- Smaller
companies achieve higher R&D productivity
- Collaboration
with academia key to R&D success
- Diverse
projects increase chance of success
Big Pharma is losing the game in drug development. A decade
ago, McKinsey & Company sounded the alarm, warning that the biopharma
industry was afflicted by “diminishing R&D productivity.” Despite a
doubling of investment in research and development, approvals of “new molecular
entities” had fallen precipitously (http://ibn.fm/jUNpt). Nothing appears to have changed since
then. A recent report by Deloitte laments the continued decline of returns on
R&D investment. While R&D costs have generally remained the same,
product revenues are falling, in part because many products never make it to
“blockbuster” status (i.e. sales of a billion dollars or more). With narrower
margins squeezing profits in the industry, these consultants suggest increasing
“the number of drug programs to which a pharmaceutical company has access,
without increasing, to the same degree, the capital or resource investment
required to access them.”
PreveCeutical Medical Inc. (CSE: PREV) (OTCQB: PRVCF) (FSE:
18H) has taken this advice to heart. The health sciences company has three
distinct research programs underway. Top of the line is a non-opioid pain
treatment based on cannabinoids to be administered through a proprietary
nose-to-brain, soluble gel (Sol-gel) drug delivery system. The research team is
also out to identify peptides and proteins derived from the venom of the
Caribbean blue scorpion that may have therapeutic use. The company is also
working on a smart RNA dual gene therapy for the treatment of type 2 diabetes
and obesity.
Expected returns on investment in research and development
(R&D) for the top 12 pharma companies fell from 10.1 percent in 2010 to
just 3.7 percent in 2016, according to a study by Deloitte’s Centre for Health
Solutions (http://ibn.fm/ZWD9Y).
From 2010-2016, the R&D divisions of the top 12 pharmaceutical companies
were able to advance 376 products to late-stage development. With total
forecast sales of $1.7 trillion, each drug was projected to be a blockbuster;
average sales for the 376 candidates were $4.5 billion.
It is unlikely that more than just a handful have lived up
to expectations. Of 667 new biopharmaceuticals launched in the U.S. over the
past 20 years, only 19 drugs, less than three percent, have reached the $1
billion mark (http://ibn.fm/o7QWT).
However, averages, like most generalizations can mislead. Deloitte found “a
negative correlation between company size and both predicted returns and cost
per product.” Big Pharma may be getting it wrong, but smaller biopharmas like
PreveCeutical appear to be using models that achieve higher R&D
productivity.
Perhaps increased collaboration with academia may be an
aspect of PreveCeutical’s innovative approach. The company is working with the
University of Queensland in Australia on two major research projects. The
cooperation, which is being undertaken through UniQuest Pty. Ltd., the
development arm of the university, is centered on PreveCeutical’s Sol-gel
system and its Smart RNA Dual Gene Therapy.
The Sol-gel system is an innovative nose-to-brain drug
delivery platform that holds the promise of making medication regimens more
effective. When therapeutic compounds are taken orally (as many are), they
travel through the stomach and intestines and are metabolized, reducing their
effectiveness. However, the Sol-gel system works via nasal administration and
delivers the therapeutic agent to the mucosal tissue, where it forms a gel and
is time released to the brain, increasing bioavailability. It will be used
initially for a cannabidiol-based agent designed to provide relief across a
range of indications such as pain, inflammation, seizures and neurological
disorders. Additionally, the gel stays in the nasal passages, slowly
releasing the CBD while keeping it active for up to seven days. This ease of
application and its long-lasting effects may be attractive for patients when
compared to other delivery systems.
Another project in the development pipeline involves the
identification of peptides and proteins in the venom of Caribbean blue
scorpion, with the object of engineering ‘Nature Identical™’ compounds.
Synthesizing compounds that are identical to the natural venom is expected to
facilitate more commercially viable formulations. PreveCeutical already has an
over-the-counter (OTC), commercially available oral solution of scorpion venom,
CELLB9, on the market. CELLB9 has been used to treat inflammation, bacterial
infections, pain and tumors.
PreveCeutical is also working on a Smart RNA Dual Gene
Therapy for the treatment of type 2 diabetes and obesity. Gene therapy involves
the substitution of defective genes in a cell with genetically altered genes.
The team has already put five genes implicated in diabetes and obesity on a
target short-list.
In June 2018, the company raised C$6.5 million ($4.9
million) to continue its ambitious research focused on preventative compounds
using organic and nature-identical compounds, according to a Crystal Equity
update (http://ibn.fm/ykwy1).
For more information, visit the company’s website at www.PreveCeutical.com
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