NOVEMBER 2024LIFE SCIENCES REVIEW8IN MY OPINIONBy Rüdiger Schulze, Vice President and General Manager, DACH, UltragenyxESTABLISHING A BIOTECH COMPANY IN EUROPE:A MISSION IMPOSSIBLE?recently saw an announcement for a conference entitled `The billion dollar question: to launch or out-license in Europe.' A few years ago, nobody would even have asked that question. Europe was considered a no-brainer; everybody would launch their new product in Europe as it was considered to be the second most attractive place for commercialising innovations after the USA. In the past two decades, the share of small biotech companies in the development and commercialisation of pharmaceutical innovation has increased dramatically ­ particularly for orphan drugs ­ and many newcomers have successfully established themselves in Europe. But the exit of Bluebird from Europe in 2021 following unsuccessful price negotiations in Germany for their gene therapy Zynteglo, approved for ß-thalassemia, has sent a shockwave through the industry. Even before that, many newly launched drugs failed to reach their commercial targets - particularly those launched by companies who launched a product for the first time, according to a McKinsey analysis. Following higher interest rates, the number of biotech IPOs has dwindled in the last 18 months, and share prices have fallen to an extent that threatens many companies' existence. It is so difficult today to bridge the gap to profitability that biotechs need to think even more carefully about if, when, and how to approach Europe.In the past, for most biotechs, `Europe' meant a focus on the five biggest markets, Germany, France, Italy, Spain, and the UK, even though these represent less than 50 percent of the European population. Now, the proposed new EU pharmaceutical regulation demands equal access in every member state and makes full data exclusivity contingent on launching in every member state within two years after marketing authorisation. The introduction of a joint European HTA for ATMPs from 2025 and for all orphan drugs from 2028 has the potential to simplify and accelerate access in small countries that do not maintain their own HTA, whereas it will not make things easier in large markets because the JCA verdict will not be binding for local authorities. Similarly, joint procurement can put more pressure on prices but also reduces the number of parties to negotiate with and hence has the potential to accelerate market access.The complexity of European pricing and reimbursement systems has always been daunting. I
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