Wed, Oct 1, 2014, 11:42 AM EDT - U.S. Markets close in 4 hrs 18 mins

Recent

% | $
Quotes you view appear here for quick access.

POZEN Inc. Message Board

mini_maxx 22 posts  |  Last Activity: Sep 29, 2014 8:08 PM Member since: Dec 12, 2008
SortNewest  |  Oldest  |  Highest Rated Expand all messages
  • Reply to

    Big volume so far

    by bgubbor Sep 29, 2014 10:22 AM
    mini_maxx mini_maxx Sep 29, 2014 8:08 PM Flag

    Plachetka must have had a reason for saying in the Q2 CC in early August that he expected to hear by the end of September whether the supplier's facility was now in compliance with FDA requirements. So even if there's no news this month there probably will be shortly. The main question is whether the news will be that the FDA has signed off based on the supplier's extensive paperwork or that the FDA wants to do a re-inspection. Even if there's a re-inspection, if everything checks out we should see approval by the December 28 PDUFA date. If the FDA says no re-inspection is needed, Plachetka said POZN would ask the FDA for quicker approval.

  • Reply to

    Dividend?

    by capitalgains68 Sep 9, 2014 12:22 PM
    mini_maxx mini_maxx Sep 9, 2014 4:40 PM Flag

    It will depend heavily on whether (a) PA is approved this year, which would bring in a $10mm payment from Sanofi (with another $10mm due on launch, but that probably won't happen until 2015), and (b) POZN completes an ex-US deal for PA and/or Treximet that brings in a substantial upfront payment. If neither of those happens POZN should still be marginally profitable based on Vimovo royalties but I don't know if it will pay a dividend, especially since there's some uncertainty whether HZNP will be able to maintain its level of Vimovo sales after it's excluded from a couple of pharmacy formularies beginning in January.

    Even if (a) and/or (b) above occurs, I doubt that they'll pay as big a dividend as they did in 2013. At that time they were sitting on $90mm in cash and wanted to distribute as much of it as possible because they had a loss in 2013 which meant that any distribution would be a nontaxable return of capital. So they distributed around $60mm and are now down to around $30mm in cash. The dividend could go back up to 2013 levels in future years if PA performs as well as POZN hopes.

    We may soon have a better idea of whether PA will be approved this year. In POZN's Q2 CC in early August Plachetka said he anticipates that the active ingredient supplier for PA will hear from the FDA by the end of September whether it's now in compliance with the FDA's manufacturing requirements or whether a re-inspection of its facility will be needed.

  • Reply to

    Launch of Treximet?

    by dimbulb000 Sep 2, 2014 1:15 PM
    mini_maxx mini_maxx Sep 4, 2014 10:54 AM Flag

    Thanks. According to p.10 of PTX's August slide presentation, "recent price increase brings [Treximet] price in line with first-line brands," but Drysdale has emphasized that (unlike HZNP) PTX has carefully coordinated with insurers on pricing to avoid any nasty formulary exclusions. I know it's approved for second-line use so I would assume a prescription for that indication wouldn't require pre-authorization. Not sure about an off-label first-line prescription.

  • Reply to

    Launch of Treximet?

    by dimbulb000 Sep 2, 2014 1:15 PM
    mini_maxx mini_maxx Sep 4, 2014 10:33 AM Flag

    This may be a dumb question but why would a doctor have to get prior insurance authorization for prescribing Treximet? It's not that expensive a drug.

  • Reply to

    Launch of Treximet?

    by dimbulb000 Sep 2, 2014 1:15 PM
    mini_maxx mini_maxx Sep 4, 2014 8:51 AM Flag

    So why is the stock down? Probably some "sell the news" (of the closing) profit-taking. Could also have to do with something unrelated to Treximet, but that seems unlikely.

  • Reply to

    Launch of Treximet?

    by dimbulb000 Sep 2, 2014 1:15 PM
    mini_maxx mini_maxx Sep 4, 2014 12:18 AM Flag

    Drysdale in the recent CC relating to the closing of the Treximet deal with GSK, which is archived on the PTX website, said PTX would begin selling it in late August and would be more or less up to speed in September, though some forms of promotion such as newspaper ads might be phased in later. So presumably they're selling it (GSK never stopped, they just stopped promoting it in 2012), but I'm sure there are no sales numbers yet.

  • Reply to

    New here and have a question

    by oldsteve88 Aug 29, 2014 3:19 PM
    mini_maxx mini_maxx Aug 29, 2014 6:03 PM Flag

    I would just add that there's little need to develop new drugs when they can add new territories and, in the case of PA, new indications for their existing drugs. As you know, PA is GI-protected aspirin and POZN is currently seeking approval for secondary prevention of heart attack and stroke in the US. It will soon file an application for the same indication in the EU and other territories, and its US partner Sanofi is likely to eventually file for additional indications in arthritis and colon and perhaps other types of cancer. POZN recently acquired the right to use the FDA approval dossier for Treximent, the migraine remedy, as the basis for obtaining approvals and thus licensing the rights ex-US. And although AZN currently holds the ex-US rights to Vimovo, an arthritis remedy, and pays POZN a royalty, POZN has said AZN is looking to assign the rights elsewhere so it's possible there will be a new ex-US distributor that will increase the sales on which POZN's royalty is paid. Once the FDA and EU approve PA -- and all the clinical work appears to be done -- POZN's only expenses should be the minimal ones related to potentially negotiating new agreements and cranking out the paperwork required of a public company. (Sanofi should bear the cost of any clinical work needed for additional indications for PA.)

  • mini_maxx mini_maxx Aug 20, 2014 12:29 PM Flag

    Actually the royalty POZN will get on US sales beginning in 2018 is 20% of the 18% that's paid to the Canadian pension fund to which they sold off the rights a few years ago, i.e., 3.6%. This was clarified in the POZN cc that was held the morning the deal for assignment of US rights to Treximet to PTX was announced a few months ago. Still, 3.6% of $100 million or more in US sales isn't trivial. But the big win for POZN in this deal is its ability to fully exploit Treximet ex-US, where POZN always retained the rights.

  • Reply to

    Great CC for POZN...

    by play_tow Aug 7, 2014 11:18 AM
    mini_maxx mini_maxx Aug 9, 2014 3:54 PM Flag

    That may be, but POZN submitted the application for EU approval for Vimovo in October 2009 and it was approved in October 2010. Given that the PA submission will be to the same coordinating agency for the EU in the Netherlands, it's possible it will act even faster this time given its familiarity with the process uses to ensure GI protection (from the effects of naproxen in the case of Vimovo and aspirin in the case of PA). In any case, barring something unforeseen, it seems unlikely that it will take longer than 12 months from submission.

  • Reply to

    Diverging from HZNP....Reality Returns

    by play_tow Jul 29, 2014 10:01 AM
    mini_maxx mini_maxx Aug 1, 2014 3:39 PM Flag

    I agree that CVS's assumption that taking naproxen + esomeprazole separately is the same as taking Vimovo is dubious. According to POZN in the April 30, 2010 PR announcing FDA approval of Vimovo (and in various presentations and SEC filings as well), "VIMOVO has been developed as a sequential-delivery tablet formulation combining an immediate-release esomeprazole magnesium layer and an enteric-coated naproxen core. As a result, esomeprazole is released first in the stomach, prior to the dissolution of naproxen in the small intestine. The enteric coating prevents naproxen release at pH levels below 5.5 providing protection against possible local gastric toxicity of naproxen." This immediate release/sequential delivery feature suggests that just taking two pills may not provide the same degree of GI protection. Admittedly, POZN's P3 trials didn't prove that because they compared Vimovo to enteric-coated naproxen rather than to naproxen + esomeprazole taken separately. That's probably what the FDA wanted because I think enteric-coated naproxen was the standard of care. But it's the reason Vimovo was designed the way it was and seems plausible.

    I assume CVS thinks it risks no liabiity by taking Vimovo off formulary because if doctors prescribe it patients can still get it, they just have to pay full freight. I have no idea whether it's possible to fashion a legal challenge on the theory that they've made the drug the doctor wanted unaffordable and forced substitution of two drugs that may not work as well.

  • Reply to

    Diverging from HZNP....Reality Returns

    by play_tow Jul 29, 2014 10:01 AM
    mini_maxx mini_maxx Aug 1, 2014 2:45 PM Flag

    I agree that CVS's assumption that taking naproxen + esomeprazole separately is the same as taking Vimovo is dubious. According to POZN in the April 30, 2010 PR announcing FDA approval of Vimovo (and in various presentations and SEC filings as well), "VIMOVO has been developed as a sequential-delivery tablet formulation combining an immediate-release esomeprazole magnesium layer and an enteric-coated naproxen core. As a result, esomeprazole is released first in the stomach, prior to the dissolution of naproxen in the small intestine. The enteric coating prevents naproxen release at pH levels below 5.5 providing protection against possible local gastric toxicity of naproxen." This immediate release/sequential delivery feature suggests that just taking two pills may not provide the same degree of GI protection. Admittedly, POZN's P3 trials didn't prove that because they compared Vimovo to enteric-coated naproxen rather than to naproxen + esomeprazole taken separately. That's probably what the FDA wanted because I think enteric-coated naproxen was the standard of care. But it's the reason Vimovo was designed the way it was and seems plausible.

    I assume CVS thinks it risks no liabiity by taking Vimovo off formulary because if doctors prescribe it patients can still get it, they just have to pay full freight. I have no idea whether it's possible to fashion a legal challenge on the theory that they've made the drug the doctor wanted unaffordable and forced substitution of two drugs that may not work as well.

  • Reply to

    Regarding CVS

    by matrixmania55 Jul 28, 2014 4:21 PM
    mini_maxx mini_maxx Jul 28, 2014 4:56 PM Flag

    Matrix, thanks for the info. I'm a little confused though. Are you saying that if Rite Aid and Walgreen follow CVS and take Vimovo off formulary (which may or may not happen), it won't matter because patients with employer-provided health insurance will order a 90-day supply directly from the insurer, and the insurer will still cover the drug? I thought some insurance plans say they'll cover only drugs on a formulary -- or is that only if you buy it at a drug store? Thanks again.

  • Reply to

    A Reminder of the POZN-Horizon Contract on VIMOVO

    by play_tow Jul 28, 2014 10:53 AM
    mini_maxx mini_maxx Jul 28, 2014 11:12 AM Flag

    Forgot to make my point, which is that Vimovo is priced modestly ex-US so we shouldn't face a scenario like today's with HZNP.

  • Reply to

    A Reminder of the POZN-Horizon Contract on VIMOVO

    by play_tow Jul 28, 2014 10:53 AM
    mini_maxx mini_maxx Jul 28, 2014 11:09 AM Flag

    Ex-US sales of Vimovo approached $100mm last year and POZN gets 6% of that, increasing to 10% in 2016. Granted, there's some uncertainty as to whether AZN will transfer its ex-US rights and, if it does, whether the new licensee will be better or worse, but that aside, US + foreign sales of Vimovo should still net POZN at least $15-20 million a year by 2016 even if HZNP's sales decline dramatically. That could be a nice little add-on to what PA, which I agree is what POZN is mostly about, will hopefully bring in.

  • Reply to

    no one talking about HZNP here yet?

    by waiting4kerx Jul 28, 2014 8:36 AM
    mini_maxx mini_maxx Jul 28, 2014 9:53 AM Flag

    Yup, today's news coupled with the uncertainty about whether the FDA will approve PA this time around isn't helping. I think it will though so I'm not selling at these levels.

  • Reply to

    no one talking about HZNP here yet?

    by waiting4kerx Jul 28, 2014 8:36 AM
    mini_maxx mini_maxx Jul 28, 2014 9:49 AM Flag

    Personally, I've stayed away from HZNP just because I was afraid of a news release like this morning's, though I didn't expect it to happen too soon. I'm still staying away. Maybe Walbert will pull a rabbit out of a hat but the risk that other payers will follow CVS and Express is just too great.

  • Reply to

    no one talking about HZNP here yet?

    by waiting4kerx Jul 28, 2014 8:36 AM
    mini_maxx mini_maxx Jul 28, 2014 9:40 AM Flag

    Well you knew this would happen eventually. Charging $800 a month for GI-protected naproxen (and ibuprofen)? HZNP overreached IMO. POZN thought AZN was charging too much and HZNP more than quadrupled its price. Better to have charged less and promoted more to reach a mass market.

    Oh well, at least this won't affect HZNP's or POZN's revenues in 2014, and hopefully PA will be approved and launched by early 2015. By almost every conservative estimate, PA alone should more than justify POZN's current valuation unless it completely bombs, which seems unlikely.

  • Reply to

    Dead Money now

    by matrixmania55 Jul 16, 2014 9:18 AM
    mini_maxx mini_maxx Jul 16, 2014 11:02 AM Flag

    Exactly what I'm doing and plan to do, and I own a ton as well.

  • Reply to

    Dead Money now

    by matrixmania55 Jul 16, 2014 9:18 AM
    mini_maxx mini_maxx Jul 16, 2014 10:59 AM Flag

    Of course, any ex-US deal for PA would have to be conditioned on FDA and EU approval. If the mfg problem is as minor as POZN claims, that shouldn't hold up a deal, just as it didn't hold up the deal with Sanofi for the US. But it's also possible POZN will hold off expecting it will get a better deal following approval.

  • Reply to

    Dead Money now

    by matrixmania55 Jul 16, 2014 9:18 AM
    mini_maxx mini_maxx Jul 16, 2014 10:54 AM Flag

    There's a good chance they'll also announce an ex-US deal for PA, and possibly for Treximet (now that Glaxo has made that easier by turning over the FDA approval dossier for Treximet to POZN as part of the PTX deal), before year-end. POZN suggested in an earlier CC that AZN is looking to transfer the ex-US rights to Vimovo to a third party so we may also hear something about that. Any or all of that would be positive though perhaps not blockbuster news.

POZN
7.53+0.19(+2.59%)11:42 AMEDT

Trending Tickers

i
Trending Tickers features significant U.S. stocks showing the most dramatic increase in user interest in Yahoo Finance in the previous hour over historic norms. The list is limited to those equities which trade at least 100,000 shares on an average day and have a market cap of more than $300 million.