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Post by HeyNow on Feb 18, 2015 14:16:37 GMT
fwiw, my take on everything is that the most likely reason why Teva bailed on CellCure was because Teva felt Cell Cure's patent position in the RPE program was no match to OCAT's... so they concluded they'd be throwing money away working with CellCure, even though they had a sweetheart deal.
I agree with JHam that West probably doesn't agree with Teva's analysis on CellCure's IP position, and is charging ahead with the RPE program anyway. If Teva believed CellCure was on solid ground with their RPE IP position, I think they would have renewed the agreement, so that fact that they did not renew is a positive endorsement of OCAT's RPE IP position... IMO.
I still don't think you can take the next step assuming Teva will now do a RPE deal with OCAT... but you certainly can't rule it out either.
Right, but now Cell Cure has their very own patent protection on virtually the same method and can work freely in the space regardless of OCAT's patents. You'd think that if Teva made the deal before Cell Cure had IP protection, they'd want to continue the agreement after they secure protection. Obviously Teva wasn't happy with something, but I am having a hard time seeing how it relates to the issuing of patent. So maybe they abandoned the partnership for another reason. Like the IP moat of their competitor that is first to clinic. Im curious why you think teva pulled chute? If not concerns about the potential of the technology, nor the IP, then what?
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Post by Wallace907 on Feb 18, 2015 14:23:06 GMT
Right, but now Cell Cure has their very own patent protection on virtually the same method and can work freely in the space regardless of OCAT's patents. You'd think that if Teva made the deal before Cell Cure had IP protection, they'd want to continue the agreement after they secure protection. Obviously Teva wasn't happy with something, but I am having a hard time seeing how it relates to the issuing of patent. So maybe they abandoned the partnership for another reason. Like the IP moat of their competitor that is first to clinic. Im curious why you think teva pulled chute? If not concerns about the potential of the technology, nor the IP, then what? good question. along with elements of the pfizer/RCL partnership, the cell cure and teva partnership used to blanket arguments that discredited OCATs IP estate.
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Post by jckrdu on Feb 18, 2015 14:26:39 GMT
Right, but now Cell Cure has their very own patent protection on virtually the same method and can work freely in the space regardless of OCAT's patents. You'd think that if Teva made the deal before Cell Cure had IP protection, they'd want to continue the agreement after they secure protection. Obviously Teva wasn't happy with something, but I am having a hard time seeing how it relates to the issuing of patent. I'm not 100% aligned on the bolded assumption above.
On why Teva made the deal with BTX in the first place - given OCAT's IP in RPE - that's a good question.
I'll answer my own bolded question above....
West is a salesman. Maybe he gave Teva a story about BTX's IP position in RPE that initially sounded plausible to Teva. So, Teva does a low risk deal from their perspective as it had huge upside for them. Afterwards, they do more DD and conclude they're pushing up a rope as they realize there's a low probability they'll be able to get freedom to operate in RPE given OCAT's continually updated and improving RPE IP position.
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Post by JHam on Feb 18, 2015 14:41:58 GMT
For anyone interested. Here is the patent: patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=HITOFF&p=1&u=%2Fnetahtml%2FPTO%2Fsearch-bool.html&r=1&f=G&l=50&co1=AND&d=PTXT&s1=8,956,866.PN.&OS=PN/8,956,866&RS=PN/8,956,866 It is true that many of the claims in the original application were amended or cancelled due to prior art, citing OCAT and another group. I don't see that as a big deal though and even OCAT had to do the same thing when authoring their patent. Msemporda tweeted: "IP Narrowed 2 Culture Method Only & TEVA walks"I don't understand how one makes that conclusion. Teva knew about that from the beginning so why make the agreement in the first place? Anyway, I'll shut up as I sound like a broken record.
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Post by JHam on Feb 18, 2015 15:09:25 GMT
Right, but now Cell Cure has their very own patent protection on virtually the same method and can work freely in the space regardless of OCAT's patents. You'd think that if Teva made the deal before Cell Cure had IP protection, they'd want to continue the agreement after they secure protection. Obviously Teva wasn't happy with something, but I am having a hard time seeing how it relates to the issuing of patent. So maybe they abandoned the partnership for another reason. Like the IP moat of their competitor that is first to clinic. Im curious why you think teva pulled chute? If not concerns about the potential of the technology, nor the IP, then what? Could be many things. Maybe they decided that hRPE derived AMD treatment was not the method of choice for any slew of reasons; potential regulatory issues ahead with commercialization, unfixable issue with immunosuppressants, delivery method causes cataracts in some patients Maybe Teva decided they'd prefer to start their very own AMD program Maybe see more promise in a different method of treatment for AMD; gene therapy? Maybe they decided they'd rather focus their resources different areas; immunotherapy, neurological disease (they just pumped in $120M to Eagle yesterday): www.fiercebiotech.com/story/eagle-soars-teva-steps-120m-pact-rival-treanda-franchise/2015-02-18)Maybe it is because they somehow just realized that OCAT's method came before CC's and they'd rather pour their resources into a company further along and what they feel is a better method of deriving hRPE's (even though CC has never injected RPE into a human and pre-clinical results were pretty similar). Anything is possible.
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Post by rickrick on Feb 18, 2015 15:31:03 GMT
Not a method of choice sounds plausible to me. Reg med and BP have already proven stem cell therapy is not the only game in town. For various reasons they could be looking at some other promising, more profitable therapy.
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Post by icellman on Feb 18, 2015 17:54:22 GMT
Jham-
This may shock you, but I felt the same way when I saw the news on TEVA. I don't necessarily see the connection and why would TEVA go that route.
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Post by JHam on Feb 18, 2015 18:06:02 GMT
So maybe they abandoned the partnership for another reason. Like the IP moat of their competitor that is first to clinic. Im curious why you think teva pulled chute? If not concerns about the potential of the technology, nor the IP, then what? Could be many things. Maybe they decided that hRPE derived AMD treatment was not the method of choice for any slew of reasons; potential regulatory issues ahead with commercialization, unfixable issue with immunosuppressants, delivery method causes cataracts in some patients Maybe Teva decided they'd prefer to start their very own AMD program Maybe see more promise in a different method of treatment for AMD; gene therapy? Maybe they decided they'd rather focus their resources different areas; immunotherapy, neurological disease (they just pumped in $120M to Eagle yesterday): www.fiercebiotech.com/story/eagle-soars-teva-steps-120m-pact-rival-treanda-franchise/2015-02-18)Maybe it is because they somehow just realized that OCAT's method came before CC's and they'd rather pour their resources into a company further along and what they feel is a better method of deriving hRPE's (even though CC has never injected RPE into a human and pre-clinical results were pretty similar). Anything is possible. Here is another theory. Maybe big pharma is looking for a method that has better cell survival rate. Cell survival rate has been a big issue so far for OCAT and they have been pretty quiet on the topic. Maybe treating younger patients via the suspension method will help, but we won't know until we have P2 data. Perhaps big pharma is not interested in methods that are only getting a 10% cell survival rate and Teva saw that Cell Cure's approach ultimately achieving the same results. Maybe Teva is more interested in The California Project and their sheet transplantation method which gets a much better survival rate than the suspension method. The California Project has CIRM funding and will probably start their trial sometime this year. Check this slide from this slide deck: 894acfa90051d7a2a27e-8978d0c3c4c8cb744d658542db70335f.r59.cf1.rackcdn.com/TUES_1130_Humayan_RPE_JR_post.pdf
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Post by ridda on Feb 18, 2015 18:39:12 GMT
That 10% survival rate. Wasn't that the statistic prior to them discovering that utilizing the cells at an earlier stage of development and prior to pigmentation improved survival?
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Post by JHam on Feb 18, 2015 18:46:54 GMT
That 10% survival rate. Wasn't that the statistic prior to them discovering that utilizing the cells at an earlier stage of development and prior to pigmentation improved survival? You could be right, but I remember someone somewhere, wasn't it Schwartz? mentioning the survival rate recently and it still wasn't very impressive. If I am wrong on that then anyone please correct me.
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Post by actcfan on Feb 18, 2015 19:01:25 GMT
I'm also not sure how big of a deal the 10% is for some of the reasons already stated: - The 10% when I heard it was very early in Phase 1 and there is certainly a chance it has been improved upon (4 issued and 26 pending patent applications for "methods of treatment") - I believe there are only a need for 50-60k cells total, so if they inject 300k (as mentioned by Anglade recently) 30k is still pretty good coverage for early stage patients - It has been mentioned a few times that the cells potentially proliferate once engrafted, we'll see though.
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Post by JHam on Feb 18, 2015 19:06:02 GMT
I read that OCATA has worked out this issue in the past two years and cell survival rate has improved significantly. Lanza said one RPE cell takes care about 100 cones/rods. During one interview, Lanza explained that implanted cells traveled to the edge or the back and started working from there, it may not be easy to detect that. That's why no 100% correlation between pigmentation and visual acuity. Efficacy is also related to the surgeon's hand, surface pressure, and etc. The new FDA guideline has one section talking about OCATA's procedure. That is precisely my point.
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Post by JHam on Feb 18, 2015 19:09:31 GMT
I'm also not sure how big of a deal the 10% is for some of the reasons already stated: - The 10% when I heard it was very early in Phase 1 and there is certainly a chance it has been improved upon (4 issued and 26 pending patent applications for "methods of treatment") - I believe there are only a need for 50-60k cells total, so if they inject 300k (as mentioned by Anglade recently) 30k is still pretty good coverage for early stage patients - It has been mentioned a few times that the cells potentially proliferate once engrafted, we'll see though. Appreciate the response. You could be right. I was just trying to mention one other possibility. I agree, we will see sooner or later. One thing that I think everyone is in agreement on is that for the sake of AMD sufferers it would be great if these therapies work.
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Post by ridda on Feb 18, 2015 19:40:53 GMT
SS did speak about it in his last presentation. He spoke of how they were able to improve cell survival utilizing the cells at an earlier stage of development as I stated. No where in his presentation did he frame the issue as you have put it. Only spoke of modifing the process which led to a greater cell survival rate.
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Post by JHam on Feb 18, 2015 19:46:46 GMT
SS did speak about it in his last presentation. He spoke of how they were able to improve cell survival utilizing the cells at an earlier stage of development as I stated. No where in his presentation did he frame the issue as you have put it. Only spoke of modifing the process which led to a greater cell survival rate. Thanks. How did I "frame" it? I said that to my knowledge they haven't only reported low survival rate percentages and that I remember Schwartz mentioning something recently, but that it wasn't that much better. What you said though does ring a bell, so hopefully they'll be able to prove it in P2.
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Post by Wallace907 on Feb 18, 2015 19:48:00 GMT
Could be many things. Maybe they decided that hRPE derived AMD treatment was not the method of choice for any slew of reasons; potential regulatory issues ahead with commercialization, unfixable issue with immunosuppressants, delivery method causes cataracts in some patients Maybe Teva decided they'd prefer to start their very own AMD program Maybe see more promise in a different method of treatment for AMD; gene therapy? Maybe they decided they'd rather focus their resources different areas; immunotherapy, neurological disease (they just pumped in $120M to Eagle yesterday): www.fiercebiotech.com/story/eagle-soars-teva-steps-120m-pact-rival-treanda-franchise/2015-02-18)Maybe it is because they somehow just realized that OCAT's method came before CC's and they'd rather pour their resources into a company further along and what they feel is a better method of deriving hRPE's (even though CC has never injected RPE into a human and pre-clinical results were pretty similar). Anything is possible. Here is another theory. Maybe big pharma is looking for a method that has better cell survival rate. Cell survival rate has been a big issue so far for OCAT and they have been pretty quiet on the topic. Maybe treating younger patients via the suspension method will help, but we won't know until we have P2 data. Perhaps big pharma is not interested in methods that are only getting a 10% cell survival rate and Teva saw that Cell Cure's approach ultimately achieving the same results. Maybe Teva is more interested in The California Project and their sheet transplantation method which gets a much better survival rate than the suspension method. The California Project has CIRM funding and will probably start their trial sometime this year. Check this slide from this slide deck: 894acfa90051d7a2a27e-8978d0c3c4c8cb744d658542db70335f.r59.cf1.rackcdn.com/TUES_1130_Humayan_RPE_JR_post.pdfon the bolded: that 10% figure was just a number thrown out by schwartz, he went on to say that it might even be less than that. Further, he noted that the RPE neutralize and phagocytose toxic elements which could also lead to their demise. Simply adding another injection down the road may dramatically increase survival. Advancement in a specialized canela may also help. Klimanskaya & Zarbin did use a conditioned medium(bovine corneal endothelium) in order to improve cell survival by 200%, but OCAT will use photoreceptor progenitors in lieu of over-engineering RPE this early development(hence "next gen" RPE). Im not sure anyone has proposed treating early stage patients with the scaffold method due to its invasive nature. You wouldn't give someone a lung transplant if they have asthma, would you?
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Post by ridda on Feb 18, 2015 19:54:55 GMT
SS did speak about it in his last presentation. He spoke of how they were able to improve cell survival utilizing the cells at an earlier stage of development as I stated. No where in his presentation did he frame the issue as you have put it. Only spoke of modifing the process which led to a greater cell survival rate. Thanks. How did I "frame" it? I said that to my knowledge they haven't only reported low survival rate percentages and that I remember Schwartz mentioning something recently, but that it wasn't that much better. What you said though does ring a bell, so hopefully they'll be able to prove it in P2. As an ongoing concern.
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Post by HeyNow on Feb 18, 2015 20:24:14 GMT
Thanks. How did I "frame" it? I said that to my knowledge they haven't only reported low survival rate percentages and that I remember Schwartz mentioning something recently, but that it wasn't that much better. What you said though does ring a bell, so hopefully they'll be able to prove it in P2. As an ongoing concern. He actually framed it as the potential reason why Teva abandoned their partnership with Cell Cure
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horus
Junior Member
Posts: 96
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Post by horus on Feb 18, 2015 20:49:06 GMT
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Post by guruzim on Feb 18, 2015 22:08:20 GMT
I'm a generally positive guy, but I'd like to say - we shouldn't infer anything from this.
Just off of the top of my head, here are plenty of reasons that make sense that have nothing to do with Ocata
* Questions about efficacy of the treatment * Questions about partners management * Questions about regulatory environment * Questions about another project that they needed the funds for with a higher potential for profit * Questions about profitability of an effective cure * Questions about competition in the space by NIH in Great Britain using iPS * "Convinced Ocata has an IP moat and we shouldn't be in this space"
See how much less convincing the Ocata one is, just competing against top of my head reasons?
I'm long OCAT and I don't see anything here other than just another thing going on in the same space.
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