Innovation Pharmaceuticals Inc (IPIX)

[BooDog]

Brilacidin, its antibiotic/anti-inflammatory therapy, a novel and potentially blockbuster product due to its unique phosphodiesterase 4 inhibition mechanism (greatly needed in the medical arena). The family of defensin mimetics are effective in treating resistant strains of both gram positive and negative bacteria. Brilacidin is worthy of small initial investment even without a supporting pipeline, once it clears its way to pivotal trial status. It's simply a matter of timing the investment for brilacidin, which one would look for rapid declines in price per share or dilutive events to initiate a small long position over the next couple of years. If a breakthrough therapy status designation is given by FDA, by all means, initiate, reinforce, and accumulate.

We're here now imo

https://seekingalpha.com/article/4052542-criticism-cellceutix-pipeline-business-plan-warranted-2-fold-evaluation

In a Phase 2b study, Brilacidin stood toe-to-toe with the blockbuster antibiotic daptomycin to treat Gram-positive acute bacterial skin and skin structure infections, showing non-inferiority with a similar safety profile for a single dose of Brilacidin versus a 7-day therapy regimen for daptomycin. To be clear, the antibiotic properties in one infusion of Brilacidin rivaled that of a drug doing over $1 billion in annual sales that takes seven days to complete the course.

https://seekingalpha.com/article/4059084-cellceutix-new-standard-care-oral-mucositis-making

Q: Prurisol TM uses the same active moiety as the approved HIV drug ZIAGEN®. That's great in that the FDA's 505(b)(2) pathway can expedite development. However ZIAGEN®is known to have side effects. Some don't seem to understand the difference between Prurisol TM and ZIAGEN®. Could you please explain why they aren't the same drug.

“


"A: Prurisol TM ( abacavir (a-hydroxy)-acetate; abacavir glycolate) is a prodrug ester analog of abacavir that differs in form from ZIAGEN® (abacavir sulfate), which is a salt form of abacavir. Quite simply, it is not the same drug, but its shared similarity does allow us to leverage much of the data on ZIAGEN® in our development of Prurisol TM.

What you are referring to with respect to side effects is that ZIAGEN®has demonstrated increased risk for hypersensitivity reactions in patients who have the HLA-B*5701 allele. The risk is easily mitigated for Prurisol TM through readily available screening for the HLA-B*5701 allele and eliminating the small number of patients positive for the allele from receiving Prurisol TM. This de-risking is underscored by a nearly 2,000-patients clinical study of ZIAGEN® utilizing companion diagnostics to screen for the allele that resulted in reducing immunologically-confirmed hypersensitivity reactions to zero. We're using the same methodology.

I'll add that we're not overly concerned about diminishing the market potential due to prevalence of the HLA-B*5701 allele in psoriasis patients. During the screening for clinical studies of Prurisol TM, only about 10.5% of patients were excluded due to HLA-B*5701. Overall, there are about 7.5 million Americans with psoriasis."

https://seekingalpha.com/article/3988240-interview-new-cellceutix-president-dr-bertolino

The Value of a New Psoriasis Drug

Psoriasis is a condition that causes red, thick, scaly patches on the skin. Sometimes, the swelling and pain go into the joints and spine, a condition known as psoriatic arthritis. Present, Cellceutix is only focused on psoriasis and while that could be the only indication it ever works on, there is a theme for approved drugs in that they also work on other conditions.


To wit, I must concede that some of these are difficult to discern exactly where sales fall for certain indications because they are approved for multiple maladies. However, it's easy to see the type of value drugs in the space command. Here's a few examples of leading drugs and their sales in 2015:



Drug

Manufacturer

2015 Sales

Indication(s)


Humira (adalimumab)

AbbVie (NYSE: ABBV)

$14 Billion

Psoriasis, Rheumatoid Arthritis, Crohn's, other autoimmune diseases


Remicade (infliximab)

Johnson & Johnson (NYSE: JNJ)

$6.6 Billion

Psoriasis, Arthritis, Crohn's, other autoimmune diseases


Enbrel (etanercept)

Amgen (NASDAQ: AMGN)

$5.4 Billion

Psoriasis, Rheumatoid Arthritis, Arthritis, ankylosing spondylitis


Stelara (ustekinumab)

Johnson & Johnson

$2.5 Billion

Psoriasis, Psoriatic Arthritis, Crohn's


Biologics, injectable medications of genetically engineering proteins constructed from human genes, dominate the space when it comes to treating moderate to severe psoriasis. Doctors are more frequently going straight to prescribing biologics instead of long-used drugs such as Soriatane, Gengraf or Rheumatrex, each of which have a list of generics today.

Those sales figures are reflective of just how very large the market is. It is estimated that about 7.5 million Americans suffer from psoriasis. Add in the rest of the world and there could be as many as 125 million people dealing with the itching and soreness associated with the condition. GlobalData estimates that the market just for psoriasis drugs tops $6 billion currently and that it will more than double to at least $13 billion by 2024.

Competition is fierce. Eli Lilly's Taltz and Novartis' Cosentyx, two drugs that recently got the nod from the FDA to treat psoriasis, have been spending heavily of direct to consumer advertising to build brand recognition. These drugmakers are not just looking ahead, but behind too because there are several more drugs coming down the pipeline that will compete for market share. J&J is turning heads with its guselkumab. For some of the older drugs on the market, biosimilars (the equivalent of a generic for a biologic drug) are just around the corner too, putting more pressure to keep innovating. Embattle pharma Valeant (NYSE: VRX), who agreed to pay AstraZeneca (NYSE: AZN) up to$445 million for Siliq (brodalumab) this summer got a positive vote from a FDA advisory panel in its bid to win approval for its biologic for psoriasis.


On a slightly different note, after its bid to merge with Allergan fell apart, Pfizer spun around in May and paid a 55% premium to acquire Anacor Pharmaceuticals (NASDAQ: ANAC) in a$5.2 billion deal for the crown jewel of the topical eczema treatment crisaborole. Crisaborole is also being evaluated for treating psoriasis.

https://seekingalpha.com/article/4029310-new-oral-psoriasis-drug-tops-cellceutix-catalysts

When Brilacidin for ABSSSI comes back in play...
https://seekingalpha.com/article/2422945-did-the-medicines-company-trump-cellceutix-and-others-in-a-1b-plus-skin-infection-market