China--Transforming the FDA and Leveling the Playing Field For Small Biotechs

[NPfisherman]

Salutations FPC'ers,

A few days ago, I had a discussion with a couple of fellows here about China, and new drug development, and wanted to make my position clear... China will end up shortening/ streamlining the FDA process, while forcing Big Pharma to play fair with small biotechs, and here is how...

Some of the problems discussed here regarding current drug approval is: 1) How long it takes to get through the FDA process from beginning to end... 12 years... a long time to wait when you have a resistant disease... a lifetime, so to say.. and, 2) at what cost ??? a cost of over 50 million dollars for Phase III alone... How can a small biotech succeed needing that kind of money, and the need to survive for 12 years ??

But wait...what if... things are like this:

linkedin.com/pulse/china-gr...

Getting the IND (Investigational New Drug ) application process completed is faster in OZ, New Zealand, and China... Instead of waiting that lifetime ...(12 years)... the same drug could be approved in 1/2 the time ...

Of course, there are various takes on the issue: Is it safe, how do they compare. etc...

mercatus.org/economic-insig...

and as for the cost??

communities.springernature....

The cost alone will drive this ship for the small biotechs with the guts to not wait forever for a large Pharma company to come and make them an offer which may, or may not come.... Look at Dextech--completed Phase IIb in 2020, so where is the Phase III ?? The reality is that some companies like Dextech (Drug--Osteodex) could take their completed Phase IIb results, get approved to transfer the data to China, and complete Phase 3 for 3 million dollars, and if approved, the cash flow can begin... and in a lot shorter time than the 4 years that they have waited already for a Big Pharma partner... Competition and price will drive the market to China.. Small biotechs will change the play book to China..

And, if the FDA believes enough in Chinese drugs to make importation allowable like this:

thehill.com/homenews/408944...

What are we to believe?? That suddenly... (poof)....the Chinese drugs got better quality... or is the quality just fine, but only during a drug shortage.. or are they really ok, and the FDA wishes you to think otherwise..?? Which is the case??

Some say that Chinese drugs will NEVER be for them...Everyone must chose their own path....For those with a challenging, unstable disease, the chance to have additional options would be most welcome, provided they can travel abroad.. if not to China, then Oz, or New Zealand..

As always, I welcome all questions, comments, etc...

Don Pescado

[cujoe]

NP - As many/most patients who read here have advanced disease, the notion that we can tolerate a 12 year wait for new drug approvals is the foremost reason that most of us have developed treatment strategies that lie at the edge or fully outside of SOC. PSMA, both as a diagnostic and therapeutic tools were in use for as long as five years in Europe and AU, before FDA approvals for their use here.

Even now access to PSMA theranostics (outside of clinical trials) is still limited to those heavily treated CR patients that have failed all other options, not to mention the direct-to-patient quote I got from my MO of ~$100K for Pluvicto. Patients with the means are more frequently traveling outside the US for all sorts of healthcare services they either can't get here or are priced out of having access to.

Not much chance for major change in time for most of us to benefit, so our best options are to pay close attention to the diverse treatment options being used both in SOC and by our n=1 outlier patient community. Share openly, do lots of research, and ask lots of questions. We travel on separate roads, but share the same journey.

Thanks for a thoughtful post. Also see my subsequent MNM post that shows how we get closed off from potential treatment options by the FDA at both ends of the spectrum.

Stay positive, safe, & well,

Ciao, cujoe

[Maxone73 in reply to cujoe]

I agree but partially. I think adoption depends on who develops the drug, market choice and so on. I am on ARASENS trial, that triplet therapy was approved by FDA first and by EMA afterwards (and from what I know not yet officially adopted as SOC in Italy, they had to create a "study" for a single patient, me, because the public health system was not going to give me darolutamide). And Bayer is an european company. Ok in this case it was the combo that had to be approved, not the drug itself, but still...

[NPfisherman in reply to Maxone73]

Max,

The question is... will it change the rules, and in our favor. ..? Only time will tell, but my intuition says... highly likely on the rules... fair to middling on being in our favor...

Congratulations on getting the " good stuff", aka darolutamide... clinical trials make our world go round...

DD

[Maxone73 in reply to NPfisherman]

I am in favor! The larger the number of companies and researchers the more advancements we will have, always been like that, mid pharma and small pharma are a reality now 😜

[NPfisherman in reply to Maxone73]

If the reality of running an IND to the finish line is within the grasp of the small in China, it forces both sides to look at things on a more level playing field status... all IMHO... Have a great weekend, Max ..

DD

[cujoe in reply to NPfisherman]

I keep coming back to the fact that the US is one of only two developed countries that allows direct-to-consumers advertising for scripted pharma products, the other being New Zealand.(?) Last time I saw numbers on corporate outlays for advertising, the four largest pharma cos spent more money on advertising than they did on research. So, much of the constant blather about how expensive it is to do clinical research is just corporate diversion from the $$$ they needlessly spend on advertising.

wakeforestlawreview.com/202...

en.wikipedia.org/wiki/Direc...

Money talks - and politicians listen (very well, it seems) to what money says.

Stay positive, while being S&W,

Ciao - K9 terror

[NPfisherman in reply to cujoe]

K9 of Terror and Big Pharma knowledge,

Great reply.... If they just put as much into a cure, as they did reaping 425 billion dollars annually from consumers... we might not need a forum.... Money talks ,indeed ...

Ahhh, the life of a Big Pharma marionette .... aren't we all?? The commercials on TV.... being a consumer... Can someone please get Lume' deodorant to stop advertising ?? Mother of Pearl......

Do not get me wrong , fellow members... I have benefited from being placed on ADT plus abiraterone intermittently... benefited from the best scans available both times...Axumin and Pylarify... I can acknowledge that with gratitude, but....

The issue that great medications sit around waiting for Phase III, while Big Pharma plays the waiting game with small biotechs... eventually buying them out even.. The only way real change can occur is if the dynamic changes, IMHO... China changes the dynamic...

DD

[Maxone73]

Well, normally when I ask what's the best phone in relation to quality "iPhone" is the answer, and it's made in China anyway...so...it's not just a matter of chinese drugs, but "western" projects developed in China, as it already happens with high quality technology we use every day.

I used to import marble cutting blades from China, my chinese agent always told me "you pay this much for these blades and you get compliments, I can get you blades that look exactly the same at 1/20th of the cost if you want, but don't expect to have satisfied customers. In China we range from great quality to trash, it's up to you and about the budget you want to invest"...like the old saying, when you pay peanuts....

[NPfisherman in reply to Maxone73]

Max,

I agree... you get what you pay for....but with a cost of only 11 million for a fully completed phase 1-3.... For small biotechnology companies, the chance to prove concept in phase I and II is within affordability.

Osteodex could be on the market in 3 years .. the company has already waited 3 years.... This is a drug that could change outcomes for bony metastasis in several cancers ....

Big Pharma plays the tune, and small biotechnology companies wait. ...because 50 million for Phase III is a LOT of money.....and we... We matter to them as a consumer only...

DD

[Maxone73 in reply to NPfisherman]

I have written them saying I can help crowdfunding….and also with that 30 years old looking website!

[NPfisherman in reply to Maxone73]

Max,

Pray tell... who did you write to about crowdfunding, and the website.. ?? Feel free to message me, because I...can not message you...

More...Later...

DD

[Maxone73 in reply to NPfisherman]

joking about crowdfunding, but yes I have written to OsteoDex guys to ask them when we will see a step forward…and if they wanted a new website 😜😜 it really looks awful

They have been publishing facts like that they are looking for some patents first to then look for a partner for phase 3. I swear I was this close to propose them to make it a “patients owned company”

[NPfisherman in reply to Maxone73]

For some with bony metastases, this drug could put an end to needing ADT, or prolong vacations for IADT.... and yet, we wait... because of the system and the resistance to change...Thanks for making the effort to help them...

Fish

[Maxone73 in reply to NPfisherman]

Fresh from my search: sciencedirect.com/science/a...

[NPfisherman in reply to Maxone73]

Can you imagine... slowing down aggressiveness and metastasis??

I tell people.... CRISPR will change how we treat disease... so many genetic diseases... just cut out the bad, and insert the good... what a concept??

So for us... this alone could change the 5 and 10 year survival rate for advanced prostate cancer significantly..

Thanks for the reply...

DD

[Maxone73 in reply to NPfisherman]

It works well with melanoma as well:

nordiclifescience.org/dexte...

what is sad is that it has been around since 2015 I think!

[Maxone73]

I am not even sure that they got my email, but honestly, self funded research sounds appealing!