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SPPI » Topics » Overview

These excerpts taken from the SPPI 10-K filed Mar 31, 2009.

Overview

We are a commercial stage biopharmaceutical company committed to developing and commercializing innovative therapies with a focus primarily in the areas of hematology-oncology and urology. We have a fully developed commercial infrastructure that is responsible for the sales and marketing of two drugs in the United States, namely Fusilev and Zevalin. Our lead developmental drug is apaziquone (formerly EOquin), which is presently being studied in two large Phase 3 clinical trials for non-muscle invasive bladder cancer under a strategic collaboration with Allergan Inc. Another drug, ozarelix is in a Phase 2 clinical trial for benign prostatic hypertrophy (BPH).

Our business strategy for 2009 is comprised of the following initiatives:


	•	Maximizing the growth potential for our marketed drugs, Fusilev and Zevalin. The company’s near-term outlook depends on sales and marketing successes associated with our two marketed drugs. We launched Fusilev in August 2008 and were able to successfully achieve broad utilization in community offices and institutions. Our second drug, Zevalin, is marketed by our subsidiary RIT Oncology LLC (RIT), which was formed in December 2008. A dedicated commercial organization comprised of sales representatives, account managers, medical science liaisons and a complement of other marketing personnel support the sales and marketing of these drugs. Together with multiple initiatives to address historical barriers to uptake of Zevalin, we believe we can capture the substantial growth potential in sales for both Fusilev and Zevalin. Both drugs have additional applications on file with the U.S. Food and Drug Administration (FDA) for new, larger indications in non-Hodgkin’s lymphoma and metastatic colorectal cancer, respectively. We plan to fully capitalize on these potential indication approvals in a cash-efficient manner by staging appropriate infrastructure expansions to facilitate broad customer reach and to address other market requirements, as appropriate. These supplemental applications are currently under review by the FDA, with regulatory decisions expected in second half of 2009.

	•	Maximizing the asset value of apaziquone. We took a giant step forward with our lead development asset, apaziquone, in late 2008 with the signing of a strategic collaboration with Allergan. We retained exclusive rights to apaziquone in Asia, including Japan and China while Allergan received exclusive rights to apaziquone for the treatment of bladder cancer in the rest of the world, including the United States, Canada and Europe. In the United States, we will co-promote apaziquone with Allergan and share in its profits and expenses. This drug is presently being studied, under a special protocol assessment procedure with the FDA and scientific advice from the European Medicines Agency (EMEA), in two large Phase 3 clinical trials for non-muscle invasive bladder cancer. Our goal is to complete enrollment in these two trials and also begin a study in Bacillus Calmette-Guérin, or BCG, refractory bladder cancer by the end of 2009. These studies have been and will be strategically placed in centers worldwide that have extensive clinical trial experience, so as to ensure proper execution. These studies are designed to clinically differentiate this drug versus standard of care, and to ultimately successfully address the unmet needs in this disease. We hope to continue to partially monetize this asset through seeking additional strategic collaborations in markets where we have sole rights. Specifically, our goal is to secure new partnerships for this agent in Japan and selected markets in Asia.

	•	Optimizing our development portfolio. We continue to build on our core expertise in clinical development for the treatment of cancer and urology. We remain reliant on in-licensing strategies to seek drugs for development. Most recently, the company has undertaken a criteria-based portfolio review, which is expected to result in streamlining our pipeline drugs, allowing for greater focus and integration of our development and commercial goals. The portfolio will be assessed based on factors that include, among others things, probability of clinical success, time and cost of development, market potential, synergies with marketed and other developmental drugs, and competitive landscape. As a result of this portfolio evaluation, a determination will be made whether to: 1) continue with the drug’s clinical development; 2) terminate its development; or 3) out-license rights to a third party for development and commercialization.


	•	Managing our financial resources effectively. We remain committed to fiscal discipline, a policy which has allowed us to become exceptionally well capitalized among our peers, despite a very challenging fiscal environment. This policy includes the pursuit of non-dilutive funding options, prudent expense management, and the achievement of critical synergies within our operations in order to maintain a reasonable burn rate. Despite the build-up in operational infrastructure to facilitate the marketing of two drugs, we intend to be fiscally prudent in any expansion we undertake. In terms of revenue generation, we hope to become more reliant on sales from currently marketed drugs and intend to pursue out-licensing of apaziquone and select pipeline drugs in select territories, as discussed above. When appropriate, we may pursue other sources of financing, including non-dilutive financing alternatives. While we are currently focused on advancing our key drug development programs, we anticipate that we will make regular determinations as to which other programs, if any, to pursue and how much funding to direct to each program on an ongoing basis, based on clinical success and commercial potential.

	•	Expanding commercial bandwidth through licensing and business development. It remains our goal to identify drugs that will create strong synergies with our currently marketed drugs, including drugs in development. To this end, we will continue to explore strategic collaborations as these relate to drugs that are either in advanced clinical trials or are currently on the market. We believe that such opportunistic collaborations will provide synergies with respect to how we deploy our internal resources. In this regard, we intend to identify and secure drugs that have significant growth potential either through enhanced marketing and sales efforts or through pursuit of additional clinical development.

	•	Further enhancing the organizational structure to meet our corporate objectives. We have highly experienced staff in pharmaceutical operations, clinical development, regulatory and commercial functions who come from small and mid-size biotech companies to large pharmaceutical companies. We recently strengthened the ranks of our management team, and will continue to pursue talent on an opportunistic basis. Finally, we remain committed to running a lean and efficient organization, while effectively leveraging our critical resources.

Overview

We are a commercial stage biopharmaceutical company committed to
developing and commercializing innovative therapies with a focus
primarily in the areas of hematology-oncology and urology. We
have a fully developed commercial infrastructure that is
responsible for the sales and marketing of two drugs in the
United States, namely Fusilev and Zevalin. Our lead
developmental drug is apaziquone (formerly EOquin), which is
presently being studied in two large Phase 3 clinical trials for
non-muscle invasive bladder cancer under a strategic
collaboration with Allergan Inc. Another drug, ozarelix is in a
Phase 2 clinical trial for benign prostatic hypertrophy (BPH).

Our business strategy for 2009 is comprised of the following
initiatives:


	•	Maximizing the growth potential for our marketed drugs, Fusilev and Zevalin. The company’s near-term outlook depends on sales and marketing successes associated with our two marketed drugs. We launched Fusilev in August 2008 and were able to successfully achieve broad utilization in community offices and institutions. Our second drug, Zevalin, is marketed by our subsidiary RIT Oncology LLC (RIT), which was formed in December 2008. A dedicated commercial organization comprised of sales representatives, account managers, medical science liaisons and a complement of other marketing personnel support the sales and marketing of these drugs. Together with multiple initiatives to address historical barriers to uptake of Zevalin, we believe we can capture the substantial growth potential in sales for both Fusilev and Zevalin. Both drugs have additional applications on file with the U.S. Food and Drug Administration (FDA) for new, larger indications in non-Hodgkin’s lymphoma and metastatic colorectal cancer, respectively. We plan to fully capitalize on these potential indication approvals in a cash-efficient manner by staging appropriate infrastructure expansions to facilitate broad customer reach and to address other market requirements, as appropriate. These supplemental applications are currently under review by the FDA, with regulatory decisions expected in second half of 2009.

	•	Maximizing the asset value of apaziquone. We took a giant step forward with our lead development asset, apaziquone, in late 2008 with the signing of a strategic collaboration with Allergan. We retained exclusive rights to apaziquone in Asia, including Japan and China while Allergan received exclusive rights to apaziquone for the treatment of bladder cancer in the rest of the world, including the United States, Canada and Europe. In the United States, we will co-promote apaziquone with Allergan and share in its profits and expenses. This drug is presently being studied, under a special protocol assessment procedure with the FDA and scientific advice from the European Medicines Agency (EMEA), in two large Phase 3 clinical trials for non-muscle invasive bladder cancer. Our goal is to complete enrollment in these two trials and also begin a study in Bacillus Calmette-Guérin, or BCG, refractory bladder cancer by the end of 2009. These studies have been and will be strategically placed in centers worldwide that have extensive clinical trial experience, so as to ensure proper execution. These studies are designed to clinically differentiate this drug versus standard of care, and to ultimately successfully address the unmet needs in this disease. We hope to continue to partially monetize this asset through seeking additional strategic collaborations in markets where we have sole rights. Specifically, our goal is to secure new partnerships for this agent in Japan and selected markets in Asia.

	•	Optimizing our development portfolio. We continue to build on our core expertise in clinical development for the treatment of cancer and urology. We remain reliant on in-licensing strategies to seek drugs for development. Most recently, the company has undertaken a criteria-based portfolio review, which is expected to result in streamlining our pipeline drugs, allowing for greater focus and integration of our development and commercial goals. The portfolio will be assessed based on factors that include, among others things, probability of clinical success, time and cost of development, market potential, synergies with marketed and other developmental drugs, and competitive landscape. As a result of this portfolio evaluation, a determination will be made whether to: 1) continue with the drug’s clinical development; 2) terminate its development; or 3) out-license rights to a third party for development and commercialization.


	•	Managing our financial resources effectively. We remain committed to fiscal discipline, a policy which has allowed us to become exceptionally well capitalized among our peers, despite a very challenging fiscal environment. This policy includes the pursuit of non-dilutive funding options, prudent expense management, and the achievement of critical synergies within our operations in order to maintain a reasonable burn rate. Despite the build-up in operational infrastructure to facilitate the marketing of two drugs, we intend to be fiscally prudent in any expansion we undertake. In terms of revenue generation, we hope to become more reliant on sales from currently marketed drugs and intend to pursue out-licensing of apaziquone and select pipeline drugs in select territories, as discussed above. When appropriate, we may pursue other sources of financing, including non-dilutive financing alternatives. While we are currently focused on advancing our key drug development programs, we anticipate that we will make regular determinations as to which other programs, if any, to pursue and how much funding to direct to each program on an ongoing basis, based on clinical success and commercial potential.

	•	Expanding commercial bandwidth through licensing and business development. It remains our goal to identify drugs that will create strong synergies with our currently marketed drugs, including drugs in development. To this end, we will continue to explore strategic collaborations as these relate to drugs that are either in advanced clinical trials or are currently on the market. We believe that such opportunistic collaborations will provide synergies with respect to how we deploy our internal resources. In this regard, we intend to identify and secure drugs that have significant growth potential either through enhanced marketing and sales efforts or through pursuit of additional clinical development.

	•	Further enhancing the organizational structure to meet our corporate objectives. We have highly experienced staff in pharmaceutical operations, clinical development, regulatory and commercial functions who come from small and mid-size biotech companies to large pharmaceutical companies. We recently strengthened the ranks of our management team, and will continue to pursue talent on an opportunistic basis. Finally, we remain committed to running a lean and efficient organization, while effectively leveraging our critical resources.

Overview

We are a commercial stage biopharmaceutical company committed to developing and commercializing innovative therapies with a focus primarily in the areas of hematology-oncology and urology. We have a fully developed commercial infrastructure that is responsible for the sales and marketing of two drugs in the United States, namely Fusilev and Zevalin. Our lead developmental drug is apaziquone, which is presently being studied in two large Phase 3 clinical trials for bladder cancer under a strategic collaboration with Allergan Inc. Another drug, ozarelix is in a Phase 2 clinical trial for BPH.

Our business strategy for 2009 is comprised of the following initiatives:


	•	Maximizing the growth potential for our marketed drugs, Fusilev and Zevalin. The company’s near-term outlook depends on sales and marketing successes associated with our two marketed drugs. We launched Fusilev in August 2008 and were able to successfully achieve broad utilization in community offices and institutions. Our second drug, Zevalin, is marketed by our subsidiary RIT Oncology LLC (RIT), which was formed in December 2008. A dedicated commercial organization comprised of sales representatives, account managers, medical science liaisons and a complement of other marketing personnel support the marketing and sales of these drugs. Together with multiple initiatives to address historical barriers to uptake of Zevalin, we believe we can capture the substantial growth potential in sales for both Zevalin and Fusilev. Both drugs have additional applications on file with the FDA for new, larger indications in non-Hodgkin’s lymphoma and metastatic colorectal cancer, respectively. We plan to fully capitalize on these potential indication approvals in a cash-efficient manner by staging appropriate infrastructure expansions to facilitate broad customer reach and to address other market requirements, as appropriate. These supplemental applications are currently under review by the FDA, with regulatory decisions expected in second half of 2009.

	•	Maximizing the asset value of apaziquone. We took a giant step forward with our lead development asset, apaziquone, in late 2008 with the signing of a strategic collaboration with Allergan. We retained exclusive rights to apaziquone in Asia, including Japan and China while Allergan received exclusive rights to apaziquone for the treatment of bladder cancer in the rest of the world, including the United States, Canada and Europe. In the United States, we will co-promote apaziquone with Allergan and share in its profits and expenses. This drug is presently being studied, under a special protocol assessment procedure with the FDA and scientific advice from the EMEA, in two large Phase 3 clinical trials for non-muscle invasive bladder cancer. Our goal is to complete enrollment in these two trials and also begin a second study in BCG refractory bladder cancer by the end of 2009. These studies have been and will be strategically placed in centers worldwide that have extensive clinical trial experience, so as to ensure proper execution. These studies are designed to clinically differentiate this drug versus standard of care, and to ultimately successfully address the unmet needs in this disease. We hope to continue to partially monetize this asset through seeking additional strategic collaborations in markets where we have sole rights. Specifically, our goal is to secure new partnerships for this agent in Japan and selected markets in Asia.

	•	Optimizing our development portfolio. We continue to build on our core expertise in clinical development for the treatment of cancer and urology. We remain reliant on in-licensing strategies to seek drugs for


		development. Most recently, the company has undertaken a criteria-based portfolio review, which is expected to result in streamlining of our pipeline drugs that will allow for greater focus and integration of our development and commercial goals. The portfolio will be assessed based on factors that include, among others, probability of clinical success, time to and cost of development, market potential, synergies with marketed and other developmental drugs and competitive landscape. As a result of this portfolio evaluation a determination will be made of whether to: 1) continue with the drug’s clinical development; 2) terminate its development; or 3) out-license rights to a third party for development and commercialization.


	•	Managing our financial resources effectively. We remain committed to fiscal discipline, a policy which has allowed us to become exceptionally well capitalized among our peers, despite a very challenging fiscal environment. This policy includes the pursuit of non-dilutive funding options, prudent expense management, and the achievement of critical synergies within our operations in order to maintain a reasonable burn rate. Despite the build-up in operational structure to facilitate the marketing of two drugs, we intend to be fiscally prudent in any expansion we undertake. In terms of revenue generation, we hope to become more reliant on sales from currently marketed drugs and intend to pursue out-licensing of apaziquone in select territories and select pipeline drugs, as discussed above. If and when appropriate, we may pursue other sources of financing, including non-dilutive financing alternatives. While we are currently focused on advancing our key drug development programs, we anticipate that we will make regular determinations as to which other programs, if any, to pursue and how much funding to direct to each program on an ongoing basis in response to the scientific and clinical success of each drug candidate, as well as an ongoing assessment as to the drug candidate’s commercial potential.

	•	Expanding commercial bandwidth through licensing and business development. It remains our goal to identify drugs that will create strong synergies with our currently marketed drugs, including drugs in development. To this end, we will continue to explore strategic collaborations as these relate to drugs that are either in advanced clinical trials or are currently on the market. We believe that such opportunistic collaborations will provide synergies not only with respect to how we deploy our internal resources, but also in terms of how customers and investors view our drug offerings. In this regard, we intend to identify and secure drugs that have significant growth potential either through enhanced marketing and sales efforts or through pursuit of additional clinical development.

	•	Further enhancing the organizational structure to meet our corporate objectives. We have highly experienced staff in pharmaceutical operations, clinical development, regulatory and commercial functions. All key functional areas are comprised of individuals with extensive experience in the health care industry derived from small and mid-size biotech companies to large pharmaceutical companies. We also recently strengthened the ranks of our management team, and will continue to pursue talent on an opportunistic basis. Finally, we remain committed to running a lean and efficient organization, while effectively leveraging our critical resources

Overview

We are a commercial stage biopharmaceutical company committed to
developing and commercializing innovative therapies with a focus
primarily in the areas of hematology-oncology and urology. We
have a fully developed commercial infrastructure that is
responsible for the sales and marketing of two drugs in the
United States, namely Fusilev and Zevalin. Our lead
developmental drug is apaziquone, which is presently being
studied in two large Phase 3 clinical trials for bladder cancer
under a strategic collaboration with Allergan Inc. Another
drug, ozarelix is in a Phase 2 clinical trial for BPH.

Our business strategy for 2009 is comprised of the following
initiatives:


	•	Maximizing the growth potential for our marketed drugs, Fusilev and Zevalin. The company’s near-term outlook depends on sales and marketing successes associated with our two marketed drugs. We launched Fusilev in August 2008 and were able to successfully achieve broad utilization in community offices and institutions. Our second drug, Zevalin, is marketed by our subsidiary RIT Oncology LLC (RIT), which was formed in December 2008. A dedicated commercial organization comprised of sales representatives, account managers, medical science liaisons and a complement of other marketing personnel support the marketing and sales of these drugs. Together with multiple initiatives to address historical barriers to uptake of Zevalin, we believe we can capture the substantial growth potential in sales for both Zevalin and Fusilev. Both drugs have additional applications on file with the FDA for new, larger indications in non-Hodgkin’s lymphoma and metastatic colorectal cancer, respectively. We plan to fully capitalize on these potential indication approvals in a cash-efficient manner by staging appropriate infrastructure expansions to facilitate broad customer reach and to address other market requirements, as appropriate. These supplemental applications are currently under review by the FDA, with regulatory decisions expected in second half of 2009.

	•	Maximizing the asset value of apaziquone. We took a giant step forward with our lead development asset, apaziquone, in late 2008 with the signing of a strategic collaboration with Allergan. We retained exclusive rights to apaziquone in Asia, including Japan and China while Allergan received exclusive rights to apaziquone for the treatment of bladder cancer in the rest of the world, including the United States, Canada and Europe. In the United States, we will co-promote apaziquone with Allergan and share in its profits and expenses. This drug is presently being studied, under a special protocol assessment procedure with the FDA and scientific advice from the EMEA, in two large Phase 3 clinical trials for non-muscle invasive bladder cancer. Our goal is to complete enrollment in these two trials and also begin a second study in BCG refractory bladder cancer by the end of 2009. These studies have been and will be strategically placed in centers worldwide that have extensive clinical trial experience, so as to ensure proper execution. These studies are designed to clinically differentiate this drug versus standard of care, and to ultimately successfully address the unmet needs in this disease. We hope to continue to partially monetize this asset through seeking additional strategic collaborations in markets where we have sole rights. Specifically, our goal is to secure new partnerships for this agent in Japan and selected markets in Asia.

	•	Optimizing our development portfolio. We continue to build on our core expertise in clinical development for the treatment of cancer and urology. We remain reliant on in-licensing strategies to seek drugs for


		development. Most recently, the company has undertaken a criteria-based portfolio review, which is expected to result in streamlining of our pipeline drugs that will allow for greater focus and integration of our development and commercial goals. The portfolio will be assessed based on factors that include, among others, probability of clinical success, time to and cost of development, market potential, synergies with marketed and other developmental drugs and competitive landscape. As a result of this portfolio evaluation a determination will be made of whether to: 1) continue with the drug’s clinical development; 2) terminate its development; or 3) out-license rights to a third party for development and commercialization.


	•	Managing our financial resources effectively. We remain committed to fiscal discipline, a policy which has allowed us to become exceptionally well capitalized among our peers, despite a very challenging fiscal environment. This policy includes the pursuit of non-dilutive funding options, prudent expense management, and the achievement of critical synergies within our operations in order to maintain a reasonable burn rate. Despite the build-up in operational structure to facilitate the marketing of two drugs, we intend to be fiscally prudent in any expansion we undertake. In terms of revenue generation, we hope to become more reliant on sales from currently marketed drugs and intend to pursue out-licensing of apaziquone in select territories and select pipeline drugs, as discussed above. If and when appropriate, we may pursue other sources of financing, including non-dilutive financing alternatives. While we are currently focused on advancing our key drug development programs, we anticipate that we will make regular determinations as to which other programs, if any, to pursue and how much funding to direct to each program on an ongoing basis in response to the scientific and clinical success of each drug candidate, as well as an ongoing assessment as to the drug candidate’s commercial potential.

	•	Expanding commercial bandwidth through licensing and business development. It remains our goal to identify drugs that will create strong synergies with our currently marketed drugs, including drugs in development. To this end, we will continue to explore strategic collaborations as these relate to drugs that are either in advanced clinical trials or are currently on the market. We believe that such opportunistic collaborations will provide synergies not only with respect to how we deploy our internal resources, but also in terms of how customers and investors view our drug offerings. In this regard, we intend to identify and secure drugs that have significant growth potential either through enhanced marketing and sales efforts or through pursuit of additional clinical development.

	•	Further enhancing the organizational structure to meet our corporate objectives. We have highly experienced staff in pharmaceutical operations, clinical development, regulatory and commercial functions. All key functional areas are comprised of individuals with extensive experience in the health care industry derived from small and mid-size biotech companies to large pharmaceutical companies. We also recently strengthened the ranks of our management team, and will continue to pursue talent on an opportunistic basis. Finally, we remain committed to running a lean and efficient organization, while effectively leveraging our critical resources

These excerpts taken from the SPPI 10-K filed Mar 14, 2008.

Overview

On March 7, 2008, we received approval from the U.S. Food and Drug Administration, or FDA, of our new drug application, or NDA, for our drug product, LEVOleucovorin (formerly, ISO-Vorin^tm). We anticipate launching LEVOleucovorin in the U.S. market in mid-2008. Also, during the fourth quarter of 2008, we will launch sumatriptan injection, the generic form of GlaxoSmithKline’s Imitrex^® injection, through our commercialization partner, Par Pharmaceutical Companies, Inc. We are a biopharmaceutical company that acquires, develops and commercializes a diversified portfolio of drug products, with a focus on oncology, urology and other critical health challenges. We are focused on executing our business strategy, which is comprised of the following four parts:


	•	Acquiring and developing a broad and diverse pipeline of late-stage clinical and commercial products with a focus on oncology and urology.

We acquire and develop multiple novel, late-stage oncology drug products that address niche markets. A late-stage focus helps us effectively manage the high cost of drug development by focusing on compounds that have already passed the many costly hurdles in the pre-clinical and early clinical process. Our strategy allows us to leverage organizational, collaborative, commercial and scientific efficiencies from a therapeutic focus on oncology and urology.


	•	Establishing a commercial organization for LEVOleucovorin that will be available if and when each of the other drug products in our pipeline are approved. As we transform from a development to a commercial organization, we are building a foundation for successful product launches.

	•	Continuing to build a team with significant drug development and commercialization expertise in our areas of focus and creating a culture of success that allows our people to thrive.

We have built the foundation of a team with significant experience in oncology and urology drug development. We endeavor to leverage the talents of our team and add people who have relevant experience. Our team members have, in the past, been responsible for the development of drugs such as adriamycin, cisplatin, carboplatin, paclitaxel, Etoposide, Buspar, Cialis, Nefazodone and Stadol, among others. We also have, and will continue to bring, commercialization experience to the Company as we build our commercial infrastructure.


	•	Leveraging the expertise of partners around the world in areas of manufacturing, development and commercialization to assist us in the execution of our strategy.

Overview

On March 7, 2008, we received approval from the
U.S. Food and Drug Administration, or FDA, of our new drug
application, or NDA, for our drug product, LEVOleucovorin
(formerly,
ISO-Vorin^tm).
We anticipate launching LEVOleucovorin in the U.S. market in
mid-2008. Also, during the fourth quarter of 2008, we will
launch sumatriptan injection, the generic form of
GlaxoSmithKline’s
Imitrex^®
injection, through our commercialization partner,
Par Pharmaceutical Companies, Inc. We are a
biopharmaceutical company that acquires, develops and
commercializes a diversified portfolio of drug products, with a
focus on oncology, urology and other critical health challenges.
We are focused on executing our business strategy, which is
comprised of the following four parts:


	•	Acquiring and developing a broad and diverse pipeline of late-stage clinical and commercial products with a focus on oncology and urology.

We acquire and develop multiple novel, late-stage oncology drug
products that address niche markets. A
late-stage
focus helps us effectively manage the high cost of drug
development by focusing on compounds that have already passed
the many costly hurdles in the pre-clinical and early clinical
process. Our strategy allows us to leverage organizational,
collaborative, commercial and scientific efficiencies from a
therapeutic focus on oncology and urology.


	•	Establishing a commercial organization for LEVOleucovorin that will be available if and when each of the other drug products in our pipeline are approved. As we transform from a development to a commercial organization, we are building a foundation for successful product launches.

	•	Continuing to build a team with significant drug development and commercialization expertise in our areas of focus and creating a culture of success that allows our people to thrive.

We have built the foundation of a team with significant
experience in oncology and urology drug development. We endeavor
to leverage the talents of our team and add people who have
relevant experience. Our team members have, in the past, been
responsible for the development of drugs such as adriamycin,
cisplatin, carboplatin, paclitaxel, Etoposide, Buspar, Cialis,
Nefazodone and Stadol, among others. We also have, and will
continue to bring, commercialization experience to the Company
as we build our commercial infrastructure.


	•	Leveraging the expertise of partners around the world in areas of manufacturing, development and commercialization to assist us in the execution of our strategy.

This excerpt taken from the SPPI 10-K filed Mar 14, 2007.

Overview

Spectrum Pharmaceuticals, Inc. (the “Company”) is a biopharmaceutical company engaged in the business of acquiring and advancing a diversified portfolio of drug candidates, with a focus on oncology, urology and other critical health challenges for which there are few other treatment options. Our expertise lies in identifying undervalued drugs with demonstrated safety and efficacy, and adding value through further clinical development and selection of the most viable and low-risk methods of commercialization. We currently have ten drugs in development, including five in late stage clinical development. We expect to have two drugs approved by the FDA, and begin two registrational Phase 3 clinical trials in 2007. Additionally, we expect to launch another drug in 2008.

2.	Summary of Significant Accounting Policies and Estimates

This excerpt taken from the SPPI 10-Q filed Nov 3, 2006.

Overview

Spectrum Pharmaceuticals, Inc. is a pharmaceutical company engaged in the business of acquiring, developing and commercializing prescription drugs for various indications. While we directly own certain patent rights, the drugs we are currently developing, which are focused on the treatment of cancer and other unmet medical needs, are in-licensed from third parties whereby we acquired rights to develop and commercialize those compounds in territories specified in the agreements. We are also actively seeking FDA approval for marketing generic versions of branded drugs whose patent protection has either already expired, or is scheduled to expire in the foreseeable future. We currently have a few generic products approved by the FDA for marketing in the United States. In addition, we have a few neurology compounds that we may out-license to third parties for further development.

New drug development is an inherently uncertain, lengthy and expensive process. We focus our research and development efforts principally on clinical stage drug candidates, for which the primary expenses relate to the conduct of clinical trials necessary to demonstrate to the satisfaction of the FDA, and other regulatory authorities in the United States and other countries, that the products are both safe and effective in their respective indications and that they can be produced by a validated consistent manufacturing process. The number, size, scope and timing of the clinical trials necessary to bring a product candidate to development, completion and commercialization cannot readily be determined at an early stage nor, given the timelines of the trials extending over periods of years, can future costs be estimated with precision. While generic drug development is also subject to approval by regulatory authorities, the costs and timelines of development, completion and commercialization can be significantly shorter, and compared to new drug development, relatively less uncertain and less expensive.

This excerpt taken from the SPPI 10-Q filed Aug 8, 2006.

Overview

Spectrum Pharmaceuticals, Inc. is a specialty pharmaceutical company engaged in the business of acquiring, developing and commercializing prescription drugs for various indications. While we directly own certain patent rights, the drugs we are currently developing, which are focused on the treatment of cancer and other unmet medical needs, are in-licensed from third parties whereby we acquired rights to develop and commercialize those compounds in territories specified in the agreements. We are also actively seeking FDA approval for marketing generic versions of branded drugs whose patent protection has either already expired, or is scheduled to expire in the foreseeable future. We currently have three generic products approved by the FDA for marketing in the United States, ciprofloxacin tablets, fluconazole tablets, and carboplatin injection. In addition, we have a few neurology compounds that we may out-license to third parties for further development.

New drug development is an inherently uncertain, lengthy and expensive process. We focus our research and development efforts principally on clinical stage drug candidates, for which the primary expenses relate to the conduct of clinical trials necessary to demonstrate to the satisfaction of the FDA, and other regulatory authorities in the United States and other countries, that the products are both safe and effective in their respective indications and that they can be produced by a validated consistent manufacturing process. The number, size, scope and timing of the clinical trials necessary to bring a product candidate to development completion and commercialization cannot readily be determined at an early stage, nor, given the timelines of the trials extending over periods of years, can future costs be estimated with precision. While generic drug development is also subject to approval by regulatory authorities, the costs and timelines of development completion and commercialization can be significantly shorter, and compared to new drug development, relatively less uncertain and less expensive.

EXCERPTS ON THIS PAGE:

10-K (4 sections)	Mar 31, 2009

10-K (2 sections)	Mar 14, 2008

10-K	Mar 14, 2007

10-Q	Nov 3, 2006

10-Q	Aug 8, 2006

Spectrum Pharmaceuticals (SPPI)

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