Innovation Pharmaceuticals Inc (IPIX)

[georgejjl]

Dare to compare Prurisol with its competition

We will use the Pareto principle and just compare to those treatments that capture of at least 80% of the market share total. So, we will compare Prurisol to the top four treatments: Humira, Stelara, Otezla, and Embrel in that order which in total hold well over 80% of the market share.

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Humira, Adalimumab is a human monoclonal antibody targeting tumor necrosis factor alpha (TNF). Doses of 50 mg subcutaneously twice weekly, resulting in PASI 75 responses of 49% at 12 weeks and 59% at 24 weeks/

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2504074/

Humira costs patients, their employers and health insurance companies about $20,000 for one year of treatment.

Possible serious side effects from treatment with Stelara

http://articles.chicagotribune.com/2011-05-24/business/ct-biz-0525-humira-biogenerics-20110524_1_way-for-genetic-engineering-biotech-drugs-abbott-s-humira

Possible serious side effect from Humira treatment:

https://www.humira.com/important-safety-information
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Stelara (ustekinumab) Stelara is administered by
subcutaneous injection.

Patients treated with STELARA® achieved consistent efficacy, regardless of whether they had prior exposure to a biologic or were biologic-naïve (PASI 75 in 63% [360/571] and 74% [565/760], respectively, at Week 12).

https://www.stelarahcp.com/plaque-psoriasis/efficacy

For patients < 100kg - $27,978.00/year (the first year would be about $33,573.00 since they receive an induction dose at 0 and 4 weeks.)
For Patients > 100kg - $55,956.00/year

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Oral OTEZLA® (apremilast)


At week 16, 40 percent (33/83) of patients receiving OTEZLA 30 mg twice daily demonstrated statistically significant and clinically meaningful improvements compared with 12 percent (10/84) of patients on placebo in the primary endpoint, Psoriasis Area and Severity Index (PASI)-75 response (P < 0.0001).

http://ir.celgene.com/releasedetail.cfm?releaseid=936118

The cost per PASI-75 responder at Year 1 was $34,472 for Otezla apremilast, $57,816 for etanercept, $44,791 for adalimumab, $45,319 for ustekinumab 45 mg, and $87,378 for ustekinumab 90 mg (Figure 1).

https://www.aad.org/eposters/Submissions/getFile.aspx?id=1108&type=sub

Potential side effects of Otezla

http://www.otezla.com/

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Enbrel (entanercept)

34% of patients receiving etanercept 25 mg SC twice weekly (55/162) achieved PASI 75 at 12 weeks and 44% (71/162) at 24 weeks. Also, 49% of those receiving etanercept 50 mg (81/164) achieved PASI 75 at 12 weeks, and 59% (97/164) at 24 weeks.

http://www.ncbi.nlm.nih.gov/pubmed/14667953

Possible side effects of Enbrel

https://www.enbrel.com/

Cost of Enbrel

https://www.aad.org/eposters/Submissions/getFile.aspx?id=1108&type=sub

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Prurisol oral pill. Prurisol is a prodrug (ester) of abacavir.

By Week 12, 46% of patients receiving 200mg per day of Prurisol with “moderate” psoriasis achieved IGA 0/1 (equivalent to PASI 90)

The new upcoming next Phase 2b trial with Prurisol will test the safety and efficacy of 300 mg/day and 400 mg/day. That is 150% of the maximum 200 mg/day and 200% of the maximum 200 mg/day in the latest Phase 2 trial with Prurisol.

Safety of Prurisol

Prurisol appears to have an efficacy approaching that of biologics but
without the harmful side effects.

Prurisol cost to make

Prurisol is a prodrug (ester) of abacavir.

Abacavir cost is $2.01 per 300 mg pill and up. you have to believe that the cost to make abacavir is less than $2.00 per pill.

http://www.pharmacychecker.com/generic/price-comparison/abacavir/300+mg/

Prurisol is a relatively simple and extremely cost effective five-step manufacturing process. Chemical compounding is a well understood chemical manufacturing process that has been in use for over 100 years. For example Sir Ronald Fisher's statistical methods including the Design of Experiments have been in use for over 80 years to optimize the yield of chemical processes by the intelligent optimization of factors involved in the chemical reactions.

Look at Scheme II at the following link for the chemical reactions need to convert abacavir to Prurisol.

https://www.google.com/patents/WO2013103601A1?cl=en

However, the production of monoclonal antibodies is a relatively new and expensive manufacturing process.

Assuming that Prurisol meets or exceeds 75% at or above PASI 75 without significant side effects, then Prurisol should own well over 50% of the market share almost immediately after FDA approval.

Good luck and GOD bless,

George