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This excerpt taken from the LLY 10-K filed Feb 22, 2010. Product
Acquisitions
In December 2009, we entered into a licensing and collaboration
agreement with Incyte Corporation to acquire rights to its
compound, and certain follow-on compounds, for the treatment of
inflammatory and autoimmune diseases. The lead compound was in
the development stage (Phase II clinical trials for
rheumatoid arthritis) and had no alternative future use. As with
many development-phase compounds, launch of the product, if
approved, was not expected in the near term. The charge of
$90.0 million for acquired IPR&D related to this
arrangement was included in expense in the fourth quarter of
2009 and is deductible for tax purposes. As part of this
agreement, Incyte has the option to co-develop these compounds
and the option to co-promote in the United States.
In June 2008, we entered into a licensing and development
agreement with TransPharma Medical Ltd. (TransPharma) to acquire
rights to its product and related drug delivery system for the
treatment of osteoporosis. The product, which is administered
transdermally using TransPharma’s proprietary technology,
was in Phase II clinical testing, and had no alternative
future use. Under the arrangement, we also gained non-exclusive
access to TransPharma’s ViaDerm drug delivery system for
the product. As with many development-phase products, launch of
the product, if approved, was not expected in the near term. The
charge of $35.0 million for acquired IPR&D related to
this arrangement was included as expense in the second quarter
of 2008 and is deductible for tax purposes.
In January 2008, our agreement with BioMS Medical Corp. to
acquire the rights to its compound for the treatment of multiple
sclerosis became effective. At the inception of this agreement,
this compound was in the development stage (Phase III
clinical trials) and had no alternative future use. As with many
development-phase compounds, launch of the product, if approved,
was not expected in the near term. In the third quarter of 2009,
data from the Phase III clinical trials showed there were
no statistically significant differences between dirucotide and
placebo on the primary or secondary endpoints of the study, and
ongoing clinical trials and the arrangement were discontinued.
The charge of $87.0 million for acquired IPR&D related
to this arrangement was included as expense in the first quarter
of 2008 and is deductible for tax purposes.
In October 2007, we entered into an agreement with Glenmark
Pharmaceuticals Limited India to acquire the rights to a
portfolio of transient receptor potential vanilloid
sub-family 1
(TRPV1) antagonist molecules, including a clinical-phase
compound. The compound was in early clinical phase development
as a potential next-generation treatment for various pain
conditions, including osteoarthritic pain, and had no
alternative future use. As with many development-phase
compounds, launch of the product, if approved, was not expected
in the near term. The charge of $45.0 million for acquired
IPR&D was deductible for tax purposes and was included as
expense in the fourth quarter of 2007. Development of this
compound has been suspended.
In October 2007, we entered into a global strategic alliance
with MacroGenics, Inc. (MacroGenics) to develop and
commercialize teplizumab, a humanized anti-CD3 monoclonal
antibody, as well as other potential next-generation anti-CD3
molecules for use in the treatment of autoimmune diseases. As
part of the arrangement, we acquired the exclusive rights to the
molecule, which was in the development stage (Phase II/III
clinical trial for individuals with recent-onset type 1
diabetes) and had no alternative future use. As with many
development-phase compounds, launch of the product, if approved,
was not expected in the near term. The charge of
$44.0 million for acquired IPR&D was deductible for
tax purposes and was included as expense in the fourth quarter
of 2007.
In January 2007, we entered into an agreement with OSI
Pharmaceuticals, Inc. to acquire the rights to its compound for
the treatment of type 2 diabetes. At the inception of this
agreement, this compound was in the development stage (Phase I
clinical trials) and had no alternative future use. As with many
development-phase compounds, launch of the product, if approved,
was not expected in the near term. The charge of
$25.0 million for acquired IPR&D related to this
arrangement was included as expense in the first quarter of 2007
and was deductible for tax purposes.
51
In connection with these arrangements, our partners are
generally entitled to future milestones and royalties based on
sales should these products be approved for commercialization.
These excerpts taken from the LLY 10-K filed Feb 27, 2009. Product
Acquisitions
In June 2008, we entered into a licensing and development
agreement with TransPharma Medical Ltd. (TransPharma) to acquire
rights to its product and related drug delivery system for the
treatment of osteoporosis. The product, which is administered
transdermally using TransPharma’s proprietary technology,
was in Phase II clinical testing, and had no alternative
future use. Under the arrangement, we also gained non-exclusive
access to TransPharma’s ViaDerm drug delivery system for
the product. As with many development-phase products, launch of
the product, if approved, was not expected in the near term. The
charge of $35.0 million for acquired IPR&D related to
this arrangement was included as expense in the second quarter
of 2008 and is deductible for tax purposes.
In January 2008, our agreement with BioMS Medical Corp. to
acquire the rights to its compound for the treatment of multiple
sclerosis became effective. At the inception of this agreement,
this compound was in the development stage (Phase III
clinical trials) and had no alternative future use. As with many
development-phase compounds, launch of the product, if approved,
was not expected in the near term. The charge of
$87.0 million for acquired IPR&D related to this
arrangement was included as expense in the first quarter of 2008
and is deductible for tax purposes.
In October 2007, we entered into an agreement with Glenmark
Pharmaceuticals Limited India to acquire the rights to a
portfolio of transient receptor potential vanilloid sub-family 1
(TRPV 1) antagonist molecules, including a clinical-phase
compound. The compound was in early clinical phase development
as a potential next-generation treatment for various pain
conditions, including osteoarthritic pain, and had no
alternative future use. As with many development-phase
compounds, launch of the product, if approved, was not expected
in the near term. The charge of $45.0 million for acquired
IPR&D was deductible for tax purposes and was included as
expense in the fourth quarter of 2007. Development of this
compound has been suspended.
In October 2007, we entered into a global strategic alliance
with MacroGenics, Inc. (MacroGenics) to develop and
commercialize teplizumab, a humanized anti-CD3 monoclonal
antibody, as well as other potential next-generation anti-CD3
molecules for use in the treatment of autoimmune diseases. As
part of the arrangement, we acquired the exclusive rights to the
molecule, which was in the development stage (Phase II/III
clinical trial for individuals with recent-onset type 1
diabetes) and had no alternative future use. As with many
development-phase compounds, launch of the product, if approved,
was not expected in the near term. The charge of
$44.0 million for acquired IPR&D was deductible for
tax purposes and was included as expense in the fourth quarter
of 2007.
In January 2007, we entered into an agreement with OSI
Pharmaceuticals, Inc. to acquire the rights to its compound for
the treatment of type 2 diabetes. At the inception of this
agreement, this compound was in the development stage (Phase I
clinical trials) and had no alternative future use. As with many
development-phase compounds, launch of the product, if approved,
was not expected in the near term. The charge of
$25.0 million
for acquired IPR&D related to this arrangement was included
as expense in the first quarter of 2007 and was deductible for
tax purposes.
In connection with these arrangements, our partners are
generally entitled to future milestones and royalties based on
sales should these products be approved for commercialization.
We often enter into collaborative arrangements to develop and
commercialize drug candidates. Collaborative activities might
include research and development, marketing and selling
(including promotional activities and physician detailing),
manufacturing, and distribution. These collaborations often
require milestone and royalty or profit share payments,
contingent upon the occurrence of certain future events linked
to the success of the asset in development, as well as expense
reimbursements or payments to the third party. Each
collaboration is unique in nature and our more significant
arrangements are discussed below.
Product Acquisitions In June 2008, we entered into a licensing and development agreement with TransPharma Medical Ltd. (TransPharma) to acquire rights to its product and related drug delivery system for the treatment of osteoporosis. The product, which is administered transdermally using TransPharma’s proprietary technology, was in Phase II clinical testing, and had no alternative future use. Under the arrangement, we also gained non-exclusive access to TransPharma’s ViaDerm drug delivery system for the product. As with many development-phase products, launch of the product, if approved, was not expected in the near term. The charge of $35.0 million for acquired IPR&D related to this arrangement was included as expense in the second quarter of 2008 and is deductible for tax purposes. In January 2008, our agreement with BioMS Medical Corp. to acquire the rights to its compound for the treatment of multiple sclerosis became effective. At the inception of this agreement, this compound was in the development stage (Phase III clinical trials) and had no alternative future use. As with many development-phase compounds, launch of the product, if approved, was not expected in the near term. The charge of $87.0 million for acquired IPR&D related to this arrangement was included as expense in the first quarter of 2008 and is deductible for tax purposes. In October 2007, we entered into an agreement with Glenmark Pharmaceuticals Limited India to acquire the rights to a portfolio of transient receptor potential vanilloid sub-family 1 (TRPV 1) antagonist molecules, including a clinical-phase compound. The compound was in early clinical phase development as a potential next-generation treatment for various pain conditions, including osteoarthritic pain, and had no alternative future use. As with many development-phase compounds, launch of the product, if approved, was not expected in the near term. The charge of $45.0 million for acquired IPR&D was deductible for tax purposes and was included as expense in the fourth quarter of 2007. Development of this compound has been suspended. In October 2007, we entered into a global strategic alliance with MacroGenics, Inc. (MacroGenics) to develop and commercialize teplizumab, a humanized anti-CD3 monoclonal antibody, as well as other potential next-generation anti-CD3 molecules for use in the treatment of autoimmune diseases. As part of the arrangement, we acquired the exclusive rights to the molecule, which was in the development stage (Phase II/III clinical trial for individuals with recent-onset type 1 diabetes) and had no alternative future use. As with many development-phase compounds, launch of the product, if approved, was not expected in the near term. The charge of $44.0 million for acquired IPR&D was deductible for tax purposes and was included as expense in the fourth quarter of 2007. In January 2007, we entered into an agreement with OSI Pharmaceuticals, Inc. to acquire the rights to its compound for the treatment of type 2 diabetes. At the inception of this agreement, this compound was in the development stage (Phase I clinical trials) and had no alternative future use. As with many development-phase compounds, launch of the product, if approved, was not expected in the near term. The charge of $25.0 million
for acquired IPR&D related to this arrangement was included as expense in the first quarter of 2007 and was deductible for tax purposes. In connection with these arrangements, our partners are generally entitled to future milestones and royalties based on sales should these products be approved for commercialization.
We often enter into collaborative arrangements to develop and commercialize drug candidates. Collaborative activities might include research and development, marketing and selling (including promotional activities and physician detailing), manufacturing, and distribution. These collaborations often require milestone and royalty or profit share payments, contingent upon the occurrence of certain future events linked to the success of the asset in development, as well as expense reimbursements or payments to the third party. Each collaboration is unique in nature and our more significant arrangements are discussed below. These excerpts taken from the LLY 10-K filed Oct 21, 2008. Product
Acquisitions
In October 2007, we entered into an agreement with Glenmark
Pharmaceuticals Limited India whereby we acquired the rights to
a portfolio of transient receptor potential vanilloid
sub-family 1
(TRPV1) antagonist molecules, including a clinical-phase
compound. The compound is currently in early clinical phase
development as a potential next-generation treatment for various
pain conditions, including osteoarthritic pain, and had no
alternative future use. As with many development-phase
compounds, launch of the product, if approved, was not expected
in the near term. Our charge for acquired IPR&D was
$45.0 million, is deductible for tax purposes, and was
included as expense in the fourth quarter of 2007.
In October 2007, we entered into a global strategic alliance
with MacroGenics, Inc. (MacroGenics) to develop and
commercialize teplizumab, a humanized anti-CD3 monoclonal
antibody, as well as other potential next-generation anti-CD3
molecules for use in the treatment of autoimmune diseases. As
part of the arrangement, we acquired the exclusive rights to the
molecule, which was in the development stage (Phase II/III
clinical trial for individuals with recent-onset type 1
diabetes) and had no alternative future use. As with many
development-phase compounds, launch of the product, if approved,
was not expected in the near term. Our charge for acquired
IPR&D was $44.0 million, is deductible for tax
purposes, and was included as expense in the fourth quarter of
2007.
In January 2007, we entered into an agreement with OSI
Pharmaceuticals, Inc. to acquire the rights to its compound for
the treatment of type 2 diabetes. At the inception of this
agreement, this compound was in the development stage (Phase I
clinical trials) and had no alternative future use. As with many
development-phase compounds, launch of the product, if approved,
was not expected in the near term. Our charge for acquired
IPR&D related to this arrangement was $25.0 million,
was included as expense in the first quarter of 2007, and is
deductible for tax purposes.
In December 2007, we entered into an agreement with BioMS
Medical Corp. to acquire the rights to its compound for the
treatment of multiple sclerosis. This agreement was contingent
upon clearance under the
Hart-Scott-Rodino
Anti-Trust Improvements Act and became effective after
clearance was received in January 2008. This compound is in the
development stage (Phase III clinical trials) and has no
alternative future use. As with many development-phase
compounds, launch of the product, if approved, was not expected
in the near term. Our charge for acquired IPR&D related to
this arrangement was $87.0 million, is deductible for tax
purposes, and will be included as expense in the first quarter
of 2008.
Table of Contents
In connection with these arrangements, our partners are
generally entitled to future milestones and royalties based on
sales should these products be approved for commercialization.
The components of the charges included in asset impairments,
restructuring, and other special charges in our consolidated
statements of income are described below.
Product Acquisitions In October 2007, we entered into an agreement with Glenmark Pharmaceuticals Limited India whereby we acquired the rights to a portfolio of transient receptor potential vanilloid sub-family 1 (TRPV1) antagonist molecules, including a clinical-phase compound. The compound is currently in early clinical phase development as a potential next-generation treatment for various pain conditions, including osteoarthritic pain, and had no alternative future use. As with many development-phase compounds, launch of the product, if approved, was not expected in the near term. Our charge for acquired IPR&D was $45.0 million, is deductible for tax purposes, and was included as expense in the fourth quarter of 2007. In October 2007, we entered into a global strategic alliance with MacroGenics, Inc. (MacroGenics) to develop and commercialize teplizumab, a humanized anti-CD3 monoclonal antibody, as well as other potential next-generation anti-CD3 molecules for use in the treatment of autoimmune diseases. As part of the arrangement, we acquired the exclusive rights to the molecule, which was in the development stage (Phase II/III clinical trial for individuals with recent-onset type 1 diabetes) and had no alternative future use. As with many development-phase compounds, launch of the product, if approved, was not expected in the near term. Our charge for acquired IPR&D was $44.0 million, is deductible for tax purposes, and was included as expense in the fourth quarter of 2007. In January 2007, we entered into an agreement with OSI Pharmaceuticals, Inc. to acquire the rights to its compound for the treatment of type 2 diabetes. At the inception of this agreement, this compound was in the development stage (Phase I clinical trials) and had no alternative future use. As with many development-phase compounds, launch of the product, if approved, was not expected in the near term. Our charge for acquired IPR&D related to this arrangement was $25.0 million, was included as expense in the first quarter of 2007, and is deductible for tax purposes. In December 2007, we entered into an agreement with BioMS Medical Corp. to acquire the rights to its compound for the treatment of multiple sclerosis. This agreement was contingent upon clearance under the Hart-Scott-Rodino Anti-Trust Improvements Act and became effective after clearance was received in January 2008. This compound is in the development stage (Phase III clinical trials) and has no alternative future use. As with many development-phase compounds, launch of the product, if approved, was not expected in the near term. Our charge for acquired IPR&D related to this arrangement was $87.0 million, is deductible for tax purposes, and will be included as expense in the first quarter of 2008.
Table of ContentsIn connection with these arrangements, our partners are generally entitled to future milestones and royalties based on sales should these products be approved for commercialization.
The components of the charges included in asset impairments, restructuring, and other special charges in our consolidated statements of income are described below. These excerpts taken from the LLY 10-K filed Feb 29, 2008. Product
Acquisitions
In October 2007, we entered into an agreement with Glenmark
Pharmaceuticals Limited India whereby we acquired the rights to
a portfolio of transient receptor potential vanilloid
sub-family 1
(TRPV1) antagonist molecules, including a clinical-phase
compound. The compound is currently in early clinical phase
development as a potential next-generation treatment for various
pain conditions, including osteoarthritic pain, and had no
alternative future use. As with many development-phase
compounds, launch of the product, if approved, was not expected
in the near term. Our charge for acquired IPR&D was
$45.0 million, is deductible for tax purposes, and was
included as expense in the fourth quarter of 2007.
In October 2007, we entered into a global strategic alliance
with MacroGenics, Inc. (MacroGenics) to develop and
commercialize teplizumab, a humanized anti-CD3 monoclonal
antibody, as well as other potential next-generation anti-CD3
molecules for use in the treatment of autoimmune diseases. As
part of the arrangement, we acquired the exclusive rights to the
molecule, which was in the development stage (Phase II/III
clinical trial for individuals with recent-onset type 1
diabetes) and had no alternative future use. As with many
development-phase compounds, launch of the product, if approved,
was not expected in the near term. Our charge for acquired
IPR&D was $44.0 million, is deductible for tax
purposes, and was included as expense in the fourth quarter of
2007.
In January 2007, we entered into an agreement with OSI
Pharmaceuticals, Inc. to acquire the rights to its compound for
the treatment of type 2 diabetes. At the inception of this
agreement, this compound was in the development stage (Phase I
clinical trials) and had no alternative future use. As with many
development-phase compounds, launch of the product, if approved,
was not expected in the near term. Our charge for acquired
IPR&D related to this arrangement was $25.0 million,
was included as expense in the first quarter of 2007, and is
deductible for tax purposes.
In December 2007, we entered into an agreement with BioMS
Medical Corp. to acquire the rights to its compound for the
treatment of multiple sclerosis. This agreement was contingent
upon clearance under the
Hart-Scott-Rodino
Anti-Trust Improvements Act and became effective after
clearance was received in January 2008. This compound is in the
development stage (Phase III clinical trials) and has no
alternative future use. As with many development-phase
compounds, launch of the product, if approved, was not expected
in the near term. Our charge for acquired IPR&D related to
this arrangement was $87.0 million, is deductible for tax
purposes, and will be included as expense in the first quarter
of 2008.
In connection with these arrangements, our partners are
generally entitled to future milestones and royalties based on
sales should these products be approved for commercialization.
The components of the charges included in asset impairments,
restructuring, and other special charges in our consolidated
statements of income are described below.
Product Acquisitions In October 2007, we entered into an agreement with Glenmark Pharmaceuticals Limited India whereby we acquired the rights to a portfolio of transient receptor potential vanilloid sub-family 1 (TRPV1) antagonist molecules, including a clinical-phase compound. The compound is currently in early clinical phase development as a potential next-generation treatment for various pain conditions, including osteoarthritic pain, and had no alternative future use. As with many development-phase compounds, launch of the product, if approved, was not expected in the near term. Our charge for acquired IPR&D was $45.0 million, is deductible for tax purposes, and was included as expense in the fourth quarter of 2007. In October 2007, we entered into a global strategic alliance with MacroGenics, Inc. (MacroGenics) to develop and commercialize teplizumab, a humanized anti-CD3 monoclonal antibody, as well as other potential next-generation anti-CD3 molecules for use in the treatment of autoimmune diseases. As part of the arrangement, we acquired the exclusive rights to the molecule, which was in the development stage (Phase II/III clinical trial for individuals with recent-onset type 1 diabetes) and had no alternative future use. As with many development-phase compounds, launch of the product, if approved, was not expected in the near term. Our charge for acquired IPR&D was $44.0 million, is deductible for tax purposes, and was included as expense in the fourth quarter of 2007. In January 2007, we entered into an agreement with OSI Pharmaceuticals, Inc. to acquire the rights to its compound for the treatment of type 2 diabetes. At the inception of this agreement, this compound was in the development stage (Phase I clinical trials) and had no alternative future use. As with many development-phase compounds, launch of the product, if approved, was not expected in the near term. Our charge for acquired IPR&D related to this arrangement was $25.0 million, was included as expense in the first quarter of 2007, and is deductible for tax purposes. In December 2007, we entered into an agreement with BioMS Medical Corp. to acquire the rights to its compound for the treatment of multiple sclerosis. This agreement was contingent upon clearance under the Hart-Scott-Rodino Anti-Trust Improvements Act and became effective after clearance was received in January 2008. This compound is in the development stage (Phase III clinical trials) and has no alternative future use. As with many development-phase compounds, launch of the product, if approved, was not expected in the near term. Our charge for acquired IPR&D related to this arrangement was $87.0 million, is deductible for tax purposes, and will be included as expense in the first quarter of 2008. In connection with these arrangements, our partners are generally entitled to future milestones and royalties based on sales should these products be approved for commercialization.
The components of the charges included in asset impairments, restructuring, and other special charges in our consolidated statements of income are described below.
This excerpt taken from the LLY 10-K filed Feb 28, 2007. Product
Acquisitions
In January 2007, we entered into an agreement with OSI
Pharmaceuticals, Inc. to acquire the rights to its compound for
the potential treatment of Type 2 diabetes. At the inception of
this agreement, this compound was in the development stage
(Phase I clinical trials) and had no alternative future
uses. As with many development phase compounds, launch of the
product, if approved, was not expected in the near term. Our
charge for acquired IPR&D related to this arrangement was
$25.0 million and will be included as expense in the first
quarter of 2007.
In 2004, we incurred an IPR&D charge of $29.9 million
related to a development stage compound acquired from Merck KGaA
for a potential treatment for insomnia. This compound did not
have any alternative future use.
The components of the charges included in asset impairments,
restructuring, and other special charges in our consolidated
statements of income are described below.
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