Antares: Responding to Two Questions on Teva’s AB Rated Competitor to EpiPen (ATRS, Buy, $2.44)
Purpose of the Blog
I very much appreciate questions and feedback from subscribers to my website. I have had two recent questions that I have responded to that may be of interest to other investors interested in the Teva collaboration with Antares to develop an AB rated generic equivalent to Mylan’s EpiPen. For more details on this situation, refer to my recent report.
Question 1:
Barclays has a note out this morning (12/17) adjusting Mylan numbers up slightly reflecting “lower probability that TEVA will enter the market in 2H 15 with an AB rated EpiPen. MYL’s spring loaded delivery vs Teva’s operator force could make approval difficult”. Not sure why they would have arrived at that conclusion….MYL’s opinion? The fact that Otrexup is approved would seemingly make the device issue moot, unless there is something different about the active ingredients. Have you heard anyone else raise this issue?
Response: My assessment of the situation stems from information coming from Antares. The FDA has issued no information on whether it will grant an AB rating for Teva’s injector device. Earlier in 2014, Antares was silent on the potential for an AB rating and they were actually downplaying the possibility. Then about two months ago, they became more positive and said that they were optimistic that they would get an AB rating. At the Oppenheimer conference on December 10th, they said that they were going to be shipping large quantities of injectors to Teva in early 2015 anticipation of the launch of an AB rated generic to EpiPen.
Could something have happened in the interim? Antares has said that Teva was waiting on one final feedback from the FDA in December in regard to the AB rating but did not specify what this involved. I called the Company to see if there is any change in their positive posture on the AB rating. They remain very confident.
Question 2: I’m hoping you can add some insight regarding AB rated generics. We’re hoping (and believing) that Teva will receive an AB rating on their generic Epi. If another AB Epi were to come along and be approved, how would the pharmacy determine which product to substitute for the branded drug?
It’s my understanding that Sandoz Is trying to get a generic AB rated Epi approved and marketed. They, like Teva, where sued by the branded inventor company, but unlike Teva they have not settled out of court (where their case still resides). Are you familiar with the Sandoz threat and how likely they may be in achieving their goal?
Response: Sanofi received approval of Alivi-Q, which is an epinephrine auto-injector, on August 13, 2012. This was approved under the 505 (b) 2 pathway as a new product and was not AB rated. This means that it has to be sold as a new drug. It has had no discernible impact on Epi-Pen sales. Antares is not aware nor am I of any other company trying to develop an AB rated product.
Tagged as Antares Pharma Inc., ATRS, EpiPen + Categorized as Smith On Stocks Blog