Antares: AMAG Issues Guidance on Timing of Subcutaneous Makena (ATRS, Buy, $1/05)
I recently wrote a report on Antares entitled Makena has the Potential to Make a Very Significant Contribution to EPS that highlighted the potentially significant impact on Antares' earnings of the subcutaneous formulation of Makena being developed jointly by Antares and AMAG Pharmaceuticals.
In a press release summarizing 1Q, 2016 results, AMAG issued some very positive guidance on the timing of approval for the subcutaneous formulation as quoted below:
“Continued development of the next-generation program to deliver Makena subcutaneously via an auto-injector, with a range of activities underway, such as CMC work and pilot pharmacokinetic studies. The company currently anticipates filing the supplemental New Drug Application (sNDA) in the second quarter of 2017 and recently received confirmation from the FDA that the review time will be six months from submission.”
If this guidance is correct, we could see the launch of subcutaneous Makena in early 2018. In the aforementioned report, I estimated that this product would have a much more positive impact on Antares’s bottom line than would the (now uncertain) launch of an AB rated version of EpiPen. Subcutaneous Makena is the most important product in the Antares pipeline with the possible exception of QST. I don’t think this is fully recognized and reflected in the stock.
Tagged as Antares Pharma Inc., ATRS, subcutaneous formulation of Makena + Categorized as Company Reports, LinkedIn
Thanks Larry. Priority review was expected, but getting confirmation brings a big smile to my face. AMAG also expects another 7 years of orphan drug status due to the benefits of the sub-Q injector, which would take drug exclusivity thru 2025. The timing of their filing should mean approval in 2017. Prior to then, how much additional share can they snag from compounding pharmacies once their single dose, preservative free vial replaces their multi-use vial? The benefit of a convenient, painless self administration device should also take share from competing alternatives. AMAG will be highly motivated to transition all prescribing docs to the sub-Q device as soon as launched. The patient benefit will be wonderful compared to large needle, deep muscle injections. This launch will be similar to an AB drug, only better as the drug will be exclusive and AMAG, for competitive reasons, will be highly motivated to move all of the drugs business to the sub-Q injector.
Another Antares drug, QS-T, if all goes according to plan, will also be approved in 2017. I agree 100% that none of these events are reflected in the stocks price. Ditto for all other known pipeline potential. There will also be more alliance deals announced.