DNDN » Topics » OVERVIEW

These excerpts taken from the DNDN 10-K filed Mar 12, 2009.
OVERVIEW
 
Dendreon Corporation (“Dendreon”, the “Company”, “we”, “us”, or “our”), a Delaware corporation originally formed in 1992 as Activated Cell Therapy, Inc., is a biotechnology company focused on the discovery, development and commercialization of novel therapeutics that may significantly improve cancer treatment options for patients. Our product portfolio includes active cellular immunotherapy, monoclonal antibody and small molecule product candidates to treat a wide range of cancers. Our most advanced product candidate is Provenge® (sipuleucel-T), an active cellular immunotherapy that has completed two Phase 3 trials for the treatment of asymptomatic, metastatic, androgen-independent prostate cancer. Prostate cancer is the most common non-skin cancer among men in the United States, with over one million men currently diagnosed with the disease, and the second leading cause of cancer deaths in men in the United States. On November 9, 2006, we completed our submission of our Biologics License Application (our “BLA”) to the U.S. Food and Drug Administration (“FDA”) for Provenge based upon the survival benefit seen in our completed D9901 and D9902A studies for Provenge. The FDA’s Cellular, Tissue and Gene Therapies Advisory Committee (the “Advisory Committee”) review of our BLA for the use of Provenge in the treatment of patients with asymptomatic, metastatic, androgen-independent prostate cancer was held on March 29, 2007. The Advisory Committee was unanimous (17 yes, 0 no) in its opinion that the submitted data established that Provenge is reasonably safe for the intended population and the majority (13 yes, 4 no) believed that the submitted data provided substantial evidence of the efficacy of Provenge in the intended population. On May 8, 2007, we received a Complete Response Letter from the FDA regarding our BLA. In its letter, the FDA requested additional clinical data in support of the efficacy claim contained in our BLA, as well as additional information with respect to the chemistry, manufacturing and controls (“CMC”) section of the BLA. In a meeting with the FDA on May 29, 2007, we received confirmation that the FDA will accept either a positive interim or final analysis of survival from our ongoing Phase 3 D9902B IMPACT (IMmunotherapy for Prostate AdenoCarcinoma Treatment) study to support licensure of Provenge. The primary endpoint of the IMPACT study is overall survival (an event-driven analysis), and time to objective disease progression is a secondary endpoint. In October 2007, we completed our target enrollment of over 500 patients in the IMPACT study. On October 6, 2008, we announced the receipt of interim results from our IMPACT study. The independent data monitoring committee (the “IDMC”) reported to us a 20 percent reduction in the risk of death in the Provenge arm of the study relative to placebo. The IDMC observed no safety concerns and recommended that the study continue to its final analysis, which is anticipated by the end of April 2009. If the study demonstrates approximately a 22 percent reduction in the risk of death, based on 304 events, we would expect the study to meet its primary endpoint of overall survival. In such event, we believe these data would be sufficient to address the FDA’s request for additional clinical information to support the proposed efficacy claim and we would amend our BLA. We own worldwide commercialization rights for Provenge.


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OVERVIEW


 



Dendreon Corporation (“Dendreon”, the
“Company”, “we”, “us”, or
“our”), a Delaware corporation originally formed in
1992 as Activated Cell Therapy, Inc., is a biotechnology company
focused on the discovery, development and commercialization of
novel therapeutics that may significantly improve cancer
treatment options for patients. Our product portfolio includes
active cellular immunotherapy, monoclonal antibody and small
molecule product candidates to treat a wide range of cancers.
Our most advanced product candidate is
Provenge®

(sipuleucel-T), an active cellular immunotherapy that has
completed two Phase 3 trials for the treatment of asymptomatic,
metastatic, androgen-independent prostate cancer. Prostate
cancer is the most common non-skin cancer among men in the
United States, with over one million men currently diagnosed
with the disease, and the second leading cause of cancer deaths
in men in the United States. On November 9, 2006, we
completed our submission of our Biologics License Application
(our “BLA”) to the U.S. Food and Drug
Administration (“FDA”) for Provenge based upon the
survival benefit seen in our completed D9901 and D9902A studies
for Provenge. The FDA’s Cellular, Tissue and Gene Therapies
Advisory Committee (the “Advisory Committee”) review
of our BLA for the use of Provenge in the treatment of patients
with asymptomatic, metastatic, androgen-independent prostate
cancer was held on March 29, 2007. The Advisory Committee
was unanimous (17 yes, 0 no) in its opinion that the submitted
data established that Provenge is reasonably safe for the
intended population and the majority (13 yes, 4 no) believed
that the submitted data provided substantial evidence of the
efficacy of Provenge in the intended population. On May 8,
2007, we received a Complete Response Letter from the FDA
regarding our BLA. In its letter, the FDA requested additional
clinical data in support of the efficacy claim contained in our
BLA, as well as additional information with respect to the
chemistry, manufacturing and controls (“CMC”) section
of the BLA. In a meeting with the FDA on May 29, 2007, we
received confirmation that the FDA will accept either a positive
interim or final analysis of survival from our ongoing Phase 3
D9902B IMPACT (IMmunotherapy for Prostate AdenoCarcinoma
Treatment) study to support licensure of Provenge. The primary
endpoint of the IMPACT study is overall survival (an
event-driven analysis), and time to objective disease
progression is a secondary endpoint. In October 2007, we
completed our target enrollment of over 500 patients in the
IMPACT study. On October 6, 2008, we announced the receipt
of interim results from our IMPACT study. The independent data
monitoring committee (the “IDMC”) reported to us a
20 percent reduction in the risk of death in the Provenge
arm of the study relative to placebo. The IDMC observed no
safety concerns and recommended that the study continue to its
final analysis, which is anticipated by the end of April 2009.
If the study demonstrates approximately a 22 percent
reduction in the risk of death, based on 304 events, we would
expect the study to meet its primary endpoint of overall
survival. In such event, we believe these data would be
sufficient to address the FDA’s request for additional
clinical information to support the proposed efficacy claim and
we would amend our BLA. We own worldwide commercialization
rights for Provenge.





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Table of Contents







OVERVIEW
 
We are a biotechnology company focused on the discovery, development and commercialization of novel therapeutics that harness the immune system to fight cancer. Our portfolio includes active immunotherapy, monoclonal antibody and small molecule product candidates to treat a wide range of cancers. Our most advanced product candidate is Provenge (sipuleucel-T), an active cellular immunotherapy for prostate cancer.
 
We have incurred significant losses since our inception. As of December 31, 2008, our accumulated deficit was $563.3 million. We have incurred net losses as a result of research and development expenses, clinical trial expenses, contract manufacturing expenses and general and administrative expenses in support of our operations and research efforts. We anticipate incurring net losses over at least the next several years as we continue our clinical trials, apply for regulatory approvals, develop our technology, expand our operations and develop the infrastructure


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to support the commercialization of Provenge and other product candidates we may develop. The majority of our resources continue to be used in support of Provenge. We own worldwide commercialization rights for Provenge.
 
We will not generate revenue from the sale of our potential commercial therapeutic products in the U.S. until Provenge or another product candidate we may develop is approved by the U.S. Food and Drug Administration (the “FDA”). Without revenue generated from commercial sales, we anticipate that we will continue to fund our ongoing research, development and general operations from our available cash resources and future offerings of equity, debt or other securities.
 
In September 2005, we announced plans to submit our biologics license application (our “BLA”) to the FDA for approval to market Provenge. This decision followed a pre-BLA meeting in which we reviewed safety and efficacy data with the FDA from our two completed Phase 3 clinical trials for Provenge, D9901 and D9902A. In these discussions the FDA agreed that the survival benefit observed in the D9901 study in conjunction with the supportive data obtained from study D9902A and the absence of significant toxicity in both studies was sufficient to serve as the clinical basis of our BLA submission for Provenge. Provenge was granted Fast Track designation from the FDA for the treatment of asymptomatic, metastatic, androgen-independent (also known as hormone refractory) prostate cancer patients, which enabled us to submit our BLA on a rolling basis.
 
On August 24, 2006, we submitted the clinical and non-clinical sections of our BLA and on November 9, 2006, we submitted the chemistry, manufacturing and controls (“CMC”) section, completing our submission of our BLA to the FDA for Provenge. On January 12, 2007, the FDA accepted our BLA filing and assigned Priority Review status for Provenge.
 
The FDA’s Cellular, Tissue and Gene Therapies Advisory Committee (the “Advisory Committee”) review of our BLA for the use of Provenge in the treatment of patients with asymptomatic, metastatic, androgen-independent prostate cancer was held on March 29, 2007. The Advisory Committee was unanimous (17 yes, 0 no) in its opinion that the submitted data established that Provenge is reasonably safe for the intended population and the majority (13 yes, 4 no) believed that the submitted data provided substantial evidence of the efficacy of Provenge in the intended population.
 
On May 8, 2007, we received a Complete Response Letter from the FDA regarding our BLA. In its letter, the FDA requested additional clinical data in support of the efficacy claim contained in the BLA, as well as additional information with respect to the CMC section of the BLA. In a meeting with the FDA on May 29, 2007, we received confirmation that the FDA will accept a positive interim or final analysis of survival from our ongoing Phase 3 D9902B IMPACT (IMmunotherapy for Prostate AdenoCarcinoma Treatment) study to support licensure of Provenge. These analyses are event driven, rather than time specific.
 
On October 6, 2008, we announced the receipt of interim results from our IMPACT study. The independent data monitoring committee (the “IDMC”) reported to us a 20 percent reduction in the risk of death in the Provenge arm of the study relative to placebo. The IDMC observed no safety concerns and recommended that the study continue to its final analysis, which is anticipated by the end of April 2009. If the study demonstrates approximately a 22 percent reduction in the risk of death, based on 304 events, we would expect the study to meet its primary endpoint of overall survival. In such event, we believe these data would be sufficient to address the FDA’s request for additional clinical information to support the proposed efficacy claim and we would amend our BLA.
 
We would also expect to increase our investments in commercial infrastructure in preparation for the possible approval of Provenge. The level of increased investment would depend on our ability to access additional financing, either through the capital markets, borrowings or through partnership opportunities with Provenge. The IMPACT study may not meet the prespecified statistical criteria, but still provide additional supportive evidence of efficacy to support amending our BLA. The decision to amend the BLA will be based on several factors, including the totality of the data from our three phase 3 studies and whether such data demonstrate a favorable benefit to risk profile for patients with asymptomatic, metastatic, androgen-independent prostate cancer. If the IMPACT study fails to provide sufficient positive evidence of survival to allow us to amend on BLA we expect to focus our efforts on the TRPM8 clinical program and explore potential business development opportunities.
 
Other potential product candidates we have under development include Neuvengetm, our investigational active cellular immunotherapy for the treatment of patients with breast, ovarian and other solid tumors expressing HER2/


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neu. We are also developing an orally-available small molecule targeting TRPM8 that could be applicable to multiple types of cancer as well as benign prostatic hyperplasia. In December 2008 we filed an investigational new drug application (“IND”) to investigate this small molecule in advanced cancer patients. The IND was cleared by the FDA in January 2009.
 
OVERVIEW


 



We are a biotechnology company focused on the discovery,
development and commercialization of novel therapeutics that
harness the immune system to fight cancer. Our portfolio
includes active immunotherapy, monoclonal antibody and small
molecule product candidates to treat a wide range of cancers.
Our most advanced product candidate is Provenge (sipuleucel-T),
an active cellular immunotherapy for prostate cancer.


 



We have incurred significant losses since our inception. As of
December 31, 2008, our accumulated deficit was
$563.3 million. We have incurred net losses as a result of
research and development expenses, clinical trial expenses,
contract manufacturing expenses and general and administrative
expenses in support of our operations and research efforts. We
anticipate incurring net losses over at least the next several
years as we continue our clinical trials, apply for regulatory
approvals, develop our technology, expand our operations and
develop the infrastructure





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Table of Contents






to support the commercialization of Provenge and other product
candidates we may develop. The majority of our resources
continue to be used in support of Provenge. We own worldwide
commercialization rights for Provenge.


 



We will not generate revenue from the sale of our potential
commercial therapeutic products in the U.S. until Provenge
or another product candidate we may develop is approved by the
U.S. Food and Drug Administration (the “FDA”).
Without revenue generated from commercial sales, we anticipate
that we will continue to fund our ongoing research, development
and general operations from our available cash resources and
future offerings of equity, debt or other securities.


 



In September 2005, we announced plans to submit our biologics
license application (our “BLA”) to the FDA for
approval to market Provenge. This decision followed a pre-BLA
meeting in which we reviewed safety and efficacy data with the
FDA from our two completed Phase 3 clinical trials for Provenge,
D9901 and D9902A. In these discussions the FDA agreed that the
survival benefit observed in the D9901 study in conjunction with
the supportive data obtained from study D9902A and the absence
of significant toxicity in both studies was sufficient to serve
as the clinical basis of our BLA submission for Provenge.
Provenge was granted Fast Track designation from the FDA for the
treatment of asymptomatic, metastatic, androgen-independent
(also known as hormone refractory) prostate cancer patients,
which enabled us to submit our BLA on a rolling basis.


 



On August 24, 2006, we submitted the clinical and
non-clinical sections of our BLA and on November 9, 2006,
we submitted the chemistry, manufacturing and controls
(“CMC”) section, completing our submission of our BLA
to the FDA for Provenge. On January 12, 2007, the FDA
accepted our BLA filing and assigned Priority Review status for
Provenge.


 



The FDA’s Cellular, Tissue and Gene Therapies Advisory
Committee (the “Advisory Committee”) review of our BLA
for the use of Provenge in the treatment of patients with
asymptomatic, metastatic, androgen-independent prostate cancer
was held on March 29, 2007. The Advisory Committee was
unanimous (17 yes, 0 no) in its opinion that the submitted data
established that Provenge is reasonably safe for the intended
population and the majority (13 yes, 4 no) believed that the
submitted data provided substantial evidence of the efficacy of
Provenge in the intended population.


 



On May 8, 2007, we received a Complete Response Letter from
the FDA regarding our BLA. In its letter, the FDA requested
additional clinical data in support of the efficacy claim
contained in the BLA, as well as additional information with
respect to the CMC section of the BLA. In a meeting with the FDA
on May 29, 2007, we received confirmation that the FDA will
accept a positive interim or final analysis of survival from our
ongoing Phase 3 D9902B IMPACT (IMmunotherapy for Prostate
AdenoCarcinoma Treatment) study to support licensure of
Provenge. These analyses are event driven, rather than time
specific.


 



On October 6, 2008, we announced the receipt of interim
results from our IMPACT study. The independent data monitoring
committee (the “IDMC”) reported to us a
20 percent reduction in the risk of death in the Provenge
arm of the study relative to placebo. The IDMC observed no
safety concerns and recommended that the study continue to its
final analysis, which is anticipated by the end of April 2009.
If the study demonstrates approximately a 22 percent
reduction in the risk of death, based on 304 events, we would
expect the study to meet its primary endpoint of overall
survival. In such event, we believe these data would be
sufficient to address the FDA’s request for additional
clinical information to support the proposed efficacy claim and
we would amend our BLA.


 



We would also expect to increase our investments in commercial
infrastructure in preparation for the possible approval of
Provenge. The level of increased investment would depend on our
ability to access additional financing, either through the
capital markets, borrowings or through partnership opportunities
with Provenge. The IMPACT study may not meet the prespecified
statistical criteria, but still provide additional supportive
evidence of efficacy to support amending our BLA. The decision
to amend the BLA will be based on several factors, including the
totality of the data from our three phase 3 studies and whether
such data demonstrate a favorable benefit to risk profile for
patients with asymptomatic, metastatic, androgen-independent
prostate cancer. If the IMPACT study fails to provide sufficient
positive evidence of survival to allow us to amend on BLA we
expect to focus our efforts on the TRPM8 clinical program and
explore potential business development opportunities.


 



Other potential product candidates we have under development
include
Neuvengetm,

our investigational active cellular immunotherapy for the
treatment of patients with breast, ovarian and other solid
tumors expressing HER2/





38





Table of Contents






neu. We are also developing an orally-available small molecule
targeting TRPM8 that could be applicable to multiple types of
cancer as well as benign prostatic hyperplasia. In December 2008
we filed an investigational new drug application
(“IND”) to investigate this small molecule in advanced
cancer patients. The IND was cleared by the FDA in January 2009.


 




These excerpts taken from the DNDN 10-K filed Mar 12, 2008.
OVERVIEW
 
We are a biotechnology company focused on the discovery, development and commercialization of novel therapeutics that harness the immune system to fight cancer. Our portfolio includes active immunotherapy, monoclonal antibody and small molecule product candidates to treat a wide range of cancers. Our most advanced product candidate is Provenge (sipuleucel-T), an active cellular immunotherapy for prostate cancer.
 
We have incurred significant losses since our inception. As of December 31, 2007, our accumulated deficit was $491.6 million. We have incurred net losses as a result of research and development expenses, clinical trial expenses, contract manufacturing expenses and general and administrative expenses in support of our operations and marketing efforts. We anticipate incurring net losses over at least the next several years as we continue our clinical trials, apply for regulatory approvals, develop our technology, expand our operations and develop the infrastructure to support the commercialization of Provenge and other product candidates we may develop. The


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Table of Contents

majority of our resources continue to be used in support of Provenge. We own worldwide commercialization rights for Provenge.
 
We will not generate revenue from the sale of our potential commercial therapeutic products in the U.S. until Provenge or another product candidate we may develop is approved by the U.S. Food and Drug Administration (“FDA”). Without revenue generated from commercial sales, we anticipate that we will continue to fund our ongoing research, development and general operations from our available cash resources and future offerings of equity, debt or other securities. We anticipate our operating expenses to decrease in 2008.
 
In September 2005, we announced plans to submit our biologics license application (our “BLA”) to the FDA for approval to market Provenge. This decision followed a pre-BLA meeting in which we reviewed safety and efficacy data with the FDA from our two completed Phase 3 clinical trials for Provenge, D9901 and D9902A. In these discussions the FDA agreed that the survival benefit observed in the D9901 study in conjunction with the supportive data obtained from study D9902A and the absence of significant toxicity in both studies was sufficient to serve as the clinical basis of our BLA submission for Provenge. Provenge was granted Fast Track designation from the FDA for the treatment of asymptomatic, metastatic, androgen-independent prostate cancer patients, which enabled us to submit our BLA on a rolling basis.
 
On August 24, 2006, we submitted the clinical and non-clinical sections of our BLA and on November 9, 2006, we submitted the chemistry, manufacturing and controls (“CMC”) section, completing our submission of our BLA to the FDA for Provenge. On January 12, 2007, the FDA accepted our BLA filing and assigned Priority Review status for Provenge.
 
The FDA’s Cellular, Tissue and Gene Therapies Advisory Committee (the “Advisory Committee”) review of our BLA for the use of Provenge in the treatment of patients with asymptomatic, metastatic, androgen-independent (also known as hormone refractory) prostate cancer was held on March 29, 2007. The Advisory Committee was unanimous (17 yes, 0 no) in its opinion that the submitted data established that Provenge is reasonably safe for the intended population and the majority (13 yes, 4 no) believed that the submitted data provided substantial evidence of the efficacy of Provenge in the intended population.
 
On May 8, 2007, we received a Complete Response Letter from the FDA regarding our BLA. In its letter, the FDA requested additional clinical data in support of the efficacy claim contained in the BLA, as well as additional information with respect to the CMC section of the BLA. As a result, our Board of Directors, on May 16, 2007, approved the reduction of company personnel that were focused on the near term commercialization activities of Provenge. This resulted in immediate personnel reductions of approximately 18% of our total workforce, or the elimination of approximately 40 positions. In a meeting with the FDA on May 29, 2007, we received confirmation that the FDA will accept either a positive interim or final analysis of survival from our ongoing Phase 3 D9902B IMPACT (IMmunotherapy for Prostate AdenoCarcinoma Treatment) study to support licensure of Provenge. These analyses are event driven, rather than time specific. We anticipate that interim results will be available from our IMPACT study during the second half of 2008. Recently, the FDA agreed to amend the special protocol assessment for the IMPACT study. This amendment will enable us to receive final results from the IMPACT study approximately one year earlier than previously anticipated with comparable power for the study. We anticipate that final results will be available from our IMPACT study during the second half of 2009. Upon the receipt of positive interim or final analysis of survival, we intend to amend our BLA.
 
The special protocol assessment for the IMPACT study, as amended in September 2005, elevated survival to the primary endpoint. Men with asymptomatic or minimally symptomatic disease were eligible for the study. We completed the target enrollment of 500 patients in the IMPACT study during October 2007.
 
OVERVIEW


 



We are a biotechnology company focused on the discovery,
development and commercialization of novel therapeutics that
harness the immune system to fight cancer. Our portfolio
includes active immunotherapy, monoclonal antibody and small
molecule product candidates to treat a wide range of cancers.
Our most advanced product candidate is Provenge (sipuleucel-T),
an active cellular immunotherapy for prostate cancer.


 



We have incurred significant losses since our inception. As of
December 31, 2007, our accumulated deficit was
$491.6 million. We have incurred net losses as a result of
research and development expenses, clinical trial expenses,
contract manufacturing expenses and general and administrative
expenses in support of our operations and marketing efforts. We
anticipate incurring net losses over at least the next several
years as we continue our clinical trials, apply for regulatory
approvals, develop our technology, expand our operations and
develop the infrastructure to support the commercialization of
Provenge and other product candidates we may develop. The





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Table of Contents






majority of our resources continue to be used in support of
Provenge. We own worldwide commercialization rights for Provenge.


 



We will not generate revenue from the sale of our potential
commercial therapeutic products in the U.S. until Provenge
or another product candidate we may develop is approved by the
U.S. Food and Drug Administration (“FDA”).
Without revenue generated from commercial sales, we anticipate
that we will continue to fund our ongoing research, development
and general operations from our available cash resources and
future offerings of equity, debt or other securities. We
anticipate our operating expenses to decrease in 2008.


 



In September 2005, we announced plans to submit our biologics
license application (our “BLA”) to the FDA for
approval to market Provenge. This decision followed a pre-BLA
meeting in which we reviewed safety and efficacy data with the
FDA from our two completed Phase 3 clinical trials for Provenge,
D9901 and D9902A. In these discussions the FDA agreed that the
survival benefit observed in the D9901 study in conjunction with
the supportive data obtained from study D9902A and the absence
of significant toxicity in both studies was sufficient to serve
as the clinical basis of our BLA submission for Provenge.
Provenge was granted Fast Track designation from the FDA for the
treatment of asymptomatic, metastatic, androgen-independent
prostate cancer patients, which enabled us to submit our BLA on
a rolling basis.


 



On August 24, 2006, we submitted the clinical and
non-clinical sections of our BLA and on November 9, 2006,
we submitted the chemistry, manufacturing and controls
(“CMC”) section, completing our submission of our BLA
to the FDA for Provenge. On January 12, 2007, the FDA
accepted our BLA filing and assigned Priority Review status for
Provenge.


 



The FDA’s Cellular, Tissue and Gene Therapies Advisory
Committee (the “Advisory Committee”) review of our BLA
for the use of Provenge in the treatment of patients with
asymptomatic, metastatic, androgen-independent (also known as
hormone refractory) prostate cancer was held on March 29,
2007. The Advisory Committee was unanimous (17 yes, 0 no) in its
opinion that the submitted data established that Provenge is
reasonably safe for the intended population and the majority (13
yes, 4 no) believed that the submitted data provided substantial
evidence of the efficacy of Provenge in the intended population.


 



On May 8, 2007, we received a Complete Response Letter from
the FDA regarding our BLA. In its letter, the FDA requested
additional clinical data in support of the efficacy claim
contained in the BLA, as well as additional information with
respect to the CMC section of the BLA. As a result, our Board of
Directors, on May 16, 2007, approved the reduction of
company personnel that were focused on the near term
commercialization activities of Provenge. This resulted in
immediate personnel reductions of approximately 18% of our total
workforce, or the elimination of approximately 40 positions. In
a meeting with the FDA on May 29, 2007, we received
confirmation that the FDA will accept either a positive interim
or final analysis of survival from our ongoing Phase 3 D9902B
IMPACT (IMmunotherapy for Prostate AdenoCarcinoma Treatment)
study to support licensure of Provenge. These analyses are event
driven, rather than time specific. We anticipate that interim
results will be available from our IMPACT study during the
second half of 2008. Recently, the FDA agreed to amend the
special protocol assessment for the IMPACT study. This amendment
will enable us to receive final results from the IMPACT study
approximately one year earlier than previously anticipated with
comparable power for the study. We anticipate that final results
will be available from our IMPACT study during the second half
of 2009. Upon the receipt of positive interim or final analysis
of survival, we intend to amend our BLA.


 



The special protocol assessment for the IMPACT study, as amended
in September 2005, elevated survival to the primary endpoint.
Men with asymptomatic or minimally symptomatic disease were
eligible for the study. We completed the target enrollment of
500 patients in the IMPACT study during October 2007.


 




This excerpt taken from the DNDN 10-K filed Mar 14, 2007.
OVERVIEW
 
We are a biotechnology company focused on the discovery, development and commercialization of novel therapeutics that harness the immune system to fight cancer. Our portfolio includes active immunotherapy, monoclonal antibody and small molecule product candidates to treat a wide range of cancers. The product candidates most advanced in development are active immunotherapies designed to stimulate a patient’s immune system for the treatment of cancer. Our most advanced product candidate is Provenge (sipuleucel-T), an active cellular immunotherapy for the treatment of prostate cancer.
 
We have incurred significant losses since our inception. As of December 31, 2006, our accumulated deficit was $392.4 million. We have incurred net losses as a result of research and development expenses, clinical trial expenses, contract manufacturing expenses and general and administrative expenses in support of our operations. We anticipate incurring net losses over at least the next several years as we continue our clinical trials, apply for regulatory approvals, develop our technology, expand our operations and develop the infrastructure to support the commercialization of Provenge and other product candidates we may develop. We own worldwide commercialization rights for Provenge.
 
We may or may not generate revenue from the sale of our potential commercial therapeutic products during the next year depending upon the approval of Provenge by the U.S. Food & Drug Administration (“FDA”). Without revenue generated from commercial sales, we anticipate that we will continue to fund our ongoing research, development and general operations from our available cash resources, future offerings of equity, debt or other securities and with license fees and milestone payments received from our collaborators. We expect our costs to increase in the future as a result of increased clinical trial costs, contract manufacturing costs and costs associated with operating our New Jersey manufacturing facility. In January 2006, we announced the realignment of our resources to focus on achieving FDA approval for Provenge as expeditiously as possible and to reduce operating costs. The majority of our resources were used to complete our biologics license application (our “BLA”), during 2006 and prepare for the commercialization of Provenge. We anticipate operating expenses to increase in the future as we continue our commercialization efforts for Provenge.
 
In September 2005, we announced plans to submit our BLA to the FDA to market Provenge. This decision followed a pre-BLA meeting in which we reviewed safety and efficacy data with the FDA from our two completed Phase 3 clinical trials for Provenge, D9901 and D9902A. In these discussions the FDA agreed that the survival benefit observed in the D9901 study in conjunction with the supportive data obtained from study D9902A and the absence of significant toxicity in both studies was sufficient to serve as the clinical basis of our BLA submission for Provenge. Provenge was granted Fast Track designation from the FDA for the treatment of asymptomatic, metastatic, androgen-independent prostate cancer patients, which enabled us to submit our BLA on a rolling basis. On August 24, 2006, we submitted the clinical and non-clinical sections of our BLA and on November 9, 2006, we submitted the chemistry, manufacturing and controls (“CMC”) section, completing our submission of our BLA to the FDA for Provenge. On January 12, 2007, the FDA accepted our BLA filing and assigned Priority Review status for Provenge. The goal for reviewing a product with Priority Review status is six months from the filing date. The Prescription Drug User Fee Act (“PDUFA”) date for the anticipated completion of review by the FDA of the Provenge BLA is May 15, 2007. Provenge will be reviewed by the FDA’s Cellular, Tissue and Gene Therapies Advisory Committee on March 29, 2007.
 
In August 2002, we divided our D9902 trial into D9902A discussed above and D9902B, our ongoing supportive Phase 3 study, now known as the IMPACT (IMmunotherapy for Prostate AdenoCarcinoma Treatment) study. The IMPACT study was initiated in June 2003 under a Special Protocol Assessment (“SPA”) for the treatment of men with asymptomatic, metastatic, androgen-independent prostate cancer whose tumors had been classified as Gleason score 7 or less. Based upon results of the two completed Phase 3 studies, D9901 and D9902A, we met with the FDA and amended the D9902B SPA protocol to open the trial to men regardless of Gleason score and to elevate survival to the primary endpoint. Approximately 500 men will be enrolled and men with asymptomatic or minimally symptomatic disease are eligible for the study. We expect to complete enrollment in the IMPACT study during 2007. Safety data from our IMPACT study has been included in our BLA.


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This excerpt taken from the DNDN 10-K filed Mar 15, 2006.

OVERVIEW

 

We are a biotechnology company focused on the discovery, development and commercialization of novel therapeutics that harness the immune system to fight cancer. Our portfolio includes active immunotherapy, monoclonal antibody and small molecule product candidates to treat a wide range of cancers. The product candidates most advanced in development are active immunotherapies designed to stimulate a patient’s immune system for the treatment of cancer. Our most advanced product candidate is Provenge (sipuleucel-T), an active cellular immunotherapy for the treatment of prostate cancer.

 

We have incurred significant losses since our inception. As of December 31, 2005, our accumulated deficit was $300.7 million. We have incurred net losses as a result of research and development expenses, clinical trial expenses, contract manufacturing expenses and general and administrative expenses in support of our operations and marketing expenses. We anticipate incurring net losses over at least the next several years as we continue our clinical trials, apply for regulatory approvals, develop our technology, expand our operations and develop the infrastructure to support the commercialization of Provenge and other product candidates we may develop.

 

We anticipate that we will not generate revenue from the sale of our potential commercial therapeutic products during the next year. Without revenue generated from commercial sales, we anticipate that we will continue to fund our ongoing research, development and general operations from our available cash resources, future equity offerings and with license fees and milestone payments received from our collaborators. The timing and level of funding from our existing or future collaborations will fluctuate based upon the success of our research programs, our ability to meet milestones and receipt of approvals from government regulators. We expect research and development expenses to increase in the future as a result of increased clinical trial costs, contract manufacturing costs and costs associated with operating our New Jersey manufacturing facility. In January 2006, we announced the realignment of our resources to focus on achieving regulatory approvals for Provenge as expeditiously as possible and to reduce operating costs. The majority of our resources have now been deployed to complete the BLA during 2006 and prepare for the commercialization of Provenge. We anticipate net cash utilized for operating and capital expenditures for 2006 to be approximately $100 million. In addition, clinical trial costs may grow at a faster rate compared to research and other preclinical expenses as we continue our ongoing clinical trials.

 

Provenge (sipuleucel-T)

 

In September 2005, we announced plans to submit a BLA to the FDA to market Provenge. This decision followed a pre-BLA meeting in which we reviewed safety and efficacy data with the FDA from our two completed Phase 3 clinical trials, D9901 and D9902A. In these discussions the FDA agreed that the survival benefit observed in the D9901 study in conjunction with the supportive data obtained from study D9902A and the absence of significant toxicity in both studies is sufficient to serve as the clinical basis of a BLA submission for Provenge. We anticipate submitting a BLA for Provenge to the FDA in 2006 on a rolling basis. We own commercialization rights for Provenge worldwide. Provenge has Fast Track designation from the FDA for the treatment of asymptomatic patients with metastatic, androgen-independent prostate cancer.

 

Our first Phase 3 clinical trial of Provenge, D9901, was a randomized double-blind placebo-controlled study in 127 men with asymptomatic, metastatic, androgen-independent prostate cancer. The trial was designed to measure a delay in time to disease progression. Time to the onset of disease related pain was a secondary endpoint that was to be evaluated in concert with the results from a second, identical companion trial, D9902. After disease progression, placebo patients were given the option to receive salvage therapy of Provenge on a separate open label study. The protocols for both trials required patients to be followed for survival for three years after enrollment.

 

34


Trial D9901 approached, but did not meet, its primary endpoint of showing a statistically significant delay in time to disease progression in the overall patient population in the study. The trial results did, however, identify a group of patients, those with tumors that had been classified as Gleason score 7 or less, who appeared to benefit most significantly by treatment with Provenge compared to patients who received placebo. Gleason score is a common measure of the aggressiveness of a patient’s tumor and ranges in score from 2 to 10. In these men, Provenge appeared to delay disease progression. Our second Phase 3 trial, D9902, was still underway when the D9901 results on progression were obtained and the survival follow up was still ongoing. Based on discussions with the FDA, we amended D9902 to contain two parts: D9902 Part A (D9902A) included those patients enrolled regardless of Gleason score, and Part B (D9902B), which initially restricted enrollment to those patients most like the group of patients that appeared to benefit in D9901, those with Gleason scores of 7 or less.

 

We completed the planned three year follow-up for survival on the D9901 patients and disclosed in February 2005 that a significant survival advantage was seen in those patients who had been randomized to the Provenge arm compared to those who had been randomized to receive placebo. According to the final three year intent-to-treat analysis, patients who received Provenge had a median survival of 25.9 months compared to 21.4 months for patients in the placebo arm, a 4.5 month or 21% improvement (p-value = 0.01, hazard ratio = 1.7). This hazard ratio implies that patients who received placebo have a relative risk of dying that is 70 percent higher than that of patients who received Provenge. In addition, 34 percent of patients who received Provenge were alive at 36 months compared to 11 percent of patients who received placebo. The survival benefit seen with Provenge was independent of a patient’s Gleason score. A Cox multivariate regression analysis was used to test the validity of the survival benefit seen in this study. The results showed that patients who received placebo had a relative risk of dying more than twice as high as that of patients who received Provenge (p-value = 0.002, adjusted hazard ratio = 2.1).

 

In October 2005, we disclosed results from the second randomized Phase 3 trial, D9902A. Trial D9902A also did not meet its primary endpoint of showing a statistically significant delay in time to disease progression. In the D9902A study, the three-year final survival analysis in the intent-to-treat population of the double-blind, placebo-controlled study of Provenge in 98 men with asymptomatic, metastatic, androgen-independent prostate cancer showed those patients who received Provenge had a median survival of 19.0 months compared to 15.7 months for patients in the placebo arm, a 3.3 month or 21% improvement (p-value = 0.331, hazard ratio = 1.3). A Cox multivariate regression analysis of overall survival, which adjusts for the same prognostic factors known to influence survival utilized in D9901, met the criteria for statistical significance (p-value = 0.023; adjusted hazard ratio = 1.9). The hazard ratio observed in this analysis was similar to that seen in our D9901 trial. In addition, at the three-year final follow up, 32 percent of patients who received Provenge were alive compared to only 21 percent of the patients who received placebo, a 52 percent improvement in the survival rate.

 

An integrated analysis of the survival data from these two companion Phase 3 clinical studies, D9901 and D9902A, showed a statistically significant survival benefit in the overall intent-to-treat population of 225 patients. In this analysis, those patients who received Provenge had a median survival of 23.2 months compared to 18.9 months for patients in the placebo arm (p-value = 0.011; hazard ratio = 1.5). A Cox multivariate regression analysis of the integrated data for overall survival also met the criteria for statistical significance (p-value = 0.0006; adjusted hazard ratio = 1.8). In addition, at the three-year final follow up, 33 percent of patients who received Provenge were alive compared to only 15 percent of the patients who received placebo. In both studies, Provenge was generally well tolerated.

 

We are currently conducting another Phase 3 clinical trial of Provenge, D9902B. Based on the results of the two completed Phase 3 studies, D9901 and D9902A, we met with the FDA and have amended the D9902B SPA protocol to open the trial to men regardless of Gleason score and to elevate survival to the primary endpoint. Approximately 500 men will be enrolled and men with asymptomatic or minimally symptomatic disease are eligible for the study. We expect to complete enrollment in the D9902B study, now known as the IMPACT (IMmunotherapy for Prostate AdenoCarcinoma Treatment) study, prior to any prospective approval of Provenge by the FDA. We recently disclosed that enrollment has been completed in a Phase 3 double-blind placebo

 

35


controlled trial called PROTECT (PROvenge Trial of Early Prostate Cancer Treatment) (P-11) in androgen-dependent prostate cancer.

 

Neuvenge (lapuleucel-T)

 

Neuvenge is our investigational active cellular immunotherapy for the treatment of patients with breast, ovarian and other solid tumors expressing HER2/neu. In December 2004, we announced results from two Phase 1 studies of Neuvenge indicating that Neuvenge stimulated an immune response and may provide clinical benefit in patients with advanced, metastatic HER2/neu positive breast cancer. We are evaluating future development plans for Neuvenge.

 

Preclinical Research and Development Programs

 

In addition to other active immunotherapies in preclinical research and development, we have monoclonal antibody and small molecule product candidates in preclinical research and development programs. These also include product candidates being developed with our collaborators.

 

Our collaboration with Genentech, Inc. targets the development of product candidates directed against trp-p8, an ion channel found in prostate cancer cells. We are currently engaged in discovering, evaluating and developing small molecule therapeutics that modify trp-p8 function. We have discovered selective trp-p8 small molecule agonists that induce cell death and inhibit the growth of trp-p8 positive tumors in animals. Lead compounds are orally bio-available and potent agonists of trp-p8 function.

 

Our collaboration with Abgenix, Inc. is focused on the discovery, development and commercialization of fully-human monoclonal antibody candidates against a membrane-bound serine protease. Under the terms of the collaboration, Abgenix, Inc. will use its human antibody technologies to generate and select antibodies against this serine protease. Both Dendreon and Abgenix will have the right to co-develop and commercialize, or, if co-development is not elected, to solely develop and commercialize, any antibody product candidates discovered during the collaboration. The companies will share equally in the product development costs and any profits from sales of products successfully commercialized from co-development efforts.

 

This excerpt taken from the DNDN 10-Q filed Aug 8, 2005.

OVERVIEW

 

We are a biotechnology company focused on the discovery, development and commercialization of targeted therapies for cancer. Our portfolio includes active immunotherapy, monoclonal antibody and small molecule product candidates to treat a wide range of cancers. The product candidates most advanced in development are active immunotherapies designed to stimulate a patient’s immune system for the treatment of cancer. Our most advanced product candidate is Provenge®, an active immunotherapy for the treatment of prostate cancer.

 

We have incurred significant losses since our inception. As of June 30, 2005, our accumulated deficit was $256.2 million. We have incurred net losses as a result of research and development expenses, clinical trial expenses, contract manufacturing expenses, general and administrative expenses in support of our operations and marketing expenses. We anticipate incurring net losses over at least the next several years as we continue our clinical trials, apply for regulatory approvals, develop our technology, expand our operations and develop the infrastructure to support the commercialization of Provenge and other product candidates we may develop.

 

We anticipate that we will not generate revenue from the sale of our commercial therapeutic products for the next few years. Without revenue generated from commercial sales, we anticipate that we will continue to fund our ongoing research, development and general operations from our available cash resources, and with license fees and milestone payments received from our current or future collaborators. The timing and level of funding from our existing or future collaborations will fluctuate based upon the success of our research programs, our ability to meet milestones and receipt of approvals from government regulators. We expect research and development expenses to increase in the future as a result of increased contract manufacturing costs and clinical trial activity. Clinical trial costs may grow at a faster rate compared to research and other preclinical expenses as we continue our ongoing clinical trials and advance other potential products in clinical development.

 

Provenge (APC8015)

 

Our first Phase 3 clinical trial, D9901, of Provenge, was a double-blind placebo-controlled study in 127 men with asymptomatic, metastatic, androgen-independent prostate cancer. The trial was designed to measure a delay in time to disease progression. Time to the onset of disease related pain was a secondary endpoint that was to be evaluated in concert with the results from a second, identical companion trial, D9902. After disease progression, placebo patients were given the option to receive salvage therapy on a separate open label study. Both protocols required patients to be followed for survival for three years after enrollment.

 

Trial D9901 approached, but did not meet its main objective of showing a statistically significant delay in the median time to disease progression in the overall patient population in the study. The trial results did, however, identify a group of patients, those with tumors that had been classified as Gleason score 7 or less, who appeared to benefit most significantly by treatment with Provenge compared to patients who received placebo. Gleason score is a common measure of the aggressiveness of a patient’s tumor and ranges in score from 2 to 10. In these men, Provenge appeared to delay disease progression. Our second Phase 3 trial, D9902, was still underway when the D9901 results on progression were obtained and the survival follow up was still ongoing. Based on discussions with the Food and Drug Administration (FDA), we amended D9902 to contain two parts: D9902 Part A (D9902A) includes those patients enrolled regardless of Gleason score, and Part B (D9902B) restricts enrollment to those patients most like the group of patients that appeared to benefit in D9901, those with Gleason scores of 7 or less. Trial D9902B has received a positive Special Protocol Assessment from the FDA.

 

We completed the planned three year follow-up for survival on the D9901 patients and disclosed this year that a significant survival advantage was seen in those patients who had been randomized to the Provenge arm compared to those who had been randomized to receive placebo. According to the final three year intent-to-treat analysis, patients who received Provenge had a median survival of 25.9 months compared to 21.4 months for patients in the placebo arm, a 4.5 month (21%) improvement (p-value = 0.01, hazard ratio = 1.7). This hazard ratio implies that patients who received placebo have a relative risk of dying that is 70 percent higher than those patients who received Provenge. In addition, 34 percent of patients who received Provenge were alive at 36 months compared to 11 percent of patients who received placebo (p-value = 0.0046). The survival benefit seen with Provenge was independent of a patient’s Gleason score.

 

More recently, we disclosed results from the second randomized Phase 3 trial, D9902A. In the D9902A study, the three-year final survival analysis in the intent-to-treat population of the double-blind, placebo-controlled study of Provenge in 98 men with asymptomatic, metastatic, androgen-independent (hormone-refractory) prostate cancer showed a 20 percent improvement in median survival for patients who were randomized to receive Provenge compared to placebo. In addition, at the three-year final follow up, the percentage of patients alive in the Provenge-treated group was substantially greater than the percentage of patients alive who received placebo. As expected from the interim analysis, the results from this study did not

 

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meet the criteria for statistical significance based on a log rank test. A secondary analysis using a Cox multivariate regression analysis of overall survival, which adjusts for prognostic factors known to influence survival, met the criteria for statistical significance. The hazard ratio observed in this analysis was similar to that seen in our D9901 trial.

 

A supplemental analysis that examined pooled survival data from the two companion Phase 3 clinical studies (D9901 and D9902A) showed a statistically significant survival benefit in the overall intent-to-treat population of 225 patients. In this analysis, a 23 percent increase in median survival was seen in patients randomized to receive Provenge compared to placebo. In addition, at the three-year final follow up, the percentage of patients alive in the Provenge-treated group was substantially greater than the percentage of patients alive who received placebo. In the combined D9901 and D9902A analysis, a Cox multivariate regression analysis of overall survival also met the criteria for statistical significance. In both studies, Provenge was generally well tolerated.

 

Further analyses of the D9902A data are ongoing and we anticipate presenting the results at an upcoming medical meeting.

 

Provenge has Fast Track designation from the FDA for the treatment of men with Gleason score 7 or less with asymptomatic, metastatic, androgen-independent prostate cancer. We are currently conducting a pivotal Phase 3 clinical trial of Provenge, D9902B, in this indication. We recently completed enrollment in a Phase 3 double-blind placebo-controlled trial, P-11, in men with androgen-dependent prostate cancer. We own commercialization rights for Provenge worldwide.

 

We expect to have discussions with the FDA in the second half of 2005 to determine the most efficient pathway to regulatory approval of Provenge. If the FDA agrees that the survival benefit observed in D9901 and D9902A is sufficient to serve as the clinical basis of an application then we would anticipate submitting a Biologics License Application (BLA) in 2006. We may amend the current ongoing D9902B study protocol to enroll men regardless of their Gleason score. If D9902B is amended and is required for regulatory approval and is successful in meeting its specified endpoints, we would submit a BLA after 2006. Notwithstanding the foregoing, as noted in “Factors that May Affect Results of Operations and Financial Condition”, there can be no assurance that FDA approval of Provenge will be granted as the FDA can delay, limit or withhold approval of a product candidate for many reasons.

 

Neuvenge (APC8024)

 

Neuvenge is our investigational active immunotherapy for the treatment of patients with breast, ovarian and other solid tumors expressing HER2/neu. In December 2004, we announced results from two Phase 1 studies of Neuvenge indicating that Neuvenge stimulated an immune response and may provide clinical benefit in patients with advanced, metastatic HER2/neu positive breast cancer. We are presently designing a Phase 2 clinical trial of Neuvenge in metastatic breast cancer, as well in other HER2/neu expressing cancers.

 

Preclinical Research and Development Programs

 

In addition to other active immunotherapies in preclinical research and development, we have monoclonal antibody and small molecule product candidates in preclinical research and development programs. We have a monoclonal antibody program that targets HLA-DR and the use of antibodies directed to this target to kill cancer cells. Other monoclonal antibody and small molecule product candidates include product candidates being developed with our collaborators.

 

Our collaboration with Genentech, Inc. targets the development of product candidates directed against trp-p8, a cancer-specific ion channel. We are currently engaged in discovering, evaluating and developing monoclonal antibody and small molecule therapeutics that modify trp-p8 function.

 

Our collaboration with Abgenix, Inc. is focused on the discovery, development and commercialization of fully-human monoclonal antibody candidates against a membrane-bound serine protease. Under the terms of the collaboration, Abgenix, Inc. will use its human antibody technologies to generate and select antibodies against this serine protease. Both companies will have the right to co-develop and commercialize, or, if co-development is not elected, to solely develop and commercialize, any antibody product candidates discovered during the collaboration. The companies will share equally in the product development costs and any profits from sales of products successfully commercialized from co-development efforts.

 

We also are collaborating with Dyax Corp. to discover, develop and commercialize monoclonal antibody, small protein and peptide inhibitors for two endotheliase enzymes. Under the terms of this agreement, both companies will jointly develop any product candidates that may be identified and will share commercialization rights and will share profits, if any, from any marketed products.

 

Page 10


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This excerpt taken from the DNDN 10-Q filed May 9, 2005.

OVERVIEW

 

We are a biotechnology company focused on the discovery, development and commercialization of targeted therapies for cancer. Our portfolio of product candidates includes active immunotherapies, monoclonal antibodies and small molecules to treat a wide range of cancers. The product candidates most advanced in development are active immunotherapies designed to stimulate a patient’s immune system for the treatment of cancer. Our most advanced product candidate is Provenge, an active immunotherapy for the treatment of prostate cancer.

 

We have incurred significant losses since our inception. As of March 31, 2005, our accumulated deficit was $238.7 million. We have incurred net losses as a result of research and development expenses, clinical trial expenses, contract manufacturing expenses, general and administrative expenses in support of our operations and marketing expenses. We anticipate incurring net losses over at least the next several years as we continue our clinical trials, apply for regulatory approvals, develop our technology, expand our operations and develop the infrastructure to support the commercialization of Provenge.

 

We anticipate that we will not generate revenue from the sale of our commercial therapeutic products for the next two years. Without revenue generated from commercial sales, we anticipate that we will continue to fund our ongoing research, development and general operations from our available cash resources, and with revenue, including license fees and milestone payments, received from our current or future collaborators. The timing and level of funding from our existing or future collaborations will fluctuate based upon the success of our research programs, our ability to meet milestones and receipt of approvals from government regulators. We expect research and development expenses to increase in the future as a result of increased research and clinical trial activity. Clinical trial costs may grow at a faster rate compared to research and other preclinical expenses as we continue our ongoing clinical trials and advance other potential products in clinical development.

 

Our first Phase 3 clinical trial for Provenge, D9901, was a double-blind placebo controlled clinical trial in men with metastatic androgen-independent prostate cancer. The trial was designed to measure a delay in time to disease progression. Time to the onset of disease related pain was a secondary endpoint that was to be evaluated in concert with the results from a second, identical companion trial, D9902. Patients were given the option to receive salvage therapy on a separate open label study. Both protocols required patients to be followed for survival for three years after enrollment.

 

Trial D9901 approached, but did not meet its main objective of showing a statistically significant delay in the median time to disease progression in the overall patient population in the study. The trial results did, however, identify a group of patients, those with tumors that had been classified as Gleason score 7 or less, who appeared to benefit most significantly by treatment with Provenge compared to patients who received placebo. Gleason score is a common measure of the aggressiveness of a patient’s tumor and ranges in score from 2 to 10. In these men, Provenge appeared to delay disease progression. Our second Phase 3 trial, D9902, was still underway when the D9901 results on progression were obtained and the survival follow up was still ongoing. Based on discussions with the Food and Drug Administration (FDA), we amended D9902 to contain two parts: D9902 Part A (D9902A) includes those patients enrolled regardless of Gleason score, and Part B (D9902B) restricts enrollment to those patients most like the group of patients that appeared to benefit in D9901, those with Gleason scores of 7 or less. Trial D9902B has received a positive Special Protocol Assessment from the FDA.

 

More recently, we completed the planned three year follow-up for survival on the D9901 patients and disclosed that a significant survival advantage was seen in those patients who had been assigned to the Provenge arm compared to those who had been assigned to receive placebo. According to the final three year intent-to-treat analysis, patients receiving Provenge had a median survival of 25.9 months compared to 21.4 months for patients in the placebo arm, a 4.5 month improvement (p-value = 0.01, hazard ratio = 1.7). This hazard ratio implies that patients receiving placebo have a relative risk of dying that is 70 percent higher than those patients receiving Provenge. In addition, 34 percent of patients receiving Provenge were alive at 36 months compared to 11 percent of patients receiving placebo (p-value = 0.0046). The survival benefit seen with Provenge was independent of a patient’s Gleason score. As in previous studies, Provenge was generally well tolerated.

 

Final results from trial D9902A also did not achieve statistical significance for delaying the time to disease progression. A preliminary analysis of overall survival in the D9902A clinical trial indicated that both the survival rates and the median survival benefit compared to placebo show trends that are similar to the results observed in the final three-year survival analysis of the D9901 study. We plan to complete the final pre-specified, three year survival analysis of the D9902A study in the summer of 2005.

 

Provenge has Fast Track designation from the FDA for the treatment of men with Gleason score 7 or less with asymptomatic, metastatic androgen-independent prostate cancer. We are currently conducting a pivotal Phase 3 clinical trial

 

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of Provenge, D9902B, in this indication. We are also completing a Phase 3 double-blind placebo controlled trial (P-11) in androgen-dependent prostate cancer. We own commercialization rights for Provenge worldwide.

 

If the final pre-specified three year survival analysis of D9902A is supportive to the data from D9901, we would anticipate submitting a biologics license application in 2006. Based on the results from D9901 and D9902A, we may amend the current D9902B protocol to enroll men regardless of their Gleason score. If D9902B is amended and is required for regulatory approval and is successful in meeting its specified endpoints, we would submit a biologics license application after 2006.

 

Neuvenge (APC8024)

 

Neuvenge is our investigational immunotherapy for the treatment of patients with breast, ovarian and other solid tumors expressing HER2/neu. In December 2004, we announced results from two Phase 1 studies of Neuvenge indicating that Neuvenge stimulated an immune response and may provide clinical benefit in patients with advanced, metastatic HER2/neu positive breast cancer. The data indicates that Neuvenge stimulates a robust immune response and is well-tolerated. We are presently designing Phase 2 trials of Neuvenge in women with metastatic breast cancer.

 

Preclinical Research and Development Programs

 

In addition to other active immunotherapies in preclinical research and development, we have monoclonal antibody and small molecule product candidates in preclinical research and development programs. These include product candidates being developed with our collaborators.

 

Our collaboration with Genentech, Inc. targets the development of product candidates directed against trp-p8, a cancer-specific ion channel. We are currently engaged in discovering, evaluating and developing monoclonal antibodies and small molecule therapeutics that modify trp-p8 function.

 

Our collaboration with Abgenix, Inc. is focused on the discovery, development and commercialization of fully-human monoclonal antibodies against a membrane-bound serine protease. Under the terms of the collaboration, Abgenix, Inc. will use its human antibody technologies to generate and select antibodies against this serine protease. Both companies will have the right to co-develop and commercialize, or, if co-development is not elected, to solely develop and commercialize, any antibody product candidates discovered during the collaboration. The companies will share equally in the product development costs and any profits from sales of products successfully commercialized from co-development efforts.

 

We also are collaborating with Dyax Corp. to discover, develop and commercialize monoclonal antibody, small protein and peptide inhibitors for two endotheliase enzymes. Under the terms of this agreement, both companies will jointly develop any product candidates that may be identified and will share commercialization rights and will share profits, if any, from any marketed products.

 

We have a monoclonal antibody program that targets HLA-DR and the use of antibodies directed to this target to kill cancer cells.

 

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