In a drug's lifecycle, the first 6-12 months after launch are critical for overall success. After years of R&D, the days until patent expiry are counted and the medical community needs to quickly learn about the new drug's benefits. Until early 2020, this largely happened at medical congresses and through MSLs visiting doctors. Then, COVID-19 came along and face-to-face interactions had to be reduced to a minimum. Doctors were hardly seeing their patients, not to speak of pharma MSLs or reps. Congresses were canceled.
Now, in fall 2020, it is a good time for an interim assessment. The news is out on multiple launches stalling, and we've listed six of them below. Later in the post, we want to understand common challenges and sketch out ideas on rethinking launch strategies for the “new normal”. With the second wave of COVID-19 just hitting, it very much looks like we may never go back to the “old normal”; the pandemic may well last long enough to change our behavior and communication patterns forever.
Six drug launches delayed and disrupted by COVID-19
Understandably, drug launches planned for late Q1 and Q2 were hit the hardest, as pharma companies scrambled to adapt to the pandemic, and evidence is still patchy for Q3 launches. While some companies delayed the launch completely, others went through but found their sales expectations smashed.
Ongentys (Neurocrine Biosciences) for Parkinson’s disease
Neurocrine Biosciences was forced to delay the launch of its Parkinson’s treatment, Ogentys (opicapone), after it received FDA approval in April. The delay is predicted to lead to a slow first year, which Neurocrine will hope picks up and hits its predicted peak global sales of just over $300 million in 2025.
Sarclisa (Sanofi) for multiple myeloma
The FDA approved Sarclisa (isatuximab) as a new treatment option for patients with difficult-to-treat multiple myeloma in early March. Sanofi had high hopes that the drug would take a chunk of the market share from Johnson & Johnson’s Darzalex; however, a full launch was delayed in light of COVID-19. While Sanofi will still hope the drug reaches its predicted sales of around $500m by 2024, the continued growth of Darzalex – boosted by FDA approval for a subcutaneously injected formulation that reduces injection time from hours to minutes – makes playing catch-up all the more difficult.
Zeposia (Bristol-Myers Squibb) for MS
Bristol-Myers Squibb (BMS) was banking on undercutting Novartis’ Mayzent and extolling the virtues of a strong safety profile when the FDA approved Zeposia (ozanimod) in March. However, its entry into an increasingly competitive multiple sclerosis (MS) market, over which the threat from generics looms, was delayed until June in response to the pandemic. It remains to be seen how big an impact the delay will have on first-year sales, which some analytics predicted to earn as much as $91 million.
Rybelsus (Novo Nordisk) for type 2 diabetes
Although Novo Nordisk did a small-scale rollout of its oral type 2 diabetes medication, Rybelsus (semaglutide), in 2019, the company prepared a full field force team to go to market more aggressively in 2020 along with a European launch following EU approval in April. However, the launch “stalled” in response to COVID-19. In the end, Novo Nordisk was able to incorporate far more digital elements into the launch and provide educational materials in relation to COVID-19.
Zynteglo (Bluebird Bio) gene therapy
The European launch of Bluebird Bio’s gene therapy, Zynteglo (LentiGlobin), had already been delayed by EMA demands for changes to the manufacturing process when the pandemic struck. In January 2020, the company said it expected the deliver the first dose imminently in Germany; however, that timeline was revised to the second half of the year. The company was also forced to delay submitting the drug for FDA approval.
Even for drugs that have made it to market as planned, the pandemic has had a notable impact. Biogen has highlighted the pandemic as a major reason why its MS treatment, Vumerity (diroximel fumarate), has failed to live up to expectations, with conferences being canceled and doctors reluctant to adopt new treatments while the usual lines of communication were limited. As a result, from its launch in December until mid-2020, Vumerity had earned $16 million in sales, barely making a dent in the performance of the drug its predecessor, Tecfidera, which earned nearly $2.3 billion in sales in the first half of the year.
Challenge meets opportunity: Empowering HCPs and patients for the “new normal”
It is easy to attribute the examples above to pharma not getting access to HCPs. From our conversations with HCPs, we believe this ignores the root cause.
COVID forces HCPs to rethink all aspects of their communications. The experienced eye of a clinician often needs training and auxiliary tools to work in a remote setting reliably and efficiently. Zoom calls with pharma are the least of their concerns.
When we spoke to HCPs about newly launched medications, their biggest concern was about real-world tolerability. Having fewer check-ins with patients – or potentially skipping visits entirely in case of a lockdown – how would they know if the treatment works for the patient? In the absence of a reliable feedback loop with patients, and as long as the new launch does not address a major unmet medical need, many doctors rather prescribe tried and tested medications.
For pharma, this brings about a new success factor for launches: Minimizing the barrier to prescription in a remote setting. One major opportunity in this context is to provide offerings that guide patients during initiation and enable doctors to remotely understand patients’ experiences. It requires pharma to truly understand their doctors’ real-world challenges and to start thinking about solutions for doctors rather than “just” launching a drug. Those who succeed, will not only outperform the competition during COVID-19 and beyond, but also ensure patients getting as early as possible access to potentially life-saving or life-changing drugs.
COVID-19: An inflection point for the use of digital technology
The storm created by the COVID-19 pandemic has been a tough one to ride out for many pharma companies that found their launch budgets badly allocated to an environment that had changed almost overnight. Although many of the drugs listed here are still predicted to achieve their long-term sales forecasts, the short-term damage can be felt from not only a financial perspective but also in being forced to make patients wait for vital drugs and being unable to provide physicians with the necessary safety and efficacy information. It has highlighted the need for pharma to be better prepared to adapt to changeable conditions.
In our follow-up blog post, we will take a look at some of the drugs that launched on (and even ahead of) schedule despite COVID-19 and how the pharma companies behind them were able to utilize their digital capabilities to rapidly adapt to the pandemic.
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