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Expert Financial Analysis and Reporting

Antares; Are Mylan’s Woes A Potential Positive for AB Rated Generic to EpiPen (ATRS, $1.37, Buy)

You cannot turn on the business news channels without hearing extensive comments and condemnation by pundits and politicians about Mylan's aggressive price hikes on EpiPen. Investors are asking if this could somehow expedite approval of Antares/Teva's AB rated generic to EpiPen.

As far as I know, Teva has not yet submitted a response to the Complete Response Letter that was received earlier this year and this is an obvious gating factor. However, it seems quite possible that the FDA will assign high priority once the submission is made and this could expedite approval. I think there is a reasonable chance for approval of the AB rated generic in 2017, but this is not based on any hard evidence.

The recent  strength in the stock price is probably in large part due to this. However, if momentum investors are attracted to the stock for this reason and do their homework, they may discover that this is only a small part of the story.

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  1. Direct from Teva IR, they will be providing an update on Gx Epi this coming Friday as part of their global generic strategy webinar. Teva IR confirmed this directly with me last week.

  2. ATRS could be quite lively the balance of this year. QST safety trial news is expected any day. The QST user trial may be completed as well. Then, if all is well (and it’s expected to be), the NDA will get filed this year (November time frame is the speculation). Gx Epi update will come from Teva this Friday. Other new drug partnership news could also come at any time as new partnerships opportunities have been alluded to in past presentations. Antares shows two new injectors on their website, a large volume auto-injector and an adjustable dose auto injector. The large volume AI delivers a dosage up to 2.25ML (called Bigshot) and looks like the Quickshot AI. Testosterone is usually not injected at levels above .5 ML so I doubt it’s T related. It’s also not the AMAG injector. Both of the newly pictured injectors look clinic-ready. Time will tell what specific purpose(s) drove the development of those injectors and the time could be soon. I highly doubt they were random developments. I also wonder what’s next for the pen injector. The description states that they are multi-dose and variable dose in application. That aligns with Exenatide obviously but also other diabetic drugs, as well as additional possibilities.

  3. ATRS continues its relentless uptrend and it’s quite easy to understand why. Unknowns that should be known, and soon, include the results of the QST supplemental safety trial. News will hit on that front before the end of this month. Once that piece is confirmed to be positive, nothing else stands in the way of the NDA being completed and submitted before year end, which should also act as a positive catalyst. News of a QST marketing partner could come at any time once the safety trial proves to be positive. Another alliance partnership announcement could come soon (TBD). The variable dose auto-injector, I’m believing that’s going to be another Teva deal, perhaps we’ll learn sooner than later on that one as well. Bigshot might be for QSM (I’m guessing yes) and because that injector has recently appeared on the products page, I’m guessing the formality of knowing that drug/device combo will be sooner than later.

    Regardless, Gx epipen is front row center in the minds of many and it’s easy to understand why. Mylan is on the hot seat. They become the new poster child for all the things wrong with big pharma when they hold a monopoly position with a drug. The FDA is also on the hot seat. It’s the generic drug offices job to guide for generic approvals, especially large first to market generics, then get those new generics approved, quickly. Since that is their stated goal, how was it possible that Teva was led to believe they were buttoned up with their Gx epi ANDA submission in December of 2014 with everything the FDA required, led to believe as of July 2015 that approval would occur before year end 2015, then suddenly blindsided by the FDA when they slowed their review process and ultimately issued a CRL. Think about that for a moment. Teva has submitted hundreds of successful generic and/or ANDA filings. They know the process. The FDA is supposed to guide generic filings for approval, especially priority review filings for large first to market generics like Gx Epipen. No patents were in the way of approval as the key device patent expired June 2015, and the settlement with Mylan in April 2012 allowed entry of a competitive product that was a copy of their device (per the wording in the settlement). How was it possible that the FDA incorrectly guided Teva on this filing? Siggi Olafsson has repeatedly said the issue is clinical. This defies all logic and FDA stated goals and protocol. Our lawmakers need to uncover answers from the FDA regarding Teva’s Gx epipen filing.

  4. Congress continues with their ruthless grilling of Mylan’s CEO. Her answers regarding epipen did not go over well with our lawmakers. What role did Mylan’s lobbyists play in delaying generic AB competition? I’m speculating a very big role, and it’s gotten Mylan in hot, boiling hot water. There is no place to hide and our law makers won’t stop digging until they’ve gotten the answers they’re looking for. The FDA will be equally grilled as to why the issued the Gx epipen CRL. I predict a good outcome for Teva and Antares, time will tell.

    Good news on the QST trial conclusion front for Antares. The NDA will get filed in Q4. So who will the marketing partner be? Maybe we’ll learn something along those lines next week when Bob Apple speaks at the investor conference. Stay tuned….

  5. QST has the potential to be best in class in testosterone replacement market taking share from both orals and injectables. It has huge potential and is barely of at all facored into the stock price.


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