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LLY » Topics » Pipeline

These excerpts taken from the LLY 10-K filed Feb 27, 2009.
Pipeline
 
•  We, along with our partner Daiichi Sankyo Company Limited, are seeking from the U.S. Food and Drug Administration (FDA) approval for prasugrel as a treatment for patients with acute coronary syndrome being managed with percutaneous coronary intervention. The Cardiovascular and Renal Drugs Advisory Committee of the FDA reviewed prasugrel during a hearing and unanimously recommended it for approval. The FDA will consider the recommendation as it continues its review and makes its final decision.
 
•  Prasugrel was approved for marketing by the European Commission under the trade name Efient in February 2009 for the prevention of atherothrombotic events in patients with acute coronary syndromes undergoing percutaneous coronary intervention.
 
•  We received a complete response letter from the FDA for olanzapine long-acting injection (LAI) for acute and maintenance treatment of schizophrenia in adults. We are continuing to work with the agency on the new drug application (NDA). The FDA does not require any additional clinical trials for the continued review of the NDA. Per the agency’s request, we are preparing a proposed Risk Evaluation and Mitigation Strategy, which will be submitted in the near future. In addition, olanzapine long-acting injection was approved by the European Commission under the trade name Zypadheratm.
 
•  We withdrew our supplemental NDA from the FDA for Cymbalta for the management of chronic pain. We plan to resubmit the application in the first half of 2009, adding data from a recently completed study in chronic osteoarthritis pain of the knee.
 
•  The FDA approved Alimta, in combination with cisplatin, as a first-line treatment for locally advanced and metastatic non-small cell lung cancer (NSCLC) for patients with nonsquamous histology. The European health authorities also approved Alimta, in combination with cisplatin, as a first-line treatment for non-small cell lung cancer patients with other than predominantly squamous cell histology.
 
•  We submitted tadalafil as a treatment for pulmonary arterial hypertension (PAH) to regulatory authorities in the U.S., Europe, and Japan.
 
•  The FDA approved Cymbalta for the management of fibromyalgia, a chronic pain disorder. In addition, the European Commission approved Cymbalta for the treatment of generalized anxiety disorder (GAD).
 
•  We, along with our partner Amylin Pharmaceuticals, Inc. (Amylin), submitted Byetta as a monotherapy treatment for type 2 diabetes to the FDA.
 
•  The European Commission approved a new indication for Forsteo® for the treatment of osteoporosis associated with sustained, systemic glucocorticoid therapy in women and men at increased risk for fracture. We have also received an approvable letter from the FDA for Forteo for the same indication.


-21-

 

 
•  We terminated development of our AIR Insulin program, which was being conducted in collaboration with Alkermes, Inc. The program had been in Phase III clinical development as a potential treatment for type 1 and type 2 diabetes. This decision was not a result of any observations during AIR Insulin trials relating to the safety of the product, but rather was a result of increasing uncertainties in the regulatory environment and a thorough evaluation of the evolving commercial and clinical potential of the product compared to existing medical therapies.
 
Pipeline


 






















































































• 
 We, along with our partner Daiichi Sankyo Company Limited, are
seeking from the U.S. Food and Drug Administration (FDA)
approval for prasugrel as a treatment for patients with acute
coronary syndrome being managed with percutaneous coronary
intervention. The Cardiovascular and Renal Drugs Advisory
Committee of the FDA reviewed prasugrel during a hearing and
unanimously recommended it for approval. The FDA will consider
the recommendation as it continues its review and makes its
final decision.
 
• 
 Prasugrel was approved for marketing by the European Commission
under the trade name Efient in February 2009 for the prevention
of atherothrombotic events in patients with acute coronary
syndromes undergoing percutaneous coronary intervention.
 
• 
 We received a complete response letter from the FDA for
olanzapine long-acting injection (LAI) for acute and maintenance
treatment of schizophrenia in adults. We are continuing to work
with the agency on the new drug application (NDA). The FDA does
not require any additional clinical trials for the continued
review of the NDA. Per the agency’s request, we are
preparing a proposed Risk Evaluation and Mitigation Strategy,
which will be submitted in the near future. In addition,
olanzapine long-acting injection was approved by the European
Commission under the trade name
Zypadheratm.

 
• 
 We withdrew our supplemental NDA from the FDA for Cymbalta for
the management of chronic pain. We plan to resubmit the
application in the first half of 2009, adding data from a
recently completed study in chronic osteoarthritis pain of the
knee.
 
• 
 The FDA approved Alimta, in combination with cisplatin, as a
first-line treatment for locally advanced and metastatic
non-small cell lung cancer (NSCLC) for patients with nonsquamous
histology. The European health authorities also approved Alimta,
in combination with cisplatin, as a first-line treatment for
non-small cell lung cancer patients with other than
predominantly squamous cell histology.
 
• 
 We submitted tadalafil as a treatment for pulmonary arterial
hypertension (PAH) to regulatory authorities in the U.S.,
Europe, and Japan.
 
• 
 The FDA approved Cymbalta for the management of fibromyalgia, a
chronic pain disorder. In addition, the European Commission
approved Cymbalta for the treatment of generalized anxiety
disorder (GAD).
 
• 
 We, along with our partner Amylin Pharmaceuticals, Inc.
(Amylin), submitted Byetta as a monotherapy treatment for type 2
diabetes to the FDA.
 
• 
 The European Commission approved a new indication for
Forsteo®

for the treatment of osteoporosis associated with sustained,
systemic glucocorticoid therapy in women and men at increased
risk for fracture. We have also received an approvable letter
from the FDA for Forteo for the same indication.





-21-




 





 














• 
We terminated development of our AIR Insulin program, which was
being conducted in collaboration with Alkermes, Inc. The program
had been in Phase III clinical development as a potential
treatment for type 1 and type 2 diabetes. This decision was not
a result of any observations during AIR Insulin trials relating
to the safety of the product, but rather was a result of
increasing uncertainties in the regulatory environment and a
thorough evaluation of the evolving commercial and clinical
potential of the product compared to existing medical therapies.


 




These excerpts taken from the LLY 10-K filed Oct 21, 2008.
Pipeline
 
•  On December 26, 2007, together with our collaboration partner Daiichi Sankyo Company, Limited, we submitted a New Drug Application (NDA) for prasugrel to the U.S. Food and Drug Administration (FDA). The proposed trademark for prasugrel is Effienttm. The submission follows the release of results of the TRITON TIMI-38 Phase III head-to-head study of prasugrel versus clopidogrel in November.
 
•  In January 2008, the FDA approved Cialis® for once-daily use to treat erectile dysfunction. Cialis was approved by the European Commission for once-daily use in June 2007.
 
•  In November, the FDA approved Cymbalta for the maintenance treatment of major depressive disorder in adults. In February, the FDA approved Cymbalta for the treatment of generalized anxiety disorder. During 2007, we submitted a Supplemental New Drug Application to the FDA for Cymbalta for the management of fibromyalgia.


-18-

Table of Contents

 
•  In October, with our collaboration partners Amylin Pharmaceuticals, Inc., and Alkermes, Inc., we announced positive results from a 30-week comparator study of once-weekly exenatide long-acting release injection and Byetta® (exenatide) injection taken twice daily in patients with type 2 diabetes.
 
•  In the second quarter, we submitted NDAs to the FDA and the European Medicines Agency (EMEA) for approval of olanzapine (Zyprexa) long-acting injection. In late February 2008, the FDA issued a “not approvable” letter, stating it needs more information to better understand the risk and underlying cause of excessive sedation events that have been observed in about one percent of patients in clinical trials.
 
•  In September, the FDA approved Evista® for a new use to reduce the risk of invasive breast cancer in two populations: postmenopausal women with osteoporosis and postmenopausal women at high risk for invasive breast cancer.
 
•  We submitted an application to the EMEA for centralized review of Alimta®, in combination with cisplatin, for the first-line treatment of non-small cell lung cancer.
 
Pipeline


 
































• 
 On December 26, 2007, together with our collaboration
partner Daiichi Sankyo Company, Limited, we submitted a New Drug
Application (NDA) for prasugrel to the U.S. Food and Drug
Administration (FDA). The proposed trademark for prasugrel is
Effienttm.

The submission follows the release of results of the TRITON
TIMI-38 Phase III
head-to-head
study of prasugrel versus clopidogrel in November.
 
• 
 In January 2008, the FDA approved
Cialis®

for once-daily use to treat erectile dysfunction. Cialis was
approved by the European Commission for once-daily use in June
2007.
 
• 
 In November, the FDA approved Cymbalta for the maintenance
treatment of major depressive disorder in adults. In February,
the FDA approved Cymbalta for the treatment of generalized
anxiety disorder. During 2007, we submitted a Supplemental New
Drug Application to the FDA for Cymbalta for the management of
fibromyalgia.





-18-




Table of Contents





 









































• 
 In October, with our collaboration partners Amylin
Pharmaceuticals, Inc., and Alkermes, Inc., we announced positive
results from a 30-week comparator study of once-weekly exenatide
long-acting release injection and
Byetta®

(exenatide) injection taken twice daily in patients with type 2
diabetes.
 
• 
 In the second quarter, we submitted NDAs to the FDA and the
European Medicines Agency (EMEA) for approval of olanzapine
(Zyprexa) long-acting injection. In late February 2008, the FDA
issued a “not approvable” letter, stating it needs
more information to better understand the risk and underlying
cause of excessive sedation events that have been observed in
about one percent of patients in clinical trials.
 
• 
 In September, the FDA approved
Evista®

for a new use to reduce the risk of invasive breast cancer in
two populations: postmenopausal women with osteoporosis and
postmenopausal women at high risk for invasive breast cancer.
 
• 
 We submitted an application to the EMEA for centralized review
of
Alimta®,

in combination with cisplatin, for the first-line treatment of
non-small cell lung cancer.


 




These excerpts taken from the LLY 10-K filed Feb 29, 2008.
Pipeline
 
•  On December 26, 2007, together with our collaboration partner Daiichi Sankyo Company, Limited, we submitted a New Drug Application (NDA) for prasugrel to the U.S. Food and Drug Administration (FDA). The proposed trademark for prasugrel is Effienttm. The submission follows the release of results of the TRITON TIMI-38 Phase III head-to-head study of prasugrel versus clopidogrel in November.
 
•  In January 2008, the FDA approved Cialis® for once-daily use to treat erectile dysfunction. Cialis was approved by the European Commission for once-daily use in June 2007.
 
•  In November, the FDA approved Cymbalta for the maintenance treatment of major depressive disorder in adults. In February, the FDA approved Cymbalta for the treatment of generalized anxiety disorder. During 2007, we submitted a Supplemental New Drug Application to the FDA for Cymbalta for the management of fibromyalgia.
 
•  In October, with our collaboration partners Amylin Pharmaceuticals, Inc., and Alkermes, Inc., we announced positive results from a 30-week comparator study of once-weekly exenatide long-acting release injection and Byetta® (exenatide) injection taken twice daily in patients with type 2 diabetes.
 
•  In the second quarter, we submitted NDAs to the FDA and the European Medicines Agency (EMEA) for approval of olanzapine (Zyprexa) long-acting injection. In late February 2008, the FDA issued a “not approvable” letter, stating it needs more information to better understand the risk and underlying cause of excessive sedation events that have been observed in about one percent of patients in clinical trials.


-18-

 

 
•  In September, the FDA approved Evista® for a new use to reduce the risk of invasive breast cancer in two populations: postmenopausal women with osteoporosis and postmenopausal women at high risk for invasive breast cancer.
 
•  We submitted an application to the EMEA for centralized review of Alimta®, in combination with cisplatin, for the first-line treatment of non-small cell lung cancer.
 
Pipeline


 


















































• 
 On December 26, 2007, together with our collaboration
partner Daiichi Sankyo Company, Limited, we submitted a New Drug
Application (NDA) for prasugrel to the U.S. Food and Drug
Administration (FDA). The proposed trademark for prasugrel is
Effienttm.
The submission follows the release of results of the TRITON
TIMI-38 Phase III
head-to-head
study of prasugrel versus clopidogrel in November.
 
• 
 In January 2008, the FDA approved
Cialis®
for once-daily use to treat erectile dysfunction. Cialis was
approved by the European Commission for once-daily use in June
2007.
 
• 
 In November, the FDA approved Cymbalta for the maintenance
treatment of major depressive disorder in adults. In February,
the FDA approved Cymbalta for the treatment of generalized
anxiety disorder. During 2007, we submitted a Supplemental New
Drug Application to the FDA for Cymbalta for the management of
fibromyalgia.
 
• 
 In October, with our collaboration partners Amylin
Pharmaceuticals, Inc., and Alkermes, Inc., we announced positive
results from a 30-week comparator study of once-weekly exenatide
long-acting release injection and
Byetta®
(exenatide) injection taken twice daily in patients with type 2
diabetes.
 
• 
 In the second quarter, we submitted NDAs to the FDA and the
European Medicines Agency (EMEA) for approval of olanzapine
(Zyprexa) long-acting injection. In late February 2008, the FDA
issued a “not approvable” letter, stating it needs
more information to better understand the risk and underlying
cause of excessive sedation events that have been observed in
about one percent of patients in clinical trials.





-18-




 





 























• 
 In September, the FDA approved
Evista®
for a new use to reduce the risk of invasive breast cancer in
two populations: postmenopausal women with osteoporosis and
postmenopausal women at high risk for invasive breast cancer.
 
• 
 We submitted an application to the EMEA for centralized review
of
Alimta®,
in combination with cisplatin, for the first-line treatment of
non-small cell lung cancer.


 




EXCERPTS ON THIS PAGE:

10-K (2 sections)
Feb 27, 2009
10-K (2 sections)
Oct 21, 2008
10-K (2 sections)
Feb 29, 2008

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