Investment Highlights
Fast Facts
Stock exchange listing: Toronto Stock Exchange (TSX)
Stock symbol: NPC
Shares outstanding: 78.0 M
Cash > $16.5 M
Clinical Development
Drugs that halt
neurodegenerative diseases
Allon Therapeutics Inc. (TSX: NPC) is a clinicalstage
biotechnology company focused on
developing the first drugs
that impact the
progression of neurodegenerative diseases.
Therapies available today treat only symptoms
and have no
effect on the course of
the disease.
Major market strategy –
demonstrated human efficacy
Allon has two opportunities in major markets
of unmet need: Alzheimer’s disease and
cognitive impairment associated with
schizophrenia. For both of these indications,
the Company has demonstrated
human efficacy in Phase 2 clinical trials and
intends to advance to commercialization in
these markets in partnership with a major
pharmaceutical company.
Complementary
orphan strategy
In 2010, Allon embarked on a complementary
strategic path: pursuing approval in
a smaller “orphan drug” disease called
Progressive Supranuclear Palsy (PSP). This
market is estimated at $750 million, but
with a more direct and less costly pathway,
and the opportunity to retain more of the
value for Allon and its shareholders.
PSP is made more attractive by “orphan
drug” regulations that streamline the approval
process and exclude competition for
several years. Many of the world’s leading
biotech and pharma companies have succeeded
with this strategy.
Orphan drug status: faster route to value
There is a strong scientific rationale for Allon’s strategy: The pathology of PSP involves impairment of the brain protein tau – and Allon’s animal research plus Phase 2 clinical trial in pre-Alzheimer’s patients demonstrate that davunetide is the most advanced tau therapy in the world.
Allon expects to begin an advanced efficacy trial in PSP patients at mid-year 2010 -- and believes that sufficiently
positive results would enable davunetide to qualify for approval in PSP from the U.S. Food and Drug Administration
(FDA) based on this trial.
2010 progress in Allon’s PSP program includes:
- Orphan drug designation for davunetide
in the United States (FDA) and the European Union, the world’s two largest pharmaceutical markets; - Fast track status in the U.S. (FDA);
- A Phase 1 clinical trial that expanded
the demonstrated safety range and pharmacokinetic profile of davunetide at dosage levels higher than previously investigated in the Company’s clinical trials; and - Initiation of a pilot study at University
of California, San Francisco to validate the trial design for the mid-year efficacy clinical trial.
Allon believes this next trial will not just provide data for a potential approval in PSP, but will also define the opportunity in other tau-related diseases, such as Alzheimer’s, schizophrenia
and several types of frontotemporal
dementia.
Because orphan drug designation does not restrict a drug from larger diseases, it will have no impact on the Company’s strategy to seek approval in much larger larger markets, such as Alzheimer’s and schizophrenia, in collaboration with a major pharma partner.
