I wonder whether it was so bright for POH to ignore the potential in Asia to rely only on USA. Trials in Thailand can be had for a fraction of the cost and recruitment seems easier, and trials can be completed sooner.
Correct…clinical trials outside of the US can be much cheaper, easier to recruit and faster to complete. That’s why the number of clinical trials being conducted outside of the US has exploded. BUT… there can be concerns about things like ethics and quality of data.
For example, Alchemia had about 40% Russian patient recruitment for its Phase 3 testing of HA-1, probably due to cost considerations. However, investors came to regret this. The trial failed and when the data analysis came in one ACL poster immediately asked “What the hell went on in Russia”? I’m not sure if they ever found out. However the fact that a doctor in Russia who typically earns $200 a month can make $5000 per patient s/he signs up for a clinical trial doesn’t exactly inspire confidence.
Non-US trials are also attractive because they can be much faster. Apparently there’s even a term for go-to countries when drug developers need positive data fast: they’re called “rescue countries.” The data may be fast, but I’m not sure it’s the kind of data that would convince a big pharma to inlicense a product post-Phase 2. (1)
The unmet market for oxy patches would surely be massive even if the profit margin is less.
I would question this. I believe that transdermal patches have a fairly high rate of acceptance in Asia, especially in Japan. However, opioids don’t, due to multiple barriers, including the following:
availability and cost (in some countries patients must bear the full cost)
regulatory restrictions to accessibility
requirement for permission/registration of a patient to render them eligible to receive an opioid prescription
requirement for physicians and other clinicians to receive a special authority/license to prescribe opioids
restrictions on prescription forms (eg. requirement for duplicate prescriptions, special prescription forms, restrictive access to these forms or a requirement for payment)
prescription limits (eg. prescription limits might be as low as 5-7 days supply)
use of stigmatising terminology for opioid analgesics in regulations (2)
For all of these reasons, opioid consumption is much lower in Asia than in the West as shown by the stats. Annual opioid consumption in South Korea is the highest in Asia (41 mg/capita). Thailand, for example, is 3 mg/capita, the Philippines .6 mg/capita and India just .26 mg/capita. This pales in comparison to the US (750 mg/capita), Australia (427 mg/capita) or Germany (396 mg/capita).
In summary, I think there are some fairly compelling reasons why POH has made the decision to both trial its oxymorphone patch in the US and aim for the US market, rather than Asia.
(20min delay)