Antares: AMAG Submits Supplemental New Drug Application to FDA for Makena® Auto-Injector for Subcutaneous Use: (Antares (ATRS, Buy, $2.86)
AMAG announced on April17, 2017 that it had submitted a sNDA for the Makena Auto-Injector. This was in line with guidance. AMAG anticipates a six-month FDA review timeline with the potential for approval and launch in the fourth quarter of 2017. AMAG developed the Makena auto-injector using an auto-injector developed by Antares.
AMAG revealed that it will request Orange Book listing of the eligible Antares patents, the last of which expires in 2026. This could be important. Orphan Drug exclusivity for Makena administered as an intra-muscular injection expires in February 2018. Thereafter, generics to the intra-muscular injected product can come to market. However, there are reasons to believe that such generics may be delayed meaningfully beyond February 2018 as I explained in my initiation report on AMAG.
The subcutaneous dosage form has two major advantages. It causes much less pain on injection. Also, it is much easier to administer saving meaningful costs when administered in a doctor’s office. It is likely to be priced at parity with the intra-muscular dosage form. This may make managed care reimbursement relatively easier and quicker to attain.
Because of the Antares patents, any potential competitor to the sub-cutaneous injector will not be able to copy the Antares device, but must use a different device. This means that they would have to follow the 505 (b) 2 regulatory pathway and if they gained approval, the product would not be AB rated so that a pharmacist could substitute it. This rival product would have to be promoted as a branded product. I think that this could be a very big profit opportunity for Antares. See my recent report for an update on my investment thinking on Antares.
This year, particularly October, is shaping up to produce some very exciting news:
- October 15, 2017 A legal settlement allows the marketing of AB rated version of Byetta after this data if FDA grants approval.
- October 17, 2017 Makena Auto—Injector could be approved
- October 20, 2017 QST could be approved
- Sometime in late 2017 AB rated generic to EpiPen could be approved
Tagged as Antares Pharma Inc., ATRS, Makena Auto-Injector + Categorized as Company Reports, LinkedIn