The first oral drug for the treatment of opioid-induced constipation (OIC) in adults with chronic, non-cancer pain will soon become available in the US. Amitiza, the twice-daily pill developed by Sucampo Pharmaceuticals and licensed to Takeda, got the go-ahead from the FDA yesterday, boosting its originator’s share price by 24%.
The chloride channel activator has beaten its main oral OIC rival, Nektar and AstraZeneca’s naloxegol, to market. But Nektar is working on a new angle: the company intends to coformulate naloxegol with opioids, creating a single-pill painkiller that does not cause constipation (Nektar and Astra’s naloxegol set for silver medal after trial success, November 12, 2012). This is a strategy which Sucampo might like to consider.
Developing an Amitiza-opioid combination would have another advantage: protecting Amitiza’s all-too-short patent life. Generic competition is expected in 2018 (Event – Sucampo hopes to get sales moving through the pipeline with Amitiza approval, March 27, 2013).
The drug’s looming patent expiry explains Sucampo’s determination to gain approval for Amitiza in all the indications it can – the drug is already sold in the US for chronic idiopathic constipation and irritable bowel syndrome with constipation. Analysts at Edison estimate that the drug will have peak sales of $215m in this indication in the US, with US sales in the other two indications reaching a total of $375m.
New places, new people
Thanks to the approval, Sucampo is worth $97m more as a company than it was on Monday, with a 24% share price rise yesterday and a further 8% so far today. It will receive further bounty in the shape of a $10m payment from Takeda when Amitiza goes on sale, with up to $50m in commercial milestone payments following. Given that the sales infrastructure is already in place, it probably won’t have long to wait for the first wedge. For its part, Takeda’s share price increased by 4% today.
Sucampo and Takeda will now attempt to expand Amitiza’s launch into new territories and new patient populations. Edison analysts predict that the product will soon be launched for chronic idiopathic constipation and filed for OIC in the UK and Switzerland.
Moreover, later this year the companies will start phase III trials geared towards gaining approval for Amitiza in paediatric constipation. This could be a significant opportunity given that the label for Linzess, the anti-constipation drug from Forest Laboratories and Ironwood Pharmaceuticals, contains a warning forbidding its use in children (Pressure on Forest management eases with IBS pill’s approval, August 31, 2012).
Given that Takeda and Sucampo clearly have plans for making the most of Amitiza, they might be expected to be open to the idea of combining it with an opioid, too.