I would argue that PFE has spoken out on Remoxy and in the affirmative. In October, PFE issued a stand alone PR announcing that it would proceed with Remoxy and specified what must be done and when. Most recently, in the Q4 PR issued earlier this week, PFE included a discrete paragraph restating its intention to proceed with Remoxy. In the grand scheme of PFE's drug development world that's a lot of mentions.
In its Q4 report to shareholders and prior to today's market opening, PFE reported the following:
"Remoxy -- Pfizer will continue the development program for Remoxy Extended-Release Capsules CII. Having achieved technical milestones related to manufacturing and following guidance received from theFDA in 2013, Pfizer is proceeding with the additional clinical studies and other actions required to address the Complete Response Letter received in June 2011. As previously disclosed, the complete response submission is not expected to occur prior to mid-2015."
Logical: You wrote "I could certainly be wrong as the FDA can do surprising things..."
That's my point (hope?). The WSJ publishes a plethora of articles (most notably those of Scott Gottlieb, a former high level FDA functionary in a variety of capacities) addressing arbitrary, even capricious actions undertaken by the FDA involving NDAs and the like. Why would not an ANDA be afforded similar treatment, especially one that runs counter to a stated "good" FDA public policy undertaking? All too often if there's a will, there's a way when it comes to bureaucratic actions.
To that point, why would not approvals of the Teva and copy cat generic versions of OxyContin that you envision (leading to price erosion and greater drug supply/demand/diversion/abuse) be anathema to FDA stated policy regarding ER opioid formulations? How might the REMS mandate and its application/administration be manipulated by the FDA so as to be another barrier to approval and market entry?
I don't mean to be argumentative (call me cynical, if you like) but I do, of course, hope you are wrong!
Where's fgnoms when we need him? For years he has been proclaiming in this forum that Purdue's intellectual properties were impregnable to any and all wanabee ER oxycodone comers. Ditto for the "new" reformulated abuse resistant version. And specifically, that Purdue would blow Remoxy to smithereens the moment it came on the market. And now this indignity: Teva prevails in court - at least in round one!
By his own admission, his posts have been invariably made in good faith and are always true and correct. We need his wise counsel now!
Logic: So you are discounting Barbier's belief (a belief that he intimates is shared by PFE) that "if Remoxy gains US approval it will become a blockbuster, POTENTIALLY EVEN EXPLOITING THE FDA'S GUIDELINES TO FORCE ALL OTHER OXYCODONE FORMULATIONS, INCLUDING PURDUE'S OXYCONTIN, OFF THE MARKET"....THE POTENTIAL FOR REMOXY TO ECLIPSE ALL OTHER FORMULATIONS, INCLUDING OXYCONTIN, IS WHAT PERSUADED PFIZER TO STAY WITH THE PARTNERSHIP, MR BARBIER SAYS." [Source: EP Vantage 10/25/13 interview] You are also assuming that the FDA will more or less routinely and promptly accept and approve the ANDAs of Teva and others during the pendency of the Remoxy NDA resubmission, leaving Pfizer and especially the uncharacteristically loquacious Mr. Barbier hanging out to dry.
Maybe you are correct but I'd like to think that the FDA will stick to its opioid-abuse-deterrence-as-good-public-policy guns. Once again, I give you Barbier's words: "If [Remoxy] does gain approval, AND IS PROVABLY BETTER THAN OXYCONTIN AT DEFYING ADDICTS' ATTEMPTS TO ABUSE IT, THERE WILL THEN BE AN IMPETUS FOR THE AGENCY TO REMOVE OXYCONTIN FROM SALE.
On Wednesday morning, Pain Therapeutics dropped 12% on what we initially thought was no news. The stock kept dropping and at one point was down close to 17%. We eventually found the cause of the dip. In a non-jury trial, a U.S. judge decided that generic drug maker TEVA pharmaceuticals did not infringe any of Purdue's valid patents in making a generic version of oxycontin. In the ruling, the judge stated that, while Purdue showed clear evidence that TEVA violated at lest 4 of the 5 patents involved in the suit, that TEVA had showed clear and convincing evidence that those patents were obvious and therefore invalid. Recall, one key requirement for being granted a patent is that the invention be non-obvious to "a practitioner skilled in the art". In other words, someone qualified to work in the field the invention covers.
If this decision stands, the potential negative read-through for PTIE is that Pfizer may have second thoughts about Remoxy. But our view is that this was an over-reaction and an opportunity to add to a long term PTIE position. First, this ruling is not necessarily the end of the story. Purdue has already stated that it will appeal this decision. Without looking at the particulars of the case, it is impossible to know who will prevail in an appeal, but the story is far from over. Second, even if Teva succeeds and eventually brings a generic tamper-resistant oxycontin to market, pricing pressure may not be as large as in other, non-tamper proof drugs. While a 30% reduction in price may ensue, we do not expect that TEVA would be entering the market with a view to severely undercut the price of oxycontin. Even if the $2.81 billion in oxycontin sales were to decrease by 30% and then be split 3 ways, this still represents over $650 million per year in potential revenue to Pfizer. Given the low cost of running the remain studies to get to market for Remoxy, it is hard to see Pfizer dropping the program this late into the game.
We added to our PTIE position on this dip and were immediately rewarded as the stock recovered to end the week at $4.71. We are long PTIE.
It's worth revisiting the EP Vantage October 25 interview with Barbier, edited excerpts from which follow:
[In deciding to keep faith with PTIE's oxycodone project Remoxy, PFE is betting that it can convince the FDA of its safety and abuse-resistant bona fideson the third time of asking.....If Remoxy gains US approval it will become a blockbuster, potentially exploiting the FDA's guidlines on opioids to force all other oxycodone formulations, INCLUDING PURDUE'S OXYCONTIN, OFF THE MARKET (emphasis added). "Our belief, and certainly our strategy, is that upon approval Remoxy becomes the gold standard of abuse resistance",PTIE's CEO Remi Barbier tells EP Vantage......Studies of the new formulation's pharmacokinetics and other aspects will be complete in around a year, potentially allowing for a PDUFA date in late 2015. "The good news is we know exactly why it was not approved. The bad news is that it has taken PFE some time to stabilise the manufacturing process. PFE has now reached a point where they are confident that the manufacturing platform is 100% stable, so now it's off to the races" stated Barbier.....The potential for Remoxy to eclipse all other oxycodone formulations, INCLUDING OXYCONTIN (emphasis added), is what persuaded PFE to stay the with the partnership, Mr Barbier says. If the pill does gain approval, and is provably better that OxyContin at defying addicts' attempts to abuse it, there will be an impetus for the agency to remove OxyContin from sale.]
If, in fact, PFE shares Barbier's perspective on the Remoxy opportunity, it's hard to see why PFE would now abandon ship based on one judge's decision in the Purdue vs Teva patent litigation.
Published 12/30/13 by Rajesh Patel, Ph.D.
In our last weekly review, we covered the Shelf Registration statement filed by DRRX on December 20th. Since DRRX is awaiting a PDUFA decision from the FDA regarding their post-surgical pain therapy, Posidur, the market naturally took the S-3 with it's attendant At-the-market financing facility (ATM) as a potentially negative sign.
As we outlined in our weekly review, the lock-up provisions from Durect's November 13th financing precluded the company from raising additional capital at least until February 11th, just one day before the PDUFA date. At publication time for our weekly review, we had reached out to DRRX CFO Matt Hogan to confirm our reading of the details of the most recent S-3.
Here is Matt's Response to our inquiry:
We will not use the ATM or otherwise raise any equity before Feb 6 (actually we wouldn't do anything anyway before the PDUFA date of Feb 12 regardless of the lockup). I'd view this as general housekeeping. We thought we'd refresh our shelf, which was about half used up and would expire in 1.5 years. As long as we were doing that, we figured we'd put an ATM in place at the same time. I don't know if we'll ever use the ATM, but the administrative cost of setting it up is modest and it's nice to have the flexibility. These ATMs have become rather common and in the right circumstances they can entail a lower cost of raising capital that an underwritten deal. Just like having as many tools at our disposal. I'm out of the office till Friday, but if you'd like to discuss this in more depth, I'm happy to chat then. [emphasis added]
This is a clear and unequivocal statement regarding the company's intentions regarding the ATM facility. As we suggested in our weekly-review, the facility is in place for future planning beyond the Feb. 12th PDUFA date. (Note the Feb 6th date mentioned in the email was in reference to a specific question we asked about the 11/8 offering announcement + 90 days. After we contacted Matt we realized that the closing date for the offering was actually 11/13.)
Investors who had a knee-jerk reaction to the S-3 and ATM facility, assuming it meant the company had bad news from the FDA already were clearly jumping the gun. While approval of the Posidur NDA is not guaranteed, the recent S-3 is about year-end housekeeping rather than a reflection on approval prospects for Posidur.
We are long DRRX.
"So when does this start to run? Maybe the shelf offering turned investors off, I'm not sure but this selling 6 weeks out really doesn't make a lot of sense."
DRRX's management has justifiably earned the sobriquet of "the gang that can't shoot straight" when it comes to product development. I hope you are correct in your assumption that this time around Posidur will be the exception to that rule. SeekingAlpha analysts, however, while generally bullish on Posidur as a new drug candidate, see product approval or a CRL as 50/50 outcomes come February 12. Makes sense to me.
TheFreeDictionary defines a Shelf Registration thusly:
"A procedure that allows firms to file one registration statement covering several issues of the same security. SEC Rule 415, adopted in the 1980s, allows a corporation to comply with registration requirements up to two years prior to a public offering of securities. With the registration "on the shelf," the corporation, by simply updating regularly filed annual, quarterly, and related reports to the SEC, can go to the market as conditions become favorable with a minimum of administrative preparation and expense."
Facts and circumstances (as yet unknown to the public) will determine when, as and if any shares are sold (and at what price). This is considered to be a routine (and prudent) corporate practice. It is too soon to read anything more into this corporate action.
From PharmaTimesOnline - 12/18/13
The US opioid market is dominated by non tamper-resistant formulations, but the Food and Drug Administration’s promotion of TRF therapies could well result in the departure of non-TRF treatments from the market, say new forecasts.
Purdue Pharma’s Oxycontin is the only opioid pain treatment among the 50 top-selling pharmaceuticals in the USA, and unless the FDA mandates TRF therapies, further genericisation and lack of novel mechanism of actions (MOAs) will ensure opioids are absent from the top 50 by 2018, warns the study, from Frost & Sullivan.
Nevertheless, it sees large opportunities for tamper-resistant technologies, as well as combination therapies to minimise side effects from opioid products.
With 25 million Americans suffering from moderate-to-severe chronic pain that interferes with their daily lives, orally-delivered pain products will continue to dominate the market, says the study. Oxycontin leads this category, generating $2.77 billion in sales in 2012, while the transdermal category was led by Johnson & Johnson’s Duragesic (fentanyl transdermal) patch for cancer-induced pain and Endo’s Lidoderm (lidocaine) patch for chronic pain.
FDA’s push for abuse-deterrent formulations will also spell a boom for extended-release opioids. So far, in spite of the continued development of extended-release formulations, immediate-release products have dominated the market, with a 91% market share. This is partly due to the recent requirement for a risk evaluation mitigation strategy (REMS) for extended-release formulations. However, with FDA favouring TRF therapies, extended-release drugs will find greater favour among drug developers, says F&S.
“Another outcome of the FDA’s endorsement of TRFs is the flooding of the pain therapy pipeline with new TRF opioid-based therapies,” says Jennifer Lazar Brice, life sciences global research director at F&S. “In this scenario, Pfizer has significant opportunity to grow, with its broad pipeline of oral (TRFs), transdermals and IV candidates,” she adds.
As opioids are the mainstay of pain treatment, there is a substantial market for a therapy for opioid-induced constipation. Nektar Therapeutics’ NKTR-118, a Phase III candidate for this condition, will be of particular interest, the study notes.
It also expects companies which develop a novel, non-opioid MOA therapy to gain particularly in this market. Healthcare providers will be keenly watching developments in calcitonin gene-related (CGRP-targeted therapies.
“Overall, the future of the pain market is heavily dependent upon the FDA’s decision to remove non-TRF generic therapies from the market. This move will create a huge opportunity for new TRF therapies to remain branded,” says Ms Lazar Brice.