Drug launching during Covid 19 time

Pharma companies are making tough decisions as the coronavirus pandemic becomes the sole focus for nearly every major drugmaker and government regulator.

Clinical trials are suspended, sales reps are benched, drug launches are reevaluated.

Some companies have decided to delay drug launches altogether, while others are forging ahead during this uncertain time.

The delayed launch

Bristol Myers Squibb was one company making these decisions. Its multiple sclerosis drug Zeposia won approval from the Food and Drug Administration (FDA) in late March, right as the coronavirus crisis ramped up in the U.S.

When the company announced the approval, it also announced that the treatment launch would be delayed due to the pandemic. Tina Deignan, VP of immunology at BMS, said taking into account patient, provider and BMS employees’ health, it was “not the right time” to launch the treatment.

“First, we partnered closely with the neurology community, physician level advisors and patient advocacy groups, to understand the change in patient care that was happening in the MS community, the shift to telemedicine” Deignan said. “We asked, what would a launch look like in the context of an emergency pandemic for our company? Looking at what it means for our employee base and with our primary focus on the health and wellbeing of patients and employees base. We decided this is not the right time to launch a new drug in the MS space.”

That decision came along with broader stay home orders that forced many companies to begin remote work. But Deignan said the launch teams didn’t miss a beat. The marketing launch meeting was quickly switched to a virtual meeting, an early sign that the move to digital was going to be smooth.

Without a launch to execute, the Zeposia marketing team is still planning for the launch at a later time, Deignan said, while juggling digital engagement with doctors and MS patients.

“We’re not completely dark as related to educating the community,” Deignan said. “We’re putting some of our promotional messages into the digital space. We’ve chosen to delay the launch, but we’re still engaging the community to ensure they understand what Zeposia brings, what the data looks like and address the patient needs.”

That includes engagement through Zeposia’s website and some virtual programs for healthcare providers (HCPs). BMS is also continuously gathering insights from the community during this time, to help inform their decisions about the product going forward and about the type of engagement or education patients and HCPs need.

“We’re also conscious that physicians may be in a space where this isn’t the most relevant right now because of COVID-19,” Deignan said. “We need to get the balance right.”

The response from the MS community to delay the launch, however, was “almost universally positive,” she adds.

When the drug does finally hit the market, it may be well-suited to the new normal, Deignan said. BMS does not yet have a specific timeline for the Zeposia launch, noting that they’re keeping an open mind during an uncertain time.

“The excitement of the team about Zeposia has not abated one bit,” Deignan said. “We will be the only therapy that doesn’t require testing. So when we return to our new normal, that will allow physicians to treat patients in a more straightforward manner, without having to send them to other places to get tests done. It could be an interesting offering, assuming we return to a world where people are more cautious.”

The altered launch

For Clarus Therapeutics, a men’s-health focused pharma company, the launch of its new product came just weeks before the coronavirus crisis shuttered the U.S.

Clarus launched Jatenzo, a testosterone replacement pill for men, in mid-February. At that time, there were only a few isolated cases of COVID-19 and the outbreak had not yet gotten a foothold in the U.S.

Once hospitals and doctor’s offices began not accepting sales reps, the team at Clarus made a quick switch to virtual.

“We had to quickly pivot, we literally pivoted within three days,” said Frank Jaeger, chief commercial officer at Clarus. “We pulled our reps on a Thursday and by Monday all materials were approved through medical regulatory legal and submitted to FDA for first use. On Tuesday, our reps were out there able to virtually educate doctors. Three days after pulling them from the field.”

Jaeger said the team didn’t have much of a choice to delay that launch because the product hit the market about four weeks before stay home orders and other restrictions began affecting the U.S.

So the launch pivoted to digital-only. Sales reps met with doctors virtually and Clarus signed up to present data at future virtual medical meetings, Jaeger said. The company also shifted investment from in-person events for doctors to more virtual education programs and a virtual speakers bureau.

An important factor to this launch was ensuring that the HCP audience had the bandwidth for this virtual education. Because Jatenzo is prescribed by specialists, these doctors had switched to seeing patients virtually and were not necessarily swamped with coronavirus concerns.

“We talked to HCPs to understand from their perspective, if we were to provide virtual education, is it going to appear insensitive?” Jaeger said. “Prior to this, they didn’t have bandwidth for virtual programs, but now’s the right time. Our HCP audience was quick to point out they had time for education because they are not on the frontlines for COVID-19.”

Clarus went into the launch focusing only on doctor education, but the switch to digital also freed up additional resources for patient education. The company began an effort to educate patients of its targeted HCPs using programmatic advertising and geofencing.

While the coronavirus significantly changed Clarus’s original launch strategy, the company was able to shift quickly and continue its launch.

“The difference between big pharma and smaller companies is big pharma is good at the ability to execute, but smaller companies have a leg up because they can pivot more quickly,” Jaeger said. (Ver)