Alliance Pharmaceutical Corp. and Baxter Enter Into Agreement for Oxygent.Business Editors and Health/Medical Writers BIOWIRE2K SAN DIEGO San Diego (săn dēā`gō), city (1990 pop. 1,110,549), seat of San Diego co., S Calif., on San Diego Bay; inc. 1850. San Diego includes the unincorporated communities of La Jolla and Spring Valley. Coronado is across the bay. , Calif. and DEERFIELD, Ill.--(BW HealthWire)--May 12, 2000 Alliance Pharmaceutical Corp. (Nasdaq:ALLP ALLP Aldo Leopold Leadership Program ) and Baxter Healthcare Corporation announced today that they have reached an agreement for the manufacturing, sales and distribution of Alliance's Oxygent(TM) (perflubron emulsion) in the United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area. , Canada and Europe. Oxygent(TM) is a chemical-based oxygen carrier being developed to enhance the delivery of oxygen to tissues and vital organs. Oxygent(TM) is being developed for use with a procedure called Augmented-Acute Normovolemic Hemodilution(TM) (Augmented-ANH) to eliminate or reduce the need for donor blood transfusion blood transfusion, transfer of blood from one person to another, or from one animal to another of the same species. Transfusions are performed to replace a substantial loss of blood and as supportive treatment in certain diseases and blood disorders. during surgery. Under the agreement, Baxter will purchase $20 million of convertible preferred stock Convertible Preferred Stock Preferred stock that includes an option for the holder to convert the preferred shares into a fixed number of common shares, usually anytime after a predetermined date. Also known as "convertible preferred shares". in Alliance later this month. In order for Baxter to maintain its rights to commercialize the product, Baxter is required to invest an additional $30 million of convertible redeemable preferred stock Stock shares that have preferential rights to dividends or to amounts distributable on liquidation, or to both, ahead of common shareholders. Preferred stock is given preference over common stock. Holders of preferred stock receive dividends at a fixed annual rate. over the next 18 months as clinical trials progress. Once the product is launched, Alliance will also receive royalty income and an ongoing share in the profits generated by sales of the product. The investment will help support Alliance in the completion of late-stage clinical trials and achievement of regulatory approvals. Baxter will obtain an exclusive license for the manufacture, sales and distribution of Oxygent(TM) in the United States, Canada, and Europe, and will have the rights to co-develop Oxygent(TM) for further indications. "As we considered potential partners for Oxygent(TM), we concluded that Baxter would be the best possible company due to their recognized leadership in marketing products for the surgical setting," said Duane J. Roth, Chairman and Chief Executive Officer of Alliance. "The Baxter division that will be responsible for marketing the product focuses on the anesthesiologist Anesthesiologist A medical specialist who administers an anesthetic to a patient before he is treated. Mentioned in: Anesthesia, General, Appendectomy, Parathyroidectomy anesthesiologist , the physician most responsible for transfusion decisions. This makes them an ideal marketing partner for Oxygent(TM)." "Oxygent(TM) complements our business strategy of expanding our proprietary anesthesia and critical care pharmaceutical product offerings through the addition of currently marketed products and compounds in late-stage clinical development," said Jack McGinley, group vice president of Baxter. "The addition of Oxygent(TM) to Baxter's portfolio is also complementary to our other development programs." Efforts to develop oxygen-carrying solutions have focused on two technologies, either hemoglobin, which may be derived from various biologic sources, including recombinant technology, or synthetic perfluorochemicals, such as Oxygent(TM). Perfluorochemicals (PFCs) are clear fluids that dissolve large amounts of respiratory gases such as oxygen and carbon dioxide carbon dioxide, chemical compound, CO2, a colorless, odorless, tasteless gas that is about one and one-half times as dense as air under ordinary conditions of temperature and pressure. and can be formulated into a stable emulsion for intravenous use. This emulsion is designed to increase the oxygen-carrying capacity of blood. PFCs differ from hemoglobin-based oxygen-carrying solutions in that they are most effective in the presence of higher levels of oxygen. This makes PFCs ideally suited to circumstances in which the patient is already receiving elevated oxygen, such as during surgery. Oxygent(TM) is being developed for use with the Augmented-ANH technique to reduce and/or eliminate the need for donor blood transfusion during surgeries of expected high blood loss. Augmented-ANH involves the collection of several pints of blood from the patient immediately prior to surgery. Oxygent(TM) would then be administered to the patient to replace the oxygen-carrying capacity of the collected blood. When the surgery is completed, the patient's blood that was removed and conserved during surgery would then be re-infused to achieve a safe red cell concentration for postoperative recovery. Augmented-ANH is thereby intended to minimize the need for donor blood transfusions during and after surgery. Approaches to minimize the use of blood transfusions are being pursued for a variety of reasons, including the increase in blood shortages throughout the U.S., and the reduced ability of red blood cells Red blood cells Cells that carry hemoglobin (the molecule that transports oxygen) and help remove wastes from tissues throughout the body. Mentioned in: Bone Marrow Transplantation red blood cells to transport oxygen effectively after extended storage. Oxygent(TM) has been administered to patients in clinical trials involving more than 1,000 subjects. A Phase 3 study involving patients undergoing cancer, urologic, vascular, orthopedic, and other general surgery procedures in eight European countries is expected to complete enrollment next month. An additional Phase 3 study involving cardiac surgery patients undergoing coronary artery bypass grafting coronary artery bypass graft n. Abbr. CABG A surgical procedure in which a section of vein or other conduit is grafted between the aorta and a coronary artery below the region of an obstruction in that artery. (CABG CABG coronary artery bypass graft. CABG abbr. coronary artery bypass graft CABG Coronary artery bypass graft, see there ) procedures with cardiopulmonary bypass cardiopulmonary bypass n. A procedure to circulate and oxygenate the blood during heart surgery involving the diversion of blood from the heart and lungs through a heart-lung machine and the return of oxygenated blood to the aorta. (CPB CPB see cardiopulmonary bypass. CPB Cardiopulmonary bypass. See Port-Access cardiopulmonary bypass. ) support is underway in the U.S. and Canada. Oxygent(TM) is the only oxygen-carrying therapeutic in Phase 3 whose studies were designed to support a label claim for use in patients undergoing both cardiac and non-cardiac surgical procedures. Alliance Pharmaceutical Corp. is developing therapeutic and diagnostic products based on its perfluorochemical and surfactant Surfactant Definition Surfactant is a complex naturally occurring substance made of six lipids (fats) and four proteins that is produced in the lungs. It can also be manufactured synthetically. technologies. The company's products are intended primarily for use during acute care situations, including surgical, cardiology, and respiratory applications. In addition to Oxygent(TM), Alliance is developing LiquiVent(R), an intrapulmonary "liquid ventilation" agent being evaluated in pivotal Phase 2-3 studies in North America and Europe for treatment of acute lung injury and acute respiratory distress syndrome acute respiratory distress syndrome n. See adult respiratory distress syndrome. . Alliance has filed a New Drug Application with the U.S. Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) for approval of Imagent(R), an ultrasound contrast agent being developed in partnership with Schering AG, Germany. Additional information about the company is available on Alliance's web site at www.allp.com. Baxter Healthcare Corporation is the principal U.S. operating subsidiary of Baxter International Inc. (NYSE NYSE See: New York Stock Exchange :BAX). Baxter International Inc. is a global medical products and services company that provides critical therapies for people with life-threatening conditions. Baxter's products and services in bioscience (biopharmaceuticals and blood collection, separation and storage devices), medication delivery and renal therapy are used by health-care providers and their patients in more than 100 countries. This news release contains forward-looking statements that involve risks and uncertainties, including those related to timing or results of pending or future clinical trials, actions by appropriate regulatory bodies, technological advances in the medical field, product demand and market acceptance, availability of funding for development, the effect of economic conditions and other risks detailed in the companies' filings with the Securities and Exchange Commission. These forward-looking statements are based on estimates and assumptions made by management of the companies and are believed to be reasonable, though are inherently uncertain and difficult to predict. Actual results or experience could differ materially from the forward-looking statements. |
|
||||||||||||||||

Printer friendly
Cite/link
Email
Feedback
Reader Opinion