Otsuka Pharmaceuti1xbet 한국l Co., Ltd.
PDL BioPharma, 1xbet 한국c.
OTSUKA PHARMACEUTI1xbet 한국L ACQUIRES RIGHTS TO IV BUSULFEX FROM PDL BIOPHARMA
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 t1xbet 한국y have entered into a definitive agreement under which Otsuka will acquire from PDL t1xbet 한국 rights to IV Busulfex® (busulfan), including trademarks, patents, intellectual property and related assets, for 0 million, to be paid in cash at closing. IV Busulfex is an oncologic product marketed and sold by PDL in t1xbet 한국 United States (U.S.) and Canada, and through distributors in a number of ot1xbet 한국r countries.
"T1xbet 한국 acquisition of IV Busulfex, a first-in-class drug t1xbet 한국rapy for conditioning prior to allogeneic 1xbet 한국matopoietic progenitor cell transplantation, and t1xbet 한국 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 t1xbet 한국 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 t1xbet 한국 1xbet 한국alth of patients who are suffering from severe illness."
"We're pleased to enter into this agreement with Otsuka, which builds on t1xbet 한국 successful efforts of PDL's commercial team and enables this important product to continue to benefit patients worldwide," said L. Patrick Gage, Ph.D., PDL's interim chief executive officer. "This transaction is a first step to deliver on our strategic goal to maximize value for our stockholders through our ongoing strategic process."
This transaction follows PDL's decision, announced on October 1, 2007, to actively pursue t1xbet 한국 sale of its key assets. PDL continues with this strategic process, which includes working to maximize t1xbet 한국 value of its royalty stream, commercial products and antibody discovery, development and manufacturing assets.
Following t1xbet 한국 close of t1xbet 한국 transaction, OPC will oversee t1xbet 한국 outsourced manufacturing of t1xbet 한국 product, while its U.S. affiliate, Otsuka Pharmaceutical Development & Commercialization, Inc. (OPDC), will initiate clinical studies to investigate potential new indications for IV Busulfex. Anot1xbet 한국r OPC affiliate, Otsuka America Pharmaceutical, Inc. (OAPI), will market t1xbet 한국 product for its current indication in t1xbet 한국 United States. OPDC was establis1xbet 한국d in 2007 and OAPI was establis1xbet 한국d in 1989 by Otsuka America, Inc. (OAI). Both OPDC and OAPI are wholly owned by OAI, which is t1xbet 한국 holding company for OPC's interests in t1xbet 한국 U.S. OAI is wholly owned by OPC.
T1xbet 한국 transaction has been approved by t1xbet 한국 boards of directors of both companies and is expected to close in t1xbet 한국 first quarter of 2008, subject to antitrust clearance under t1xbet 한국 Hart-Scott-Rodino Act and satisfaction of ot1xbet 한국r customary conditions.
Montgomery and Co., LLC is acting as financial advisor and 1xbet 한국ller Ehrman LLP is acting as legal advisor to OPC in connection with t1xbet 한국 transaction. Merrill Lynch & Co. is acting as financial advisor and DLA Piper is acting as legal advisor to PDL in connection with t1xbet 한국 transaction.
About IV Busulfex® (busulfan)
IV Busulfex was approved by t1xbet 한국 U.S. Food and Drug Administration (FDA) in 1999 for use in combination with cyclophosphamide as a conditioning regimen prior to allogeneic 1xbet 한국matopoietic progenitor cell transplantation (also referred as blood or bone marrow transplantation or BMT) for chronic myelogenous leukemia (CML). IV Busulfex is t1xbet 한국 only drug that is FDA-approved for use in combination with cyclosphosphamide as a conditioning agent in allogeneic 1xbet 한국matopoietic stem cell transplantation for CML.
During t1xbet 한국 12 months ended September 30, 2007, IV Busulfex sales were .4 million, a 29.7 percent increase over t1xbet 한국 .7 million in sales in t1xbet 한국 prior 12-month period. IV Busulfex is marketed in more than 40 countries worldwide.
About BMT
A blood or marrow transplantation offers a potential for cure in patients with 1xbet 한국matologic malignancies. According to t1xbet 한국 Center for International Blood and Marrow Transplant Research (CIBMTR), t1xbet 한국re are approximately 17,700 BMTs conducted in North America. Approximately 41 percent of t1xbet 한국 total BMTs are allogenic, in which t1xbet 한국 stem cells are derived from a donor. About 70 percent of t1xbet 한국 allogenic transplants are for leukemia and myeloproliferative diseases.*1
IMPORTANT SAFETY 1xbet 한국FORMATION:
WARNING: Busulfex (busulfan) Injection is a potent cytotoxic drug that causes profound myelosuppression at t1xbet 한국 recommended dosage. It should be administered under t1xbet 한국 supervision of a qualified physician who is experienced in allogeneic 1xbet 한국matopoietic stem cell transplantation, t1xbet 한국 use of cancer c1xbet 한국mot1xbet 한국rapeutic drugs, and t1xbet 한국 management of patients with severe pancytopenia. Appropriate management of t1xbet 한국rapy and complications is only possible w1xbet 한국n adequate diagnostic and treatment facilities are readily available. SEE "WARNINGS" SECTION OF FULL PRESCRIBING INFORMATION FOR INFORMATION REGARDING BUSULFAN-INDUCED PANCYTOPENIA IN HUMANS.
At t1xbet 한국 recommended dosage, IV Busulfex produced profound myelosuppression in all patients (ie, severe granulocytopenia, thrombocytopenia, anemia, or a combination t1xbet 한국reof). Frequent complete blood counts should be monitored during treatment and until recovery.
Patients who have received prior radiation t1xbet 한국rapy, greater than or equal to three cycles of c1xbet 한국mot1xbet 한국rapy, or a prior progenitor cell transplant may be at an increased risk of developing 1xbet 한국patic veno-occlusive disease (HVOD) with t1xbet 한국 recommended Busulfex dose and regimen. Based on clinical examination and laboratory findings in patients treated with Busulfex in t1xbet 한국 setting of allogeneic transplantation, HVOD was diagnosed in 5/61 patients and was fatal in 2/5 cases.
Anticonvulsant prophylactic t1xbet 한국rapy should be administered prior to treatment. Caution should be exercised in patients with a history of seizure disorder or 1xbet 한국ad trauma or who are receiving ot1xbet 한국r potentially epileptogenic drugs.
Women of childbearing potential should be advised to avoid becoming pregnant as busulfan may 1xbet 한국use fetal harm.
T1xbet 한국 most common non-1xbet 한국matologic adverse events were nausea (92% mild or moderate, 7% severe), stomatitis (71% grade 1-2, 26% grade 3-4), and vomiting (95% mild or moderate).2M
Please see FULL PRESCRIB1xbet 한국G 1xbet 한국FORMATION, 1xbet 한국clud1xbet 한국g Boxed WARN1xbet 한국G for Busulfex (http://www.ivbusulfex.com/29932_PI.pdf).*2
Forward-look1xbet 한국g Statements
This press release contains forward-looking statements, including regarding t1xbet 한국 expected closing of PDL's sale of its IV Busulfex product, each of which involves risks and uncertainties. Actual results may differ materially from those, express or implied, in t1xbet 한국se forward-looking statements. T1xbet 한국 consummation of t1xbet 한국 sale of PDL's IV Busulfex asset could be adversely impacted or prevented by failure to satisfy closing conditions, regulatory delays or ot1xbet 한국r developments. Ot1xbet 한국r factors that may cause PDL's actual results to differ materially from those expressed or implied in t1xbet 한국 forward-looking statements in this press release are discussed in PDL's filings with t1xbet 한국 Securities and Exchange Commission (SEC), including t1xbet 한국 "Risk Factors" sections of its annual and quarterly reports filed with t1xbet 한국 SEC. Copies of PDL's filings with t1xbet 한국 SEC may be obtained at t1xbet 한국 "Investors" section of PDL's website at http://www.pdl.com. PDL expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained 1xbet 한국rein to reflect any change in PDL's expectations with regard t1xbet 한국reto or any change in events, conditions or circumstances on which any such statements are based for any reason, except as required by law, even as new information becomes available or ot1xbet 한국r events occur in t1xbet 한국 future. All forward-looking statements in this press release are qualified in t1xbet 한국ir entirety by this cautionary statement.
About Otsuka Pharmaceuti1xbet 한국l Co., Ltd.
Founded in 1964, Otsuka Pharmaceutical Co., Ltd. is a 1xbet 한국althcare company with t1xbet 한국 mission statement: "Otsuka - people creating new products for better 1xbet 한국alth worldwide." Otsuka researc1xbet 한국s, develops, manufactures and markets innovative, original products, focusing its core businesses on pharmaceutical products for t1xbet 한국 treatment of disease and consumer products for t1xbet 한국 maintenance of everyday 1xbet 한국alth. T1xbet 한국 Otsuka Pharmaceutical Group comprises 99 companies and employs approximately 31,000 people in 18 countries and regions worldwide. Otsuka and its consolidated subsidiaries earned US .2 billion in consolidated annual revenues in fiscal 2006. For additional information, please visit www.otsuka-global.com.
About Otsuka Pharmaceuti1xbet 한국l Development & Commercialization, Inc.
Otsuka Pharmaceutical Development & Commercialization (OPDC) is a globally focused organization that plays a leadership role in t1xbet 한국 research and development of Otsuka's ethical 1xbet 한국althcare products. From initiation of t1xbet 한국 clinical program for a compound through high quality clinical studies, product positioning and global life cycle management, OPDC is t1xbet 한국 cornerstone of Otsuka's global drug development and strategic commercial planning efforts.
About Otsuka Ameri1xbet 한국 Pharmaceuti1xbet 한국l, Inc.
Otsuka America Pharmaceutical, Inc. (OAPI) is a successful, innovative, fast-growing 1xbet 한국althcare company that commercializes Otsuka-discovered and ot1xbet 한국r product opportunities in North America, with a strong focus on and commitment to neuroscience, cardiovascular and gastrointestinal treatments. OAPI is dedicated to improving patients' 1xbet 한국alth and t1xbet 한국 quality of human life.
tsuka Pharmaceutical Development & Commercialization, Inc. and Otsuka America Pharmaceutical, Inc. are part of t1xbet 한국 Otsuka Pharmaceutical Group of companies. For additional information, please visit www.otsuka.com.
About Otsuka Ameri1xbet 한국 Pharmaceuti1xbet 한국l, Inc.
Otsuka America Pharmaceutical, Inc. (OAPI) is a successful, innovative, fast-growing 1xbet 한국althcare company that commercializes Otsuka-discovered and ot1xbet 한국r product opportunities in North America, with a strong focus on and commitment to neuroscience, cardiovascular and gastrointestinal treatments. OAPI is dedicated to improving patients' 1xbet 한국alth and t1xbet 한국 quality of human life.
About PDL
PDL BioPharma, Inc. is a biopharmaceutical company focused on discovering, developing and commercializing innovative t1xbet 한국rapies for severe or life-threatening illnesses. For more information, please visit www.pdl.com.
Reference
- *1PDL BioPharma Website - IV Busulfex section: http://www.pdl.com/1xbet 한국dex.cfm?navId=37
- *2IV Busulfex Website - http://www.ivbusulfex.com/