Trying to make an awkward topic feel more mainstream, Ironwood Pharmaceuticals Inc. and Forest Laboratories Inc. chose the popular television show Modern Family to introduce a commercial for their constipation drug Linzess. The campaign is the first direct-to-consumer push from Ironwoodand Forestas the firms lookto improve the sales of the primary care product.

In the spot that debuted April 9, people rub their stomachs and talk about the feeling of having a giant knot or bricks piling up in their belly. It’s part of the companies’ strategy to avoid the old-fashioned route of talking about constipation behind closed doors by taking a modern, up-to-date approach to frank discussions of the topic.

That sort of spotlight could be the key to invigorating product sales. Currently, Linzess (linaclotide) brought in $118.8 million in 2013 for the two companies. “We view Linzess as a substantial product that has the potential to do well north of $500 million in sales,” Forest’s Exec VP-Sales and Marketing Bill Meury said in an interview. Analysts estimate sales of $340 million for the drug in 2015 and revenues that could reach upwards of $1.3 billion by 2020 Also see "Ironwood’s Next Steps For Linzess: DTC and Traditional Lifecycle Management" - Pink Sheet, 16 December, 2013..

FDA approved Linzess August 2012 at a 145 mcg dose for chronic idiopathic constipation (CIC) and at 290 mcg for constipation-predominant irritable bowel syndrome (IBS-C), a disease subtype marked mainly by abdominal pain Also see "Linzess Continues On Strong Launch Trajectory, Says Ironwood/Forest" - Pink Sheet, 23 July, 2013..

The direct-to-consumer campaign, which is a first for both companies, includes the nationwide television ads that launched April 9 and print ads that began circulating April 4, as well as a digital presence for the drug. The ads will be circulated more in certain markets, but Meury emphasized that the push truly is nationwide. The drug is approved for treatment in both men and women, but the marketing is skewed slightly more toward women between the ages of 25 to 60. The first print ads appeared in People magazine, as well as Cooking Light and Better Homes & Gardens.

The campaign is expected to last 12 months with an emphasis on the first four to six months, but could continue, depending on its success. While it’s too early to begin measuring its impact, Ironwood Senior Director of Customer Communications Sharon DeBacco told “The Pink Sheet” DAILY that traffic to the drug’s website has already begun to increase.

Success of the DTC campaign will be measured through three metrics: awareness, consumer inquiries and treatment. Traffic on digital forms of the campaign will inform customer inquiries and they will monitor actual prescription trends, but Meury explained that Forest and Ironwood will be conducting extensive consumer surveys to measure awareness. “Consumer awareness of Linzess is currently in the single digits,” said Meury, who noted that awareness typically ticks up three to five times from baseline after a DTC campaign.

Neither Forest nor Ironwood would put a dollar amount on the cost of the campaign, but Meury noted it is one of the larger DTC campaigns being conducted. Ironwood disclosed during its last quarterly call that 2014 sales and marketing expenses from both companies for Linzess will be in the range of $240 million to $270 million.

Forest and Ironwood are promoting to both primary care doctors and gastroenterologists, with 1,300 sales reps from Forest and another 200 from Ironwood promoting the product to physicians. The campaign is a complement to a physician awareness campaign the partners have been conducting since its launch in December 2012. Meury admits that “neither a physician awareness nor a DTC campaign work entirely independent of the other.” The companies began informing doctors a month ago that the DTC campaign would begin and to expect patient inquiries about the drug.

Being More Direct About Constipation

While Forest has plenty of primary care drugs in its arsenal as well as antidepressants, traditionally a major area for DTC, this is the first time the company has chosen to go the DTC route ([A#14140121003]). “DTC is something that has to be assessed on a brand-by-brand basis,” said Meury.

For Forest, the time was right – more than 70% of health plan formularies are now covering the medication and the drug is priced at an affordable price point, about $6 per day. “Pushing a drug to consumers doesn’t make sense if they don’t have access to it,” he added.

Constipation, unlike depression, is a market that isn’t as widely talked about, the companies pointed out. “These patients are suffering 110 days a year and about 70% to 80% of them are unsatisfied with treatment. Patients think this is just the way that their body is,” said DeBacco.

Market research showed the companies that 42% of patients think there are no new treatments for constipation and that these patients often rely on over-the-counter products that are ineffective in treating the chronic condition Also see "Market Snapshot: Taking Constipation Seriously – Linaclotide Success Raises Hopes For Market Resurgence" - Pink Sheet, 4 July, 2011..

“There are rare opportunities in the marketplace with high unmet need, patients that are symptomatic and unsatisfied, but physicians aren’t actively proactively managing and screening these patients,” according to Ironwood Chief Commercial Officer Thomas McCourt. “Unless these patients raise their hand and push doctors on this, then they aren’t getting treated.”

Both McCourt and DeBacco emphasized that the aim of the DTC campaign is to categorize the symptoms of the condition, validate patient feelings, and give them the tools to talk to their doctors about what they are feeling. “We want to give them the words they need,” McCourt said in an interview. For that reason, the visual aspect of the campaign is extremely important. “When you only have 60 seconds, you need to communicate clearly and concisely,” said Meury.

The stomachs in the commercial harken back to a marketing campaign that consumers are already familiar with – the campaign that promoted Novartis’ irritable bowel syndrome drug Zelnorm (tegaserod) several years ago. Market research showed that consumers had a favorable experience with the 5-HT4 agonist, despite its withdrawal from the market in 2007 due to class-wide concerns about cardiovascular risks. Zelnorm, which was initially approved in 2002 as a short-term treatment for IBS-C and later cleared for chronic constipation, quickly became a market leader in spite of OTC competition and had $566 million in sales in 2006 Also see "Schooled On Prilosec And Zelnorm: Ironwood/Forest Aim Linzess At OTC-Dominated Market" - Pink Sheet, 3 September, 2012..

“What we heard from doctors and patients is that Zelnorm was a positive, effective drug,” said McCourt. The current Linzess ads are not meant to be modeled after the former Novartis ads, said the companies, but use the same imagery because patients “identify” with the images and associate them with the condition of constipation.

Ironwood/Forest Hoping To Change The Conversation About Constipation

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