Princeton, NJ, Tokyo, Japan and Redwood City, Calif., December 17, 2007 -- Otsuka Pharmaceutical Co., Ltd. (OPC) and PDL BioPharma, Inc. (NASDAQ: PDLI) today announced that they have entered into a definitive agreement under which Otsuka will acquire from PDL the rights to IV Busulfex® (busulfan), including trademarks, patents, intellectual property and related assets, for $200 million, to be paid in cash at closing. IV Busulfex is an oncologic product marketed and sold by PDL in the United States (U.S.) and Canada, and through distributors in a number of other countries.
IV Busulfex was approved by the U.S. Food and Drug Administration (FDA) in 1999 for use in combination with cyclophosphamide as a conditioning regimen prior to allogeneic hematopoietic progenitor cell transplantation (also referred as blood or bone marrow transplantation or BMT) for chronic myelogenous leukemia (CML). IV Busulfex is the only drug that is FDA-approved for use in combination with cyclosphosphamide as a conditioning agent in allogeneic hematopoietic stem cell transplantation for CML.
During the 12 months ended September 30, 2007, IV Busulfex sales were $29.4 million, a 29.7 percent increase over the $22.7 million in sales in the prior 12-month period. IV Busulfex is marketed in more than 40 countries worldwide.
"The acquisition of IV Busulfex, a first-in-class drug therapy for conditioning prior to allogeneic hematopoietic progenitor cell transplantation, and the oncology expertise of PDL accelerates Otsuka's global oncology business," said Tatsuo Higuchi, President and Representative Director of Otsuka Pharmaceutical Co., Ltd. "We are currently developing first-in-class oncology drugs in the United States, including drugs to treat severe cancer pain (currently in phase II), along with oral mucositis and leukemia (currently in phase I). Our focus is on global opportunities to contribute to the health of patients who are suffering from severe illness."
During the 12 months ended September 30, 2007, IV Busulfex sales were $29.4 million, a 29.7 percent increase over the $22.7 million in sales in the prior 12-month period. IV Busulfex is marketed in more than 40 countries worldwide.
"The acquisition of IV Busulfex, a first-in-class drug therapy for conditioning prior to allogeneic hematopoietic progenitor cell transplantation, and the oncology expertise of PDL accelerates Otsuka's global oncology business," said Tatsuo Higuchi, President and Representative Director of Otsuka Pharmaceutical Co., Ltd. "We are currently developing first-in-class oncology drugs in the United States, including drugs to treat severe cancer pain (currently in phase II), along with oral mucositis and leukemia (currently in phase I). Our focus is on global opportunities to contribute to the health of patients who are suffering from severe illness."
This transaction follows PDL's decision, announced on October 1, 2007, to actively pursue the sale of its key assets. PDL continues with this strategic process, which includes working to maximize the value of its royalty stream, commercial products and antibody discovery, development and manufacturing assets.
Following the close of the transaction, OPC will oversee the outsourced manufacturing of the product, while its U.S. affiliate, Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC), will initiate clinical studies to investigate potential new indications for IV Busulfex. Another OPC affiliate, Otsuka America Pharmaceutical, Inc. (OAPI), will market the product for its current indication in the United States. OPDC was established in 2007 and OAPI was established in 1989 by Otsuka America, Inc. (OAI). Both OPDC and OAPI are wholly owned by OAI, which is the holding company for OPC’s interests in the U.S. OAI is wholly owned by OPC.
Following the close of the transaction, OPC will oversee the outsourced manufacturing of the product, while its U.S. affiliate, Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC), will initiate clinical studies to investigate potential new indications for IV Busulfex. Another OPC affiliate, Otsuka America Pharmaceutical, Inc. (OAPI), will market the product for its current indication in the United States. OPDC was established in 2007 and OAPI was established in 1989 by Otsuka America, Inc. (OAI). Both OPDC and OAPI are wholly owned by OAI, which is the holding company for OPC’s interests in the U.S. OAI is wholly owned by OPC.
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