R&D departments in large pharmaceutical companies often resist repurposing projects. Their leaders are rewarded for discovering new chemical entities, not for finding new applications for existing drugs, creating an internal funding barrier that business units must overcome.
For old molecules lacking composition-of-matter patents, a robust IP moat can be built by combining new use patents, patents on novel administration forms, and securing market exclusivity through Orphan Drug Designation for rare diseases.
To overcome pharma's preference for new chemical entities (NCEs), Cereno created a second-generation drug by deuterating its original molecule. This modification improved the metabolite profile and, critically, made it a patentable NCE, opening doors for broader platform deals.
A key driver of Sweden's entrepreneurial biotech culture is a law allowing inventors, such as university professors, to personally own the patents from their research. This contrasts with the US model where institutions retain IP rights, giving Swedish academics a direct incentive to commercialize their discoveries.
A powerful, unsolicited validation for Cereno's drug came when Phase 2a investigators asked to continue treating patients post-trial. Securing FDA approval for compassionate use demonstrated strong physician conviction and provided valuable long-term safety and tolerability data.
Cereno's CEO reconnected with a prominent cardiologist he'd worked with 20 years earlier. This long-dormant relationship was pivotal; the expert agreed to chair the Scientific Advisory Board and then recruited other leading physicians, instantly giving the company top-tier scientific validation.
Lacking early VC interest, Cereno went public and attracted a large retail investor base. A pivotal factor was an investor-created Discord server, which evolved into a 5,000-member hub for data, competitive intelligence, and community engagement, fostering long-term support.
Cereno's CEO leveraged a consultancy market downturn to his advantage. Having worked with a firm on strategy and communications, he seized the opportunity when it closed down, hiring four key people he already knew and trusted, instantly building out his internal team with proven talent.
Cereno Scientific chose a Phase 2b trial over a combined 2b/3 to maintain flexibility. A combined trial locks in the design for both phases upfront, whereas a standalone 2b allows for optimization before Phase 3 and creates a cleaner, more attractive asset for a potential acquisition deal.
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