Launch and COVID-19: Pharma’s Dilemma

Whilst both the FDA and the EMA have signaled a commitment to continuing day to day activities and flexibility in how advisory and committee meetings may function virtually, we are still seeing short-term postponements taking place. Planned meetings for April and May have been rescheduled by the FDA for June and new PDUFA dates have now been announced. Products affected by these changes include Roche’s risdiplam in spinal muscular atrophy (SMA) and Intercept’s obeticholic acid in non-alcoholic steatohepatitis (NASH).

The FDA has suggested multiple options for conducting virtual reviews, however as of April 13th it has not scheduled a virtual advisory committee. Some applicants may choose to delay in favor of having an in-person meeting due to concerns surrounding robustness of presentation impact and a lack of interactivity potentially affecting review outcomes. Further questions remain about whether the FDA can maintain its typical pace assessing applications. long-term separation among agency colleagues, travel restrictions for site inspection, and administrative prioritization of pandemic-related efforts could result in slower agency output. Officially, the FDA has not signaled any specific impact on existing user fee goals, but products with fee goals between April and July (of which there are 48 in total) are most likely to be impacted.

Changes to how medicine is practiced during the pandemic, as well as an upending of the promotional and educational activities usually undertaken, create challenges for products set to launch in the coming months. These challenges include:

These challenges will be most acutely experienced by products launching in a competitive space where satisfactory alternatives exist, as well as products from small-cap biotechs with less marketing experience and smaller promotional budgets. On the flipside, drugs for life-threatening diseases that have few other options on the market would be more protected from launch disruption. In most cases we expect launches are likely to underperform relative to pre-pandemic expectations, with a much flatter uptake curve expected over the next 6 months.

Whilst we are likely to see some delay in launches in April and May as pharma grapples with disruptions to normal commercial and promotional activities, we expect many companies will resist more significant delays to their launch plans. Why? Because the patent clock is still ticking and there is little certainty around when disruptions affecting the launch environment will improve.

Products highly reliant on in-person diagnostics, administration or monitoring are more likely to consider delays in commercial launch. Similarly, larger companies with more cash flow security are better positioned to take a longer view on launch timing and may be willing to delay by a quarter or more if they calculate a significant improvement in launch conditions.

Looking at examples of how companies are adapting, Biohaven, who launched an oral CGRP migraine therapy rimegepant right before the pandemic hit the US, are trying to stay nimble and have revamped their marketing tactics through use of webinars, telemedicine, DTC and social media tactics. On April 7, Biohaven announced its recent collaboration with Cove, a telemedicine company, to facilitate remote evaluations for migraine sufferers in lieu of in-office visits and to boost patients’ access to rimegepant. However, despite these efforts, a recent survey noted that neurologists remain hesitant in modifying patients’ migraine treatment regimens and will likely not be utilizing rimegepant due to lack of experience with the product.

In contrast, BMS has taken the decision to delay launching ozanimod for the treatment of relapsing multiple sclerosis. This decision gives BMS a better opportunity to maximise impact of launch, though it also provides existing therapies in the MS market such as Novartis’ Gilenya and Mayzent more time to prepare for the competition.

The impact of the COVID-19 pandemic has undermined months of launch planning, introduced complications and delays into the regulatory process, and severely constricted promotional and educational opportunities for new products. Investment in digital and virtual launch strategies are likely to produce interesting innovations but are unlikely to fully replace in-person channels. This constraint on KOL and prescriber engagement combined with continuing disruption within healthcare practices are likely to dampen interest resulting in sub-optimal launch performance for all but the most innovative new medicines. We anticipate that many new products will attempt to relaunch post pandemic, but the success of such a strategy will vary greatly depending on the specific competitive dynamics.

In the meantime, questions also persist as to supply chain stability and manufacturing prospects for both foreign and domestic drugmakers, given the FDA’s notice that most routine and pre-approval manufacturing facility inspections will be postponed through April. In future commentary on the impact of COVID-19 on the biopharmaceutical industry, Deallus will look to assess the stability of the supply chain, and how manufacturing constraints and shipping of APIs, excipients, and finished drug products may impact companies, payers, HCPs, and patients.

References

1. https://www.ema.europa.eu/en/human-regulatory/overview/public-health-threats/coronavirus-disease-covid-19#impact-on-ema-activities-and-meetings-section
2. https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-10/guidanceclinicaltrials_covid19_en.pdf
3. https://pink.pharmaintelligence.informa.com/PS141893/As-US-FDA-Settles-Into-Teleworking-Will-Application-Reviews-Be-Affected
4. https://pink.pharmaintelligence.informa.com/PS141974/US-FDA-Exploring-Virtual-Advisory-Cmtes-Might-Sponsors-Want-To-Wait-For-InPerson-Meetings
5. https://www.pmlive.com/pharma_news/lilly_suspends_most_clinical_trials_as_covid-19_disruption_continues_1329884
6. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-focuses-safety-regulated-products-while-scaling-back-domestic
7. https://seekingalpha.com/article/4334888-bristol-myers-ozanimod-approval-and-news-good-bad-and-ugly-of-biopharma
8. https://www.fiercepharma.com/special-report/10-most-anticipated-drug-launches-2020
9. https://microsmallcap.com/rockwell-medical-fda-approval-rmti-stock-growth/
10. https://www.ema.europa.eu/en/human-regulatory/overview/public-health-threats/coronavirus-disease-covid-19#impact-on-ema-activities-and-meetings-section
11. https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-10/guidanceclinicaltrials_covid19_en.pdf
12. https://www.roche.com/media/releases/med-cor-2020-04-07.htm