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H2R

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Alias Born 07/17/2014

H2R

Re: H2R post# 4200

Tuesday, 05/09/2017 2:33:30 PM

Tuesday, May 09, 2017 2:33:30 PM

Post# of 4817
Epi: Continued guidance for launch dates

The next project we are working on for Teva has a high public profile. As many of you know, Mylan's EpiPen product has been the subject of considerable public discussion over the past year and we will continue to work closely with Teva helping their generic version to the market.

Teva has submitted all the answers to all the questions in the complete response letter and is engaged in an ongoing dialogue with the FDA. They continue to believe that there is a potential for a late 2017 or early 2018 launch of an AV rated generic and have indicated that a successful conclusion of this project remains a high priority for them. We continue to build and ship pre-launch quantities of Epi devices to Teva and are nearing the completion of the pre-launch quantity purchase order.



from the Q&A:

We've always maintained and continue to maintain that we have a product that we believe is fully of sub suitable to the EpiPen and although the market has been changing with an Ag or the EpiPen for Mylan and some other products gaining some market share because of pricing and so forth it's still a material market. Mylan has indicated that they believe they're going to sell over $600 this year in the EpiPen sales and we'll see where that comes out. It could be higher, it could be a little bit lower. But generally, I think what's important about the EpiPen not only from an economic standpoint is really being able to provide patients the first generic EpiPen in an obviously first time ever.