Copaxone Reaches MS Market Share High Following Tysabri Withdrawal
This article was originally published in The Pink Sheet Daily
Executive Summary
Teva’s multiple sclerosis therapy glatiramer gained the leading market position in both total and new prescriptions in March, the company says. Copaxone’s gains followed Biogen Idec/Elan’s marketing suspension of the competing MS therapy Tysabri and the addition of a liver damage warning to Biogen’s Avonex.
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Teva's multiple sclerosis therapy Copaxone became the U.S. market leader in March following Biogen Idec/Elan's Feb. 28 withdrawal of Tysabri , Teva said. "In March 2005, for the first time, Copaxone gained the leading market position in terms of both total and new prescriptions in the U.S. according to monthly IMS data," the company said in a May 3 first quarter earnings release. "In the U.S., we achieved in Q1 our highest quarterly market share of 32.3%," CFO Dan Suesskind said during a same-day conference call. U.S. sales of Copaxone (glatiramer) rose 18% to $163 mil. during the first quarter. Ex-U.S. sales climbed at a greater rate - up 34% to $93 mil. Overall, worldwide sales of the MS therapy rose 23% for the quarter to $256 mil. The global increase for Copaxone "represents the highest rate of growth in the global MS market," CEO Israel Makov said during the call. Makov also noted that "Copaxone continues to lead the other MS therapies in opportunity share, defined as new-to-therapy patients and net switch patients." "Quarter-over-quarter, Copaxone opportunity share increased from 31% to 37%," Makov said. Copaxone's gains came at the expense of Tysabri (natalizumab). Biogen Idec and Elan voluntarily suspended marketing the MS therapy on Feb. 28 following reports of two cases of progressive multifocal leukoencephalopathy in clinical trials (1 (Also see "Tysabri Study Participants To Undergo MRI, Physical In Search For Cause Of Adverse Events" - Pink Sheet, 28 Feb, 2005.)). A third case of PML was subsequently identified (2 (Also see "Tysabri Withdrawal Prompts Biogen Idec To Suspend Financial Guidance" - Pink Sheet, 1 Apr, 2005.)). A further boon for Copaxone came when Biogen Idec added a hepatic injury warning to Avonex (interferon beta-1a) labeling during the first quarter (3 (Also see "Biogen Idec Adds Liver Warning To Multiple Sclerosis Therapy Avonex" - Pink Sheet, 16 Mar, 2005.)). Teva has been highlighting Copaxone's safety profile in the wake of the Tysabri withdrawal and the Avonex labeling change, "We have always emphasized the...long-term efficacy and the importance of long-term safety data which Copaxone alone...offers to chronic MS patients," Makov told analysts. "The seriousness of the events surrounding the withdrawal of Tysabri from the market clearly brought the issue of safety to the foreground," he said. "We have been carefully monitoring Copaxone since well before its launch and have compiled over 340,000 patient years of safety data," the exec said. Serono also has reported strong market share gains for its MS therapy Rebif (interferon beta-1A) following the Tysabri withdrawal. U.S. share for Rebif, which is co-marketed by Pfizer, reached an all-time high at the end of March, Serono said (4 (Also see "Rebif Gains New Multiple Sclerosis Rx Share Following Tysabri Withdrawal" - Pink Sheet, 22 Apr, 2005.)). - Sue Sutter |