THOUSAND OAKS, CA, USA I October 22, 2013 I Amgen (NASDAQ: AMGN) today announced that it has entered into a definitive agreement with F. Hoffmann-La Roche (“Roche”) to acquire Roche’s rights to filgrastim and pegfilgrastim in approximately 100 markets, effective Jan. 1, 2014.
Roche has held the rights to filgrastim and pegfilgrastim under license from Kirin-Amgen, Inc. (a joint venture between Amgen and Kirin Holdings Co. Limited, of Japan) in Eastern Europe, Latin America, Asia, the Middle East and Africa since 1989. The franchise generated approximately $200 million in sales in these territories in 2012.
Filgrastim and pegfilgrastim are white blood cell boosting therapeutics used to reduce the risk of infection in patients receiving chemotherapy. They are marketed by Amgen in the United States and Europe under the trade names NEUPOGEN® and Neulasta®, respectively.
“This agreement will enable Amgen to reach more patients around the world with two of our innovative medicines,” said Robert A. Bradway, chairman and chief executive officer of Amgen. “The transaction will also allow us to build experience and capacity in countries that will be important in accelerating future growth of Amgen’s pipeline products.”
Amgen anticipates this deal will be accretive starting in 2014.
Amgen will begin distributing and selling product as soon as practical in countries where the Company has an existing commercial presence. In countries where Amgen does not have a presence, Roche or its distributors will continue to sell and distribute the products for an interim transition period.
“Amgen and Roche will work closely to ensure a seamless transition of the business, marketing authorizations, and most importantly, product supply to the physicians and patients that rely on these important medicines,” said Anthony C. Hooper, executive vice president, Global Commercial Operations of Amgen. “Amgen is pleased to have the opportunity to prevent patients receiving myelosuppressive chemotherapy from developing febrile neutropenia in additional markets around the world.”
Amgen has grown to be the world’s largest independent biotechnology company reaching millions of patients around the world. A worldwide leader in biologics manufacturing, Amgen has an outstanding track record of reliably delivering high-quality medicines to patients who need them.
Kyowa Hakko Kirin Co., Ltd. of Japan will continue to retain product rights and market filgrastim and pegfilgrastim in some selected Asian territories, including China and Japan.
About Neulasta and NEUPOGEN
Neulasta (pegfilgrastim) is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia. Neulasta is not indicated for the mobilization of peripheralblood progenitor cells for hematopoietic stem cell transplantation.
NEUPOGEN (filgrastim) is indicated to decrease the incidence of infection‚ as manifested by febrile neutropenia‚ in patients with nonmyeloid malignancies receiving myelosuppressive anticancer drugs associated with a significant incidence of severe neutropenia with fever. A complete blood count and platelet count should be obtained prior to chemotherapy, and twice per week during NEUPOGEN therapy to avoid leukocytosis and to monitor the neutrophil count.
Important Safety Information
Do not administer Neulasta to patients with a history of serious allergic reactions to pegfilgrastim or filgrastim. NEUPOGEN is contraindicated in patients with known hypersensitivity to E coli-derived proteins, filgrastim‚ or any component of the product.
Serious allergic reactions, including anaphylaxis, can occur in patients receiving Neulasta or NEUPOGEN. Reported events have occurred with initial and/or subsequent treatment. Allergic reactions can recur within days after the discontinuation of initial anti-allergic treatment. Permanently discontinue Neulasta or NEUPOGEN in patients with serious allergic reactions.
Splenic rupture, including fatal cases, can occur following the administration of Neulasta and NEUPOGEN. Evaluate for an enlarged spleen or splenic rupture in patients who report left upper abdominal or shoulder pain after receiving Neulasta or NEUPOGEN.
Acute respiratory distress syndrome (ARDS) can occur in patients receiving Neulasta or NEUPOGEN. Evaluate patients who develop fever and lung infiltrates or respiratory distress after receiving Neulasta or NEUPOGEN for ARDS. Discontinue Neulasta or NEUPOGEN in patients with ARDS.
Alveolar hemorrhage, manifesting as pulmonary infiltrates and hemoptysis requiring hospitalization, has been reported in healthy donors undergoing peripheral blood progenitor cell mobilization, an unapproved use of NEUPOGEN. Hemoptysis resolved with discontinuation of NEUPOGEN.
Severe sickle cell crises can occur in patients with sickle cell disorders receiving Neulasta. Severe and sometimes fatal sickle cell crises can occur in patients with sickle cell disorders receiving filgrastim, the parent compound of pegfilgrastim.
Thrombocytopenia has been reported commonly in patients receiving NEUPOGEN. Platelet counts should be monitored closely.
The granulocyte colony-stimulating factor (G-CSF) receptor, through which pegfilgrastim and filgrastim act, has been found on tumor cell lines. The possibility that pegfilgrastim and filgrastim act as growth factors for any tumor type, including myeloid malignancies and myelodysplasia, diseases for which they are not approved, cannot be excluded.
Bone pain and pain in extremity occurred at a higher incidence in Neulasta-treated patients as compared with placebo-treated patients. In clinical trials involving NEUPOGEN, bone pain was the most frequently reported adverse event.
About Amgen
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people’s lives. A biotechnology pioneer since 1980, Amgen has grown to be the world’s largest independent biotechnology company, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
SOURCE: Amgen
Post Views: 168
THOUSAND OAKS, CA, USA I October 22, 2013 I Amgen (NASDAQ: AMGN) today announced that it has entered into a definitive agreement with F. Hoffmann-La Roche (“Roche”) to acquire Roche’s rights to filgrastim and pegfilgrastim in approximately 100 markets, effective Jan. 1, 2014.
Roche has held the rights to filgrastim and pegfilgrastim under license from Kirin-Amgen, Inc. (a joint venture between Amgen and Kirin Holdings Co. Limited, of Japan) in Eastern Europe, Latin America, Asia, the Middle East and Africa since 1989. The franchise generated approximately $200 million in sales in these territories in 2012.
Filgrastim and pegfilgrastim are white blood cell boosting therapeutics used to reduce the risk of infection in patients receiving chemotherapy. They are marketed by Amgen in the United States and Europe under the trade names NEUPOGEN® and Neulasta®, respectively.
“This agreement will enable Amgen to reach more patients around the world with two of our innovative medicines,” said Robert A. Bradway, chairman and chief executive officer of Amgen. “The transaction will also allow us to build experience and capacity in countries that will be important in accelerating future growth of Amgen’s pipeline products.”
Amgen anticipates this deal will be accretive starting in 2014.
Amgen will begin distributing and selling product as soon as practical in countries where the Company has an existing commercial presence. In countries where Amgen does not have a presence, Roche or its distributors will continue to sell and distribute the products for an interim transition period.
“Amgen and Roche will work closely to ensure a seamless transition of the business, marketing authorizations, and most importantly, product supply to the physicians and patients that rely on these important medicines,” said Anthony C. Hooper, executive vice president, Global Commercial Operations of Amgen. “Amgen is pleased to have the opportunity to prevent patients receiving myelosuppressive chemotherapy from developing febrile neutropenia in additional markets around the world.”
Amgen has grown to be the world’s largest independent biotechnology company reaching millions of patients around the world. A worldwide leader in biologics manufacturing, Amgen has an outstanding track record of reliably delivering high-quality medicines to patients who need them.
Kyowa Hakko Kirin Co., Ltd. of Japan will continue to retain product rights and market filgrastim and pegfilgrastim in some selected Asian territories, including China and Japan.
About Neulasta and NEUPOGEN
Neulasta (pegfilgrastim) is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia. Neulasta is not indicated for the mobilization of peripheralblood progenitor cells for hematopoietic stem cell transplantation.
NEUPOGEN (filgrastim) is indicated to decrease the incidence of infection‚ as manifested by febrile neutropenia‚ in patients with nonmyeloid malignancies receiving myelosuppressive anticancer drugs associated with a significant incidence of severe neutropenia with fever. A complete blood count and platelet count should be obtained prior to chemotherapy, and twice per week during NEUPOGEN therapy to avoid leukocytosis and to monitor the neutrophil count.
Important Safety Information
Do not administer Neulasta to patients with a history of serious allergic reactions to pegfilgrastim or filgrastim. NEUPOGEN is contraindicated in patients with known hypersensitivity to E coli-derived proteins, filgrastim‚ or any component of the product.
Serious allergic reactions, including anaphylaxis, can occur in patients receiving Neulasta or NEUPOGEN. Reported events have occurred with initial and/or subsequent treatment. Allergic reactions can recur within days after the discontinuation of initial anti-allergic treatment. Permanently discontinue Neulasta or NEUPOGEN in patients with serious allergic reactions.
Splenic rupture, including fatal cases, can occur following the administration of Neulasta and NEUPOGEN. Evaluate for an enlarged spleen or splenic rupture in patients who report left upper abdominal or shoulder pain after receiving Neulasta or NEUPOGEN.
Acute respiratory distress syndrome (ARDS) can occur in patients receiving Neulasta or NEUPOGEN. Evaluate patients who develop fever and lung infiltrates or respiratory distress after receiving Neulasta or NEUPOGEN for ARDS. Discontinue Neulasta or NEUPOGEN in patients with ARDS.
Alveolar hemorrhage, manifesting as pulmonary infiltrates and hemoptysis requiring hospitalization, has been reported in healthy donors undergoing peripheral blood progenitor cell mobilization, an unapproved use of NEUPOGEN. Hemoptysis resolved with discontinuation of NEUPOGEN.
Severe sickle cell crises can occur in patients with sickle cell disorders receiving Neulasta. Severe and sometimes fatal sickle cell crises can occur in patients with sickle cell disorders receiving filgrastim, the parent compound of pegfilgrastim.
Thrombocytopenia has been reported commonly in patients receiving NEUPOGEN. Platelet counts should be monitored closely.
The granulocyte colony-stimulating factor (G-CSF) receptor, through which pegfilgrastim and filgrastim act, has been found on tumor cell lines. The possibility that pegfilgrastim and filgrastim act as growth factors for any tumor type, including myeloid malignancies and myelodysplasia, diseases for which they are not approved, cannot be excluded.
Bone pain and pain in extremity occurred at a higher incidence in Neulasta-treated patients as compared with placebo-treated patients. In clinical trials involving NEUPOGEN, bone pain was the most frequently reported adverse event.
About Amgen
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people’s lives. A biotechnology pioneer since 1980, Amgen has grown to be the world’s largest independent biotechnology company, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
SOURCE: Amgen
Post Views: 168
