Sloan-Kettering and SoloPak sign agreement; marks first entry into proprietary pharmaceuticals for SoloPak.CHICAGO--(BUSINESS WIRE)--Nov. 1, 1994--SoloPak Pharmaceuticals Inc., a pharmaceutical and medical device company, has signed an agreement with Sloan-Kettering Institute for Cancer Research, N.Y., acquiring the exclusive worldwide rights to Gallium Nitrate gallium nitrate Metabolism A hypocalcemia-inducer used to manage calcium levels in malignant hypercalcemia due to bone metastases. See Hypercalcemia. , Otto T. Nonnenmann, SoloPak president and chief executive officer, announced Tuesday. This marks SoloPak's first entry into proprietary pharmaceuticals. The agreement involves a grant of SoloPak equity to the Sloan-Kettering Institute and a commitment of funds to complete clinical trials in exchange for exclusive worldwide rights to the product. Gallium Nitrate is currently in clinical development for the treatment of certain cancer-related diseases and metabolic bone disease metabolic bone disease Any defect in bone absorption or deposition that alters the PTH/calcium-phosphate/vitamin D axis, often with ↑ bone fragility Etiology Fibrous dysplasia, Langerhans' cell histiocytosis/histiocytosis X, acromegaly, corticosteroid therapy, . Approved by the 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. in 1991 for the treatment of acute hypercalcemia Hypercalcemia Definition Hypercalcemia is an abnormally high level of calcium in the blood, usually more than 10.5 milligrams per deciliter of blood. in cancer patients, Gallium Nitrate is currently manufactured and marketed under the trade name ``Ganite(r)'' by Fujisawa USA, Deerfield, Ill. Under the agreement, SoloPak will be the exclusive marketer of Ganite as of December 1994, and will commence manufacturing Ganite upon FDA approval to produce the product in its Elk Grove facility. SoloPak has begun a major clinical program to gain approval of Gallium Nitrate for the treatment of chronic hypercalcemia and bone metastases bone metastases Oncology Cancer that has spread from a primary tumor to the bone in cancer patients. A New Drug Application (NDA (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any ) filing for chronic hypercalcemia is planned for late 1995, and for bone metastases in early 1997. In the therapeutic area of metabolic bone diseases, SoloPak will shortly launch clinical studies for use of Gallium Nitrate in treating Paget's disease Paget's disease n. 1. A disease, occurring chiefly in old age, in which the bones become enlarged and weakened, often resulting in fracture or deformation. Also called osteitis deformans. 2. , and a clinical study in women with osteoporosis. The NDA filing for Paget's disease is planned for 1998. According to Nonnenmann: ``The Gallium Nitrate program fits very well with SoloPak's business and corporate development plan, as we continue to create a vertically integrated company. Gallium Nitrate will complement and extend SoloPak's range of products, and marks the first entry into proprietary pharmaceuticals for under-served patient populations.'' To manage the global development program, SoloPak has recruited Brian Tambi as a consultant to head the project team. He has been closely associated with the development of Gallium Nitrate since 1987. Tambi was president of Fujisawa Pharmaceutical Co. U.S.A. from 1990 to 1992, and chairman of their global immunosuppressant immunosuppressant /im·mu·no·sup·pres·sant/ (-sah-pres´ant) an agent capable of suppressing immune responses. im·mu·no·sup·pres·sant n. An agent that suppresses the body's immune response. project team. Also recruited as a consultant to manage the clinical program was Dr. Raymond P. Warrell Jr., MD, a senior faculty member of the Memorial Sloan-Kettering Cancer Center The Memorial Sloan-Kettering Cancer Center (MSKCC) in New York City is a cancer treatment and research institution founded in 1884 as the New York Cancer Hospital. The main campus is located at 1275 York Avenue, between 67th and 68th Streets, with other locations in New and a Professor of Medicine at Cornell University Medical College in New York New York, state, United States New York, Middle Atlantic state of the United States. It is bordered by Vermont, Massachusetts, Connecticut, and the Atlantic Ocean (E), New Jersey and Pennsylvania (S), Lakes Erie and Ontario and the Canadian province of . Dr. Warrell originally discovered the activity of gallium compounds in bone diseases and has been associated with this program since its inception. He has extensive experience in the clinical development of drugs used in cancer and metabolic diseases. Sloan-Kettering Institute for Cancer Research is an affiliate of Memorial Sloan-Kettering Cancer Center, which is the world's largest private institution devoted to advancing the prevention, diagnosis, and treatment of cancer. Throughout its distinguished history, Memorial Sloan-Kettering has defined the state of the art in its field through innovations in patient care and breakthroughs in cutting-edge research. While SoloPak has traditionally specialized in the manufacture of injectable multi-source pharmaceutical products, as well as pre-filled syringes for the institutional and home health care markets, recent acquisitions have broadened its product line to include medical devices such as peripherally inserted catheters, dental needles and syringes, IV infusion sets, and in-line filters. Many of these products facilitate drug delivery in a variety of patient settings, ranging from acute care to alternate care sites, as well as the patient's home. SoloPak, with expected annual revenues of approximately $60 million, is privately held. Its manufacturing facilities are located in Elk Grove Village Elk Grove Village, village (1990 pop. 33,429), Cook and Du Page counties, NE Ill., a suburb of Chicago; inc. 1956. With a population of c.100 at the time of its establishment on open farmland, the village has grown dramatically and steadily, largely because of its and Franklin Park, Ill., and its administrative offices are in Boca Raton, Fla. CONTACT: Thorp & Co., Coral Gables, Fla. Patricia Thorp, 305/446-2700 |
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