6463: CASE STUDY 1

BKK: Commercializing a New Drug

ketamine (common anesthesia) was used as an alternative to opioid anesthetics for surgeries and

post-surgical treatment. Dr. Worthington first used this combination in lumbar surgery and was

amazed by the results. The unique effect of the drugs had reduced the length of stay in hospital,

lowered nausea, inflammation and eliminated the patients need to take opioids. It was then

broadly used for patients undergoing surgeries like lumbar, joint replacement, and neuro-surgical

spine procedures. Dr. Worthington got the patent approval and started teaching the other

surgeons on using the BKK appropriately.

The commercialization of the BKK was a critical issue to be resolved. Even though it was being

used by several surgeons, Dr. Worthington had to decide on the marketing approaches regarding

the drug. There were three approaches that will help the drug land in the market. The first option

was to find a sponsor and apply for the New Drug Application (NDA). The next approach was to

get a partner with a compounding pharmacy and produce the drugs which requires expensive

analytical testing. This pathway does not require any additional FDA (Food and Drug

Administration) approval. Selling BKK as a convenience kit where the three drugs are packed

separately in a box was the last option. Dr. Worthington had to decide which help he got from a

healthcare consultant, Ballard. After going through several options Dr. Worthington had used his

retirement savings along with Thurman Ballard chose the patent approval pathway. Angel health

has also been an important sponsor for the commercialization of the drug.

There were several challenges faced by Worthington. He put all his savings into the patent.

Finding a sponsor to file for an NDA to bring BKK as a new chemical entity was an initial

challenge faced. The sponsors had their own priorities and would not benefit Worthington. The

time taken (18-24 months) to reach the market would delay the progress further because of the
emerging analgesics. Worthington then met Tommy Siegfried, CMO (contract manufacturing

organizations) of Angel Health who helped with finding a compounding pharmacy to initiate use

of BKK in the hospitals. Although agreed on the decision, Worthington faced delay in production

lines and then the regulations governing compounding pharmacy had changed overtime making

it difficult for him to commercialize the drug. Another sponsor initiated a new idea of creating a

convenience kit packing drugs separately but was found to be too expensive than either of the

approaches.

Overuse of opioid has been a crisis that increases every year and one of the reasons for opioid

usage is prescription opioids. One day of opioid usage led in 6% of patients still taking them a

year later, whereas eight days of opioid use resulted in 13.5% of patients still using them.

Patients who used opioids for more than 31 days a year on average still struggled with addiction

in 29.9% of cases. One in seven patients who received a prescription continued to use opioids a

year later, according to 2017 research. Regardless of gender or age, heroin users are often in their

early 20s.

Worthington and his colleagues had planned various avenues towards the commercialization of

BKK, each with its own set of risks and rewards.

Patent protection is included in the advantages and institutional assistance with marketing,

production, and distribution. Due to rising legal expenditures, Worthington may lose both

ownership of his life's work and his legal right to it. Worthington and Ballard were concerned

that the large pharmaceutical industry would file patent challenges and lawsuits, impeding

BKK's marketing and economic success. According to a source close to Ballard, it will take 18-

24 months for the three pharmaceutical companies producing long-acting opioid analgesics to

bring their products to market. According to Worthington and Ballard, there is a 50% chance that
this technique will work. The benefits of finding a compounding pharmacy They anticipated a

10% annual growth rate, with annual revenues reaching 10-15 million after five years. This was

owing to government restrictions on compounded medicine marketing and promotion. They

calculated that this alternative had an 85% chance of success. Risk: Unfortunately, there were

issues establishing up the production line at the compounding pharmacy with which they had

partnered to offer BKK to angel health. Another drawback was that the legislation governing

pharmaceutical mixing had changed, limiting how compounding pharmacies could sell their

products. Advantages of the Convenience Package: As part of this method, instructions on how

to mix and inject BKK would be provided, extending the product's shelf life. As a result, the

formulation of the BKK's medications was enhanced. dangers, while the expense of employing

this method was the highest. As a result, the drug's price would rise. The product would take four

months to manufacture and four months to test in the clinic, delaying its commercial

introduction.

In my perspective, Worthington should be concerned about a rivalry that pursues the same goal.

They have a competitive advantage because they entered the market before BKK. This would

result in brand recognition, which is critical for a pharmaceutical company. Consumers are more

devoted to pharmaceutical products that have higher efficacy and fewer adverse effects.

If Worthington and Ballard were to effectively sell BKK after them, they would struggle to

convey their unique selling point to buyers. The competitors' (exparel) formulations have a much

longer duration of action than BKKs, at around 72 hours (nearly 3 days), as compared to BKKs'

40 hours (approximately 1 and a half days), putting them at a disadvantage.

Creating a presence there, whether physical or virtual, and cultivating relationships with potential

customers and business partners would be the best way for BKK to join the US market. BKK
could also employ search engine optimization (SEO), paid search, display advertising, and social

media to sell its products and services online. BKK could consider attending trade fairs and

conferences in the United States and creating ties with industry thought leaders and influencers

to promote its brand and products.

The decision to commercialize BKK was a wise one. It should, in my opinion, be made

accessible for purchase because of the extraordinary determination and aspirations that led to its

production. It was critical to discontinue painkiller use following surgery because the opioid

crisis has resulted in many deaths among Americans.BKK is one of the best nonopioid analgesics

and should be brought to market, and the best way to do so, in my opinion, is to establish

relationships with compounding pharmacies that can assist you in reaching your goals. Using this

strategy will boost success, but the rate of progress will be slower, but it can be brought into the

market safely throughout the United States.

REFERENCES:

Corporation, N. P. (n.d.). Nephron Pharmaceuticals Corporation Releases Opioid Free Pain Management

Product: BKK. Www.prnewswire.com. Retrieved October 9, 2023, from

https://www.prnewswire.com/news-releases/nephron-pharmaceuticals-corporation-releases-opioid-

free-pain-management-product-bkk-300765362.html

Goldberg, R., & Matherne, G. P. (2019, March 8). BKK: Commercializing a New Drug. Papers.ssrn.com.

https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3345361

Harvard Business Publishing Education. (n.d.). Hbsp.harvard.edu.

https://hbsp.harvard.edu/product/UV7977-PDF-ENG