Propanc Biopharma Inc (PPCB)

[Diggnun21]

Propanc May Go for ODD for PRP: HUGE!

I've been having some private message conversations with Propanc Message Board Posters about Propanc getting ODD for it's drug line or at least PRP alone, and the implications of this for PPCH PPS.

I wanted to pass along some of my own DD on this potential ODD for Propanc.

First off, according to Professor Klaus Kutz, “Once we have assessed and identified the most effective dose in animals, we plan to meet with the FDA (Food and Drug Administration), to discuss and agree upon the planned formal preclinical program to support an Investigational New Drug Application (IND) to commence human trials in 2015," said Professor Klaus Kutz, Chief Medical Officer at Propanc Health Group. "Depending on the final indication selected for our initial patient trials, we may also seek Orphan Drug Designation for our treatment given the novelty of our proenzyme formulation and depending on the size of the target patient population we propose for trials."[color=red][/color]

So what’s the big deal about ODD?

“The industry has rushed to develop orphan drugs in recent years because they cost their developers less to put through clinical trials, and command higher prices when they do launch. Trial sizes are naturally smaller than for diseases with large populations, and the lack of alternative treatments give orphan agents an advantage when up for regulatory review. Tax incentives reduce development costs further. And when orphan drugs do reach the market, on average their cost per patient is six times that of non-orphan drugs, a clear indication of their pricing power.”

Or as Stephen Rattner of NY Times put it, referring to the monstrous climb in the PPS of Jazz Pharmaceuticals, “to get drug developers to focus on these relatively small pools of patients, the federal government offers inducements like a 50 percent research-and-development tax credit as well as a longer period of market exclusivity (seven years after Food and Drug Administration approval, rather than the typical five). These long monopolies often give orphan drug makers a free hand to raise prices.”

http://opinionator.blogs.nytimes.com/2013/06/30/the-orphan-jackpot/

Other facts about ODD:

1. Worldwide orphan drug sales forecast to total 176 billion, almost double overall prescription market growth (excluding generics).

2. Orphan drugs set to be 19.1% of worldwide prescription sales by 2020 (excluding generics)

3. Median cost per patient differential 19 times higher for orphan drugs compared to non-orphan

4. Bristol-Myers Squibb set to climb to number one position in orphan drug sales to 2020

5. Phase III orphan drug development cost half that of non-orphan; potentially a quarter with US tax breaks

6. Phase III drug development time for orphan is no quicker than non-orphan

7. Orphan drug FDA approval time 10 months vs. 13 months for non-orphan

8. Expected return on investment of phase III/ filed orphan drugs 1.89 times greater than non-orphan drugs

See the link below for full Evaluation Report of 2014 Orphan Drugs:

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P.S. Image searching stock charts when ODD is announced show immediate blast-offs. Check it out.