Nordic Life Science 1
INTERVIEW The four Ps of market entry NIKOLAJ SØR
ENSEN, CEO, OREXO Although Orexo has successfully entered into the US market, you have been quite transparent about the challenges that this has entailed. Could you share some pitfalls with us? “The challenges are immense and I believe they are often underestimated. Apart from the internal challenges of developing a competitive product and meeting formal requirements from the authorities, you need to be ready to face all sorts of attempts to throw you off course. In Orexo’s case, we’ve eventually succeeded in a long patent litigation. This has of course influenced me significantly and I strongly advise is that before you enter the US market you need to carefully analyze if you have the muscle to protect your patent rights. Another significant pitfall is around pricing and reimbursement. The US market consists of multiple different pricing and reimbursement systems and the list price, which tends to be high in the US, is never the net price you will get paid.” What else is easily overlooked in the entry to a US market? “Production has in my experience been one of the main risks and causes of delays in approval by the FDA when we have looked at product-acquisition candidates. One common mistake is for senior management to almost exclusively focus on the drug candidate and the clinical evidence for the product, and give much less attention to all the other issues to handle to ensure your product meets FDA quality standards. This includes how to build a quality assurance system, or who to partner with for manufacturing, how much control to outsource to manufacturing partners. You need to address the whole spectra of challenges that come with market entry and not just the ones related to the science, although that is of course the very foundation for having something to put on the market in the first place. We tend to focus too narrowly on that, and these other aspects rarely get similar attention.” Partnering, to partner up with the right actors to actually sell what you have developed, is one of the most important decisions. What advice would you like to give to a CEO currently developing their sales organization strategy for the US market? “I have full respect for companies who take on the challenge of building a US presence and take responsibility for the commercialization of their products. This is the only way to keep most of the value created by successful products in-house, and to enable the financing of future pipeline projects. My main advice is to be prepared, make a thorough market analysis of your product’s strategic market entry options and ensure the board of directors are aware and supportive of the investments needed. Most importantly, engage with people who have done it before and who know the US market from the inside.” NLS