Having lost its dispute with partner Takeda over the marketing of the constipation drug Amitiza, Sucampo Pharmaceuticals must salvage what it can from the relationship to stave off the threat of Ironwood Pharmaceuticals' linaclotide. FDA action is due in two months for linaclotide, which is partnered with Forest Laboratories, and with analysts pencilling in blockbuster forecasts for the drug a new strategy might be required to revive Amitiza’s sales.
An expected filing in opioid-induced constipation could provide an opportunity for the Maryland group to carve a new niche. Repairing the relationship with its Japanese partner will need to be a priority; however, as an oral alternative against only one incumbent in a more clearly defined market, Amitiza may have the potential to grow once more.
Hitting the fan
Sucampo lost a binding arbitration battle with Takeda over sales of Amitiza, which have fallen well below its launch expectations; sales this year are forecast at $236m and are expected to peak at $253m before shrinking to $233m in 2018, according to EvaluatePharma data. Sucampo had claimed that the lagging revenue was the result of its Japanese partner failing to live up to its marketing obligations. As a result of the arbitration finding, the partnership will remain valid through 2020.
Sucampo shares slumped 25% to $5.23 on the news. That loss erased nearly all the gains made earlier this year when the partners announced positive phase III data in opioid-induced bowel dysfunction.
As it stands, Amitiza is the only FDA-approved drug for chronic idiopathic constipation or irritable bowel syndrome with constipation in women, an advantage that Sucampo believes has not been fully capitalised upon in a rather fertile field; the company claims that just 3% of 10 million potential patients have been prescribed with Amitiza.
Resolution of the arbitration in theory should give the two parties a chance to adjust the marketing plans and set the stage for new growth. Linaclotide, however, is due an FDA decision on September 7 in chronic idiopathic constipation and irritable bowel syndrome with constipation. Ironwood Pharmaceuticals recently reported that marketing partner Forest was planning a sales force of 1,200-1,400 and a significant direct-to-consumer campaign; the consensus forecast now reflects a steep launch trajectory, with sales of $1.09bn estimated in 2018.
Thus, unless there is a delay to the PDUFA action date or the FDA sends linaclotide back for more work, Sucampo and Takeda have virtually no time to develop plans for a re-launch of Amitiza in its original indications. A new strategy might be warranted, particularly given that the bulk of prescriptions will be written by primary care doctors; certainly building brand awareness among physicians and patients will be essential if the companies want to make any gains in a competitive space.
Fertilising the soil
International opportunities are, however, growing: with Abbott Laboratories, Sucampo last week received approval in Japan for Amitiza in chronic constipation. An approval in the UK is expected sometime in the third quarter, and this will open the door to mutual recognition approvals in other European Union countries and could be the trigger for an EU partnership, generating significant licensing fees.
The opioid-induced constipation indication also shows promise; in February Takeda and Sucampo reported a significantly higher spontaneous bowel movement response rate among patients taking Amitiza when compared with placebo in a phase III trial. The two companies plan an FDA filing this year, which could also be the trigger for milestones.
In this indication Amitiza would be entering the market against Salix Pharmaceuticals’ Relistor, which as an injectable would be vulnerable to marketing on dosing convenience. But in order to get the marketing message right and win potential Relistor patients, Sucampo needs to ensure that it is in concord with its larger partner. A re-launch as a focused drug provides the two parties with the perfect opportunity for a fresh start.
There is no question Amitiza has been a commercial disappointment. The question now is whether the two partners can make the most of the new opportunity and grow the drug in its original indications, even in the shadow of linaclotid; any hiccup in linaclotide’s launch could provide an additional opportunity. But with the partners' relationship damaged it will require careful execution to reclaim Amitiza’s promise.