Harrison and Star

Harrison and Star may have marked a victory of sorts for the status quo during Mardene Miller’s first full year overseeing day-to-day operations at the agency—but that doesn’t mean that there aren’t changes afoot.

Named president of the Omnicom shop in May 2012 after a stint as one of three SVP/managing directors, Miller replaced Ty Curran in the role. He remains CEO of Medical Specialist Communications Group, which comprises H&S and sibling Biolumina.

Tops on her to-do list, Miller told MM&M at the time of the transition, was not to fix what wasn’t broken. And that’s how she’s approached things. “Our model focused on the specialist has proven to be very successful for us, and we’ve continued on that path,” she says.

As everyone knows, that model was set in motion decades ago by agency founder Larry Star, who “had wonderful foresight in creating our mission and position to be the specialist agency, and that has continued to lead to unprecedented growth for us,” says Miller.

While most of its promotional work is still oriented toward HCPs, the agency now handles a fair amount of direct-to-patient—which is distinct from DTC in that the target audience is people currently on treatment, vs. consumers who don’t even know they have the condition. The DTP business can entail working on adherence or other strategies, like getting them to stay on treatment or switch to another.

Probably its largest-scale DTP effort involves helping long-time client Teva Neuroscience roll out a 40mg, three-time-a-week version of injectable MS drug Copaxone to doctors and patients. Miller considers this H&S’s greatest achievement last year. “That was a very good match for us,” she says of the work marching the conventional patients over from the daily to the threes-time-per-week version. “When looking at the population of patients on Copaxone, probably the lion’s share have converted over to the new formulation.”

Teva’s patient outreach system and conversion efforts have drawn praise from analysts as well. As for the legacy brand, H&S does all the patient promotion for the original Copaxone, and its popularity continues.

US sales reached $3.7 billion last year, up 6%, despite its pending generic status and a slew of competitors. The firm lost a suit earlier this year that could have delayed patent loss on the 20mg version.

Having overcome several early challenges in its launch, Copaxone has “been able to continue [with] such tenacity and become a number-one product as an injectable in an emerging oral market,” Miller says.

“Not that we don’t love working on novel innovative products—it’s what we do best,” she continues, “but to be able to work on a product like [Copaxone] that’s had problems [early on] with differentiation…[and] did not have everything going for it and yet still prevailed, I’m proud of it.”

Another DTP-related piece of business the agency worked on last year involved leukemia blockbuster Gleevec and its successor, Tasigna. As part of its work for Novartis Oncology, H&S has handled digital and CRM sales force work, US and global, for both drugs.

With the older brand’s generic status looming, Miller’s crew is helping convert patients over to Tasigna through a new marketing campaign and digital tools. “We see momentum continuing there, as well,” she says. Tasigna US sales rose 22% to $428 million last year. Novartis recently won a patent case giving the older drug an extra year of branded life.

Its other big piece of cancer-related business is handling Genentech’s bio-oncology pipeline, as well as working on several in-market brands like Avastin, whose US sales rose 3% to $2.7 billion in 2013. One product candidate that H&S was able to retain recently is cobimetinib, a MEK inhibitor being tested for melanoma in combination with Zelboraf, which happens to be another member of the H&S roster.

“We’ve had [Zelboraf] for years, so it was a natural transition for us to manage [HCP promotions on] both products,” says Miller.

H&S also picked up new HCP work for Gilead’s idelalisib, a targeted, oral inhibitor of PI3K delta for treating refractory indolent non-Hodgkin’s lymphoma. It’s undergoing FDA review with a PDUFA date slated for September. Another cancer assignment came from Eisai for Halaven, a chemotherapy for breast cancer for which the agency won HCP and patient website work.

Also coming on board last year was new client Hetlioz, Vanda Pharmaceuticals’ recently approved treatment for non-24 hour sleep-wake disorder, which affects up to 70% of people who are totally blind.

While Merkley is responsible for the TV commercials currently airing, Miller says H&S is handling physician promotion. Hetlioz is the first FDA-approved therapy for non-24, so most of the 2,000 sleep doctors have never treated the condition, Vanda has said.

The challenge, says Miller, is to identify the right specialist to communicate with. There are no “blind-ologists” out there, she says. “We have to figure out who treats these patients, and that’s challenging.” PCPs and ENTs are also part of the focus.

Meanwhile, work continues on the hematology side. H&S executed a campaign for Bayer HealthCare Pharmaceuticals hemophilia product Kogenate aimed at keeping young men on therapy. Illustrating the agency’s depth, it also handles all of the drugmaker’s consumer care products that are promoted to specialists, like aspirin and some of the other more pediatric-focused products for Bayer HealthCare Consumer Care.

H&S executives, historically, have kept financial information very close to the vest, meaning no specifics regarding performance. In keeping with that tradition, Miller declines to give an estimate of last year’s growth in either revenue or headcount, other than confirming sales are in the $50-million-to-$100-million range.

“We had a fantastic year with meeting really important milestones, new talent coming on board in the creative department, and new structural changes that provided additional opportunities,” she says.

One sign of growth: the agency opened a London office. It follows offices started in Paris and San Francisco in 2012. The office is being headed up by Kirsten Kantak, an SVP/managing director at the agency who has taken on a global MD role.

Another area it ramped up in involved bringing on a new creative leader steeped in digital—SVP/executive creative director Brian Lefkowitz, who joined from inVentiv Health’s  Palio+Ignite last fall. “Brian brings amazing perspective to lead our creative department with an eye on digital as a core,” Miller says.

Sixty percent of H&S’s work is now digital. “It’s integrated into most of what we do at the agency,” she adds.

More recently, Mario Muredda was elevated to SVP/managing director at the agency and heads up all the oncology business. Miller also name-checks H&S’s strategy department, which is the product of combining several formerly silo’d disciplines into one.

The unit “has enabled us to take on different projects and greater depth of projects for clients,” she says, especially in the pipeline area, where it does early market-shaping.

Miller says the agency’s greatest challenge continues to be finding and retaining great talent. Next is giving clients value while working within budget constraints. “Procurement is playing a much bigger role in not only agency selection but scope of work, preparation and financial milestones,” she says. The key to avoiding commoditization? “It’s all about negotiations and having your brand champions behind you.”