For some biotech and pharmaceutical companies ready to send new drugs out into the world, the coronavirus pandemic has caused a shift in drug launch practices from face-to-face interactions to virtual communication.
First seen at the end of 2019 and designated a worldwide pandemic in March, the virus prompted widespread "social distancing" measures to quell the spread of the COVID-19 disease it causes. The resulting work-from-home policies and surge in video conferencing halted the traditional in-person visits pharmaceutical sales representatives pay to many doctors.
Aimmune Therapeutics Inc., which received U.S. approval for its peanut allergy drug Palforzia in January, was among companies attempting to introduce a new product amid the coronavirus outbreak.
On a May 11 earnings call, Aimmune CEO Jayson Dallas said it was shortly after the drug's launch that shelter-in-place orders went into effect, shutting down in-person allergist visits, and the company would see sales of Palforzia later than anticipated.
"Given that the initial dose escalation and the first dose of each new dose level of Palforzia need to be administered in the allergist's office, the overall impact had been a short-term pause in the ability of new patients to be initiated on commercial treatment," Dallas said. But the marketing team was still working to distribute information to allergists for when their doors reopened.
Stifel analysts once expected Palforzia to bring in $1.3 billion in worldwide sales by 2025, but reduced the estimate to $850 million due to a slow rollout even before the pandemic had reached its height.
Cantor Fitzgerald analyst Charles Duncan said in a June 8 note that the Palforzia launch, while delayed, would likely result in a net positive for Aimmune.
"We have enhanced conviction about the long-term revenue potential of Palforzia based on ... the even pace of adoption due to 'pent-up demand' when business practices become more 'normalized' in this COVID-19 inflicted world," Duncan wrote.
Larger pharmaceutical companies have also re-examined their launch strategies. Bristol-Myers Squibb Co. postponed the market entry of its multiple sclerosis drug Zeposia, which gained U.S. approval in March.
"We did so because at the time, the healthcare system was really just bracing for the impact of COVID-19, and within the MS community specifically, we were starting to see a pretty big impact on their ability to operate," Bristol-Myers Chief Commercial Officer Christopher Boerner said during the company's May 7 second-quarter earnings call. The company launched the drug June 1.
SVB Leerink analysts predicted in October 2019 that Zeposia would bring in worldwide sales of $174 million in 2020 and then $1.7 billion by 2025.
Pfizer Inc. saw a drop in sales of Vyndaqel, launched in November 2019 to treat the rare disease ATTR cardiomyopathy. The drug sold well after launch, Pfizer reported, but new patient starts fell as the pandemic worsened, CEO Albert Bourla said on the company's April 28 earnings call.
"Vyndaqel is a good example of a recently launched product that not only is highly dependent on new patient starts, but the diagnosis process also requires a doctor's office visit and subsequent diagnostic testing through additional office visits," Bourla said. "We anticipate a drop in new patient starts and are seeing that currently."
Vyndaqel brought in $231 million in first-quarter revenue, falling short of Cowen analyst estimates of $250 million.
The impact of the pandemic on a drug's launch has varied according to the type of medication, the disease it treats and the kinds of preparation undertaken by the company, two CEOs told S&P Global Market Intelligence.
Rare diseases still drive initial uptake
Dublin, Ireland-based Horizon Therapeutics PLC introduced its newest drug Tepezza after gaining U.S. Food and Drug Administration approval in January. Designed to treat a rare condition called thyroid eye disease, Tepezza's marketing was largely conducted leading up to the launch, Horizon CEO Timothy Walbert said in an interview.
"We spent 2019 out interacting with physicians, engaging patients and doing a significant amount of pre-launch communication and education around thyroid eye disease," Walbert said. "So a lot of those activities are what drove the strong initial uptake that we're seeing."
Tepezza brought in $23.5 million in sales in its first quarter on the market despite slowdowns from COVID-19, beating expectations and causing Horizon to raise revenue guidance on the drug to $200 million for the year. Originally, the company expected $30 million to $40 million in Tepezza sales for 2020.
Tepezza is also the first approved medicine for thyroid eye disease, and thus patients were already lined up, Walbert said.
"The patients have been willing to take action, get out and get treated," Walbert said. "If a physician's office is closed, we found an alternative place to get an infusion so they can continue getting their treatment."
Horizon still needed to get the word out, however, and Walbert said the biggest challenge surrounding COVID-19 was communicating Tepezza's science without face-to-face interaction. But deep pockets helped the company drive interest in the new treatment at the physician and provider level.
"Because of the success we have with our other businesses in driving significant cash flow, we were able to resource Tepezza the same as a large-cap pharma would, so we put over a hundred million [dollars] into the pre-launch effort, which really paid off faster than we expected," Walbert said.
Preparation for upcoming launches
Myovant CEO Lynn Seely
Myovant Sciences Ltd. CEO Lynn Seely told S&P Global Market Intelligence that remote marketing has taken a leap forward in a direction it was already headed — and faster than anyone anticipated due to the pandemic.
Basel, Switzerland-based Myovant is preparing to launch relugolix, a drug submitted to U.S. regulatory authorities for approval to treat prostate cancer in men and uterine fibroids in women. With anticipated launches in 2021, the company has had to handle its scaling up virtually rather than through traditional face-to-face interactions.
"The good news is physicians have embraced telemedicine and virtual interactions much more so than they ever have before, so this is a new way of communicating and interacting for them," Seely said. "It's really hastened and facilitated the move into this era of digital marketing and educating patients and providers in a more virtual, digital way."
Two factors give Myovant an advantage during these times, Seely said: Relugolix is administered in pill form, meaning patients can receive their medication in the mail rather than going to a physician's office. Also, because it is the company's first marketed product, there is no need to overhaul the traditional marketing experience, Seely said.
"As a smaller company, we're very agile," Seely said. "Because we're building our programs anew, it gives us an opportunity to really build our commercial organization and planning with that in mind, so I think in many ways it's an opportunity for us."
Seely said much of the future of drug launch preparation will be adapting to new ways of working.
"The new world is yet to be fully determined, but I think there's going to continue to be more virtual interactions, whether it's sales representatives or medical affairs representatives," Seely said. "Patients are also looking for easier, online ways through telemedicine to get their evaluations and their prescriptions."