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| |  Zanaflex Approved For Marketing by FDA DUBLIN, IRELAND - December 3, 1996 - Elan Corporation, plc ("Elan") (NYSE: ELN) announced today that its wholly-owned subsidiary, Athena Neurosciences, Inc. ("Athena"), received approval from the U.S. Food and Drug Administration ("FDA") to market Zanaflex (tizanidine hydrochloride), the first new oral treatment for muscle spasticity in the U.S. in more than 20 years. Zanaflex is a treatment indicated for the management of increased muscle tone associated with spasticity, a condition affecting the central nervous system ("CNS") causing muscle stiffness and rigidity. Spasticity can occur as a result of many CNS disorders, particularly multiple sclerosis and spinal cord injury. "Upon review of the pivotal clinical studies, the FDA recognizes that Zanaflex is safe and effective for the treatment of a variety of patients who suffer from the debilitating symptoms of spasticity," said Jan Wallace, M.D., Athena's vice president of clinical and regulatory affairs. "This is welcome news for the many patients whose spasticity could not be effectively treated with existing options." Spasticity is an abnormal increase in involuntary muscle tone caused by damage to the CNS and is characterized by painful muscle spasms as well as muscle stiffness and rigidity. Advanced spasticity, in the worst cases, can leave patients bed-ridden and unable to move without assistance. In double-blind, placebo-controlled clinical studies, Zanaflex was shown to provide significant relief of spasticity symptoms without causing muscle weakness, which can leave patients unable to perform normal daily activities. Additionally, reported side effects did not include evidence of withdrawal effects. Both weakness and potential withdrawal effects can be characteristic of certain currently approved treatment regimens. Elan's chief executive officer, Donal Geaney, noted that Zanaflex's introduction represents a major milestone in the evolution of the combined company, which now has the core competencies of a fully integrated pharmaceutical company. "Zanaflex is the first of six neurological products in Elan's R&D pipeline to reach the marketplace and will be our first new chemical entity to enter the U.S. market after Elan and Athena's merger. Our singular focus within the neurology community has enabled the company to establish a significant sales and marketing presence that we can now capitalize upon with this important new product." Zanaflex is expected to be available in U.S. pharmacies nationwide in February 1997. Tizanidine hydrochloride was licensed in 1991 from Sandoz Pharma Ltd., which first introduced this product in 1984. Currently marketed in over 45 countries, tizanidine has a well established clinical profile. Elan is also pursuing regulatory approval of Zanaflex in Canada and the United Kingdom. Elan Corporation, plc is a leading worldwide drug delivery company with innovative drug absorption technologies designed to improve patient care in a cost-effective manner. Its principal research and manufacturing facilities are in Ireland, and through its subsidiaries in the United States and Israel. Athena Neurosciences, Inc., a wholly-owned subsidiary of Elan, discovers, develops and markets products to be used primarily for the treatment and diagnosis of central nervous system diseases and disorders. Except for historical information, the statements made in this press release contain certain forward-looking statements that involve a number of risks and uncertainties, including the degree of market acceptance and pricing of Zanaflex, as well as the other risk factors detailed from time to time for the SEC reports filed by Elan, including its report on Form 20-F for the year ended March 31, 1996, as amended November 1996.
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