bkkcommercialization

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Apr 3, 2024

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Develop your own perspective on whether you would advocate bringing BKK to market. I would advocate for bringing BKK to market. There is huge medical need and benefits to patients, as these drugs can be applied as anesthesia during surgeries for pain management and as a treatment for depression and chronic pain—thereby alleviating stress and pain and improving patient outcomes. Introducing such a novel package drug could also develop advancements in advancements in medical science and pharmacology, contributing greatly to ongoing research and development efforts and potentially leading to more effective and safer treatments. Finally there is an economic incentive, as the anesthesia market is a crowning, billion dollar industry, and the introduction of a novel form of a drug could be a huge financial opportunity. In my personal experience working with health tech startups and briefly considering a medical avenue for our technology, what I’ve mostly noticed is that there are a lot of unmet needs in the health space, but regulation and the timeline for actually bringing products to market can be long and arduous, and by the time it gets approved, market needs have changed. However, based on key points in the case such as how BKK can be an alternative aesthetic for people amidst the pressing opioid epidemic and be much more effective in pain management (meeting a lot of unmet needs currently), I believe there is a lot of value, and that the results of BKK can override the costs related to time and money for bringing this to market. Which of the three options are best? Below is a summary of the pros and cons of each option: NDA ● Confer additional patent protection and provide institutional support for marketing, production, and distribution ● Lots of interest from investors ● Keep 35% of ownership ● Highest sales and growth rate expectations ● exposed HH to greater potential litigation costs ● might lose control of his lifelong work ● BKK combined bupivacaine with an NSAID, and most of the potential competing drugs then in development leveraged a similar combination

● patent challenges and lawsuits from the big pharmaceutical world would inhibit BKK’s commercialization and overall success. Compounding pharmacy partner ● Delays in setting up production line ● Compounding pharmacies limited in how they can market products ● Annual growth rate and revenues expected to stagnant Convenience kit ● Longer shelf life ● Large marketing network between physicians and sales representatives ● No upfront costs ● Most expensive Based on these findings, I would suggest going with the NDA route. It has a lot of benefits, but what is most appealing is the funding of the NDA process, which would speed up the time it takes to go to market—this is especially crucial in a space where there is a lot of advancement and competition. The compounding route seems to just have cons, and the convenience kit’s appeal is the shelf life—however, these specifics drugs have a small duration of action, so they would be used up quickly and the shelf life might not be much of an issue. Would BKK be successful? I think BKK would be successful—it’s a new kind of drug that addresses a high demand need in anesthetize and also tackles other issues at the same time (eg opioid epidemic and safety/efficiency). It seems like there is a lot of investor interest as well, and has the potential to gain a lot of market share and generate revenue.

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