Athena Neurosciences Inc. said Tuesday that it had gained FDAmarketing approval for Zanaflex, a drug to treat muscle spasticity,nine months after receiving an approvable letter,
The approval marks the first new oral treatment for muscle stiffnessand rigidity in more than 20 years and represents the first successfulU.S. clinical development effort for the South San Franciscosubsidiary of Elan Corp. plc, of Althone, Ireland.
Zanaflex, or tizanidine hydrochloride, is designed to alleviate theincreased muscle tone associated with spasticity, a disorder of thecentral nervous system which causes muscles to become inflexible.Patients with multiple sclerosis and spinal cord injuries can be leftbedridden by spasticity.
"This drug is very important to this market and patient population,"said Jan Wallace, Athena's vice president of clinical and regulatoryaffairs.
"The Zanaflex approval represents everything for the company," saidEric Liebler, director of external relations for Athena. "It also marksan entirely new mechanism for combating spasticity."
Zanaflex works by stimulating the alpha2 adrenergic receptors toreduce muscle spasms. Wallace also noted that, compared to othercurrent remedies for spasticity, Zanaflex provides relief fromsymptoms without exacerbating weakness or creating withdrawaleffects.
Kenneth Kulju, of UBS Securities in New York, noted that Elancurrently survives on a revenue base of $325 million and that thisapproval represents "a very important incremental addition to Elan'searnings. It doesn't have to be an enormous product to be significantto Elan."
Kulju estimated that Zanaflex will provide the company roughly $40million to $45 million in yearly revenues. He also noted that Athenahas several epilepsy and multiple sclerosis drugs coming down thepipeline over the next year. "We are enthusiastic about Elan'sprospects," Kulju said.
Athena licensed tizanidine hydrochloride from Sandoz Pharma Ltd.in 1991 which currently markets the drug in more than 45 countries.Athena initially submitted Zanaflex for approval in December 1993and the FDA rejected the application in March 1995. In March 1996,the agency informed the company that the drug was approvable.Shortly thereafter, Elan purchased Athena for more than $600million.
The company expects to launch Zanaflex in February 1997. The drugcarries orphan drug status which grants Elan exclusive marketingrights in the U.S. for seven years. The company also is seekingapproval in Canada and the U.K. n
-- Lisa Seachrist Washington Editor
(c) 1997 American Health Consultants. All rights reserved.