Recent IMS data is flat, just as it has been all year. No gain, no loss. I guess the formulary ideas didn't amount to squat.
Here's some of the CS notes from Mylans IPR challenge:
IPR Hearing Generally In-Line With Expectations
¦ Bottom Line: Today's hearing of Inter Partes Review (IPR) petitions on Teva's 40 mg/ml formulation played out close to what we (and we believe Consensus) was expecting. As we mentioned in our initiation note (link), we believe it will be difficult for Teva to be successful in protecting these three patents and we model generic entry in late 2018, once appeal processes are done, but we also note that this is just one step in a three-step process that competitors would need to win in order to safely launch generic versions of the 40 mg/ml formulation.
¦ IPR hearing fair and respectful, but outcome likely in petitioners' favor. • Our expert commented the three judges who listened to both parties appearedengaged and did not express any apparent conviction either way. The petitioners argued that a 40mg/ml three times weekly was obvious based on data for once daily and once every other day administration, suggesting the new dosing regimen was obvious based on prior experience. TEVA, on the other hand, argued prior experience with 40mg/ml every other day does not suggest that lowering that dosage to three times weekly would lead to equal efficacy. We note a fourth patent that TEVA has on the formulation based on improved tolerability with three times weekly dosing was not part of the IPR hearing and provides another layer of protection for the product.
¦ PTAB decision expected in August. The decision on the IPR hearing is expected in August, and if Teva loses it has a right to appeal, extending out the process an additional 12-15 months. Petitioner has also filed a Post GrantReview (PGR) on the 4th patent and we are expecting Teva to submit their response to the PGR by May 24th. The decision on instituting the PGR is also expected by the end of August. In addition, Teva is involved in a District Court case for which it has filed patent infringement lawsuits against multiple parties including petitioner, Dr. Reddy's and Sandoz/Momenta. Given the length of time it will take all processes (including any appeals) we model entry of generic versions of Copaxone 40mg/ml in late 2018
