Eli Lilly 2008 Annual Report Download - page 15

FINANCIALS
13
ceuticals Limited India, MacroGenics, Inc., and OSI
Pharmaceuticals, totaling $114.0 million (pretax),
which decreased earnings per share by $.06.
Asset Impairments and Related Restructuring and Other
Special Charges (Notes 5 and 14)
• We recognized asset impairments, restructuring, and
other special charges of $190.6 million (pretax), which
decreased earnings per share by $.12. These charges
were primarily associated with previously announced
strategic decisions affecting manufacturing and
research facilities.
• We incurred a special charge following a settlement
with one of our insurance carriers over Zyprexa
product liability claims, which led to a reduction of
our expected product liability insurance recoveries,
and other product liability charges. This resulted
in a charge totaling $111.9 million (pretax), which
decreased earnings per share by $.09.
Late-Stage Pipeline Developments and Business
Development Activity
Our long-term success depends, to a great extent, on
our ability to continue to discover and develop innovative
pharmaceutical products and acquire or collaborate on
compounds currently in development by other biotech-
nology or pharmaceutical companies. There were a num-
ber of late-stage pipeline developments and business
development transactions within the past year, including:
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 fi nal decision.
• The Committee for Medicinal Products for Human Use
(CHMP) of the European Medicines Agency issued a
positive opinion recommending approval of prasugrel
for the prevention of atherothrombotic events in
patients with acute coronary syndromes undergoing
percutaneous coronary intervention. The CHMP
positive opinion has been referred for fi nal action to the
European Commission.
• 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
Zypadhera™.
• We withdrew our supplemental NDA from the FDA for
Cymbalta for the management of chronic pain. We plan
to resubmit the application in the fi rst 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 fi rst-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 fi rst-line treatment for
non-small cell lung cancer patients with other than
predominantly squamous cell histology.
• We submitted tadalafi l 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
fi bromyalgia, 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.
• 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.
Business Development
• We acquired all of the outstanding shares of ImClone
for a total purchase price of approximately $6.5 billion.
This strategic combination will offer both targeted
therapies and oncolytic agents along with an oncology
pipeline spanning all phases of clinical development.
It also expands our biotechnology capabilities.
• We entered into a license and a supply arrangement
with United Therapeutics Corporation related to the
U.S. commercialization rights for the PAH indication