"We continue to see no barrier to FDA approval of Mylan's generic Copaxone following patent expiry, and we look forward to being able to launch this very important first generic product for multiple sclerosis at market formation," said Mylan Inc. (Nasdaq: MYL) CEO Heather Bresch, after the US District Court for the District of Columbia ruled against Teva Pharmaceutical Industries Ltd. (NYSE: TEVA; TASE: TEVA) in its lawsuit against the US Food and Drug Administration (FDA) for lack of jurisdiction. Teva had filed a motion to block FDA from approving generic versions of Copaxone, its brand treatment for multiple sclerosis.
Bresch added, "Teva's suit against the FDA was simply a desperate, last minute tactic, among others, to delay access to more affordable generic versions of Copaxone for patients in the US."
Copaxone's US patents expire on May 24. Teva has appealed to the US Supreme Court over the expiry; the court will hear the case during its next session, which begins in October. Teva has sued the FDA for not yet deciding whether generic versions of Copaxone will require full clinical trials. It argues that there are substantive differences between brand Copaxone and generic versions of the drug, and has asked the FDA to require clinical trials, which could delay their entry to market by almost three years. The FDA has repeatedly declined to decide on the matter, although it has hinted that it will reject Teva's request.
Teva said in response, "The judge dismissed the case as premature because there has been no final action yet on the ANDAs. Without visibility to the FDA actions on the review cycle, nor any meaningful response to our Citizen Petitions, we felt this was the only option available to us. We are pleased that the judge has requested 24-hour notification of final action from FDA as to the ANDAs and continue to evaluate our options.
"Teva remains committed to advocating for the development of safe and efficacious products for the publicboth generic and branded."
Published by Globes [online], Israel business news - www.globes-online.com - on May 15, 2014
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