zipjet,
Teva is working on two alternatives to extend the commercial life of Copaxone as of now.
(Credit Suisse) A patent trial is not likely to occur before 2012. Teva is internally debating its options for proceeding with various new forms of Copaxone that could add extended commercial life via exclusivity and IP. CS has recently stated that the clarity of the success of these alternatives is not likely to come in 2011. The two possible alternatives include:
¦ Low volume: 20 mg/0.5 ml form (as compared to the 20 mg/1.0 ml marketed form), which per the FDA’s recent complete response letter, would require Teva to undertake a clinical trial of undetermined design and duration. If for example, Teva decides to
start a clinical trial by mid 2011, and the design is for one year of treatment, then a filing is not likely before 2013 after accounting for enrollment and data analysis.
¦ 3 doses per week: 40 mg dosed thrice-weekly (as compared to 20 mg daily, currently marketed); this version is progressing in a Phase 3 trial with an estimated primary completion date of November 2012 (study NCT01067521 on www.clinicaltrials.gov).
So in the end the real answer is if Teva can tie Sandoz up in the courts until next year they have a real chance of holding onto a large portion of their population. Keep in mind that Teva has increased the Copaxone pricing considerably over the last couple of years so they are in a position to price their protected dosing schemes attractively.
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