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TOPIC: Some Franshei Notes of Major Importance

Some Franshei Notes of Major Importance 19 Nov 2018 06:59 #12356

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Somebody raised by private email the issue of "stability testing" of Cytori´s ATI-0918 product and the fact that we have been reading a lot about that, but really (at least I dont) - nobody of the present lodge participants, I believe, has any particular knowledge of that whole process.
So I thought I´d query the Lodge with that search criteria for posts of Franshei and yes- up came quite a few interesting comments from him (our former pharmacological expert in that field), which shed some light and provide a lot of food for thought in the present situation of CYTX.

First though, the comment on ATI-0918 development from Hedrick in the last call:

To begin with, Cytori is developing and manufacturing chemotherapy drug ATI-0918, which is a generic pegylated liposomal doxorubicin hydrochloride intended to be bioequivalent to the European reference drug. As mentioned on previous calls, we intend to position this as a high-quality U.S.-made product with maximal clinical effectiveness primarily targeting breast and ovarian cancers. We have the goal to be the first or second generic on the market in Europe, for the target launch in 2020 via a commercial partner.

Let me give you a few specific updates on the program. The products proposed in this domain is currently under review by the (inaudible) within the EMA. The product will be available in 10R and 25R vials, identical to the EU comparative drug, and we are currently finalizing the packaging design. The program is in the manufacturing validation phase, and once both manufacture is complete, we will outsource the bulk product for sterile filling, packaging and product finish. The first finished lots will then be placed on stability testing. And the company is in the process of preparing its marketing authorization application to be filed with the EMA. That will happen next year, following 6 months of stability testing and other testing of our validated lots.

The company also continues to actively engage with a number of potential interested commercial partners for ATI-0918, and these discussions are focused outside of the U.S., specifically in Europe, EMEA and the AP. As mentioned previously, the global market for this drug is conservatively estimated to be approximately $400 million to $750 million annually. And specifically, Europe, the estimated annual market opportunity is approximately $120 million to $300 million.


So- from the above, although the remarks are pretty confusing and can be interpreted in different ways, my understanding would be that manufacturing and validation i.e. the stability testing is in process before the lots will be filled in vials and packaged by an outside Company (I believe is based in the Chicago area, where Franshei is domiciled)

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Board moderator and Site-owner. I still regret the day I started analysing the prospects of MacroPore (now Cytori) back in 2004- a left-over from the tech-bubble at that time from the century change in my portfolio- and became addicted to Cytori´s fat cell technology. :cry:

Some Franshei Notes of Major Importance 19 Nov 2018 07:04 #12357

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Frm Wikipedia: Stability testing is a method to check the quality and how the system or software behaves in different environmental parameters like temperature, voltage etc. In the pharmaceutical field, how well a product retains its quality over the life span of the product.

What is done in the pharmaceutical field can be reviewed at : Bioscreen.com

Franshei- August 9 2017

ATI 918 would be important. I think the bulk manufacturing is ongoing and stability testings will start in the beginning of the 4th Q. Multi country partnerships/distributors will come for 2019 launch. The future of CYTX will dependent on Cytori Nanomedicine as a cash cow and new leads into regenerative medicine.

Franshei- October 26 2017

Re ATI 0918, no one would sign a deal with CYTX until the manufacturing is (at least nearly) completed in a FDA inspected facility and stability testing has started. I believe the San Antonio pilot plant is now up for running and liposomal compounding is in early stages (small batches with validated analytical HPLC support). The stability testing is a one year process at room/ambient temperatures and elevated temperatures. For EU FDA filing, they need at least 6 month data (with understanding that the one year data is coming).

Franshei - November 10 2017

With very limited cash on hand, AZA is making good progress: the pilot plant has now been validated and it is been scaled up. Looks like the analytical HPLC lab is now set up to do QA. The next step is liposomal compounding at different scales (this step may very well be ongoing), before stability testing (it is usually an ongoing process during different stages of compounding).

HPLC= High-performance liquid chromatography is a technique in analytical chemistry used to separate, identify, and quantify each component in a mixture. It relies on pumps to pass a pressurized liquid solvent containing the sample mixture through a column filled with a solid adsorbent material

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Board moderator and Site-owner. I still regret the day I started analysing the prospects of MacroPore (now Cytori) back in 2004- a left-over from the tech-bubble at that time from the century change in my portfolio- and became addicted to Cytori´s fat cell technology. :cry:

Some Franshei Notes of Major Importance 19 Nov 2018 07:08 #12358

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More specifically his thinking on the "tertiary" business opportunities written in February this year has my intense- and special interest :whistle:

Franshei February 18, 2018
FAS
In December, I had several email communications with Tiago Girao and I have come to some understanding that Harris has tried very hard to make Cytori KK a success to meet the original plan for make 2018 a breakeven year for the corporate cell therapy business. Yet his efforts have virtually failed. He has obviously failed his earlier agreement (contract) with the company. After much thinking, I have also come to the conclusion that he has been let go (very similar situation as for Calhoun).
President Trump clearly indicates in the State of Union address Generic and SuperGeneric (such as ATI 0918) drugs are things for the future, in order to cut down US medical expenses.
As we have all come to realize now Cytori Nanomedicine is becoming our new focus. Tiago Girao and I have many communications on this topic in the past 12 months. All the new hires are really for this segment of the business. Harris' salary and compensation and ineffective traveling expenses are enough to cover the salaries and benefits for the 4 new employees. John Kirk's continuing support of the company is shown by his stock ownership. Tiago Girao had also told me that John Kirk is very supportive of the company in many ways.
I personally think San Antonio ATI 0918 (scale up) manufacturing and stability testings are now going on in much higher speed than before (for near mid year EU ANDA submission).
However, I believe an EU distributorship is more likely at this point. Without a completed US bioequivalency trial (cost is actually very small - about $ 1 million now- used to be below $ 250,000), it would be hard to find a decent pharma partnership. Yet, there is a company located without 100 miles from San Diego, CYTX may find an audience and they have done similar collaboration and further development. The Chinese founded company is Watson. They have very deep pocket. Of course there are many others that I can name in California (Orange County and San Francisco).
Even with a distributor for ATI 918, the potential revenue (even at very early stages of sales and marketing) would far, far exceed what John Harris can do (Tiago Girao agrees this whole heartily).

Hedrick does not know oncology and biopharmaceutics. With or without his presence as CEO, the company needs a clinical pharmacolgist/medical oncologist to move ATI 0918 US bioequivalency trail and lipo taxo phase 2.
To support all the new endeavors, CYTX should sell most if not all its cell therapy assets if they can find a buyers.
At certain point in the future, the company may have to change its name to reflect the company's main buisness.
PS 1. Hedrick may still kick around for a reason that people may forget: when AZA was acquired, he mentioned that CYTX would use AZA technologies to do cell free regenerarive medicines - so what the catch here or what is the hidden agenda.
PS 2. I personally think CYTX many still keep some aspects of the cell therapy business: celution manufacturing, research sales (leading to PMAs with outside clinicals -just like Scleradec 2 and Japanese urinary incontinent study) and BARDA . Note: the BARDA contract for phase2 covers several years, because patient accrual would be very slow. Also, Hedick did ention that there was a protocol change end of 2017 initiated by BARDA. He mentioned that study initiation would be late.

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Some Franshei Notes of Major Importance 21 Nov 2018 00:20 #12361

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New poster--long term reader and CYTX shareholder (been tough ride)
brief note for now since trying to test this out.
fortunate to be in the drug discovery/development business and also have worked with liposomes
I think we will have to wait till mid summer 2019 for 6 month stability data on the registeration batches for commercialization. Had hoped it would be earlier but perhaps Cytori can use earlier feasibility batch data for partnering.
*they seem confident of path forward but plan unclear. is it postponing Oxford or French data in Dec (they seem to downplay that)
*definitely they have a cash cow from the dox liposomes--but they can leak or not be washed completely of dox so the long manufacturing issues and delays
*I think sterile filling is to be done at Bryllan in Michigan, a reputable shop for highly cytotoxic drugs. The key is that the dox liposomes get to site of target action and you avoid dox tox in the bloodstream to some degree.

Been a fun ride with all of you posters and Fas has been a terrific guide; hope we are here n 2019!
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Some Franshei Notes of Major Importance 21 Nov 2018 08:46 #12362

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Welcome aboard SH

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Some Franshei Notes of Major Importance 22 Nov 2018 12:12 #12363

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First- happy thanksgiving to you all on the other side and welcome to SH from me too.

SH- I think you are probably right- stability testing before submission to the EMA might take a while still, but the confidence they display is out of this world, so this can only be as a result on ongoing BD discussions, which should be favorable.

We will know soon enough.

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Board moderator and Site-owner. I still regret the day I started analysing the prospects of MacroPore (now Cytori) back in 2004- a left-over from the tech-bubble at that time from the century change in my portfolio- and became addicted to Cytori´s fat cell technology. :cry:

Some Franshei Notes of Major Importance 22 Nov 2018 15:20 #12366

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They do seem confident borderline cocky considering cash hole. But Chinese money is out there...i see it first hand and in my business. Could happen that way
Watson is part of allergan so not sure about that route. My crude calculation is that if the price gets above a dollar between the warrants and Lincoln there is a chance to move into 1q 2019. Cytori can start getting 3 month stability data to share under CDA and maybe strike a partnership back ended with milestone payments. This is a big if but they are clawing at every million dollars. If only symbolically management reduce their salaries by 50 percent stock would rocket. Happy Thanksgiving to the American folks out there in food comas...

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