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Product Development
Amorfix's business model is to generate revenue through commercialization of its discovery targets, as well as co-development and partnership opportunities with established biotechnology and pharmaceutical companies. The Company’s goal is to first advance the prion diagnostic detection assays for human and veterinary care as quickly as possible to generate revenue for development of its pipeline products.
The rise in the number of infected human cases of vCJD will necessitate the need by blood product suppliers and manufacturers, such as Canadian Blood Services, to implement the Company’s diagnostic assay expeditiously to minimize and hopefully eliminate the prion contaminants from the blood supply.
Where possible Amorfix will use outside expertise to compliment its R&D needs, in areas such as diagnostic kit development, to minimize development cost as well as access well established market distribution channels through partnering companies.
Market Opportunity
Amorfix envisions significant market opportunities in the following areas:
Protecting the Food Supply: The first case
of BSE in cattle emerged in the United Kingdom 15 years ago and there has been
a concern about the food supply ever since. The disease has spread to 21
countries and into other animal species. The only way currently to detect
BSE is by a postmortem test of brain tissue. Various countries test
from 0.1% to 100% of their cows after slaughter. There is a need for an antemortem test to identify animals with BSE and remove them from the food chain. There
are estimated 1.5 billion cows in the world and currently US$200 million is
spent worldwide annually to test less than 0.1% of them for BSE.
Protecting the Blood Supply: To date a few
hundred people have been diagnosed with vCJD due to consumption of BSE-infected
meat, but it is estimated that 23,000 people are incubating the disease.
Recently, two people have been infected through blood transfusions and
thousands of people have received blood fractions made from vCJD-infected
plasma. There is a general concern that vCJD is now within the blood
transfusion systems and a screening assay for blood is urgently required to
protect everyone from the next epidemic. 81 million units of blood are
collected annually and tested for infectious agents, such as HIV-1 and hepatitis
viruses at a cost of US$4 billion.
Early Diagnosis and Treatment: Alzheimer’s
Disease (AD), Amyotrophic Lateral Sclerosis (ALS) and Parkinson’s Disease (PD) are chronic
neurodegenerative illnesses which are associated with neural deposits of AMPs
of normal protein. Unlike the TSE (prion) diseases, these diseases are
not thought to be infectious and it is believed that their AMPs result from
abnormal synthesis or metabolism of the normal neural protein. Once again the
only definitive diagnostic for these diseases is postmortem examination of brain tissue. There are currently 5 million people in North
America with AD and an equal number with dementia which may be suffering from
AD but it is impossible to diagnose due to a lack of a blood test. Worldwide
there are 460 million people over the age of 65 who should be tested annually
for AD (and potentially for PD) now that effective therapies are available. The
worldwide market for a blood-based diagnostic test would
be more than US$1 billion annually and has been
estimated to be as high as US$5 billion.
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