Cyndi Lauper counts herself as one of the 7.5 million Americans with psoriasis. Against the upbeat tempos of "Girls Just Wanna Have Fun" and heartfelt croons of "True Colors," Lauper laments that her disease sometimes takes a toll.
"It was tough getting out there on stage," she says in a commercial for Cosentyx (secukinumab), Novartis AG's best-selling immunology product. The commercial has run nationally more than 13,000 times, while the drug has earned more than $3.4 billion since coming to market about three years ago.
Cosentyx prevents an immune system-regulating protein called interleukin (IL)-17A from binding to its receptor. There are dozens of known types of ILs, and many drugmakers have their sights set on developing therapies that can target them. In the first half of 2015, Cosentyx became the first drug targeting IL-17A to come to market.
It didn't take long for direct competition to arrive, however.
Eli Lilly & Co. got the agency's OK for its IL-17A inhibitor Taltz (ixekizumab) in March 2016, and Valeant Pharmaceuticals International Inc. followed under a year later with Siliq (brodalumab), a drug that specifically blocks the IL-17A receptor.
What's more, a host of other big pharmas are advancing a group of treatments targeting IL-23, which research has shown plays a role in IL-17 production. Those treatments include Johnson & Johnson's Stelara (ustekinumab) and Tremfya (guselkumab), AbbVie Inc.'s risankizumab and Sun Pharma Industries Ltd.'s tildrakizumab.
Given the IL space's increasingly cramped quarters, companies are searching for tools that can give their products a better shot at competing. Marketing strategies are proving one of the most useful.
Small screen selling
Redness and inflammation. Silvery, scaley flakes. Patients with plaque psoriasis frequently have to deal with these kinds of symptoms — and the problem goes beyond skin appearance. A Novartis survey of about 8,300 people with moderate-to-severe psoriasis found 84% reported feeling discriminated against or humiliated because of their condition.
"We really found that visual quality of psoriasis is a major part of how patients feel and think about the disease," Eric Hughes, global development franchise head for immunology & dermatology at Novartis, said in an interview with BioPharma Dive.
In that light, Novartis has pursued direct-to-consumer (DTC) advertising. The commercials have gone past plaque psoriasis too, now detailing Cosentyx's utility in the two additional indications it secured in early 2016: psoriatic arthritis and ankylosing spondylitis.
Novartis isn't the only company to tap DTC advertising. Lilly has a commercial out for Taltz that aired about 3,700 times in the U.S., according to television research group iSpotTV.
"If you look across psoriasis, the television ads — some of them have a little bit of a negative component. They focus more on the patient suffering from their condition," Pete Salzmann, VP of immunology at Lilly, told BioPharma Dive. "What we learned in speaking to patients in market research when we were designing our creative campaign, they didn't want psoriasis to be seen as a taboo or a subject that couldn't be talked about."
Salzmann, Hughes and others say psoriasis and psoriatic arthritis lend themselves to DTC advertising. The diseases are very visual, and each carry large patient populations that can be mobilized to ask their doctors about starting a new treatment.
Companies invest money "based on where they think they need to spend the most time educating. So brands that may spend a lot of time and money in DTC and those channels could know that they have physicians that are accepting of the clinical research and are supportive of the patient decision," Victoria Summers, associate principal at sales consulting firm ZS Associates, said in an interview.
"They know if they drive in more patients to the physician to talk about their particular brand, that the physicians are very likely to say 'yes, I think this is a good thing to give a try,'" she said.
Novartis and Lilly have surely benefited from their use of DTC advertising. Revenues from their respective IL-17A inhibitors have grow quarter to quarter over the last two years.
Yet DTC isn't applauded by everyone.
Critics like the American Medical Association and some public health experts say the practice drives overuse of prescriptions and inflated drug costs. That's likely because evidence suggests advertising works, and the FDA has not signaled interest in cracking down much. In fact, it's taken a more hands off approach in recent years.
Often, a product's place in the market can determine whether DTC advertising is a safe or risky bet; ones that come later or with fewer indications usually tend to fall into the risky category.
In crowded markets, drugmakers may find themselves in a "war zone, where everyone is spending this tremendous amount of money to get their name out there, and that can create a lot of noise," Summers said. "And to break through that clutter and to get noticed, you have to invest pretty significantly — at least at the same level as the competition."
Those are some of the reasons why Valeant has steered away from television in marketing Siliq, which gained approval in February 2017 and currently holds a single indication in plaque psoriasis. "Doing DTC right now when you're the low person on the totem pole doesn't make much sense," Bill Humphries, EVP of dermatology at Valeant's Ortho Dermatologics, said in an interview.
Build the label
Valeant isn't looking to stay at the bottom. But to move higher, it will likely have to build out the label for Siliq.
In some ways, the company is behind the eight ball. Cosentyx and Taltz have relatively clean safety profiles, whereas Siliq carries a black box warning for suicidal ideation. Humphries acknowledged the added resources it takes to make sure prescribers and patients are aware of Siliq's risks, but contends the warning hasn't caused as many obstacles as some may think.
"We're starting to see some good adoption, and the stories I hear back are fantastic from physicians about the success they're seeing, anecdotally, and so that's also very exciting as this product begins to take root," he said. "It's going to be a marathon, not a sprint. But we accepted that from the beginning and knew that."
Humphries wouldn't say exactly which diseases outside of plaque psoriasis his company intends to pursue with Siliq. Currently, it has a Phase 4 study that, while not yet recruiting, aims to evaluate the drug's safety, tolerability and pharmacokinetics in pediatric subjects. Kyowa Hakko Kirin Co. Ltd., which holds rights to Siliq in Japan and other Asian countries, plans on studying it as a treatment for ankylosing spondylitis.
Meanwhile, Novartis and Lilly are searching for their own fresh indications, as well as building up withstanding victories.
The Swiss pharma is conducting two Phase 3 trials pitting Cosentyx against AbbVie Inc.'s Humira in patients with psoriatic arthritis. The trials don't read out until 2020, but data from other studies testing the drug in mild psoriasis and atopic dermatitis should come in before then.
On Lilly's end, the company is playing a little bit of catch up to its big pharma rival.
Pharmas have pursued the same indications for their IL-17s
|Plaque psoriasis||Psoriatic arthritis||Ankylosing spondylitis|
Jordan Branch / BioPharma Dive
In mid-February, Lilly revealed positive topline results from a late-stage trial assessing Taltz as a treatment for anklyosing spondylitis. While it will need to review more data as they become available, Lilly tentatively plans to file its drug for approval in that indication by year's end.
The Indianapolis-based drugmaker is also investigating Taltz in genital psoriasis and nail psoriasis — offering a chance to get out of Novartis' shadow.
"We're going to go for anything where we think we can really significantly raise expectations for patients. That's going to be our True North," Lilly's Salzmann said. "If there were a condition we thought Taltz could have a modest impact on, even if it was an area that was relatively unexplored by other competing biologics, we wouldn't go there because again it's not consistent with our brand strategy of really making a huge impact on patients."
Physicians more than patient groups
A broad label and a big budget commercial don't matter much if doctors ultimately don't prescribe the drug in question. As such, Novartis, Lilly and Valeant employ sales forces to meet with physicians and discuss their products.
FDA rules tightly police what sales reps can and can't say, but drugmakers have developed strategies to use those regulations to their advantage. A common one is to showcase how a company's drug is differentiated from competitors.
For Valeant, Siliq's mechanism of action of targeting the IL-17 receptor as opposed to the protein has made it stand out from Cosentyx and Taltz. Valeant and its rivals have also been racking up clinical data showing their treatments can go beyond 75% skin clearance — a long-held benchmark of excellence in psoriasis treatment — and provide 100% skin clearance.
"In those [competitive] situations, we typically find that the brands are thinking about kind of a niche market, so they're thinking about what is the segment of the population where I can provide a really beneficial, unique value," Summers said. "If there's something around onsets of treatment, the speed or method of action that might be a little bit unique, where you can really find patients that maybe were not as successful on other products . . . then you can start to carry that message out to the physician community."
Deciding which physicians to pinpoint is also an important decision. Some are more comfortable prescribing a topical compared to a biologic, Summers noted, while others are more obviously attached to a specific brand.
"There may be certain types of physicians that are specialty, maybe they deal with specifically challenging cases or maybe the brand knows that there's a group of physicians, and they can see in the data that these physicians tend to prescribe a lot of different IL-17s, so they're not necessarily loyal to one type," she said.
Conversely, patient groups aren't as much of a focus. Unlike therapeutic areas like rare disease, psoriasis and psoriatic arthritis have large enough populations where drugmakers can easily deliver their messages to patients through DTC advertising or other marketing channels.
"TV is very good for establishing product brand awareness, online advertising is better for a more nuanced discussion of what I expect as a patient, what my needs are. In print, a lot of people are still reading magazines," Lilly's Salzmann said.