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Expert Financial Analysis and Reporting

Antares: Teva Projects Launch of AB Rated Generic to EpiPen in Early 2018 (ATRS, Buy, $1.87)

Eyal Desheh is the Chief Financial Officer of Teva. During the recent third quarter conference call, he answered a question from an analyst about the development status of the AB rated generic to EpiPen. He said: “In terms of EpiPen, we are working very closely with the FDA. I haven’t changed my view. My expectation for EpiPen is still early 2018. There is nothing to change my view on that. We are still moving forward in good collaboration with the FDA. We have the meeting with the FDA. We understand the way forward, what needs to be done. We think pretty well. But it hasn’t changed my best estimate on the EpiPen launch.”

My sales and earnings model assumes that the launch comes in early 2018. It is encouraging that Teva seems to have a high degree of confidence that it can successfully address the issues of the CRL and gain approval.

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  1. Both Antares and Teva have recently expressed a very high degree of confidence and optimism when discussing future approval of Teva’s Gx Epipen. Antares has been working directly with Teva, and Teva directly with the FDA. Both are dialed in, as relevant to each organization, to the FDA’s requirements for resolving the CRL. Teva did meet with the FDA after they said they would do so in the September timeframe and clear pathway for approval has been solidified. Siggi Olafsson has consistently stated the following when answering questions about he CRL: They have now met multiple times with the FDA since the CRL and an agreed upon pathway has been determined for Gx AB approval. And, the issues related to the CRL are clinical and not device related. Eyal Desheh in the Q3 earnings call reiterated this confidence with his comments regarding a Q1 launch 2018 for Teva’s Gx Epipen. Be mindful that an approval for this drug will likely occur in advance of, and possibly well in advance of the stated launch timeframe. Epinephrine has a shelf life, so production of the drug along with the packaging of millions of devices can’t happen to far in advance of distribution and launch. By comparison, it took six months from Antares Sumatriptan approval until that drug was launched. I would expect a similar timeframe from approval until launch for Teva’s Gx Epipen. Thus, approval could occur sometime during the summer of 2017.

  2. Correction to the comment I wrote about – even though Seeking Alpha transcript said Eyal Desheh (I ref’d his name from the transcript), the person speaking the entire time in reference to the Epipen question was Siggo Olafsson. All else stated was correct.

  3. AMAG announcement this morning (1/9/17) ahead of their presentation at JPM included this:
    Makena Subcutaneous Auto-Injector Development Program Update: AMAG’s successful Makena intramuscular (IM) injection product has orphan drug exclusivity through February 2018. Data collection and analysis are still underway, with final results expected by the end of the first quarter of 2017. Assuming the PK data, once fully collected and analyzed, shows comparable bioavailability between the SC and IM injections, the co intends to file a supplemental new drug application (sNDA) for the SC auto-injector in the second quarter of 2017.
    There are multiple device and drug-device combination patents and patent applications in-licensed from Antares (ATRS) which relate to the subcutaneous auto-injector. The company intends to request Orange Book listing of eligible Antares drug-device patents.

    What exactly does the last sentence mean? Is that pos or neg?


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