Patch partnering

I was asked why I think that POH is likely to partner the topical TPM/Oxycodone patch within 12 months.

The starting point for any deal is two motivated parties. I think there can be no question that POH will be highly motivated to strike some kind of deal for the topical patch within the next 12 months. The way I see it, it’s imperative that Murdoch get some runs on the board, it’s imperative that POH’s pharmaceutical asset development keep moving forward but it’s also imperative that the company’s cash is preserved. Time and funding pressures will mean it’s unlikely, in my view, that Murdoch and the Board will commit to running a second Phase 2 trial of the topical patch. Studying the patch in another indication is warranted, again in my view, but a partner is needed first. So, Murdoch and the Board, I believe, have strong motivation to partner the topical TPM/Oxycodone patch, and as soon as possible.

That leaves the question of whether another party will have sufficient motivation to partner. After consideration, I think it is likely.

In terms of what a prospective partner would require of the topical patch, I refer to part of Murdoch’s address at last year’s AGM

Developing a successful drug is like putting together a complex jigsaw. In drug development the end picture is not always immediately clear. Only some of the pieces are visible, some are not and some may be missing. Sometimes all the pieces fit and sometimes they just don’t. Regardless, optimising the chances of putting it together, solving the challenges that come along and making the decisions that ultimately shape the end result need experienced hands. Ultimately our customers and partners don’t need the jigsaw put together but they do need to see that it can be. They want to know how much risk we have eliminated for them. To market our technology successfully, there are ultimately five questions we need to answer:

What evidence is there that the tech works?
What evidence removes the risk that it does something bad?
What is the evidence that the tech can be a commercial product?
What is the relevance to customers?
How does the evidence stack up relative to competition?

So can the company satisfactorily answer those five questions with respect to the topical TPM/Oxycodone patch?

In response to the first question, data won’t be as strong as the company would have liked. The primary endpoint of demonstrating that locally delivered oxycodone can significantly reduce PHN related pain, compared to placebo, wasn’t met. However, the recent trial did demonstrate that the TPM/Oxycodone patch can effectively deliver drug to the targeted site in the skin while maintaining sub-therapeutic blood levels and maintaining a safety and side effect profile in line with that of placebo. Murdoch’s view is that these findings “support the company’s current partnering discussions and support the applicability of the patch for other pain indications”. Murdoch has also stated that interest in the topical patch from prospective partners had been for indications other than PHN.

Questions 2 and 3 are answered, I think, in last week’s release. The topical TPM /Oxycodone patch was said to demonstrate:

Good three-day adhesion characteristics in line with expectations for a commercial patch;
Excellent skin tolerability, with minimal dermal irritation;
Good drug delivery with minimal (sub-therapeutic) systemic exposure to avoid opioid side effects; and
An attractive side effect profile similar to the placebo/vehicle patch, without evidence of classical opioid side effects associated with oral dosage forms (ie: nausea, constipation, sedation, etc).

Question 4, the relevance of the TPM/Oxycodone patch to customers, can be answered in the positive, in my view. Multiple independent studies and surveys have shown that patients prefer topical/transdermal options to oral medications, if available. In the case of a topical opioid patch, patients stand to benefit from reduction in pill burden; elimination of side effects of oral opioids, such as nausea, vomiting, sedation and constipation; potential elimination of risk of addiction (as systemic therapeutic levels are not reached); improved safety and minimal dermal irritation. I’d also add that, from a prescriber and a regulatory point of view, an opioid that addresses the issue of addiction has to be seen as relevant.

How does the evidence stack up relative to the competition? As far as I’m aware, there is no current competition for a topical opioid patch. And lack of competition is always an attractive feature to pharma.

The main hurdle, as I see it, comes back to the data. Will it be sufficient? It’s likely it won’t be for some -  achieving primary endpoint in at least one Phase 2 trial may be a minimum “derisking” requirement for some pharma to consider partnering. But others may be more risk tolerant. After all, even success in the PHN indication wouldn’t have guaranteed success of the patch in a different indication, just as failure in the PHN indication doesn’t mean the topical TPM/oxycodone patch will fail in another indication, such as osteoarthritis or broken bones.  Unfortunately what is guaranteed, in my view, is that any party wanting to partner will use the PHN trial failure to tighten the screws in negotiation. That, of course, isn’t good, but on the other hand, it may make dealing more attractive to pharma.
All of the above are just my thoughts. Hopefully we’ll get more thoughts from Ross Murdoch in a newsletter and conference call next week.

As a final word, for those who have lost hope in any future for the topical TPM/Oxycodone patch, it’s perhaps worth mentioning that there are numerous marketed drugs which, after failing in one indication, succeeded in another for the same or for another company. Viagra was famously a dud when Phase 1 and 2 trials were conducted in angina during the early 90s. Pfizer was due to give the drug the chop but was persuaded to first run a small additional study to investigate a reported side effect. When ten out of twelve patients responded, the fastest selling drug in US history was on its way.