LEL Lilly(Eli)

 
TIDMLEL 
 
For Immediate Release: September 26, 2011 
 
Contact: Amy Sousa, Lilly Grainne Maguire, TogoRun 
 
+1.317.276.8478 (office) +44 207.554.1813 (office) 
 
+1.317.997.1481 (mobile) +44 754.0002.009 (mobile) 
 
E-mail: sousa_amy_e@lilly.com E-mail: g.maguire@togorun.net 
 
                   ALIMTARECEIVES POSITIVE OPINION FROM CHMP 
 
              AS CONTINUATION MAINTENANCE THERAPY FOR DEADLY FORM 
 
                                OF LUNG CANCER 
 
INDIANAPOLIS, USA, 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 approve the indication 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 chemotherapy is 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., Alimta senior 
medical director with Lilly Oncology. "If approved, ALIMTA would be the first 
tailored treatment option based on efficacy 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. In this study, patients with advanced 
nonsquamous NSCLC received initial therapy with four cycles of ALIMTA plus 
cisplatin. Patients whose disease did not progress continued to the maintenance 
phase, where progression-free survival was assessed in patients who received 
ALTIMA plus best supportive care (BSC), compared with those who received 
placebo plus BSC. 
 
In the EU and U.S., ALIMTA is already approved in the first-line, maintenance 
and second-line settings for treatment of patients with advanced nonsquamous 
NSCLC. 
 
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 1.3 million cancer deaths annually. About 85 - 90 percent of all lung 
cancers are NSCLC. 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, 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. To learn 
more about Lilly's commitment to cancer, please visit www.LillyOncology.com. 
 
About Eli Lilly and Company 
 
Lilly, a leading innovation-driven corporation, is developing a growing 
portfolio of 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. 
 
P-LLY 
 
ALIMTA® (pemetrexed for injection), Lilly 
 
                                     # # # 
 
Important Safety Information for ALIMTA® (pemetrexed for injection) 
 
What is the most important information that I should know about ALIMTA? 
 
ALIMTA can suppress bone marrow function, which may cause low blood cell 
counts. 
 
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 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. 
 
Your doctor will prescribe a medicine called a "corticosteroid" to take for 3 
days during each treatment with ALIMTA. Corticosteroids lower your chances for 
getting skin reactions with ALIMTA. 
 
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. 
 
  * You must take folic acid every day for at least 5 days out of the 7 days 
    before your first dose of ALIMTA. You must keep taking folic acid every day 
    during the time you are getting treatment with ALIMTA, and for 21 days 
    after your last treatment. 
 
  * Your doctor will give you vitamin B12 injections while you are getting 
    treatment with ALIMTA. You will get your first vitamin B12 injection during 
    the week before your first dose of ALIMTA, and then about every 9 weeks 
    during treatment. 
 
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. 
 
What should I tell my doctor before receiving ALIMTA? 
 
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. 
 
Tell your doctor if you are taking other medicines, including prescription and 
nonprescription medicines, vitamins, and herbal supplements. ALIMTA and other 
medicines may affect each other, causing serious side effects. Especially, tell 
your doctor if you are taking medicines called "nonsteroidal anti-inflammatory 
drugs" (NSAIDs) for pain or swelling. 
 
What are the possible side effects of ALIMTA? 
 
Most patients taking ALIMTA will have side effects. Sometimes it is not always 
possible to tell whether ALIMTA, another medicine, or the cancer itself is 
causing these side effects. 
 
Call your doctor right away if you have a fever, chills, diarrhea, or mouth 
sores. These symptoms could mean you have an infection, which may be severe and 
could lead to death. 
 
The most common side effects of ALIMTA when given alone or in combination with 
cisplatin are: 
 
* Stomach upset, including nausea, vomiting, diarrhea, or constipation. You can 
obtain medicines to help control some of these symptoms. Call your doctor if 
you get any of these symptoms. 
 
* Low blood cell counts: 
 
* Low red blood cells. Low red blood cells may make you feel tired, get tired 
easily, appear pale, and become short of breath. 
 
* Low white blood cells. Low white blood cells may give you a greater chance 
for infection. If you have a fever (temperature above 100.4°F) or other signs 
of infection, call your doctor right away. 
 
* Low platelets. Low platelets give you a greater chance for bleeding. Your 
doctor will do blood tests to check your blood counts before and during 
treatment with ALIMTA. 
 
* Tiredness. You may feel tired or weak for a few days after your ALIMTA 
treatments. If you have severe weakness or tiredness, call your doctor. 
 
* Mouth, throat, or lip sores (stomatitis, pharyngitis). You may get redness or 
sores in your mouth, throat, or on your lips. These symptoms may happen a few 
days after ALIMTA treatment. Talk with your doctor about proper mouth and 
throat care. 
 
* Loss of appetite. You may lose your appetite and lose weight during your 
treatment. Talk to your doctor if this is a problem for you. 
 
* Rash. You may get a rash or itching during treatment. These usually appear 
between treatments with ALIMTA and usually go away before the next treatment. 
Rarely, these reactions may be severe (can lead to Stevens-Johnson syndrome or 
toxic epidermal necrolysis) and could lead to death. Call your doctor if you 
get a severe rash, itching, or blistering. 
 
Talk with your doctor, nurse, or pharmacist about any side effect that bothers 
you or that doesn't go away. 
 
These are not all the side effects of ALIMTA. For more information, ask your 
doctor, nurse, or pharmacist. 
 
How is ALIMTA given? 
 
ALIMTA is slowly infused (injected) into a vein. The injection or infusion will 
last about 10 minutes. You will usually receive ALIMTA once every 21 days (3 
weeks). 
 
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. 
 
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. 
 
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). 
 
World Health Organization, Gender in Lung Cancer and Smoking Research, 
Department of Gender, Women and Health, 2003, http://www.who.int/gender/ 
documents/en/lungcancerlow.pdf, (July 25, 2011). 
 
American Cancer Society, "What Is Non-Small Cell Lung Cancer?," December 16, 
2010, American Cancer Society, http://www.cancer.org/Cancer/LungCancer-Non-SmallCell/DetailedGuide/ 
non-small-cell-lung-cancer-what-is-non-small-cell-lung-cancer, (July 25, 2011). 
 
American Cancer Society, "What Is Non-Small Cell Lung Cancer?," October 20, 
2009, American Cancer Society, 
http://www.cancer.org/Cancer/LungCancer-Non-SmallCell/DetailedGuide/ 
non-small-cell-lung-cancer-what-is-non-small-cell-lung-cancer, (July 25, 
2011).. 
 
 
 
Eli Lilly and Company 
 
Lilly Corporate Center 
 
Indianapolis, Indiana 46285 
 
U.S.A. 
 
 
 
 
 
 
END 
 

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