Launching a new drug is an arduous task even in the best of times. Drugmakers build their commercial teams from scratch, spending months of effort and huge sums of money to ensure their med reaches as many physicians, patients and payers as possible.
Add a global pandemic to that challenging situation, and companies are faced with one of two options: Adapt or fail.
In the early months of COVID-19, drugmakers Esperion, Horizon, Eisai and Clarus, among others, faced that unexpected hurdle to bringing their drugs to market after years of planning and millions of dollars invested.
For two, Esperion and Horizon, the pandemic was the backdrop—and often the driver—for unexpected success for their novel therapies. In the case of Eisai and Clarus, the pandemic hit like a hammer, leaving both drugmakers scrambling for answers to the new challenge.
These tales of hardship, adaptation and sometimes success underscore the pharmaceutical industry's need to quickly pivot to new ways of communicating during extraordinary circumstances. They also may reveal a new path forward for drugmakers in the uncertain future of global pandemics and, potentially, rolling waves of lockdowns.
Here are their stories.
Esperion: Nexletol and Nexlizet
After nabbing back-to-back FDA approvals for their lipid-lowering game-changers Nexletol and Nexlizet in February, Michigan-based drugmaker Esperion planned an aggressive launch to take the fight right to its pricey PCSK9 class rivals.
Esperion's plan was simple: The drugmaker would launch Nexletol (bempedoic acid) on March 30 to set the stage for combo therapy Nexlizet (bempedoic acid and ezetimibe, also known as Zetia) to hit the market in July. The company would rely on its 300-strong sales team to reach as many physicians as possible and grease the wheels for the more effective combo's launch.
Then, COVID-19 struck with only weeks to go before Nexletol took the stage. Facing a full-scale commercial pivot to digital, the only option off the table was delaying the drug's March 30 launch date, CEO Tim Mayleben said.
"There was never a question about whether we were going to launch at that time," Mayleben said. "The question internally was 'how do we adapt?'"
Luckily, Esperion had adopted digital outreach tactics before the pandemic. The company tasked its field managers with migrating the company's promotional materials online and leaning into virtual meeting platforms like Zoom and Veeva Engage to replace face-to-face interactions with physicians.
That shift didn't happen overnight, Mayleben said. In fact, it took nearly a month post-launch to roll out all the digital tools needed to reach out to physicians effectively. That meant painstakingly building an outreach effort: The company went from a few hundred live engagements each week with physicians early on to a few thousand now, Mayleben said.
But one portion of that arduous effort came with an unexpected result. Esperion launched a virtual speaker series in the last week of April that gave doctors an opportunity to hear more about Nexlizet's pending launch. Not expecting a huge turnout, Esperion was shocked to see enormous attendance numbers for those sessions—five times the number other drugmakers were getting for similar events, Mayleben said—underscoring an immense interest in Nexlizet's clinical efficacy.
"We have been absolutely stunned at how successful that has been," Mayleben said.
With doctor feedback pouring in from the series, Esperion accelerated its launch plans for Nexlizet, taking the drug to market in early June—a month ahead of schedule. The decision wasn't an easy one, but after Esperion confirmed doctors' interest and the ability of its supply chain to keep pace, the drugmaker ultimately decided Nexlizet was "the right drug at the right time for physicians and patients."
With lockdowns easing across the board, Esperion's sales team is beginning to return to normal—or as close to normal as possible—but the company's pivot to digital outreach likely won't be going anywhere, Mayleben said.
Having a "nimble" corps of territory managers who are well-versed in virtual outreach tools and equipped with digital promotional materials will remain a high priority in a blended commercial future, Mayleben argued.
"This is our make-or-break moment so we have to be inventive, and that inventiveness makes us more patient-focused," Mayleben said.
Horizon Therapeutics: Tepezza
Horizon Therapeutics, once a company known for the unsavory practice of buying older meds and dramatically raising their prices to turn a profit, has trumpeted a plan in recent years to pin its future on a small stable of successful rare disease drugs.
One of the centerpieces of that plan is Tepezza, a bulging eye drug with blockbuster aspirations approved by the FDA in January.
Tepezza launched immediately after that approval, scoring a six-week head start on the pandemic before its commercial team of 100 was sidelined. For CEO Tim Walbert, that meant making an immediate shift to virtual outreach and helping existing patients find access to clinical sites to receive their Tepezza infusions, even as cities and states were locking down.
"Everything you do is fundamentally changed," Walbert said. "The question you face is 'have you built the right relationships?' If you haven't, having that dialogue about your drug's benefits [to] patients—you’re going to be chasing without a lot of success."
Despite facing a huge hurdle that early into Tepezza's launch, Walbert acknowledged that just six weeks on the market up front helped in getting initial patients on the drug. Unexpected, however, was how popular Tepezza would be so early into its launch.
Once projecting between $30 million and $40 million in Tepezza sales in 2020, Horizon has now upped its forecast to around $200 million in sales in the first year alone. Even that eye-popping increase is only a fraction of what Horizon believes it could have achieved if COVID-19 hadn't happened.
"We were still able to drive an amazing launch—without COVID-19, we may have been able to do $500 million in first-year sales," Walbert said.
Having digital promotional materials ready to go before the pandemic gave Horizon reps the ability to quickly pivot to virtual outreach, but existing relationships with doctors and enthusiasm for the drug's results also paved the way for a successful first six months, Walbert said.
Now, with its reps beginning to venture back out in the field, Horizon is leaning on those same physician relationships to chart the best path forward.
"We’re having to redefine and work with each individual physician and ask, 'what is the best way to communicate?' Walbert said. "We’re going and having our reps build a plan for each of our physicians to figure out how we can best serve them."
Eisai had its work cut out for it in marketing its recently approved insomnia med Dayvigo, a DEA-scheduled drug launching in a market full of generic competitors.
Dayvigo notched its FDA approval in December but was forced to hold back its launch until DEA scheduling came through in early April—right in the heart of the COVID-19 pandemic. Unlike other drugmakers that stuck to their launch dates, Eisai decided to postpone the rollout until June 1.
That drastic decision effectively sidelined Eisai's 250-strong commercial team and put the drugmaker nearly two months behind schedule on its physician and consumer outreach, and education campaigns. According to Ivan Cheung, CEO and president of Eisai's global neurology business, the decision was all about "sensitivity" to physicians' role in fighting COVID-19.
"From our commercial launch preparation, we’ve been ready for a late March launch for a long, long time," Cheung said. "It’s nothing to do with readiness; it’s really about sensitivity during the COVID-19 pandemic. We have to be a responsible corporate citizen."