ZS Associates’ Ben Hohn gave a presentation leading into a panel discussion
Launching a product successfully is a critical milestone for any company, and the decisions made during this phase can significantly impact its trajectory. At the recent LSX World Congress in London, ZS Associates’ Ben Hohn gave a presentation and chaired a panel on first launch and partnership trends in biotech. Among the topics discussed over the course of an enlightening session were ‘go it alone’ launches; partnering across the R&D value chain; approaches to partnering in Europe, the US, and Asia; and best practices for launching.
Making up the panel were:
Go-it-alone or partner up?
When it comes to launching a biotech product, companies must decide between doing so themselves – i.e., going it alone – or forming partnerships. Choosing between independent launches or collaborating with other firms across the R&D value chain, as well as commercial, will depend on various factors, including company resources, strategic priorities, and, of course, the nature of the product itself. Go-it-alone can certainly bring dividends – as evidenced in a previous Venari Podcast episode, in which Robert Francomano appeared as part of the Chief Commercial Officer series. As CCO of Stemline Therapeutics, he was responsible for their solo launch and commercialisation of ELZONRIS® (tagraxofusp), leading Stemline from a clinical-stage entity to an organisation with full commercial capability, which was ultimately acquired by the Menarini Group.
Interesting findings and varying expectations
A report by ZS Associates from last year showed that go-it-alone launches resulted in the highest stock value growth of all launches over a 10-year period – and Stemline reported the largest growth of all companies surveyed. In the LSX session, Hohn elaborated on recent launch strategies in his presentation, with some interesting findings. Of 25 novel first launches in the EU from 2011-2022, for example, 17 were from EU companies – enabled by an ecosystem that is increasingly welcoming for emerging pharma – all of whom chose to go it alone. In the US there were 96 novel first launches between 2011-2022, however, with 86% choosing to go it alone. Notably, smaller and emerging pharma drove over half the pharma pipeline launched in the last two years, with an expected peak revenue of over $500 million. Smaller companies are also driving about half of the activity in this sector overall in Europe.
Hohn also analysed pre-launch expectations from analysts for 51 novel US first launches from 2018-2022, classifying these into three separate brackets: those that outperformed the consensus of analyst expectations by more than 20%; those that underperformed by more than 20%; and those that were up to 20% above or below expectations. The majority met or exceeded expectations, which Hohn put down to being ‘more about the ability to forecast accurately than about how well the company launched.’ Both aspects are linked; he noted that launches must be ‘grounded in an independent company-based view of what those forecasts are and should be – because the analysts are going to get it wrong more often than they are going to get it right.’
Insights from the panel
What works for one launch won’t necessarily apply for another; companies will need to consider the particulars of their product and capabilities before deciding how to proceed. For instance, Helen Ho discussed how Blueprint Medicines went alone to launch their flagship product, the Ava Kit, a small molecule kit inhibitor, in the US; they are hoping for approval for their third indication imminently. They wanted to gauge the appetite for their rare disease product themselves before proceeding; by contrast, Blueprint partnered with Roche Genentech for their Gumbreco offering. ‘Thinking about the resource allocation, we decided that having a pharma like Roche that can bring this drug to a global market’, would be beneficial to their launch of a systemic muscle psychosis product.
Blueprint ended up discontinuing their connection with Roche, acknowledging that it had been beneficial and that they’d learned a lot about partnerships. ‘Alliances takes a lot of effort,’ Ho acknowledged. ‘People don’t think about the operational impact.’ Erik van den Berg is not fond of co-promotions himself, calling them ‘a nightmare to manage’. ‘I’m much more a fan of making really strict separations of responsibilities because then you can manage on the contractual terms and all the relationships how these are implemented.’ He cited successful dealings with Kyowa Kirin in Japan, as well as Pfizer, where tasks and responsibilities were very highly regimented: ‘Arranging your partnerships [...] so you can pick up the ball running’ is key.
Indeed, the parameters of your company will be a key factor in a product’s launch. Klaus Langhoff-Roos previously worked in senior commercial roles at Novo Nordisk before moving to StemMedical, which he described as a ‘major change’. He noted that this experience taught him that ‘you should be preparing for your own goals even if you decide to out-license’, and that ‘preparing for a co-promotion or an out-license in order to set a bar for what users should be able to do for a launch’ is one of the most effective ways of ensuring that investment in a launch is well spent. While biotechs might be more inclined to go it alone on rare disease launches, Langhoff-Roos stated that ‘being able to launch upon a conditional approval in Phase 1/2’ means avoiding the full cost of a Phase 3 programme ahead of a launch. He’s enjoyed a similar strategy at StemMedical, where a pilot commercial launch in Denmark preceded approval in northern Europe. It represents a sparser approach to what he’d been used to at Novo Nordisk, and one he’s enjoying: ‘It’s fun to be in a biotech environment, where things get done quicker.’ Ajan Reginald, meanwhile, held forth on the choices that need to be made about upscaling from small biotechs to bigger launches. ‘If you want to exit, be very careful about where you do your partnerships.’
Global picture and commercial teams are key
Global development is a key consideration for co-promotion efforts. In Europe, there is a notable concentration and growing number of companies bringing assets forward – especially in the UK, France, Germany, Sweden, and Switzerland. ‘There’s been a pullback, obviously, in recent years,’ Hohn admitted; ‘certainly that’s been the case’ over the last decade, broadly speaking. Co-promotion is less common as a business model in Europe than in the US, ‘particularly for assets that have larger field footprints’, though going it alone and outlicensing remain the ‘dominant path’ for European launches. For Helen Ho, ‘if you’re thinking about a big global program [...] how do you actually share the costs and how do you occasionally leverage expertise?’
Indeed, commercial planning is wise – even if you’re not planning to commercialise. Trying to envision the end, even with Phase 1 studies is important – as is building out your commercial team as soon as possible. In another recent episode of the Venari Podcast’s Chief Commercial Officer Series, Roivant Sciences CCO Amy Mahery notes that in commercial, there is a tendency to rely on sales reps and DTC marketing; while this is certainly part of the picture, Amy notes that her sector is all about ‘asset strategy’. She believes that commercial should be involved as soon as you start planning your vision for this asset, ‘so you need to have somebody – whether it’s new product planning or commercial strategy, marketing strategy – to be able to help shape programmes with the end in mind, because that’s really what clinical development is’.
Conclusion
The panel’s consensus seemed to be that developing one drug through just one pipeline is no longer effective. Over 50% of the pharma pipeline from 2022-2026 is expected to emerge from smaller and emerging pharma, proving that the financial power and scale of Big Pharma is not necessary for effective launches and commercialisation. In such a climate, it appears worthwhile for biotech companies to at least consider self-launching – even if they’re later acquired or choose to co-promote.