Pain Therapeutics, Inc. (NASDAQ:PTIE) is first in this list. Madison Street Partners disclosed a 9% increase in its stake in the company over the third quarter of the year, and now owns about 1.87 million shares of Common Stock, worth more than $7.3 million. This position accounts for roughly 4.5% of the fund’s equity portfolio’s total value.
Pain Therapeutics, Inc. (NASDAQ:PTIE)
Another major fund betting on this $187 million market cap biopharmaceutical company is Jean-Marie Eveillard’s First Eagle Investment Management. On early-September, the fund disclosed ownership of 4.64 million shares of Pain Therapeutics, Inc. (NASDAQ:PTIE), up from 4.47 million held by the end of the second quarter.
toot_hkaue 1 post | Last Activity: 1 hour 53 minutes ago Member since: Oct 27, 2014
You created that ID today just to greet us. Isn't that sweet of you.
really just that simple
barbier wants "investors" to believe a drug with a billion dollar potential is dropped by pizer because it might compete with another not yet developed drug of pizer's. What a complete delusional idiot
Remoxy has been a real pos for everyone who has touched it from the development side and finally pizer looked at the topline data necessary to respond to the CRL and made the trade just like anyone who owns this pos should do. No value here. Going to cash value so about 1.00. sell
Source: Seeking Alpha 12/3/14
Five publicly traded companies have at one time sold abuse deterrent painkillers in the U.S. and should be attracted by the $2.5 billion gained by rival Purdue Pharma's Oxycontin.
Pain medication specialist Mallinckrodt is already under contract to make Remoxy and is the most sensible option.
Alternatives are Endo, Actavis, Janssen, and Sandoz, all of whom are veterans in the pain market and have no competing oxycodone-only products.
After Pfizer (NYSE) returned the rights to Remoxy, an investigational extended-release (or ER) oral painkiller, to Pain Therapeutics (NASDAQ) and DURECT (NASDAQ), there is great uncertainty whether a new drug application (or NDA) for this abuse deterrent formulation of oxycodone could get resubmitted to the Food and Drug Administration (FDA) next year, if at all. However, the market is too big (Oxycontin grossed $2.46 billion last year) and the finish line so close for Remoxy to remain ignored for long. The following companies all have experience in marketing abuse deterrent painkillers. None of them have an extended-release pure oxycodone product whose sales could get cannibalized like Pfizer or Purdue Pharma, the maker of Oxycontin, making them potential partners at least in theory.
Mallinckrodt Pharmaceuticals (NYSE)
Abuse-Deterrent: Exalgo ER, Xartemis XR
Mallinckrodt is the world's largest supplier of controlled substance pain medication and is also one of the top 10 U.S. generic pharmaceutical companies, based on prescriptions written in 2013. It sells an osmotic pump oral tablet formulation of hydromorphone, Exalgo, the exterior of which is hard enough to minimize intentional abused through biting, chewing or extraction. Approved by the FDA on March 1, 2010, Exalgo had total U.S. sales of approximately $230 million for the 12 months ending February 28, 2014, according to IMS Health, but its patent expired this year. On Mar. 12, 2014, the FDA approved Xartemis XR, the first extended-release oral combination of oxycodone and acetaminophen, but did not allow abuse-deterrent language; Mallinckrodt is conducting additional studies and will be submitting additional data in the near future. In addition, Mallinckrodt is still obligated to manufacture Remoxy under the old Pfizer contract, so it's the most logical choice among this group of companies to carry out the commercialization as well.
Endo Pharmaceuticals (NASDAQ)
Abuse-Deterrent: Opana ER
Endo transitioned to a reformulated Opana ER CRF in March 2012 that incorporates a polyethylene oxide matrix rendering the tablet highly resistant to crushing without affecting its ER properties and when exposed to water forms a gel which is difficult to draw into a syringe. Post-marketing surveillance data demonstrated a significant 59% reduction in abuse for nasal abuse (snorting) to go with the already low intravenous abuse rates of the original. However, the FDA concluded that the reformulation can be compromised with methods that won't be repeated here, which was one of the factors allowing Impax and Actavis (NYSE) to launch generic versions of the non-crush-resistant formulation on January 2, 2013 and September 12, 2013, respectively, which negatively impacted revenues. Net sales of Opana ER still reached $227.9 million for the year ended December 31, 2013 and accounted for approximately 9% of Endo's 2013 total revenue.
Abuse-Deterrent: Hydromorphone ER
Actavis is the third-largest generic pharmaceutical company in the U.S. On Sept. 12, 2013 it launched oxymorphone extended-release tablets, the generic equivalent to the previously marketed formulation of Opana ER, which Endo voluntarily withdrew from sale in 2012. Then in May 13, 2014, it received approval from the FDA on its Abbreviated NDA for a generic version of Exalgo.
Janssen Pharmaceuticals, of the Johnson & Johnson (NYSE) family
Abuse-Deterrent: Nucynta ER
Janssen is the world's sixth-largest pharmaceuticals company and sells both immediate and ER versions of tapentadol. Like Opana, Nucynta ER (approved in 2011) was developed with abuse deterrent properties such as a polyethelene oxide matrix (physical barrier) which confers resistance to tablet tampering (crushing, chewing or dissolving), but both were approved prior to issuance of the FDA's Draft Guidance document and their labels do not include any mention of abuse deterrence properties or attributes.
Par Pharmaceutical (private)
Sandoz, the generic pharmaceutical division of Novartis (NYSE).
Abuse-Deterrent: generic versions (pulled off market) of OxyContin by Purdue Pharma
Par Pharmaceutical is the fifth largest U.S. generic company as ranked by IMS sales in Q3 2013, while Sandoz is the world's second largest producer of generics. Both companies settled their respective lawsuits with Purdue and agreed that their formerly marketed products infringed on patents relating to OxyContin and both agreed not to make, have made, use offer to sell, sell, or import generic oxycodone products until separate undisclosed dates. However, the settlement doesn't preclude them from marketing a branded oxycodone product like Remoxy.
Galaxy - although your manufacturing costs at 25% are clearly way too high - most drugs can be manufactured for 3 - 5% - you make a good point. However PTIE could have pulled out before spending the monies on the 5 new tests but didn't. They decided to see the results first and clearly weren't impressed. I guess we'll find out why shortly. From Remi's umming and ahhing when asked the question at the CC one or more of the tests didn't achieve their primary end points.
u better cover, shorty
Makes you wonder who they got their shares from eh! Here's Remi doing the rounds telling everyone what a great company PTIE is whilst at the same time the directors to a man are flogging their option shares to the gullible at over $5. Nothing much ever changes at PTIE. All hot air and zero delivery. What has surprised me is Remi saying that he's in touch with Pfizer pretty much every day. Is this the very same Remi who was completely shunned by Pfizer before and after the last CRL. The only contact he seemingly had then was receiving copies of the price sensitive correspondence between Pfizer and the FDA. Very handy information for Board Members to have had. You can make some quite informed decisions on your shareholding if you have that sort of information to hand.
Remember it was said in past that Pfizer wanted better terms. Remi was protecting PTIE investors It's just hardball negotiations on terms
Painkiller Remoxy (Oxycodone) May Still See An NDA Refiling By Mid-2015
Pfizer announced it was returning the Remoxy rights to the initial filers of the NDA, Pain Therapeutics, the shares of which sank 53% on the news.
However, a search on ClinicalTrials.gov reveals that Pfizer has completed all the necessary Phase I bioequivalence trials required to address the FDA's last Complete Response Letter.
That may be enough to attract a new partner for the original abuse deterrant version of oxycodone, which can gain a significant share of a market worth billions.
Remoxy is a strong investigational painkiller (an extended-release oral formulation of oxycodone) for moderate-to-severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. Pain Therapeutics were the original developers of Remoxy, under license and using technology from DURECT to design pills that discourage common methods of tampering at a time when abuse deterrence at the manufacturing level was unheard of. PTIE filed the initial new drug application (NDA) for Remoxy in June 2008 with the U.S. Food and Drug Administration (FDA). King Pharmaceuticals, a partner since 2005, assumed full control of the development of Remoxy in March 2009 and filed a resubmission of the NDA in December 2010. Pfizer acquired King Pharmaceuticals and rights to Remoxy in February 2011. After a second Complete Response Letter (or CRL) from the FDA in June 2011 requesting new clinical studies, Pfizer announced last year it received guidance from the FDA on the exact nature of the needed studies would pursue the development of Remoxy and complete the requirements in time for a third submission in mid-2015.
In a reversal of course, Pfizer notified PTIE on October 27 that it was discontinuing its agreement to develop and commercialize Remoxy, returning all the rights to PTIE. It was a big blow to PTIE, which lost out on $250M in clinical and regulatory milestones and 20% royalties after the first $1 billion in net sales in the U.S. That day, PTIE and DURECT lost 53% and 45% of their market value, respectively. Given that the oxycodone market, even just for the non-immediate release formulations, is in the billions, PTIE cannot hope to market Remoxy on its own and will have to shop for another partner. It will be much easier to secure a new partner if PTIE can show a high probability of Remoxy getting approved. The efficacy of Remoxy is not in question, so it comes down to satisfactorily addressing the CRL issue of bioequivalence. According to PTIE CEO Remi Barbier in the October 30 conference call, he had the impression after talking to Pfizer's people that the NDA can and should be filed. About the only way it would make sense to refile is if all the prerequisites were met. Remoxy turns into a viscous substance that can't be snorted nor injected; it could still be chewed (with terrible taste if done so) which necessitated the oral study. In addition to verifying the abuse deterrent claim, Mr. Barbier mentioned four Phase I trials. A search on ClinicalTrials.gov turned up that Pfizer had indeed conducted such trials for a Remoxy-like product (PF-00345439 in Table 1) in the time frame consistent with after the King Pharmaceuticals acquisition. Likewise, Pfizer also finished most of the same for its own in-house abuse-resistant oxycodone creation, ALO-02.
Table 1. FDA-Required Bioequivalence Studies Completed By Pfizer
Not on ClinicalTrials.gov
Abuse potential, oral
Abuse potential, intranasal
Abuse potential, intravenous
PTIE already has experience in transferring Remoxy from the King Pharmaceuticals agreement, and they will receive assistance from DURECT in examining the data. Thus, the bottleneck seems to be on the speed of the transfer of 100,000s of documents, which could take up to the full 6 months by contract if Pfizer wanted. Pharmaceutics is a cutthroat business, but Pfizer won't help its reputation among its myriad partners, current or future, if it were to be punitive to one of its former allies now. According to the Q3 earnings transcript, CEO Barbier concluded that, "If they have an internal competitive product, product in the same space, sits on the same shelf, targets the same customers. With REMOXY they owe a big fat royalty plus milestones. With their internal program they don't. I mean I kind of see it as a portfolio decision tied to relatively straightforward NPV math." No other explanation makes as much sense; it's certainly not due to Remoxy's efficacy, for which the FDA doesn't have a problem. Hopefully it will be just as easy for a new marketing partner to recognize Remoxy's potential to favorably compete in a multi-billion market.
Not so fast... CEO was VERY optimistic on the call yesterday..... Investors R #$%$ with the 50% hair cut..
You sell you position or add to it... I see an upside at this price...
Wow - what planet was Remi on yesterday? So 3 months ago he said he was talking everyday to PFE. Yesterday he said he hadn't seen ANY of the data from the 5 clinical trials. He did say that he'd been verbally told the top line results last Friday by PFE. When questioned about whether The trials had achieved their primary end points he wouldn't say. He must have known but he wouldn't say. So it sounds like at least one didn't.
Or maybe Pfizer reassessed the economics!!
Ptie 20%(not factoring the initial 15%)
Durect. 11.5% ( not factoring the initial lower rate)
3nd party Fees=56.5%
Rev. Over a Ten year period
Next 8 yrs=800m per yr
7billion in rev., fees about 4billion to 3nd parties or in house product&keep the 4b!!
Remi did say he doesn't have any reason to not believe what Pfizer had told him on the Friday teleconference which appears is that their trials are good but decided to terminate the agreement.
We should know in the next 30 days if NDA can be filed. Just hope if good they do a deal with a great sales force & powerhouse. Drug stores only have so much room on the shelves need a company with pull.