From the diversity of novel drugs to increasing scrutiny of pharma’s claims, medical marketers face a broader array of challenges than ever before. And just as drug developers are attempting to accommodate each patient’s unique needs, so, too, are marketers honing strategies to deliver targeted messages to patients, providers, and payers.

Two drugs working their way toward approval each represent unique marketing challenges.

The first, BioMarin’s valrox, formerly BMN 270, for hemophilia A, belongs to the splashy new family of gene therapy medications. And the second, AbbVie’s risankizumab for plaque psoriasis, a traditional biologic, faces the age-old challenge of being a latecomer in a crowded market, thus requiring marketers to demonstrate key differentiators.

Central to the marketing strategy for both drugs will be backing up messages with a wealth of strong data. “It’s not only about having data, it’s also about having the right data, because doctors are really good at seeing through superficial data drug companies want to push,” says Richard Meyer, principal, Strategic Marketing Solutions. He adds that in a shifting landscape with ever-increasing demands, some drug companies are lagging behind while a select few are rising to meet the challenge.

BioMarin, Phase III
Indication: Hemophilia A

Catalyst: Over the past year, BioMarin has made strides with its gene therapy candidate BMN 270, which it recently renamed to the much catchier valrox. During an earnings call, BioMarin president of worldwide research and development, Henry Fuchs, M.D., said the company is seeing an “increased level of enthusiasm for valrox from the patient and physician communities.” Updates for its Phase I/II clinical program are expected mid-year, with pivotal data from its Phase III program expected in 2019.

Competitive landscape: Although there are several drugs approved to help control bleeding for patients with hemophilia A, valrox would represent the first gene-therapy approach — that is, if BioMarin can beat Spark’s SPK-8011, which is neck-in-neck with its Phase I/II trial, to market. 

Yet BioMarin may have gained an edge, at least in the eyes of shareholders, after both companies presented data at the annual American Society of Hematology meeting in December. According to BioMarin’s Phase II data, valrox is well-tolerated and met its primary endpoint, demonstrating a 91% drop in average bleeding rate and a 98% drop in prophylactic infusions.

Messaging strategy: “If early studies are any indication, this could be a significant breakthrough in hemophilia,” notes Nadine Leonard, managing director at Heartbeat. 

Meyer agrees, adding valrox “has the potential to be a gamechanger” and nearly 100% bleeding control would be a “very powerful message” to both physicians and payers.

Even if valrox doesn’t meet the cure threshold, its demonstrated ability to reduce or even eliminate the need for prophylactic infusions would mean “a giant leap forward” for patients, Leonard says. “To patients, messaging feels richest in a promise of a more realistic, more livable life, not being tied down by the burden of infusions. For physicians, the mechanism of action and efficacy are the stars, while for payers it’s a triple-aim winner — more patient satisfaction, better long-run costs, and an effective solution for an entire population.”

Marketing strategy: BioMarin’s marketing strategy should focus almost exclusively on outreach to patients through advocacy communities and to physicians at specialty treatment centers. 

“Hemophiliacs tend to participate in strong online communities, so the lowest-hanging fruit is engaging as partners with these groups to ensure patient and caregiver awareness,” Leonard explains. “Their reliance on specialized treatment centers simplifies physician targeting while making rep-delivered awareness and education activities a no-brainer.”

Considering valrox represents such a leap forward in the treatment paradigm, Meyer notes, “A lot of doctors will be recommending this to patients.”

AbbVie/Boehringer Ingelheim, Phase III 
Indication: Plaque psoriasis

Catalyst: In December, AbbVie and Boehringer Ingelheim presented strong Phase III data supporting the plaque psoriasis drug risankizumab. In February, the companies presented further positive data from two Phase III trials. 

Together, these results have paved the way for near-certain FDA approval, yet risankizumab will face an uphill battle as the third drug of its kind to enter the market.

Competitive landscape: Risankizumab will compete with two other IL-23s, Janssen’s Tremfya and Sun Pharma’s tildrakizumab, setting up a latecomer challenge for the marketing team.  In addition to the IL-23s, risankizumab will enter a market similarly saturated with newly approved IL-17s from Novartis and Eli Lilly.

According to Phase III results, risankizumab bested AbbVie’s blockbuster Humira as well as Johnson & Johnson’s Stelara — two mainstays of psoriasis treatment. 

Only 2% of patients taking risankizumab encountered serious adverse events. During a quarterly earnings call, AbbVie EVP of research and development and chief scientific officer Michael Severino outlined risankizumab’s differentiators: convenient quarterly dosing and superiority over the standard of care for bio-naive, tumor necrosis factor, and adequate responder patients.

Messaging strategy: AbbVie’s psoriasis blockbuster Humira makes risankizumab messaging an “interesting challenge,” Leonard says. “If AbbVie didn’t own Humira, we’d suggest it not be shy about announcing there’s a new sheriff in town. But Humira’s got a stronghold — docs know it, trust it, and love it — and AbbVie isn’t likely to want to rush any mass exodus to a co-promote. But while behavior change away from something as trusted as Humira will take years to gather steam, [AbbVie] will probably be willing to go with the head-to-head story, just with less gusto than a real competitor might.”

Adds Meyer, “It’s going to have to make some really big claims to catch up.” He notes physicians will likely already be familiar with IL-23s, so messaging should focus almost exclusively on risankizumab’s differentiating factors.

Marketing strategy: A drug such as risankizumab requires a massive direct-to-consumer campaign. “It’s just a question of how much and how soon to manage the cannibalization impact. But with enough patients on Stelara and Enbrel, and recent aggressive marketing from [Eli Lilly’s] Taltz and [Novartis’] Cosentyx, they go big out of the gate,” Leonard predicts.

Still, owing to the late entry, it would make sense for AbbVie and Boehringer to price risankizumab competitively. This would encourage payers to add the drug to their formularies, Meyer says.

This story has been updated to reflect that risankizumab is a biologic.