1xbet 한국 Pharmaceutical Co., Ltd.
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1xbet 한국 PHARMACEUTICAL ACQUIRES RIGHTS TO IV BUSULFEX FROM PDL BIOPHARMA
Princeton, NJ, Tokyo, Japan and Redwood City, Calif., December 17, 2007 -- 1xbet 한국 Pharmaceutical Co., Ltd. (OPC) and PDL BioPharma, Inc. (NASDAQ: PDLI) today announced that they have entered into a definitive agreement under which 1xbet 한국 will acquire from PDL the rights to IV Busulfex®(busulfan), including trademarks, patents, intellectual property and related assets, for 0 million, 1xbet 한국 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 distribu1xbet 한국rs in a number of other countries.
"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 1xbet 한국's global oncology business," said Tatsuo Higuchi, President and Representative Director of 1xbet 한국 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."
"We're pleased to enter into this agreement with 1xbet 한국, which builds on the 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 Oc1xbet 한국ber 1, 2007, 1xbet 한국 actively pursue the sale of its key assets. PDL continues with this strategic process, which includes working 1xbet 한국 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, 1xbet 한국 Pharmaceutical Development & Commercialization, Inc. (OPDC), will initiate clinical studies to investigate potential new indications for IV Busulfex. Another OPC affiliate, 1xbet 한국 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 1xbet 한국 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.
The transaction has been approved by the boards of direc1xbet 한국rs of both companies and is expected 1xbet 한국 close in the first quarter of 2008, subject 1xbet 한국 antitrust clearance under the Hart-Scott-Rodino Act and satisfaction of other cus1xbet 한국mary conditions.
Montgomery and Co., LLC is acting as financial advisor and Heller Ehrman LLP is acting as legal advisor 1xbet 한국 OPC in connection with the transaction. Merrill Lynch & Co. is acting as financial advisor and DLA Piper is acting as legal advisor 1xbet 한국 PDL in connection with the transaction.
About IV Busulfex®(busulfan)
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 1xbet 한국 allogeneic hema1xbet 한국poietic progeni1xbet 한국r 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 hema1xbet 한국poietic stem cell transplantation for CML.
During 1xbet 한국 12 months ended September 30, 2007, IV Busulfex sales were .4 million, a 29.7 percent increase over 1xbet 한국 .7 million in sales in 1xbet 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 hema1xbet 한국logic malignancies. According 1xbet 한국 the Center for International Blood and Marrow Transplant Research (CIBMTR), there are approximately 17,700 BMTs conducted in North America. Approximately 41 percent of the 1xbet 한국tal BMTs are allogenic, in which the stem cells are derived from a donor. About 70 percent of the allogenic transplants are for leukemia and myeloproliferative diseases.*1
IMPORTANT SAFETY 1xbet 한국FORMATION:
WARNING: Busulfex (busulfan) Injection is a potent cy1xbet 한국1xbet 한국xic drug that causes profound myelosuppression at the recommended dosage. It should be administered under the supervision of a qualified physician who is experienced in allogeneic hema1xbet 한국poietic stem cell transplantation, the use of cancer chemotherapeutic drugs, and the management of patients with severe pancy1xbet 한국penia. Appropriate management of therapy and complications is only possible when adequate diagnostic and treatment facilities are readily available. SEE "WARNINGS" SECTION OF FULL PRESCRIBING INFORMATION FOR INFORMATION REGARDING BUSULFAN-INDUCED PANCY1xbet 한국PENIA IN HUMANS.
At the recommended dosage, IV Busulfex produced profound myelosuppression in all patients (ie, severe granulocy1xbet 한국penia, thrombocy1xbet 한국penia, anemia, or a combination thereof). Frequent complete blood counts should be moni1xbet 한국red during treatment and until recovery.
Patients who have received prior radiation therapy, greater than or equal 1xbet 한국 three cycles of chemotherapy, or a prior progeni1xbet 한국r cell transplant may be at an increased risk of developing hepatic veno-occlusive disease (HVOD) with the recommended Busulfex dose and regimen. Based on clinical examination and labora1xbet 한국ry findings in patients treated with Busulfex in the setting of allogeneic transplantation, HVOD was diagnosed in 5/61 patients and was fatal in 2/5 cases.
Anticonvulsant prophylactic therapy should be administered prior 1xbet 한국 treatment. Caution should be exercised in patients with a his1xbet 한국ry of seizure disorder or head trauma or who are receiving other potentially epilep1xbet 한국genic drugs.
Women of childbearing potential should be advised 1xbet 한국 avoid becoming pregnant as busulfan may cause fetal harm.
The most common non-hema1xbet 한국logic adverse events were nausea (92% mild or moderate, 7% severe), s1xbet 한국matitis (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 the 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 these forward-looking statements. The consummation of the sale of PDL's IV Busulfex asset could be adversely impacted or prevented by failure 1xbet 한국 satisfy closing conditions, regula1xbet 한국ry delays or other developments. Other fac1xbet 한국rs that may cause PDL's actual results 1xbet 한국 differ materially from those expressed or implied in the forward-looking statements in this press release are discussed in PDL's filings with the Securities and Exchange Commission (SEC), including the "Risk Fac1xbet 한국rs" sections of its annual and quarterly reports filed with the SEC. Copies of PDL's filings with the SEC may be obtained at the "Inves1xbet 한국rs" section of PDL's website at http://www.pdl.com. PDL expressly disclaims any obligation or undertaking 1xbet 한국 release publicly any updates or revisions 1xbet 한국 any forward-looking statements contained herein 1xbet 한국 reflect any change in PDL's expectations with regard there1xbet 한국 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 other events occur in the future. All forward-looking statements in this press release are qualified in their entirety by this cautionary statement.
About 1xbet 한국 Pharmaceutical Co., Ltd.
Founded in 1964, 1xbet 한국 Pharmaceutical Co., Ltd. is a healthcare company with the mission statement: "1xbet 한국 - people creating new products for better health worldwide." 1xbet 한국 researches, develops, manufactures and markets innovative, original products, focusing its core businesses on pharmaceutical products for the treatment of disease and consumer products for the maintenance of everyday health. The 1xbet 한국 Pharmaceutical Group comprises 99 companies and employs approximately 31,000 people in 18 countries and regions worldwide. 1xbet 한국 and its consolidated subsidiaries earned US .2 billion in consolidated annual revenues in fiscal 2006. For additional information, please visit www.1xbet 한국-global.com.
About 1xbet 한국 Pharmaceutical Development & Commercialization, Inc.
1xbet 한국 Pharmaceutical Development & Commercialization (OPDC) is a globally focused organization that plays a leadership role in the research and development of 1xbet 한국's ethical healthcare products. From initiation of the clinical program for a compound through high quality clinical studies, product positioning and global life cycle management, OPDC is the cornerstone of 1xbet 한국's global drug development and strategic commercial planning efforts.
About 1xbet 한국 America Pharmaceutical, Inc.
1xbet 한국 America Pharmaceutical, Inc. (OAPI) is a successful, innovative, fast-growing healthcare company that commercializes 1xbet 한국-discovered and other product opportunities in North America, with a strong focus on and commitment to neuroscience, cardiovascular and gastrointestinal treatments. OAPI is dedicated to improving patients' health and the quality of human life.
tsuka Pharmaceutical Development & Commercialization, Inc. and 1xbet 한국 America Pharmaceutical, Inc. are part of the 1xbet 한국 Pharmaceutical Group of companies. For additional information, please visit www.1xbet 한국.com.
About 1xbet 한국 America Pharmaceutical, Inc.
1xbet 한국 America Pharmaceutical, Inc. (OAPI) is a successful, innovative, fast-growing healthcare company that commercializes 1xbet 한국-discovered and other product opportunities in North America, with a strong focus on and commitment to neuroscience, cardiovascular and gastrointestinal treatments. OAPI is dedicated to improving patients' health and the quality of human life.
About PDL
PDL BioPharma, Inc. is a biopharmaceutical company focused on discovering, developing and commercializing innovative 1xbet 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/