Amgen 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 January 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.
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.
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics.