- Spectrum’s Commercial Footprint Expands Beyond the U.S.;
- Irrevocable License From Bayer Healthcare Leverages Spectrum’s Existing Clinical, Regulatory and Marketing Investments;
- Spectrum Will Continue To Advance ZEVALIN’s Clinical Development Program And Will Now Be Better Positioned To Grow ZEVALIN Sales Globally In The Long-Term
HENDERSON, NV, USA I January 25, 2012 I Spectrum Pharmaceuticals (NasdaqGS:SPPI) announced that it has entered into an agreement to acquire licensing rights to market ZEVALIN (ibritumomab tiuxetan) injection for intravenous use outside of the United States of America from Bayer Healthcare. ZEVALIN is currently approved in more than 40 countries outside the U.S. for the treatment of follicular B-cell non-Hodgkin’s lymphoma, including countries in Europe, Latin America and Asia. Under the agreement, Spectrum will have all rights related to marketing, sales, and patents, and access to existing inventory of ZEVALIN from Bayer. Spectrum will utilize a combination of company resources and partnerships to support the product outside the U.S.
"We are excited to expand our commercial footprint globally with an approved, state-of-the-art drug that we know very well," said Rajesh C. Shrotriya, MD, Chairman, Chief Executive Officer, and President of Spectrum Pharmaceuticals. "Our experience in the U.S. marketplace and the impressive and broadening clinical outcome data from ZEVALIN, as presented at major international scientific conferences over the past two years, has increased our confidence in the long-term potential of ZEVALIN. With the licensing of ex-U.S., worldwide rights to ZEVALIN, we will be able to further leverage our existing clinical, regulatory and marketing investments. Working closely with European investigators who have spearheaded exciting new data with ZEVALIN in recent years, Spectrum will continue to advance its clinical development program and will now be better positioned to grow ZEVALIN sales globally in the long-term. Our access to the worldwide market will help patients with follicular lymphoma who can benefit from ZEVALIN."
"The global market for ZEVALIN is several times larger than the US, with more than 350,000 cases of non-Hodgkin’s lymphoma diagnosed every year. Since acquiring the U.S. rights to ZEVALIN in 2008, we have successfully reversed the declining sales trajectory and nearly tripled 2008 sales. We hope to achieve similar milestones outside the U.S. with our focused sales and marketing efforts. This licensing transaction demonstrates our commitment to being focused on our strategy of bringing novel cancer treatments to patients while at the same time delivering value to our shareholders," concluded Dr. Shrotriya.
The closing of the agreement is subject to customary closing conditions. The Merchant Banking Group of Burrill & Company acted as advisor to Spectrum Pharmaceuticals in this transaction.
About Spectrum Pharmaceuticals, Inc.
Spectrum Pharmaceuticals, a biotechnology company with a primary focus in oncology and hematology, currently markets two oncology drugs, FUSILEV® and ZEVALIN®. In addition, Spectrum has two drugs, apaziquone and belinostat, in late stage development with a goal of filing New Drug Applications (NDAs) with the U.S. Food & Drug Administration in 2012. The Company also has a diversified pipeline of novel drug candidates. The Company’s strategy is comprised of acquiring, developing and commercializing a broad and diverse pipeline of late-stage clinical and commercial drug products. The Company has aggressive business development and commercial operation teams that support a robust drug development program encompassing clinical development, medical research, regulatory affairs, biostatistics and data management. The Company also leverages the expertise of its worldwide partners to assist in the execution of its strategy. For more information, please visit the Company’s website at www.sppirx.com.
Important ZEVALIN® Safety Information
Deaths have occurred within 24 hours of rituximab infusion, an essential component of the ZEVALIN therapeutic regimen. These fatalities were associated with hypoxia, pulmonary infiltrates, acute respiratory distress syndrome, myocardial infarction, ventricular fibrillation, or cardiogenic shock. Most (80%) fatalities occurred with the first rituximab infusion. ZEVALIN administration can result in severe and prolonged cytopenias in most patients. Severe cutaneous and mucocutaneous reactions, some fatal, can occur with the ZEVALIN therapeutic regimen.
Please see full Prescribing Information, including Boxed WARNINGS, for ZEVALIN and rituximab. Full prescribing information can be found at www.ZEVALIN.com.
About Non-Hodgkin’s Lymphoma
Non-Hodgkin’s lymphoma is defined as any of a large group of cancers of lymphocytes (a type of white blood cell). Non-Hodgkin’s lymphoma can occur at any age and are often marked by lymph nodes that are larger than normal, fever, and weight loss. There are many different categories of non-Hodgkin’s lymphoma. These categories can be divided into aggressive (fast-growing) and indolent or low grade (slow-growing), and they can be formed from either B-cells or T-cells. Prognosis and treatment depend on the stage and type of disease.
According to GLOBOCON 2008 estimates, there were approximately 355,900 new cases of non-Hodgkin’s lymphoma diagnosed and approximately 191,400 deaths globally in 2008. Over 3.5 million people worldwide are alive with a diagnosis of NHL, at various stages of disease progression and remission.
SOURCE: Spectrum Pharmaceuticals
Post Views: 57
- Spectrum’s Commercial Footprint Expands Beyond the U.S.;
- Irrevocable License From Bayer Healthcare Leverages Spectrum’s Existing Clinical, Regulatory and Marketing Investments;
- Spectrum Will Continue To Advance ZEVALIN’s Clinical Development Program And Will Now Be Better Positioned To Grow ZEVALIN Sales Globally In The Long-Term
HENDERSON, NV, USA I January 25, 2012 I Spectrum Pharmaceuticals (NasdaqGS:SPPI) announced that it has entered into an agreement to acquire licensing rights to market ZEVALIN (ibritumomab tiuxetan) injection for intravenous use outside of the United States of America from Bayer Healthcare. ZEVALIN is currently approved in more than 40 countries outside the U.S. for the treatment of follicular B-cell non-Hodgkin’s lymphoma, including countries in Europe, Latin America and Asia. Under the agreement, Spectrum will have all rights related to marketing, sales, and patents, and access to existing inventory of ZEVALIN from Bayer. Spectrum will utilize a combination of company resources and partnerships to support the product outside the U.S.
"We are excited to expand our commercial footprint globally with an approved, state-of-the-art drug that we know very well," said Rajesh C. Shrotriya, MD, Chairman, Chief Executive Officer, and President of Spectrum Pharmaceuticals. "Our experience in the U.S. marketplace and the impressive and broadening clinical outcome data from ZEVALIN, as presented at major international scientific conferences over the past two years, has increased our confidence in the long-term potential of ZEVALIN. With the licensing of ex-U.S., worldwide rights to ZEVALIN, we will be able to further leverage our existing clinical, regulatory and marketing investments. Working closely with European investigators who have spearheaded exciting new data with ZEVALIN in recent years, Spectrum will continue to advance its clinical development program and will now be better positioned to grow ZEVALIN sales globally in the long-term. Our access to the worldwide market will help patients with follicular lymphoma who can benefit from ZEVALIN."
"The global market for ZEVALIN is several times larger than the US, with more than 350,000 cases of non-Hodgkin’s lymphoma diagnosed every year. Since acquiring the U.S. rights to ZEVALIN in 2008, we have successfully reversed the declining sales trajectory and nearly tripled 2008 sales. We hope to achieve similar milestones outside the U.S. with our focused sales and marketing efforts. This licensing transaction demonstrates our commitment to being focused on our strategy of bringing novel cancer treatments to patients while at the same time delivering value to our shareholders," concluded Dr. Shrotriya.
The closing of the agreement is subject to customary closing conditions. The Merchant Banking Group of Burrill & Company acted as advisor to Spectrum Pharmaceuticals in this transaction.
About Spectrum Pharmaceuticals, Inc.
Spectrum Pharmaceuticals, a biotechnology company with a primary focus in oncology and hematology, currently markets two oncology drugs, FUSILEV® and ZEVALIN®. In addition, Spectrum has two drugs, apaziquone and belinostat, in late stage development with a goal of filing New Drug Applications (NDAs) with the U.S. Food & Drug Administration in 2012. The Company also has a diversified pipeline of novel drug candidates. The Company’s strategy is comprised of acquiring, developing and commercializing a broad and diverse pipeline of late-stage clinical and commercial drug products. The Company has aggressive business development and commercial operation teams that support a robust drug development program encompassing clinical development, medical research, regulatory affairs, biostatistics and data management. The Company also leverages the expertise of its worldwide partners to assist in the execution of its strategy. For more information, please visit the Company’s website at www.sppirx.com.
Important ZEVALIN® Safety Information
Deaths have occurred within 24 hours of rituximab infusion, an essential component of the ZEVALIN therapeutic regimen. These fatalities were associated with hypoxia, pulmonary infiltrates, acute respiratory distress syndrome, myocardial infarction, ventricular fibrillation, or cardiogenic shock. Most (80%) fatalities occurred with the first rituximab infusion. ZEVALIN administration can result in severe and prolonged cytopenias in most patients. Severe cutaneous and mucocutaneous reactions, some fatal, can occur with the ZEVALIN therapeutic regimen.
Please see full Prescribing Information, including Boxed WARNINGS, for ZEVALIN and rituximab. Full prescribing information can be found at www.ZEVALIN.com.
About Non-Hodgkin’s Lymphoma
Non-Hodgkin’s lymphoma is defined as any of a large group of cancers of lymphocytes (a type of white blood cell). Non-Hodgkin’s lymphoma can occur at any age and are often marked by lymph nodes that are larger than normal, fever, and weight loss. There are many different categories of non-Hodgkin’s lymphoma. These categories can be divided into aggressive (fast-growing) and indolent or low grade (slow-growing), and they can be formed from either B-cells or T-cells. Prognosis and treatment depend on the stage and type of disease.
According to GLOBOCON 2008 estimates, there were approximately 355,900 new cases of non-Hodgkin’s lymphoma diagnosed and approximately 191,400 deaths globally in 2008. Over 3.5 million people worldwide are alive with a diagnosis of NHL, at various stages of disease progression and remission.
SOURCE: Spectrum Pharmaceuticals
Post Views: 57
