After an unscheduled three-month delay, while the FDA reviewed the data for Amitiza in the supplemental indication of opioid-induced constipation (OIC), Sucampo should find out by the end of April if it has secured an additional revenue stream from its biggest product.
Few are expecting any real surprises given that Amitiza is already approved for chronic idiopathic constipation (CIC) and irritable bowel syndrome with constipation (IBS-C) and has a long and proven safety track record. But it will be important for Sucampo to ensure that its US partner, Takeda, is fully engaged in the sales process given the looming generic threat to the drug.
|% of market cap||64%|
|Event type||Supplementary approval|
|Date||End of April|
In February Sucampo reported that Par Pharmaceuticals had filed an ANDA for Amitiza, leading Sucampo in turn to file for patent infringement. At present Amitiza’s key patents are set to expire in 2020, so given the 30-month stay on approval following the patent infringement filing, Par will not get FDA approval for its generic before 2015. But even this timeframe looks too soon given that the patent trial should drag on longer than 30 months, meaning Par would have to launch at risk.
Therefore, rather than a generic entering the market in 2015, analysts at Edison are expecting the first copycat entrant to come in 2018. The second might come in the form of Dr Reddy’s product. The Indian generic company is running an 880-patient clinical equivalence study, which is expected to finish in the next few months, triggering another ANDA.
With several generic challengers looking to eat its lunch in its key indication, Sucampo needs to get approval for Amitiza in OIC to help ramp up sales in the time its patents remain in place. This task has been made harder by the approval of Forest Laboratories and Ironwood Pharmaceutical’s drug Linzess in August (Pressure on Forest management eases with IBS pill’s approval, August 31, 2012).
The new drug also has advantages over Amitiza, including an effect on abdominal pain and once-daily dosing. The Sucampo drug can make no such pain relief claims and is taken twice daily.
It is also facing future competition in OIC from Nektar Therapeutics and AstraZeneca’s naloxegol, which after positive long-term safety data in February is expected to be filed in the US in the third quarter, with possible approval by the first half of 2014 (Nektar and Astra’s naloxegol set for silver medal after trial success, November 12, 2012)
At present Amitiza is forecast to generate sales of $241m by 2018, which compares with the $933m for Linzess in the same year. Even with an additional indication under its belt Amitiza will have a steep hill to climb.