histology: An analysis of three large, randomized, phase III trials (* vs. the respective comparators in these three trials)
  • D2.6: Oral Presentation: Aug. 4, 2009, 1:30 p.m. PDT
    • Final results of a randomized phase II trial of pemetrexed (P) + carboplatin (Cb) +/- enzastaurin (E) versus docetaxel (D) + Cb as first-line treatment of patients (pts) with stage IIIB/IV non-small cell lung cancer (NSCLC)
  • PD9.1.1: Poster Discussion Session: Aug. 3, 2009, 10:30 a.m. PDT
    • Histological analysis in Pemetrexed treated patients with stage IIIB/IV NSCLC: Results from an open label randomized phase II study
  • PD8.1.3: Poster Discussion Session: Aug. 3, 2009, 10:30 a.m. PDT
    • Ongoing Phase II Study of Pemetrexed plus Carboplatin or Cisplatin with Concurrent Radiation Therapy Followed by Pemetrexed Consolidation in Patients with Favorable-Prognosis Inoperable Stage IIIA/B non-small cell Lung Cancer: Interim Safety Update

P-LLY

ALIMTA((R)) (pemetrexed for injection), Lilly

Important Safety Information for ALIMTA

ALIMTA is approved by the FDA in combination with cisplatin (another chemotherapy drug) for the initial treatment of advanced nonsquamous non-small cell lung cancer (NSCLC), a specific type of NSCLC. ALIMTA is not indicated for patients who have a different type of NSCLC called squamous cell.

ALIMTA is approved by the FDA for the treatment of patients with advanced nonsquamous nonsmall cell lung cancer (NSCLC), a specific type of NSCLC, to maintain the effect of initial treatment with chemotherapy and whose disease has not worsened. ALIMTA is not indicated for patients who have a different type of NSCLC called squamous cell.

ALIMTA is approved by the FDA as a single agent (used alone) for the treatment of patients with advanced nonsquamous non-small cell lung cancer (NSCLC), a specific type of NSCLC, after prior chemotherapy. ALIMTA is not indicated for patients who have a different type of NSCLC called squamous cell.

ALIMTA is approved by the FDA as a treatment for malignant pleural mesothelioma (MPM), which is a cancer that affects the inside lining of the chest cavity. ALIMTA is given with cisplatin, another anticancer medicine (chemotherapy), when surgery is not an option.

ALIMTA may not be appropriate for some patients. If you are allergic to ALIMTA, tell your doctor because you should not receive it. If you think you are pregnant, are planning to become pregnant, or are nursing, please tell your healthcare team. ALIMTA may harm your unborn or nursing baby. Your physician may advise you to use effective contraception (birth control) to prevent pregnancy while you are being treated with ALIMTA.

If you have liver or kidney problems, be sure to tell your doctor. Your dose of ALIMTA may have to be changed, or ALIMTA may not be right for you. There is a risk of side effects associated with ALIMTA therapy. ALIMTA can suppress bone marrow function. It is very important to take folic acid and vitamin B12 prior to and during your treatment with ALIMTA to lower your chances of harmful side effects.

Your healthcare professional will prescribe a medicine called a corticosteroid, which lowers your chances of getting skin reactions with ALIMTA. Ask your healthcare professional before taking medicines called NSAIDs (nonsteroidal anti-inflammatory drugs used to treat pain or swelling). Tell your doctor if you are taking other medicines, including prescription and non-prescription medicines, vitamins, and herbal supplements.

The most common side effects of ALIMTA when given alone or in combination with cisplatin, another chemotherapy drug, are low blood cell counts (red blood cells, white blood cells, and platelets); tiredness; stomach upset, including nausea, vomiting, and diarrhea; mouth, throat, or lip sores; loss of appetite; rash; and constipation.

Call your healthcare professional right away if you have a fever, chills, diarrhea, or mouth sores. These symptoms could mean you have an infection. These are not all of the side effects of ALIMTA. If you have any side effect that bothers you or that does not go away, be sure to talk with your healthcare professional.

You will have regular blood tests before and during your treatment with ALIMTA. Your doctor may adjust your dose of ALIMTA or delay your treatment based on the results of your blood test and on your general condition.

For more information about all of the side effects of ALIMTA, please talk with your healthcare team, see the Patient Prescribing Information and full Prescribing Information, visit www.ALIMTA.com, or call 1-800-545-5979.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Important Safety Information for GEMZAR (gemcitabine HCl for injection)

GEMZAR is indicated in combination with cisplatin (another type of chemotherapy) for the first-line treatment of patients with locally advanced (Stage IIIA or Stage IIIB) or metastatic (Stage IV or cancer that has spread) non-small cell lung cancer for whom surgery is not possible.

GEMZAR may not be appropriate for some patients.

If you are allergic to GEMZAR, tell your doctor you should not receive it. GEMZAR can suppress bone marrow function. There have been rare reports of serious kidney or liver toxicity with GEMZAR treatment, sometimes fatal. Serious lung toxicity has also been reported, sometimes fatal. If you think you are pregnant, are planning to become pregnant, or are nursing, please tell your healthcare team. GEMZAR may harm your unborn or nursing baby.

If you have had prior kidney or liver problems or impairment, please tell your healthcare professional. GEMZAR may not be right for you. GEMZAR has not been shown to work in children. Tell your doctor if you are taking other medicines, including prescription and non-prescription medicines, vitamins, or herbal supplements.

There is a risk of side effects associated with GEMZAR therapy. The most common side effects are low blood cell counts (red blood cells, white blood cells, and platelets); fever; infection; hair loss; tiredness; nausea, vomiting, constipation, and diarrhea; rash; shortness of breath; muscle aches; and numbness or tingling in your toes or fingers. These are not all of the side effects of GEMZAR. If you have any side effect that bothers you or that does not go away, be sure to talk with your healthcare professional. Call your healthcare professional right away if you have fever or chills. These symptoms could mean you have an infection.

You will have regular blood tests before and during your treatment with GEMZAR. Your doctor may adjust your dose of GEMZAR or delay your treatment based on the results of your blood test and on your general condition.

For more information about all of the side effects of GEMZAR, please talk with your healthcare team, see the full Prescribing Information, visit www.GEMZAR.com, or call 1-800-545-5979.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

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 products will receive additional regulatory approvals. There is also no guarantee that the products 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.

(i) World Health Organization: Global cancer rates could increase by 50% to 15 million by 2020, Fact sheet. Available at:http://www.who.int/mediacentre/news/releases/2003/pr27/en/. Accessed on 7/10/09

(Logo: http://www.newscom.com/cgi-bin/prnh/20031219/LLYLOGO )


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