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 thatunexpected hurdle to bringing their drugs to market after years of planning and millions of dollars invested.
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For two, Esperion and Horizon, the pandemic was the backdropand often thedriverfor 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 talesof hardship, adaptation and sometimessuccess underscore the pharmaceutical industry's needtoquickly 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.
After nabbing back-to-back FDA approvals for their lipid-lowering game-changers Nexletol and Nexlizet in February, Michigan-based drugmaker Esperion planned an aggressivelaunchto takethe fight right to its pricey PCSK9 class rivals.
Esperion's plan was simple: The drugmaker wouldlaunch 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 greasethe 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'sMarch 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?'"
RELATED:Esperion scores FDA nod for cholesterol-buster Nexletol
Luckily, Esperion had adopteddigital outreach tactics before the pandemic. The companytasked its field managers with migrating the company'spromotional 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 nearlyamonth 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 sessionsfive times the number other drugmakers were getting for similar events, Mayleben saidunderscoring an immense interest in Nexlizet's clinical efficacy.
"We have been absolutely stunned at how successful that has been," Mayleben said.
RELATED:Esperion notches 2nd FDA approval with cholesterol-lowering combo Nexlizet
With doctor feedback pouring in from the series, Esperion accelerated its launch plans for Nexlizet, taking the drug to market in early Junea 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 normalor as close to normal as possiblebut 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-versedin 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, once a company known for the unsavory practiceofbuying older meds and dramatically raising their prices to turn a profit, has trumpeted aplan 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, scoringa 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 thatdialogue about your drug's benefits [to] patientsyoure going to be chasing without a lot of success."
RELATED:Horizon notches blockbuster FDA approval for rare eye disease med Tepezza
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 launchwithout COVID-19, we may have been able to do $500 million in first-year sales," Walbert said.
Having digitalpromotional materials ready to go beforethe 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 itsreps beginning to venture back out in the field, Horizon is leaning on those same physician relationships to chart the best path forward.
"Were having to redefine and work with each individual physician and ask, 'what is the best way to communicate?' Walbert said. "Were 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 approvedinsomnia 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 untilDEA scheduling came through inearlyAprilright in the heart of the COVID-19 pandemic. Unlike other drugmakers that stuck to their launch dates, Eisai decided to postpone the rolloutuntil 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" tophysicians'role in fighting COVID-19.
"From our commercial launch preparation, weve been ready for a late March launch for a long, long time," Cheung said. "Its nothing to do with readiness;its really about sensitivityduring the COVID-19 pandemic. We have to bea responsible corporate citizen."
RELATED:Eisai preps for launch with insomnia med Dayvigo after buying out Purdue
However, Eisai said it began to hear from physicians who felt the pandemic madeadequate sleep even more important as lockdowns added pressure to patients' daily schedules.
Reason enough, Eisai thought, to move ahead with the Dayvigo launch. Now,it's working with physicians to establish communication moving forwardand doctors were fine with the high-tech approach.
"What we found is that, given the impact on sleep health, theres a lot of enthusiasm," said Tushar Patel, Eisai's executive director and global lead of sleep-wake disorders in the neurology business group. "The majority of physicians weve spoken to are not only interested in learning about the new medicine, but theyre very open to receiving information digitally."
Eisai has also leaned into its digital outreach to consumers for Dayvigo, hoping to establish a place in an insomnia market jam-packed with generic competitors andMerck & Co.'sBelsomra brand, which hit the scene in 2014.
That outreach plan includes Eisai's "Dayvigo Together" online campaign to connect patients with live nurse educators to help them understand their insomnia symptoms and assess whether Dayvigo could be an effective treatment for them.
Being a huge, global drugmaker comes with some obvious benefits during a pandemic, including the sheer resources to weather the storm. But size isn't everything in times of crisis, a lesson that Clarus Therapeutics learned well in the early months of COVID-19.
Clarus, the maker of oral testosterone replacement tabletJatenzo, had a long road to market: The drug'sFDA approval in April 2019 capped off an arduous, years-long clinical development program, CEO Bob Dudley, Ph.D.,said. And then it had to gear up for launch.
With those past challenges in mind, Jatenzo's February rollout plans represented a big milestone not only for Clarus, but also forDudley, who developed AndroGel's topical formula as CEO at Unimedand is now a big believerin Jatenzo's place in the testosterone replacement field.But just as the launchgotunderway, COVID-19 struckhard.
"[Launching a new drug] isa challenging task, and it turned out to be a lot more challenging than I thought," Dudley said.
RELATED:As COVID-19 social media fatigue sets in, pharma begins to restart other health conversations
Clarus' commercial team of 55 was immediately tasked with unlearning their training in face-to-face physician meetings and pivoting to virtual. For any company, that's a tall task, butClarusmade that shift with remarkable speed, Dudley said.
In the space of a single weekend, Clarus' team came up with a game plan to amp up its digital outreach and get back in front of physicianshungry for new options in testosterone replacement therapies.
"We had all of these well-trained, motivated people with a great message to deliver tohealthcareprofessionals," Dudley said. "It necessitated pivoting on a dime and figuringout how we were going to maintain some semblance of a normal launch."
Speaking to doctors virtually wasn't as easy as showing up at their offices,Dudley said, and often requirednot only educating Clarus' team to use virtual meeting technology but also doctors themselves.
"In some cases, they didnt know how to do it," Dudley said of physicians using meeting technology."We found ourselves not only communicating the message of Jatenzo, but we also had to become experts in that side of it as well.
"The flip side of that was physicians, when they embraced the technology, then we found that they were keenly interested in learning about something new."
Now, after the storm of those early months, Clarus is making the shift back to face-to-face conversations, and Dudley said his team has moved with the same sense of purpose and "nimbleness" that allowed it to succeed during the lockdowns.
What will happen in an uncertain future is still unknown, but Dudley said the lessons learned during the lockdown helped his team preparefor a "blended" commercial future.
"In this environment, you have to be nimble," he said."This is why I think weve been able to maintain forward momentum when it could have justcrashed and burned."
