Novel first launches had another great year in 2021, with 17 U.S. companies launching their first ever product. Six of these launches were approved in the last quarter of 2020. We spoke about the astonishing growth we observed in first launches between 2011 and 2018 in our blog post “First launch commercialization strategy: Go it alone or partner?” This trend has continued with 36 novel first launches in the last three years. (Note we look at US 505b2 first launches in a separate analysis).
Oncology continues to be the therapeutic area with the most first launches. Of the 83 novel first launches since 2011, 25 are oncology assets, and a significant proportion of these (~68%) are rare or orphan oncology launches. In contrast, there have been 27 rare (orphan) novel non-oncology first launches since 2011, representing ~33% of all novel first launches.
Interestingly, we see a notable increase in the number of first launches in the last five years. Almost three quarters (~73%) of the first launches from 2011-2021 launched in this period. The increase was mostly driven by more launches in the oncology and rare disease spaces. Specifically, 68% of novel oncology first launches occurred between 2017 and 2021, a significant increase compared to the 32% of first launches between 2011 and 2016. Rare launches between 2017 and 2021 saw an even bigger jump, with ~85% in that period compared to only 15% between 2011 and 2016. The FDA’s Orphan Drug Modernization Plan, which went into effect June 2017, streamlined the review process and created a 90-day review timeline goal for all orphan drug designation approval requests. This may be one factor contributing to the upward trend.
U.S. novel first launch companies overwhelmingly chose to go-it-alone (86%), while 14% co-promoted their assets with a partner. Co-promotion was more common for oncology assets compared to non-oncology rare disease assets.
Novel first launchers opting for co-promotion strategy are typically partnering with midsize and large pharma companies that have experience and existing commercial presence in the relevant indication or specialty area. For example, G1 Therapeutics and Boehringer Ingelheim (BI) entered into a three-year co-promote agreement in June 2020 regarding G1’s product Cosela in small cell lung cancer in the U.S. and Puerto Rico. As part of this collaboration, BI deployed their established lung cancer commercial team with 42 reps. To supplement these, G1 is planning to add another 15 reps, who will focus on top-tier accounts. Under the terms of the agreement, G1 retains all the global rights and will book revenues, while BI is responsible for sales force deployment and will receive initial start-up expenses along with YoY promotion fees from G1. This more capital-efficient launch structure may allow G1 to invest in further R&D programs while also allowing them to establish a commercial presence for future launches.
Of the novel 45% of U.S. first launches (37/81) subsequently also launched in Europe (U.K. included), 70% of those were in oncology and rare disease categories. Oncology companies tend to out-license in the EU, while more than half of the rare products go-it-alone.
Most U.S. first launch companies didn’t subsequently launch in Europe, likely due to a more challenging pricing and reimbursement environment. The majority of those that have launched in Europe out-licensed to a company with existing an European presence. For instance, in 2019, Puma Biotechnology licensed the European rights of Nerlynx, for HER2-positive breast cancer, to Pierre Fabre. Pierre Fabre has a strong expertise and commercial presence in the breast cancer space in Europe, and the company has so far launched the asset in Germany, U.K., Austria, Sweden and anticipates gaining access throughout Europe.
More than a third (38%) of novel U.S. first launch companies also launched their product on their own in Europe. This strategy may be most attractive when the asset has a differentiated value proposition addressing unmet needs that provides the potential for premium pricing. Products with focused target call points have lower commercialization investment requirements, and organizations seeking to build a commercial foundation for their future portfolio may also opt for this strategy. For instance, in September 2021, Albireo Pharma launched Bylvay in Germany. Bylvay is indicated for progressive familial intrahepatic cholestasis, a rare, life-threatening pediatric liver disease that currently doesn’t have any approved drug treatments. To promote Bylvay, Albireo established a modest field team in the EU to cover a limited number of call points treating this rare disease.
Many novel U.S. first launch companies have been subsequently acquired. With an average deal size of ~$10B, 36% of oncology first launches were subsequently acquired. Almost a quarter (22%) of non-oncology rare disease first launches were acquired, with an average deal size of $3-4B. Notable first launcher acquisitions that happened in recent years include Gilead’s acquisition of Immunomedics in 2020 for $21B and Merck's acquisition of Acceleron in 2021 for $11.5B.
There are 39 oncology and 36 rare disease companies that have late-staged assets in their pipeline, which will drive continued growth in novel first launches. The trend of innovation being driven by emerging companies and more acquisition by large pharma occurring post-launch, if at all, is likely to continue in the next few years.
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