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Reestablishing America’s international pharmaceutical competitiveness.

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“We all know how outrageously expensive drugs are in America. In fact, we pay the highest prescription drug prices of anywhere in the world right here in America. Nearly three times, for the same drug nearly three times what other countries pay. We have to change that. And we can.”

President Joe Biden

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While Moderna and Pfizer were the first to widely commercialize synthetically modified mRNA, numerous R&D companies/pharmaceutical companies began heavily investing in mRNA research within the last several years. In 2017, Eli Lilly dove into the mRNA domain by “signing off on a heavily back-ended
$1.8 billion deal with Germany’s CureVac to develop
up to five new-wave [mRNA] cancer vaccines.” CurVac is a German biopharmaceutical company focusing on mRNA vaccines and therapeutics.

 

Two years later, Sanofi Pasteur made a deal with Translate Bio for “an upfront payment of $45 million” and $760 million for “various milestone payments and royalties.” Seven years ago, Boehringer Ingelheim paid CureVac €35 million upfront, with another €430 million in milestones to develop a lung cancer mRNA vaccine, which today is currently in a Phase 1 clinical trial.

 

These are just a few of the partnerships that give insight into the amount of capital being exchanged in the mRNA market. Even Pfizer which has not traditionally invested into mRNA R&D has announced
it will begin developing mRNA vaccines solo.

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The market potential is projected to continually expand within the next decade. Below is a table with market valuations of mRNA vaccines and therapeutics in the Global Market. It can safely be assumed that the market potential between now and 2026 for mRNA vaccines and therapeutics could be anywhere from $.952 to $15.49 billion USD with a CAGR between 10.5% and 33.4%.

Franz-Werner Haas, the Chief Executive of CureVac, recently expressed “that items in short supply include special plastic containers and nucleotides.” This was echoed by executives in the mRNA domain who expressed “bottlenecks in the production of certain nucleotides and DNA plasmids.”

 

The vast majority of the mRNA technologies have yet to scale their modified bases since almost all are still
in preclinical and clinical trials. Given the shortage of nucleotides, it would be safe to assume that modified bases for mRNA vaccines and therapeutics, which are derived from nucleotides, are in short supply as well. Regardless, given the multitude of mRNA drugs in clinical pipelines relative to the few on the market,
there will come a time when many companies need a CDMO to scale their modified bases. This is a need
that Bright Path Labs will be able to readily meet.

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Orphan & Rare Disease Pharmaceuticals

Bright Path Labs is focused on high-priced generics, smaller vulnerable patient populations, and products lacking American-made alternatives.  The advantages of Bright Path Labs' technology is that it allows for a more responsive and agile domestic supply chain that can respond quickly to shifts in product and/or market demand.  This partnership is also supportive of the U.S. government’s recent push to help restore our country’s medicine independence (and pharmaceutical supply chain), as well as the promotion of product transparency/traceability (e.g., country of origin labeling).

Generic Markets

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Rare/Orphan diseases

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Expensive products lacking domestic manufacturing

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Repurposed Drugs
(e.g., oncolytics, antivirals, etc.)

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Branded products soon to expire