Lucky Neptune has gone salmon fishing – a matter I’ll come back to later. First I wish to discuss pain medicines.
Pfizer describes itself as a global leader in pain medicines, with its current key chronic pain products being Lyrica and Celebrex. It also has two major chronic pain products in late stage clinical trials; Remoxy (extended release oxycodone) and tanezumab (a novel nerve growth factor inhibitor).(1)
It is worthwhile considering Pfizer’s portfolio addressing the $20 billion+ chronic pain market.
With 2012 sales of $4.15 billion, Lyrica is currently Pfizer’s biggest selling drug.(2) This anti-convulsant was first approved in 2004 for the management of pain associated with postherpetic neuralgia and diabetic peripheral neuropathy and as an adjunctive therapy for the treatment of epilepsy. It is an orally administered drug, taken three times daily.(3)
Celebrex is another of Pfizer’s biggest selling drugs. It had $2.72 billion sales last year.(2) This oral NSAID was first approved in 1998 for the treatment of arthritic pain and gained popularity after being promoted as safer for the stomach than the equally effective alternative NSAID arthritic pain therapy, ibuprofen. However, Pfizer’s claims were exposed as les than truthful by The New York Times last year, when it was revealed that the company hid evidence indicating that Celebrex was just as bad as ibuprofen in causing GI side effects such as nausea, dyspepsia, diarrhea and abdominal pain. (4,5)
As has been previously discussed, the future of Pfizer’s late-stage opioid product, Remoxy, is in doubt. Remoxy has had a troubled development path, having been first knocked back by the FDA in 2008 and then again in 2011. Pfizer announced in May this year that it is now undecided as to whether it will proceed with this abuse-deterrent, twice-daily, oral oxycodone product, noting that any response to FDA concerns would take at least two more years.(6)
The future of tanezumab looks more promising. Originally tanezumab was tested for the treatment of osteoarthritic pain, but trials were halted by FDA after multiple cases of osteonecrosis were reported. Nevertheless a recent long term safety and efficacy study has demonstrated the suitability of tanezumab for the treatment of chronic lower back pain.(7) However its potential for massive commercial success is unsure, as a recently published survey reveals that half of surveyed pain specialists and three quarters of GPs are unlikely to prescribe tanezumab because of its high cost and intravenous administration.(8)
Not surprisingly, therefore, Pfizer wants to further expand its pain portfolio. The company states,
Despite these medicines, large numbers of pain sufferers still experience inadequate relief. We are working to develop novel therapeutics and improved formulations and combinations of existing therapies. Pain is a distinct group of conditions with unique underlying biology, affecting patients in different ways depending on co-morbidities, background genetics and psychology. Pfizer is interested in partnering with innovative collaborators to develop novel and differentiated medicines to address the needs of patients suffering from pain. (1)
To address shortages in its pain portfolio, Pfizer has expressed interest in “establishing alliances” to develop therapeutics that impact both chronic neuropathic pain (eg. postherpetic neuralgia and diabetic neuropathy) and chronic nociceptive pain (of which cancer pain and arthritis pain are the most common types).
Specific areas of interest for Pfizer include:
• Improved opioids with fewer side effects, including abuse-resistant formulations
• Nociceptor-specific drug delivery
• Technology platforms and products to help understand and segment patients in pain and develop Precision Medicine R&D strategies for our innovative portfolio (1)
Now consider what Phosphagenics has in development for the treatment of chronic pain.
Phosphagenics is focused on the development of abuse-resistant opioids with fewer side effects. Both its transdermal TPM oxycodone and oxymorphone patches address nociceptive pain. Now both topical and transdermal TPM oxycodone therapies have suggested indication for the treatment of neuropathic pain. Phosphagenics’ platform technology is delivering products which are both precise and innovative. The company now has a highly differentiated pain portfolio that addresses an $18 billion market.
Now to return to salmon fishing...
A key piece of advice for landing that elusive salmon, as provided by one professional salmon guide, is “Realize what worked yesterday may not work today – don’t be afraid to switch”.
Adjustments might be needed to the time of day, the bait or the technique. Decisions will be influenced by weather conditions and the current. Multiple lines might be required. The salmon guide suggests that it’s necessary to keep the bait lively, to keep moving and “behave erratically” in order to keep the fish guessing. That’s what’s needed on top of spending lots of money to get there in the first place, watching out for bears and avoiding freezing to death. Most importantly, it seems, you have to bring incredible patience to the task. As the salmon guide says, “Some of the hottest bites happen after hours and hours of absolute dead zone fishing”.
There has been some consternation about what Phosphagenics is up to with its patch development program since Neura Therapeutik stepped in as development guide this time last year. That hasn’t dissipated with last week’s Pain Program Update. Apparent changes in strategy, new patch additions, new patch indications and subsequent delays have been met with a mix of puzzlement, frustration, doubt and dismay. To the eyes of some, the company’s pain program appears increasingly less focused. To my eyes, a program is being pieced together that is both threat and solution to Pfizer’s chronic pain portfolio.
My theory only and I'm not asking that anyone share it - I think that Phosphagenics is engaged in a spot of salmon fishing.
(20min delay)