I am looking forward to PAR management responding to the implications of Zycosan that have been raised by posters.
With regard to the Edison report
(remove spaces after .com and uploads/)
https://paradigmbiopharma.com /wp-content/uploads/ 2022/12/EDPAR20221214.pdf
"
iPPS is available to patients through a Special Access Scheme in Australia"
i had thought that had been closed. If it is still open how can it be accessed, and why not associate it with bringing forward other work, for example, TGA, an early 002 readout?
Key takeouts for me from the Edison report are
"
We see this data, in combination with that from PARA_OA_008 as supportive that iPPS could
potentially have a disease modifying profile, due to the lowering of key biomarker levels that are
associated with progressive kOA. In our opinion this is encouraging, particularly when viewed in
combination with patient reported WOMAC scores. However, we note that Phase III long-term
efficacy and safety data will be critical in defining the drug’s full clinical utility."
and
"
Paradigm’s clinical development endeavours in kOA are supported by real-world data gathered
through the Australian Special Access Scheme (SAS) and FDA Expanded Access Program (EAP).
kOA patients receiving iPPS as part of the SAS have consistently reported meaningful reductions in
knee pain with twice weekly administration"
and
"
In 2021, the osteoarthritis drug market (of which kOA is a significant subset) was estimated to be
worth US$1.82bn (EvaluatePharma), with the majority of sales being attributed to symptomatic
treatments. Given the high prevalence and degenerative nature of kOA and the limitations
associated with current symptomatic treatments, we believe there is an opportunity for DMOADs to
significantly expand the kOA drug market size and garner considerable market share.Company
research indicates iPPS could be priced at US$2,000–3,000 pa and receive reimbursement for the
treatment of kOA pain and function in the United States. However, this price could rise to
cUS$6,000 if the drug can demonstrate of disease-modifying mechanism of action, management
asserts. Hence, Paradigm believes the opportunity for iPPS in knee and hip OA could potentially be
over US$10bn pa (based on 10% penetration of dissatisfied patients with knee and hip OA from a
72 million addressable market, at price of US$2,500 per year)"
Note the qualification for a $1b market, and a $10b market.Perhaps we should restrict our enthusiasm to those numbers.
I still don't understand why PAR could not get an early registration for symptomatic treatment, eg for TGA and use that for the same with FDA.
One word of caution related to symptomatic treatment, from Edison
"
we highlight sprifermin (High Line Bio/Merck) a recombinant human fibroblast
growth factor 18 analogue that has demonstrated a potentially disease-modifying profile in human
kOA. Data from the Phase II FORWARD trial showed that patients treated with sprifermin benefited
from a statistically significant increase in knee cartilage thickness (+0.05mm) at three years versus
a placebo, which was accompanied by a c50% reduction in patient WOMAC scores. In addition, a
further meta study of eight clinical trials demonstrated that patients receiving sprifermin injections
gained more, and lost less, cartilage thickness in the knee versus placebo. As such, we believe
sprifermin represent a significant potential DMOAD competitor in kOA, if it can objectively."
and
"Paradigm Biopharmaceuticals
demonstrate a disease-modifying profile .... We note that many cell
therapies are under investigation for the treatment of OA (see Invossa, Exhibit 5) and while these
may offer a potentially curative approach, restrictive pricing and complex manufacturing are likely to
limit their impact on the OA landscape, in our view. Hence, we do not view development of cell
therapies in OA as a substantial commercial threat to iPPS."
The net of it seems to be that an iPPS deal is unlikely before end of 2024 because that is when 002 ends.
So all the more reason to ask the Board to think like capitalists and manage the program to deliver what prospective partners want to see, earlier, with preliminary findings.
Advancing TGA could be a very effective way of doing that.
(20min delay)