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Wednesday, 03/13/2019 8:17:40 AM

Wednesday, March 13, 2019 8:17:40 AM

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Eli Lilly – based in Indianapolis, Indiana – led the way in manufacturing insulin from animal organs.

The company’s centralized location relative to the majority of American pig farms made it the ideal insulin producer.

Eli Lilly had a dominant position for nearly 60 years and made a fortune at it too.

Of course, big money like that — literally tens of billions of dollars — created big opportunity for small, highly innovative companies.

That’s just what happened too. It created an entirely new era in biotech, leading a small company on a growth trajectory from just two co-founders to a $48 billion takeover, and now another tiny company is following on the exact same trajectory.

The Birth of Big Biotech
For nearly 60 years Eli Lilly grew to dominate the insulin replacement market. However, one company made a discovery in the early 1970s that would risk Eli Lilly’s insulin processing cash cow.

In the early 1970s, then tiny and innovative biotech company found that it could combine strains of E. coli bacteria with human genes to produce what’s called a “biosynthetic insulin.”


The global diabetes pandemic has turned that single innovation in the early 1970s into a $35 billion a year industry today. That small company discovered biosynthetic insulin was Genentech.


Genentech ended up partnering with Eli Lilly to produce biosynthetic insulin and both companies grew steadily ever since.

Eli Lilly is now a $73 billion pharmaceutical giant.

Genentech was acquired by Swiss pharmaceutical giant Roche Holdings for $48 billion at the bottom of the credit crisis in early 2009 (right before the biotech sector went on to rise 500% in the following stock market rally).

In the end, this single innovation made big money for the giant partner and led the way for a massive fortune for the early founders of the innovative Genentech by solving one simple and expensive problem.

Now one tiny biotech company is targeting the exact same thing as Genentech with the booming cannabis industry



IMLFF
Biosynthesis
Overview

Manufacturing pharmaceutical grade cannabinoids remains a challenge, especially for those that are found in only trace amounts in the cannabis plant, but nevertheless may hold very important pharmacological benefits in humans. InMed recognized that having a reliable source of pure, pharmaceutical-grade starting materials for its products that are bio-identical to the compounds found in nature would be a critical success factor for our drug development strategy.

Biosynthesis is the process of genetically modifying an organism to produce a compound that it otherwise would not normally make. Currently, biosynthesis processes are used in multiple industrial applications, including use of bacteria or yeast-based systems for the production of pharmaceutical products, including human insulin, vitamins and antibiotics.
In the current and rapidly emerging cannabinoid pharmaceutical sector, InMed’s biosynthesis approach to the production of pharmaceutical grade, bio-identical cannabinoids are a potentially disruptive technology.


There are several key advantages of manufacturing cannabinoids through a biosynthetic process:

Cost savings relative to the existing agricultural methods (plant-grow-harvest-extract-purify);
Enhanced production, streamlined purification and quality control versus other manufacturing methods; potentially easier path for scale-up and systems optimization;
Access to minor cannabinoids that are currently economically unfeasible to extract from plant sources and develop into drug candidates


And Bio-identical cannabinoids to those found in nature, in comparison to those produced by other chemical manufacturing methods where isomers (structural variations) may be a problem.


Over the last several years, InMed has made material strides in our biosynthesis program. In mid-2015, InMed commenced the development of a biosynthesis process for the manufacturing of cannabinoids through a research collaboration with Dr. Vikramaditya Yadav from the Department of Biological and Chemical Engineering at the University of British Columbia. Utilizing the basis of a vector created by InMed, Dr. Yadav commenced a Research and Development Project titled “The Metabolic Engineering of yeast and bacteria for synthesis of cannabinoids and cannabis derived terpenoids” under a Collaborative Research Agreement.

Strong financial position with sufficient cash runway (into 2021)

3Q18: Engage CMO for bio-fermentation process optimization and scale up (completed on time)
3Q18: Engage CMO for purification process development and scale up (completed on time)

1H19: Finalize fermentation and purification process development and scale up


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