Pierfrancesco Morosini, CEO,

Icrom

"Icrom has seen a transformation of our model from a pure API manufacturer into a CDMO with the capacity to work on the development of complex and new APIs, especially those used in clinical trials."

Can you introduce Icrom to our international audience? Icrom is an Italian CDMO leader for the production of APIs and GMP intermediates. We also provide high-tech services for the development of chemical processes. The company was founded in the 1960s by a French entrepreneur, and in 1996 it was acquired by a group of companies called Proxis Développement. Since then, the company started experiencing high growth and made several substantial investments. For instance, in 2018, we opened a new R&D center and in 2020, we completed the construction of a new and larger warehouse and a Quality Unit building including state-of-the art QC labs . Could you highlight some recent milestones? In the past, Icrom was exclusively recognized as a generic API manufacturer. The company has seen a transformation of our model from a pure API manufacturer into a CDMO with the capacity to work on the development of complex and new APIs, especially those used in clinical trials. Over the last 10 years, we have made important investments to sustain this transition. Earlier this year, we started building a GMP “clinical-scale-API” manufacturing facility, which will be fully dedicated to CDMO activity. Can you elaborate on the significance of your R&D center and explain how it has boosted your capabilities? The new R&D center allows us to concentrate more expertise by bringing in a higher number of scientists. Moreover, this expertise is supporting our consolidation in different specialties, such as biocatalysis, flow chemistry and high-potency APIs, including ADC. By investing in this new R&D center, we are expanding our scope and keeping up with the latest technologies, future-proofing for what is becoming a much more complex and dynamic field. We see the market approaching increasingly more complex molecules to tap into unmet medical needs, so we must be prepared to respond to complex chemistry. What is Icrom’s international footprint and what is your strategy for further expansion? Icrom has a presence already in 40 countries. Historically, we have been strong in regulated markets such as Europe and Japan, and our aim is to gain more market share in North America. For this reason, we are targeting biotech companies as our preferred clients and we are developing capabilities and services to clinical APIs, particularly high-potency APIs. The US is the world’s biggest center for pharmaceutical research, with outstanding hubs like San Francisco and Boston. We are actually looking to acquire a manufacturing site devoted to clinical APIs in one of these areas to be closer to our US clients in the future. This would be our second manufacturing site and the first outside of Italy. What are the main trends that are shaping the industry today? The Italian pharmaceutical industry is seeing great hype at the moment. Throughout the years, Italy has been able to develop special technologies for the production of APIs and finished dosage forms, positioning itself as a manufacturing and export leader, as well as a center of excellence for specialty pharma production, including biosimilars and high potency drugs. The pandemic has encouraged the debate regarding the reshoring of pharmaceutical production, which could accelerate the sector’s growth significantly in Italy, as well as in the rest of Europe and in the US. However, this depends greatly on the policies of each country. Large-scale investments surely need the encouragement of political action and political clarity. What are Icrom’s main objectives in the medium term? Icrom aims to become a key hub for specialty API production services not only by internal growth, but also through partnerships and acquisitions. We are building a network of strategic partners that we can turn to and complement our own service offering. Our goal is to become a boutique one-stop shop, where clients can find high-tech services and capabilities. The company and the Proxis Group are enjoying a high growth, and we expect to reach a turnover of around €200 million by the end of 2021 with further growth in 2022. Indeed, despite acquisition plans being put on hold due to the inability to travel and the difficulty of closing a deal remotely, our optimistic projections would see us making a transaction in a year’s time.

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