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Antares Pharma Inc. Message Board

  • thourough1234 thourough1234 Feb 10, 2013 9:18 AM Flag

    Otrexup Rejection By FDA Will Cost The Stock

    How Much???...In Anybodys Opinion??.....As We All Know This Can Happen First Time Around......I Just Want To See What People Think....This Could Be The Reason They Are Holding Back On Telling Pfizer Product..Although Most Of Us Think We Know What It Is....Could Announce If Otrexup Is Rejected First Time Around For Protection.....

    Sentiment: Strong Buy

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    • thourough1234:

      The FDA is certainly a wild card when it comes to approval or non-approval of new drugs, devices or the delivery methods. The issue as I see it is certainly not the drug, methotrexate, but the means of delivering the medicament. I think to talk about the rejection by the FDA at this point and what it would do to the price is premature in that I'd rather explore the why one would think the FDA would NOT approve. And I will get to that later in this post.

      The MTX (Otrexup) program and submittal to the FDA for approval, has nothing to do with Antares holding back on disclosing the partnership with Pfizer. Antares simply does not exercise or control the purse strings to do so. They are not a "Sponsor" or even a "Co-Sponsor" of these clinical trials that will ultimately cost $25 - $30million) and if they listed as either a Sponsor or Co-Sponsor, then they would also be funding (in part) the clinical trial costs for the widely reported Ibruprofen gel currently in Ph 1 by Pfizer. As such, Pfizer has the purse strings given they are funding everything (per what has been publicly disclosed):

      "Pfizer will assume full cost and responsibility for all clinical development, manufacturing, and commercialization of the product in the licensed territory, which also includes certain non-exclusive territories outside of North America."

      So, NO, Antares is not withholding a public announcement of this Pfizer drug due some back up plan if Otrexup is not approved.

      Regarding FDA approval or rejection. What can the FDA reject with this submittal? They can't reject the already approved drug, methotrexate. The only way the FDA could reject this submittal of using methotrexate would be if the agency "suddenly" found that the drug methotrexate should be pulled off the market due to newly found safety issues (ie., Vioxx). So what remains a potential issue? Answer: How the drug is getting delivered and the safety, efficacy and usability. Let's remember, this device delivering the drug is a mechanical device with operating parts. Does the device perform as intended? Has Antares somehow submitted a faulty mechanical device for the delivery of the drug?

      Just look at how many pages within the Antares "Investor Presentation" are devoted to the Otrexup program. TEN (10) out of TWENTY SIX (26) pages are devoted to the MTX in-house program.

      This is their baby and CEO Wotton and the team he has assembled are and have dotted all the " I's" and crossed all the " T's" with this program to the point where I will go as far to say, "failure is not an option".

      Below are just a few bullets points from a few of those Investor Presentation pages that might be good to read and review:

      OTREXUP™ successfully completed multiple clinical trials for Rheumatoid Arthritis patients

      MTX is widely considered the foundation of RA treatment –
      used alone or in combination with biologic agents (e.g., Humira, Enbrel)

      AHU Study design: multi-center, open label, single-dose, single-arm, in-clinic actual human use of MTX subcutaneously administered by 101 adult RA patients

      • Purpose of the study was to #$%$ the safe usability of OTREXUP, evaluate the reliability, ease of use and robustness of OTREXUP and evaluate the effectiveness of the patient education tools including written instructions for use

      • The results of the study show that self-administration of methotrexate using OTREXUP is safe and well tolerated

      • All 101 patients performed self-administration successfully thereby
      demonstrating the reliability and robustness of OTREXUP

      • 98% of patients found OTREXUP easy to use and 100% of patients found the instructions and training to be clear and easy to follow

      • Patients experienced minimal or no pain at the site of administration (mean value = 3.6mm on a 100mm VAS scale)

      • No treatment-emergent serious adverse events related to the drug

      All Clinical trials completed by 3Q12 with positive results – 4Q12 FDA
      meeting reconfirmed regulatory pathway for NDA filing

      • Market research with more than 200 rheumatologists confirms that
      OTREXUP will address a significant unmet need

      Braun, et al (2008): Subcutaneous MTX (15 mg/wk) provided better efficacy than oral MTX without a higher rate of adverse events (N=375).

      • Kremer, et al (2009): Switching from oral to SC MTX resulted in clinical improvement explained by accumulation of long chain polyglutamated MTX.

      • Bakker, et al (2011): Switching from oral to SC MTX resulted in tight control of RA in an additional 10% to 15% of patients, avoiding the use of a biologic in those patients (N= 236).

      • O’Dell, et al (2011): One-third of patients started on MTX alone had an "excellent" response that persisted out to two years. Furthermore, patients who started on MTX had radiographic evidence of disease control similar to those starting on MTX plus a biologic agent (N=766).

      • Schipper, et al (2011): Pharmacoeconomic evaluation of costs and efficacy of starting patients on MTX-alone vs. MTX plus anti-TNF in early RA results in similar remission rates, favoring an MTX-alone approach.

      • Fitzpatrick, et al (2011): In a study of resource utilization in RA management, the authors conclude, “…there is clear evidence that SC MTX, certainly from a cost perspective, is definitely worthwhile because it reduces cost of treatment without compromising patient care.”

      Again, I'm comfortable in saying repeating that in my opinion, failure of this MTX (Otrexup) program is not an option.
      jab9

      Sentiment: Strong Buy

      • 4 Replies to jab91252
      • And Jab....I Always Appreciate Your Posts...Thourough....P.S. Maybe I Am Just Hoping To Accumulate More Shares.......I Don't Have As Much As I Want Anymore...Since That 50,000 Stop Of Mine That Got Taken Out!!.......But The Topic Is Real And Possible........

        Sentiment: Strong Buy

      • Jab:
        Well-stated and supported by compelling documentation; however, there is some possibility that the FDA could ask for additional information prior to accepting Antares' application as complete. I don't know what additional information they could ask for and I don't think it is likely, however, if they do, then it'll be a blip and the stockpile will drop in the near term because an unexpected event occurred. Similarly, I don't know what projected earnings are for the next quarterly report in March; however, if they fail to meet those projections, down we go.

        For several months now, many of the posters on this message board have articulated a compelling case for the future of this company. Those of us who've read the posts and done their own due diligence clearly understand the opportunities presented; yet the price has not moved upward in a sustained fashion since this past summer, despite the well understood future pipeline and the opportunities it presents. Instead, the stock price has reacted or perhaps overreacted to the .03 cent loss reported last quarter, or to negative comments from Cramer.

        I hope I am wrong, but I do not think will see a big upswing in the price of the stock after a positive announcement by the FDA that the Otrexup application is complete. The reason for my speculation is that the market already expects the FDA to accept the application by Feb 16. But the stock price will get walloped if the application is not accepted. Similarly, if Antares misses the consensus earnings estimates when they report in March, then we'll also see the stock take a haircut. As I have stated previously, the road to Otrexup's approval, rollout, and profitability will probably not be as smooth as we'd like to expect, and every glitch and stumble it encounters will wreak havoc with the stock price. I' m in for the long haul, but I'm pragmatic. Hanovk

        Sentiment: Strong Buy

      • I completely agree, Jab9, ATRS has definitely presented all the data for a slam dunk on the FDA approval of Otrexup. Just for the record, my concurrence with T-1234's opinion relates only to the pressure on ATRS's stock price. I do not agree ATRS is holding back PR, nor do I agree that ATRS's leadership has anything but confidence that Otrexup will be approved without delay.

        Sentiment: Strong Buy

      • Jab, Excellent, informative, fact filled post ! Thanks. I'm looking forward to this coming week for ATRS

        Sentiment: Strong Buy

    • thourough.
      Are you talking acceptance of the NDA ?
      They might very well ask for extra trials or verification (which might create delays), but this will come at the approval date (December/January) after they went over all the test results (which they did with T-Jet).

    • The FDA requested that ATRS broaden the application for other labels so that they could reject it?

      • 1 Reply to rearviewforecaster
      • T-1234 is actually correct. Otrexup is one of the key reasons I invested in Antares in November 2011 and doubled up a day after the LibiGel flash crash. I have always stated a successful Otrexup will provide at least five times the revenue that all of the other combined products will provide. For a visual depiction, below is an excerpt from my revenue projections through 2018.

        2015 Gross Revenues
        $20M......HgH global royalties and margin from device and component sales
        $4M........EpiPen U.S. royalties and margin from device sales
        $10M......Vibex2 U.S. royalties and margin from device sales
        $4.5M.....Pen2 royalties and margin from device sales (EU only in 2015)
        $11M......Gelnique/Anturol global royalties
        $1.5M.....Elestrin royalties
        $350M....OTREXUP U.S. sales

        Even if Otrexup revenues are within the company's ultra conservative guidance of up to $200M, those revenues would quadruple the revenues from everything else. (Disclaimer: I have not included the one-time milestone fees that will be paid to ATRS in connection with its various partners.). So, we cannot underestimate the negative pressure on the PPS if this product fails. Indeed, there is a large contingent of shorts who are betting against the success of Otrexup. If the product fails, ATRS will take a big hit.

        That said, there are many degrees of "failure" when it comes to Otrexup. The FDA could delay the acceptance next week, it could publish a PDUFA date that is further out than some here are expecting, it could reject the drug and require additional information. As a fellow long previously posted, however, that the FDA requested ATRS to add other conditions to its application is just one reason why I believe the risk of delay or outright rejection is low. And as T-1234 pointed out, any delay from the FDA will clearly result in a temporary delay in Otrexup's approval and ultimate success. His point is that the temporary hit will create another good buying opportunity.

        As for the "failure" that Whogo is betting on, in my strong and educated opinion, Otrexup's success will impress us all. Indeed, I am very confident that soon after the approval in October 2013, Otrexup will become a household name among rhuematologists, RA patients who either do not tolerate oral MTX or have reached the maximum benefit of the oral dose, and the third-party payors who are looking for medically-acceptable alternatives to cut costs. If I'm wrong, then I will have bigger problems than being proved wrong by Whogo and the shorts..., which I why I'm not giving up my day job!!

        Sentiment: Strong Buy

    • Let me guess, you are short the stock. This week you will likely see a rise in the PPS ahead of the anticipated news. This is referred to as Bio-Run Up and some people that follow the Pharma stocks participate in a buy in ahead of anticipated news. Following the run up certainly if bad news comes in the stock could sell off and wipe out any run up or more. Place your buy/sell orders in line with what you think is going to happen, myself I feel confident that the news will be good so I am all in at this time.

      Sentiment: Strong Buy

    • Nonsense.

      Sentiment: Strong Buy

 
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