Teva Pharmaceuticals Ltd., whose new drug application(NDA) for Copaxone was rejected for review by the FDAin August, re-filed for approval of the multiple sclerosistreatment Wednesday, predicting that this time the agencywould accept the submission.
The FDA sent Jerusalem-based Teva a "refuse-to-file"letter Aug. 22, 1995, based on concerns about qualitycontrol in making and evaluating the drug. The agencyhad requested "information regarding reference standardsand markers in the chemistry section of the NDA."
Teva officials said the data were supplied and subsequentdiscussions with the FDA indicated the agency wassatisfied.
In a prepared statement, Teva Pharmaceutical USA'spresident and CEO, William Fletcher, said, "Weanticipate that the registration application will beaccepted and reviewed by the FDA in the near future."
Wall Street analysts have said the FDA's concerns didnot involve the drug's safety, efficacy or clinical trialsand that the setback was temporary.
Teva filed the Copaxone NDA in June. The drug isexpected to compete with two other multiple sclerosistreatments, both of which are versions of beta interferon.Emeryville, Calif.-based Chiron Corp.'s Betaseron is onthe U.S. market and Biogen Inc., of Cambridge, Mass.,filed its NDA for Avonex in May.
Multiple sclerosis, a neurological disease, is caused bydamage to the myelin sheath, which insulates nerve fibersthat transmit electrical impulses.
Copaxone, a copolymer 1, is a four-amino acid peptidefragment derived from myelin basic protein, which is theantigen thought to trigger the autoimmune responseresponsible for the disease. Although Copaxone'smechanism of action is not known, researchers believe itmay help prevent destruction of the myelin sheath.
Teva's stock (NASDAQ:TEVIY) ended Wednesday up$1.50 to $36.375. On Thursday, the stock closed at$38.50, up $2.125. n
-- Charles Craig
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