Painkiller Remoxy (Oxycodone) May Still See An NDA Refiling By Mid-2015 (PTIE) – Seeking…

Summary

  • 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 (PTIE) were the original developers of Remoxy, under license and using technology from DURECT (DRRX) 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 (PFE) 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

PF-00345439

Completion Date

ALO-02

Completion Date

Dose proportionality

NCT02089295

June 2014

Not on ClinicalTrials.gov

Alcohol interaction

NCT02165930

August 2014

NCT01677039

December 2012

Pivotal bioequivalence

NCT01552850

June 2012

NCT01677065

October 2012

Food effect

NCT01717027

NCT02059915

January 2013

July 2014

NCT01456507

January 2012

Abuse potential, oral

NCT01986283

August 2014

NCT01746901

August 2013

Abuse potential, intranasal

Unnecessary

NCT01775189

July 2013

Abuse potential, intravenous

Unnecessary

NCT01825447

September 2013

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.

Editor’s Note: This article covers one or more stocks trading at less than $1 per share and/or with less than a $100 million market cap. Please be aware of the risks associated with these stocks.

Disclosure: The author is long DRRX. The author wrote this article themselves, and it expresses their own opinions. The author is not receiving compensation for it (other than from Seeking Alpha). The author has no business relationship with any company whose stock is mentioned in this article. (More…)

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Painkiller Remoxy (Oxycodone) May Still See An NDA Refiling By Mid-2015 (PTIE) – Seeking…

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