High-profile candidates challenge marketers well in advance of launch

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With pharma facing ongoing scrutiny of its pricing practices, medical marketers are increasingly asked to demonstrate the superior value of new therapies. It shouldn't come as a surprise, then, that three closely watched, much-hyped drug candidates are attempting to eke out a competitive edge in the eyes of prescribers and insurance providers.

In immunology, Biogen's Phase II monoclonal antibody BIIB059 has generated plenty of buzz.

In the oncology sector, Incyte is drumming up attention with epacadostat, deployed in concert with Merck's Keytruda. Outside the limelight of the CAR-T craze, checkpoint inhibitors represent a surging segment of the oncology market as drug developers race to find combinations that improve on the success of PD-1 and PD-L1 monotherapies.

Meanwhile, the quest for a non-addictive opioid alternative has the industry eagerly awaiting Phase III data for tanezumab, a chronic pain candidate from Eli Lilly and Pfizer. In the highly charged arena of pain management, medical marketers will need to unfurl a transparent campaign that inspires confidence in tanezumab's safety profile.

The marketing of novel drugs such as BIIB059, tanezumab, and epacadostat and Keytruda will increasingly rely on physician confidence in clinical research programs — especially given that none of the three drugs will likely spur a massive direct-to-consumer ad campaign. For many KOLs, the ink is dry even before FDA approval.

Providing a transparent and competitive data package goes a long way toward convincing providers to prescribe and insurance companies to reimburse.

“As insurers merge and gain more power, they are going to have just as much say in medical marketing” as providers, notes Richard Meyer, principal at Strategic Marketing Solutions.

BIIB059
Biogen, Phase II
Indication:
Lupus

Catalyst: It's been more than seven years since the approval of Benlysta, GlaxoSmithKline's lupus drug. Now, a new generation of drugs is poised to enter the market and the mechanism of action of Biogen's BIIB059 has captured the industry's attention. “Type I interferons are crucial to lupus pathology, and BIIB059 appears to target those cells directly,” says Ben Weintraub, president of inThought Research.

Competitive landscape: BIIB059's Phase Ib data impressed with evidence that a single dose successfully inhibits interferon-responsive genes without any serious adverse events. Although Biogen's Phase II candidate trails AstraZeneca's anifrolumab, already in Phase III, BIIB059 may have a competitive edge because its research program uses an endpoint preferred by many rheumatologists.

Meanwhile, there's evidence some BIIB059 recipients could start to see improvement within four weeks, which is welcome news for patients and physicians seeking a faster alternative to Benlysta.

Messaging strategy: Differences in trial design among late-stage lupus candidates “leave a window of opportunity for Biogen,” explains Heartbeat managing director Nadine Leonard. She notes anifrolumab may “not quite be the savior rheumatologists are seeking.

“The primary endpoint used in both [anifrolumab's and Benlysta's] clinical trials is a non-validated composite endpoint that has polarized rheumatologists and created doubts about efficacy.” Biogen must clearly communicate that distinction to clinicians as part of its messaging strategy, Leonard adds.

Marketing strategy: If the Phase II and Phase III data is as impressive as the Phase Ib data, Biogen might choose to position BIIB059 as the “go-to lupus treatment,” Leonard notes. Biogen could “parallel the launch of anifrolumab with an unbranded effort that subtly seizes on the weakness of their competitor's data and encourages rheumatologists to wait for better alternatives.”

This effort could include KOL roundtables about what is needed from clinical trial output to inspire confidence, or even a general Biogen campaign that shows its commitment to finding ways to treat lupus safely and effectively.

On the branded front, Biogen could follow up with a campaign that highlights its trial data and references the unbranded messaging by proclaiming the wait is over for an effective lupus treatment.



Epacadostat/Keytruda
Incyte, phase III
Indication:
Advanced melanoma

Catalyst: Phase III data for epacadostat and Keytruda in advanced and metastatic melanoma is expected by the first half of 2018 — and according to Chantal Bayard, division manager, health, GfK Switzerland, many observers expect the data to be positive. “The hype around Incyte and epacadostat was evident at last year's ASCO conference, where much of the talk among attendees centered around this company and its portfolio.

“Almost nine months later, many physicians continue to be excited,” she adds.

Competitive landscape: Based on interim data from the Phase III program, some are predicting epacadostat and Keytruda will prove a safer option than the Yervoy and Opdivo combination, which is also being tested in advanced melanoma. Although there are no comparative studies, an Incyte spokesperson says targeting IDO1 could potentially “augment the immune response” to anti-PD-1 and PD-L1 therapies. “We have observed a lower rate of severe immune adverse events when epacadostat is combined with [Keytruda] or [Opdivo], compared to reported series of patients treated with [Yervoy] and [Opdivo].”

There's a lot riding on the Phase III melanoma trial. Bayard explains many experts believe the readout will serve as an important proof of principle for the half-dozen other oncology indications currently being tested, especially bladder cancer.

Messaging strategy: In the world of checkpoint inhibitors, Keytruda and Opdivo remain the heavyweights. For a variety of reasons, many oncologists “are either going to be in Merck's corner with Keytruda or BMS' with Opdivo,” Meyer says.

So when it comes to messaging, the combination approaches will likely engage in what Meyer describes as a “fight for share of mind with oncologists.” The seemingly superior safety profile of epacadostat and Keytruda could ultimately prove a huge advantage.

Marketing strategy: Oncologists are particularly active online and remain voracious consumers of medical journals, Meyer notes. Pre-approval marketing efforts should thus focus on regular briefings that highlight new data, high-profile presences at oncology conferences, and the deployment of KOLs to present major findings.

Also, after a drug is approved, companies touting new combination approaches could benefit from working with medical liaisons, who have more liberty to talk with doctors about off-label use.

Tanezumab
Eli Lilly/Pfizer, Phase III
Indication:
Chronic pain

Catalyst: Tanezumab, a nerve growth factor inhibitor, is being tested in six Phase III trials of patients with osteoarthritis, chronic lower back pain, or cancer pain who did not experience relief with approved therapies. Despite a 2010 clinical hold, the drug landed fast-track designation from the FDA in 2017.

Eli Lilly and Pfizer expect data from the first of those Phase III studies later this year, according to a spokesperson. Given that the drug has been touted as a non-addictive pain medication, physicians are watching tanezumab closely.

Competitive landscape: It is estimated that there are more than 27 million Americans living with osteoarthritis and 23 million living with chronic low back pain.

Meanwhile, mounting restrictions on opioid prescriptions mean chronic pain patients are in need of new options. According to a statement from Eli Lilly and Pfizer, “tanezumab does not act on opioid or benzodiazepine receptors or other targets associated with abuse, addiction, or dependence.”

A non-addictive option would enjoy a major advantage over existing chronic pain medications. “The market could be huge for them,” Meyer says.

Messaging strategy: While Leonard states physicians are “highly motivated to find opioid alternatives,” she cautions “there may be hesitancy to jump on tanezumab because of the hold the FDA put on it several years ago for potential safety issues.” However, Lilly and Pfizer could surmount this concern with superb safety data in Phase III and effective communication with physicians about the drug's safety profile. According to a spokesperson, the two companies have already been “convening meetings to review the research program and obtain input from key scientific, healthcare delivery, and pharmacy experts around the world.”

Marketing strategy: Leonard stresses tanezumab “likely can't rely on the nation's opioid epidemic to drive demand.” Rather, she suggests its clinical profile “will need to inspire confidence.”

“A unique way to do this at launch would be to document a case study of the drug's adoption in a geographic location that has been deeply affected by opioid abuse,” she continues.

“To support physicians in these areas,” Leonard says, “Lilly and Pfizer could offer one-to-one physician education on both the unfamiliar mechanism of action and the safety profile, [with a] focused look” at patient and community effects of the drug. Of course, considering how politically charged the notion of opioid advertising has become, Lilly and Pfizer should tread carefully when considering a DTC campaign, Meyer adds.

This story has been updated to clarify the number of Americans living with osteoarthritis and chronic back pain.
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