Ironwood and Allergan have long pinned hopes for IBS drug Linzess on getting patients to switch from over-the-counter remedies to treat constipation. New pain and bloating data for Linzess could help convince consumers—and analysts predict the drugmakers will queue up a marketing overhaul to sell that message.
On the heels of phase 3 trial data released Wednesday showing that 29.7% of IBS-C patients saw reduced bloating, pain and discomfort while taking Linzess, Ironwood and Allergan may immediately pivot the drug’s marketing campaign to reflect its newest trial win, Credit Suisse analyst Vamil Divan, M.D., said in a note to investors, noting that Ironwood has said "they should be able to begin promoting these new claims" without "needing to have to wait for an updated product label."
Up until now, Ironwood and Allergan have faced an uphill climb in marketing Linzess, as the companies haven't been able to use the terms "pain," "discomfort" and "bloating." According to Ironwood, "many patients do not affiliate" those symptoms with their constipation, Divan wrote.
“Management believes that updating the marketing campaign can substantially improve through the inclusion of these terms in the message they send to patients," he said. And "as the company has long maintained that the key to driving sales growth remains driving patients away from over-the-counter (OTC) remedies and into the doctor’s office, improving patients’ ability to properly communicate their symptoms to their doctors is the key to this campaign.”
All told, Divan expects to see an "uptick in Linzess prescriptions in the coming months, although the magnitude remains unclear at this time."
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Currently, two of five IBS-C sufferers never seek medical care in favor of OTC treatments, the companies have said. The drugmakers’ “Oh My Gut!” campaign, launched in April, offers a direct line to a doctor via an online telemedicine link in order to help diagnose IBS-C beyond constipation, the symptom most closely tied to patients seeking a prescription.
In a first-quarter earnings call with investors, Ironwood President Thomas McCourt said the new direct-to-consumer campaign could have a positive effect connecting doctors and IBS-C patients. Linzess’ head-to-head fight with OTC treatments was central to its recent “Wearing on You” ad campaign, which showed patients with constipation carrying oversized computer-generated boxes of laxatives, fibers and probiotics.
How much those campaigns can ramp up sales remains to be seen. But in late 2018, with Linzess sales continuing to flag, Wells Fargo analyst David Maris proposed another idea for promoting growth. After Allergan, slogging through asset sales that hadn't appeased wary investors, cut sales forecasts for the drug, he suggested Ironwood pursue a future alone. Linzess’ middling sales proved to Maris to be “a good reminder of the issue of being tethered to a partner.”
Since then, Linzess posted just 1% sales growth in the first quarter as pricing pressure offset double-digit increases in global prescriptions and units sold, Ironwood said. Despite that troubling trend and new GI competitors hitting the market, McCourt told investors not to ring the alarm bell on the drug’s market-leading sales quite yet.
“Even with some of the new competitors coming into the IBS-C and chronic constipation space, we don't believe this will be a substantial threat to net price moving forward given some of the undifferentiated clinical profiles and the limited labels of the emerging competitive products,” he said.