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To several of the old school longs here... I do not share the sentiment of most here regarding the settlement. We need more details tomorrow, but it appears that the only thing INSM walks away with is the overhang of the litigation.
I do not see where INSM is getting any finances without "phase III enabling data". TRCA and DNA have wiped the floor with INSM. TRCA/DNA even Ipsen get 50% options to almost any future products for INSM. How's INSM going to get a partner or funding (short of dilution) with those terms, who's interested in part of 50%. Unless TRCA/DNA makes big investment soon when will this deal really bear fruit? and does TRCA/DNA really want it too?
Based on this arrangement, I think INSM would have been better off letting the verdict ride and taking their chances. What really is the difference? (unless there's something undisclosed ) INSM has effectively enjoined themselves from the short stature market / the only current revenue stream we had. And we did so voluntarily? Allan always had a penchant to go it alone but now at what cost... The Boulder plant really was a stupid investment now (rstor was right based on today's events, I've reversed on that one...). INSM probably has enough product produced for years on years worth of clinical trials now... Based on this agreement, is there even room for INSM to develop non-infringing processes and compete, it doesn't seem so...
I hate to say it, but unless there's a hidden gem in there somewhere, we are going to get killed tomorrow....
I get all of that Jellybean... But we are where we are...
INSM has overhang of the jury verdict and it will cost big bucks and time to reverse any jury mistakes. INSM is most vulnerable to takeover and competition right now. Revenue stream is slow to build, PPS is in shambles (things all longs are painfully aware of). We will probably be in a position to require more operating capital soon.
So if all of these are true now, why wouldn't DNA be interested right here and right now? They probably smell blood in the water. Especially given anecdotal ALS potenial and Italy PR / hype. This is all speculation but I think DNA might be more interested in a stake in game now, before they probably didn't care...
Question is what are exclusivity terms with TRCA and what rights did DNA reserve? Or is DNA trying to get TRCA/INSM to partner or merge?
Drivers for settlement from DNA perspective....
I have been thinking about INSM and TRCA's position from DNA's vantage point. I have been lurking around this board and TRCA yahoo board (INSM yahoo mb is worthless!). Everyone makes a big deal about DNA and their strength / influence / lawyers etc. Now I agree DNA is one of "the" bio players, but face it they make so little from TRCA/IGF licensing TRCA/INSM is not even a blip on their radar. No matter what happens to INSM or TRCA it's not going to have much effect on DNA PPS.
But I think DNA may have two concerns when it comes to INSM/TRCA...
1). Potential IP loss - DNA owns the patents and will have little/no stake in any future IGF market without IP. Judge Wilkens could rule against them on IC (or) INSM will most definately appeal, so settlement mitigates this IP risk.
2). Potential longer term erosion / and stagnent HGH franchise - right now IGF isn't a threat to HGH. And one could argue without INSM/BP3 combo IGF may never threaten HGH franchises. But over time as Dr's/patients become more informed of IGF/BP3 possiblities it could erode HGH market for some indications. DNA Nutropin sales were ~380 million last year for DNA. That is only ~5% of DNA's revenue stream and HGH is not going to contribute to revenu growth very much. HGH is a crowded/competitive market. However, IGF is a new related niche growth market (but its too early to tell how market will develop / expand). DNA would like a slice of pie if IGF biology markets becomes a franchise, settlement may open that door to that expansion.
Given these thoughts I wondered, maybe DNA is the party pushing for settlement of some sort. It would reduce risk to their IP, may even get INSM to license their patents (not clear to me if license would go to DNA or TRCA, is TRCA license exclusive?). This also may postion them to wait and see how IGF develops in growth space and position them to make later move thru any license agreement they put in place.
It could be an interesting couple of days, but I'm not sure that this thing won't take more time to play out.
Good luck to all.
TRCA agreeing to a delay makes me wonder...
1. TRCA not confident they'll get an injunction or maybe they're worried about their chances with judge (ie they're not so confident of case and what judge may do)
2. TRCA wrangling with INSM to provide delay to wait for an EMEA decision or "approvable letter" type delay (like they got). If INSM gets EU marketing nod early that changes everything for TRCA and would increase strength of INSM bargaining position tremendously.
One thing is for sure INSM desparately needs to get EU approval before TRCA does. That would change the whole dynamic to this situation. I believe its possible, I think TRCA (with same retrospective application) could face some issues with approval. I never thought they would get US approval first (was wrong there). I think INSM must have a cleaner more current and compliant data package than TRCA's retrospective / licensed one.
North,
I hope you're right. I got time to read INSM / Bunslow's final brief and found it to be quite compelling. I especially liked the parts where he pointed out INSM is the one with all the investments in IGF science and how DNA never developed BP3 but now want to stifle it's innovation / benefits.
However I don't think it's likely Wilken will override the jury on all counts. I do not believe that an injunction is imminent, but when it comes to the legal system it's a crapshoot. I do like our odds better with a circuit court of appeals 3 judge panel than a CA DNA home turf jury.
Pure speculation and I can't believe I'm even writing this but I would think EU approval is more likely than a merger with TRCA. I have been following INSM for a long time... (back to CTRX days) and I can't see mgmt cutting a deal with TRCA. I think mgmt is locked an loaded for a lengthy appeals road.
In the US companies are informed about their NDA/BLA approval status weeks before it's public information. I am not sure if the EMEA works the same way... A lot of times word does get out (yes I know its illegal to trade on such info). With the kind of volume spike it would be interesting to see if there's any PR after hours whatever it is....
Again pure speculation and a lot of wishful thinking on my part. It's just as likely that the trading is pure ruor and speculation....
"COMP" is the EU orphan committee, iPlex already has their orphan status.
The "CHMP" is the committee that reviews marketing applicaions (EU equivalent of NDA). This committee will review and provided an opinion on whether a new drug should get marketing authorization and a license or not.
Their next meeting is the 2/19-2/22.
http://www.emea.eu.int/pdfs/human/press/pr/52116807en.pdf
Best regards,
Surf
You both are making some good points re: Boulder. I remember going around and around on subject with rstor1. I always sided more with jelly and rstor1 with vrtl. I seem to remember in the FDA filing there was some redacted info that lead me to believe their were production issues with Avecia.
Anyway that's all water under bridge now... We are at the point where we are. I don't like holding thru another set of rulings but I'm in for the long haul. IMO it would be pretty hard for judge to rationalize an injunction at this time. I have not kept up with court deliberations as much as others here. Where does INSM stand on inequitable conduct and chances to overturn at least some of the rulings? While I am not confident any rulings will overrule or change jury outcomes short of appeal, I was wondering whether this issue is still open or already been ruled on by judge.
Thanks in advance for discussion...
Plumbob,
They already would have to have Avecia in place.... Just like the FDA the EMEA will inspect and license the production facility for making product. I am not sure but don't think EMEA submission will license Avecia as contract mfgr (doesn't mean they can't change that later...).
Regards
I'm not bashing, but '414 patent could be relevant to EU market since I believe INSM intends to do all its mfg'ing in Boulder, CO. So unless INSM is manufacturing in EU for EU market, the patents could still be an issue in US.
Also I am a little encouraged by the amount of time jury has deliberated. I have no legal experience but common sense would tell you that jury is seriously deliberating and some of the jury must be siding with INSM for at least some of the claims. This seems like a long time to deliberate and at least issues appear to be getting a lot of consideration. This thing is obviously not a slam dunk for TRCA....
re: New production method question...
Buy4long,
I don't thnk anyone addressed your question. We don't know for sure, somone should probably pose question to INSM. But I believe the '414 patent relates to cell culture / fermentation processes to manufacture the proteins. INSM's new "shle-stable" formulation sounds like a lyophylized (freeze dried) version of the product. Chances are the cell culture methods and protein expression techniques (re 414 patent) won't be radically different. The relatively same proteins will be lyopholized at end of process (probably by INSM's fill/finish subcontractor). I don't know for sure but would guess that's what INSM will be delivering, changing cell culture / protein expression techniques and media / host etc. would be a much larger process change and would probably require clinical's to get licensure changes. Fill finish changes can potentially be made with less regulatory hurdles and with stability and equivalency studies only. That's what I figure their doing.
Hope this helps...
Did not suggest you made numbers up, that's why I sent the link.... Lots of preemies have eye issues from ROP that weren't seious enough for surgery. Surgery is performed in most severe cases to prevent retinal detachment and blindness. My whole point is there is a market here for INSM to pursue orphan status for. Without clinicals no one will know for sure, that's part of my point. Another group has apparently already been given orphan status in Europe. Many bio players are successful in niche/orphan indications and markets, some have even made a business model out of it. So where's INSM in this market, are they involved with these studies and will ultimately get this orphan indication?
ROP is a much larger market than you assume...
1100 to 1500 may have surgery, but surgery is only done for the worst cases. IGF will probably have a role in the treatment of less severe cases as well. Estimates of 14000 to 16000 of premature infants in US have some form of affliction
www.nei.nih.gov/health/rop/index.asp#3
I am personally aware of ROP risks / complications / issues that's partly what drives my interest in INSM being involved in this indication. ROP is primarily caused by prematurity and growth restricted neonatal development. Eye / vision development happens later in pregnancy term. Lights and UV therapy done in insoletes have nothing to do with retinal issues in premature infants, it's a developmental issue. Lots of ROP children who don't require surgery to prevent blindness have vision issues that IGF therapy may help address. In general there is interest in IGF's role in growth and development for small premature infants who are growth restricted or SGA (small for gestational age). This is a whole market / area that I hope INSM will be involved in and have orphan status for in key markets.
This is my last post for day..... (limited to 3 ihub posts for moment)...
Evidently they're going for orphan status in EU for rhIGFBP3 complex according to EU COMP committee. When you say "they have been working for years..." do you mean with INSM/CTRX or just that ROP Pharma's been working on indication for years. I am not aware of any INSM collaborations with ROP (and I've been INSM investor a long time). I am looking at this from the perspective that wouldn't want INSM / iPlex to be blocked from EU market for this indication if ROP Pharma is in a position to bring a product to market w/ orphan status. I am not too aware of ROP Pharma's position. I haven't seen any mention or discusssions of them as a player in the rhIGF markets prior to this orphan filing... Have you seen any info about INSM starting ROP trials in EU (or any other market for that matter)?
Sorry ihub board cut it off.... Paste the following items into your browsers URL....
http://www.emea.eu.int/pdfs/human/comp/
35763306en.pdf
The EMEA document is a PDF from their orphan committee granting orphan status to "mecasermin rinfibate" (generic name for iPlex / rhIGFBP3 complex) to "ROP Pharma AB". My original post had a typo of ROP Pharma AG, which would have meant a German corporation. "AB" is a code for a Swiss corporation??? Not sure but it's something like that....
I am really curious to know what this is about. Is a new player trying to enter onto scene with their own IP claims? or Is INSM partnered with another firm in EU for ROP indications / trials? I find it hard to believe that INSM is filing with a partner for ROP without a PR or announcement but who knows. I do recall some talk of ROP trials to kick off in EU but I don't remember where I read that. What bothers me is that even if they were kicking of trials in EU with a clinical partner I would think INSM would file for and get Orphan designation in EU themselves (like they have for short stature). Something about this doesn't add up....
I posted this earlier on yahoo but for most part it got lost in the clutter... Anyone know anything????
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Heres the latest release from the EMEA COMP board. Notice that an orphan designation is being granted for retinopathy of prematurity (ROP) to ROP pharma AG for mecasermin rinfabate (iPlex).
http://www.emea.eu.int/pdfs/human/comp/3...
I think I recall something about Insmed starting trails in EU for ROP. But who is "ROP pharma AB" and why would they hold the orphan designation for iPlex in EU? Not sure what's up with this does anyone know anything?
Thanks in advance,
Surf
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I did some checking and also found patents in Australia filed this March related to ROP pharma and ROP diagnosis/treatment. Who is ROP pharma aligned with? and does anyone know if INSM is involved???
THanks in advance.....