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buy4long,
You're probably right, but there is a more optimistic scenario. The indications that are now in "Phase II" trials (which you accurately describe as "post-PI") are for indications so horrific that they could conceivably qualify for combined PII/III trials, if the preliminary data to be released "in a month or so" (according to yesterday's CC) are as compelling as anticipated by management, and then DNA might opt in much sooner.
I perceived (again from yesterday's CC) that some form of financing is anticipated soon ... possibly before the CC next week.
Hope for the best, but expect the worst?
zake1, once again, read again.
<The Settlement, License and Development Agreement is in effect until the later of 2018 or the expiration of any subsequent Tercica/Genentech ....>
<Some of these issues end in a couple of years>
A couple of years is NOT later than 2018!
awass, you are right on.
The real losers in this deal are the patients. In my opinion ... which will not be very popular ... the best thing that could happen now is for TRCA to acquire INSM. Then TRCA would have the whole enchilada and could make IPLEX available for any and all approved indications.
This would probably be the best for INSM shareholders also.
zake1, better read it again.
If either DNA or TRCA opt in they split the costs 50/50 with INSM, but they also split the profits 50/50. They also would gain "commercial control".
That sure sounds like a partner ... a controlling partner ... to me.
The PharmaThene agreement may be a bigger deal than it appears on the surface.
PharmaThene is in the process of going public through an acquisition by Healthcare Acquisition Corporation (Amex: HAQ) ... scheduled to close this summer. The following is a power point presentation by HAQ for prospective investors, but it makes interesting reading as to what is forecast in revenues for Protexia.
http://google.brand.edgar-online.com/fetchFilingFrameset.aspx?FilingID=4897326&Type=HTML
<the judge issued an injunction pending appeal, and now SONY struck a deal>
Pardon my ignorance (I have no moderating privilege to feel sorry for) but I also fail to see any significance to our case. Two parties involved in a lawsuit have struck a deal. I would guess that is done a few hundred times every day.
Thank you. That is excellent information.
A concise description of ALS and the Phase III trial of Myotrophin (Cephalon) can be found at:
http://serendip.brynmawr.edu/bb/neuro/neuro99/web1/Rodrigo.html
Apparently Myotrophin IGF-1 is thought to be a possible treatment to delay the progression of the disease and prolong useful life. It IS NOT expected to be a cure. The drug received an approvable letter from the FDA in 1998 or 1999, if an additional Phase III trial was conducted. That trial is complete, but results are not expected until later this year. That probably explains Mr. Bruno's treatment with IGF-1 in 2003 ... which he followed up by treatment with Iplex beginning in 2004.
Mr. Bruno's experience has raised a lot of hope for a "cure" for ALS. Logic would suggest that if naked IGF-1 delays the effects of the disease, then Iplex may delay it more due to its more effective use of IGF-1. Hopefully that is the case, but to speculate about a "cure" is not justified at this juncture.
You are not even suggesting a "cure". I only use your post as a chance to expand on Mr. Bruno's testimonial.
jellybean,
TRCA announced the appointment of a COO this morning. TRCA has never had a COO. I wonder why Scarlett may be stepping back from their day-to-day operations?
http://biz.yahoo.com/bw/070228/20070228005257.html?.v=1
<The weight actually carried by the bridge depends only on how deep the operator allows the water to be. (That's also high school physics.)>
I understand what you are saying, but the above sentence is a little misleading. It has been a long time since high school physics, but I still remember that the weight of water is determined by its volume ... not depth.
If the boat floats, it has displaced a volume of water equal to its (the boat's) weight. However, the water displaced is still there so its (the water's) weight is added to the boat's weight. If the water displaced by the boat is released, the total weight will change ... but the DEPTH of the water is only an indirect measure of the total weight. It is the VOLUME of water remaining that counts.
However, if the water is dispersed along the length of the "bridge" from lock to lock, the volume of water remaining on the actual bridge (which does not extend from lock to lock) will decrease proportionally, but the weight of the boat that displaced that water will not decrease, so the bridge will still carry more weight than it would have if the boat was not there, unless the water was actually released from the "bridge" from lock to lock ......
I have confused myself.
Court dates:
http://www.xs4all.nl/~surg3on/2006-nov-INSMvsTRCA_trial_motions-Read_this_n0w/1011%20Status%20Confer...
Other dates:
Your guess is as good as anyone's.
< The remedy of damages seems to be excluded by this portion of the code...and if so, why was this not used as a defense during the trial?>
plumbobt,
The short answer is, "I don't know". Perhaps it was brought up in arguments outside the presence of the jury, perhaps not. You have to be present in a courtroom to have the benefit of everything said. We only have what has been submitted as formal briefs, etc.
Do DD may have the answer. The jury was instructed to answer questions about infringement, what damages (if any) should apply, etc., in other words to determine the "facts". The judge will now apply the facts (as determined by the jury) to the law and make the final rulings. What we are discussing now is law. The jury doesn't interpret law, so the current argument by defendants council would have been appropriate for the judge , not the jury, at the appropriate time.
Does that make any sense?
<If this is such a good legal argument, why was it not used during the trial? Its hard to believe that the legal team just recently discovered it:>
The plaintiffs did not file a motion for injunction until AFTER the trial. This is the dedendants answer to that motion.
The subject of an injunction was discussed here and elsewhere before and during the trial, but it was not a motion before the court until after the trial. Tipping their hand (even if it had been admitted ... which I doubt) would not have been very smart.
There isn't one decision, there are several. The judge has already made some and a jury has suggested others. The judge still has to rule on still others requested by the lawyers. According to the court, the earliest that any final ruling will be made is after a February 16th hearing ... how far after is anyone's guess.
It isn't as simple as "for" or "against" INSM. (You might take into consideration that almost all the decisions made to date have been "against" INSM.)
With all that uncertainty, the prudent person would probably buy some now and wait to buy the remainder after the final court ruling ... if you still feel as strongly about INSM after the final court ruling. A REALLY prudent person would probably wait for the final court ruling before buying ANY. Only you can make that decision based on your risk tolerance.
What did I do? I sold half my position before the jury verdict (a wise move), and I am still holding the other half (along with the funds from the sale) until after the final court ruling to see if I want to buy back what I sold. In hindsight, I wish I had sold all my position before the jury verdict, but that is what makes it a horse race.
Do DD has offered some excellent advice.
Good luck.
<Tercica made a big and repetitive point in the court proceedings that short stature was the only indication approved for Iplex. They also made a point of this in post trial motions. Now Iplex is being used in Italy at government request under a EU license.>
Re your arrogant reply to Dew, if you were not insinuating that Iplex for ALS is now as good as an approved application in Italy, then why did you you even make the above statement. The proof is in your use of "a EU license" instead of accurately stating that the license is granted by Cephalon (a U.S. company located in Frazer, PA).
And, if "clarity will come in time", why do you have the need to "clarify" the news that "is what it is"? You are apparently playing word games to suit your own agenda.
Is that enough factual information to "explain my disagreement" with your post which is loaded with speculation and information that is not factual.
Now you can delete it.
"When reading INSMs IC motion it's clear that some evidence for the motion was collected during the trial."
That is my impression also. That would explain why the IC hearing was scheduled after the case went to the jury. IC was not an issue officially before the court until the trial was ongoing. In fact, I seem to remember the judge making a statement to the effect that she did not want to stop the trial for an IC hearing because she was afraid that might prejudice the jury on the other issues, but I may have dreamed that.
Also, I get the impression the judge made bringing up the subject of IC as difficult as possible. (She had already ruled on the prior art question, and bringing up IC was in effect exposing her decision to further examination.)
The U.S. legal system really IS counterintuitive. Years ago in Denmark I was asked by a police official there to explain our Criminal Justice System so that he could understand the logic behind why we do what we do. I couldn't. My suspicion is that our founding fathers would be shocked today if they could see how the system has evolved ... with lawyers running the show.
I agree that it would seem more logical to rule on the IC first, but apparently the judge does not see it our way. That may be Insmed's fault to a certain extent. If you go back and read the judge's ruling after the Markman Hearing (available on Tercica's website in a PR released July 6th) the judge makes it very clear that Insmed brought a motion for summary judgement on the ivalidity of the '151 patent on the grounds of prior art by Maack and Somner. The judge denied the motion, and in doing so specifically stated that Insmed presented no evidence to support their position ... other than their attorney's arguments, and attorney's arguments are not evidence. That sounds to me like Insmed may have dropped the ball.
Apparently, some time later Insmed put forth the defense of inequitable conduct in an attempt to have the '151 declared unenforceable. Exactly when that occurred I do not know. The first I saw of it was in a court document filed in October, and it appeared the judge took a dim view of having it put on the table at such a late date. That leads me to believe the IC may have been made an isssue by Insmed as a fallback position just prior to trial, but I certainly do not know that for sure. However, if that was the case, it might explain why the judge decided to let the case go to the jury before any IC hearing. It may have been that the only question before the court at that time was the one on prior art, and she had already ruled on that. (The Insmed brief on IC wasn't even filed until AFTER the case had gone to the jury.) If that indeed was the case and I was the judge, I would be more than a little pissed for having been put in that position.
I would think though it may be a "no harm, no foul" situation in that IF the judge grants the IC motion ... which I personally doubt ... she can set aside the infringement issues with the '151 patent and adjust any royalties accordingly. If, on the other hand, she denies the IC motion Insmed now at least has put all they have into the record for an appeal.
I think we have to keep two things in mind during the next few weeks. One is that we do not know all that goes on in the court. The other is that the court (any court) does not rule on any question that does not come before it. In theory, the judge may agree with us but she can only rule on what has been brought before the court by either the plaintiffs or defendants. At the Markman Hearing Insmed had only contended prior art (which the judge rejected). The IC motion apparently came later.
Correction. The court ruled after the Markman Hearing that the "414" patent had been LITERALLY infringed, not the "151" patent as I stated. The ruling at the time on the "151" was that Insmed claimed unenforceability due to inequitable conduct, but failed to offer any evidence as proof of their claim ... only attorney argument which is not evidence. Therefore, the "151" patent was ruled valid after the Markman Hearing based on the evidence presented, or not presented.
The jury WAS instructed at trial to determine if the "151" had been infringed and, if so, was it willful. They decided both.
Insmed did eventually offer evidence (at trial I suppose) they believe will support their claim of inequitable conduct regarding the "151" patent. However, inequitable conduct is determined by the court, not the jury, so a hearing was held after the jury received the case, but before they brought in their verdict. If that is accurate, it explains why the inequitable conduct hearing was held AFTER the trial.
The remainder of my post is accurate ... I think. Sorry about that. Does anyone see it differently?
There is one other thing to be considered. Using the stop sign analogy in my previous post, it would be entirely proper to ask a jury to determine if I "willfully" disgegarded the stop sign, even if the stop sign's legality was yet to be determined. Why? Because that might have a bearing on my punishment if the stop sign was later determined to indeed be legal.
This may not answer your questions, but there are a few things you should keep in mind.
1. The court (the judge) ruled several months ago (after the Markman Hearing) that the "151" patent has been LITERALLY infringed, i.e. infringed taking the patent at face value . However, Insmed claimed there was inequitable conduct in obtaining the "151" patent that would make the patent unenforceable. The court said that would be decided (by the court) at a later date in an inequitable conduct hearing. In the meantime, the jury trial would go ahead because there were several other patents involved in the lawsuit.
2. The jury decided that Insmed WILLFULLY infringed the "151" patent (taken at face value) and WILLFULLY induced others (I suppose docs, etc.) to do likewise. The jury was not asked to decide on actual infringement because that had already been decided. I am definitely on Insmed's side, but I would have probably decided the same way. In other words, if I believe a stop sign has been illegally placed at an intersection and I choose to ignore it, is that willfull? Of course it is. If it is later determined that the stop sign was indeed illegally placed then I will be off the hook.
3. The inequitable conduct question only applies to the "151" patent.
4. The hearing scheduled for February 16th is to hear oral arguments (written briefs and exhibits will already have been submitted) on ALL post trial motions. I suppose the inequitable conduct motion will be included, but so will the injuction motion, and several others. Will a final decision on everything be issued on that day? I doubt it, but only the judge knows for sure.
You bring up good points.
I hope this meets the criteria for reposting here from YMB.
"pinequin -
You are aware are you not that TRCA has a recent (prior to the delay in EMEA's consideration of Increlex which gave INSM an advantage in Europe) agreement with a European partner which gives the partner the right to sell Increlex in Europe. In return, the European partner bought a large stake in TRCA for approximately $70 million.
I would think this agreement ... and the $70 million ... might be in jeopardy if TRCA cannot, for whatever reason, sell Increlex in Europe. If so, that would explain TRCA's risky strategy of bringing up the European situation.
This is the jist of the agreement:
"Under terms of the collaboration announced on July 18, 2006, Ipsen has granted Tercica exclusive rights to sell Somatuline® Autogel®, a leading product in the European acromegaly market, in the United States, subject to approval by the U.S. Food and Drug Administration (FDA), and in Canada. Tercica has granted Ipsen exclusive rights to sell Increlex(TM), a leading product in the United States for the treatment of short stature associated with severe Primary IGF-1 deficiency (Primary IGFD), in all regions of the world except the United States, Japan, Canada, Taiwan and certain countries of the Middle East and North Africa, subject to approval by relevant regulatory authorities."
For complete PR see:
http://biz.yahoo.com/bw/061016/200610160...
Comments?"
"This is the Insmed investors board, not the trading board, the short board, the bagholders board or a chat room. This board is for the quality of messages not the quantity. Quality messages should provide a link to the source if the intent is to share facts and research to help investors to be better informed about Insmed."
May I suggest you go back and read your numerous posts during the trial. Most are replete with information regarding your trades, opinions and conjecture ... most of which were later proven wrong.
I suppose it depends on whose ox is being gored, huh?
I know the facts now are not pleasant, for you or me, but burying them (or ignoring it when they are distorted) is not serving anyone.
Let's all have a better 2007.
"it was removed cause the information was obvious, no extra information or opinion given"
I respectfully disagree.
The original message stated the S-8 was filed Dec 29th. That was not obvious to me (and I suspect others) because I don't monitor routine SEC filings unless they are PR'd (which this one was not).
The original message also added "look out below", which is opinion and suggests more dilution is coming. That was either misquided or deliberately misleading. I don't know which, but I felt the rest of the story should be told. (The S-8 was not a 50 million share shelf registration, it was a 1 million share registration for use in the employee's stock purchase plan.)
Deleting the "to the moons" is OK, but deleting ALL oneliners is arbitrary and capricious (for the lawyers). Sometimes oneliners can say a lot.
Subject closed as far as I'm concerned, but I prefer to make my own decisions as to how much weight to give any message.
Unfortunately, this board has turned into a joke. One moderator is apparently afraid to delete anything and the other is apparently afraid to allow anything. Someone posted that an S-8 had been filed, and I posted that it was just house cleaning and of little importance. Both posts were simply factual statements, but both were deleted.
It's obvious why there have been all of 4 posts in the past 5 days. Scrolling through all the old reference material to discover nothing of value posted (or allowed) has become a waste of time.
The sad fact is that there has been more good discussion on the YMB lately than there has been here ... and that is truly a sad fact.
I wonder how long this post will last?
The S-8 registers 1,000,000 shares which "may be acquired" through the Employee Stock Purchase Plan. So, what is your point?
If DNA bought out INSM, then DNA would have an approved product and application ... Iplex. Remember though that all this is just speculation and will probably not come about.
Amen!
Once the patents expire, they are history. DNA has no patent and TRCA has a license to nothing. The rub at the moment is the 414 patent. It covers the manufacturing method and will not expire until 2018. However, INSM may ... and at this point it is only may ... have a new manufacturing method in a couple of years.
I think all this speculation about mergers and buyouts is mostly wishful thinking to "fix" the problem, but until the court makes its final rulings, we do not even know what the problem is. Everything is just speculation until then.
You will probably have to read the license agreement for your answer. It's not a stupid question though, it's an excellent question. I would bet they could not.
My quarrel was not with RTN. It was with "Seeking Alpha" (whoever that is) who made the original statement that "Insmed hasn"t filed an appeal". I was merely trying to tell RTN he may have missed CHM_760's point regarding the statement by "Seeking Alpha" being a half-truth.
Well, you have missed the point also and are now mired in semantics.
Let's drop the subject.
No appeal has been filed YET.
As has been pointed out, there is yet nothing (final decision) to appeal. The half truth could (and I believe is intended to) lead the reader to believe (by not telling the rest of the story) that Insmed has no intention of appealing. That is not the case. Insmed has indicated they will certainly appeal when the time is appropriate if the final decision reflects the jury verdict.
That is the whole truth ... no opinion involved. That is exactly why a witness in a jucicial proceeding swears to tell the truth, the WHOLE TRUTH, and nothing but the truth.
RTN,
The point is that "Insmed hasn't filed any appeal" is a half truth. People who put forth half truths may just be ignorant, but they may also have an agenda ... and that agenda is to deceive.
< The judge will also rule on INSM's plea to find the 414 patent invalid. There will be various other requests by both companies>
I think you will find the inequitable conduct matter still to be ruled on by the judge applies to the 151 patent. The jury (right or wrong) has already decided the 414 patent is valid.
Should the judge rule that the 151 patent is unenforceable because of inequitable conduct, I would think the willfull infringement issue would be moot. If that is the case, there will probably be no ruling on a willfull infringement award (if any) until after the inequitable issue is decided ... and that will probably take a few days.
I hope you are right!
<Jurors found that Insmed infringed all three of Genentech's U.S. Patents and provided monetary damages to Tercica consisting of an up-front payment of $7.5 M and a 15% royalty for past Iplex sales ranging from $0 M to $100 M and
a 20% royalty for past Iplex sales over $100 M.>
I would like for Lazard to have it right, but I am afraid they do not.
It would make no sense whatsoever for the jury to award 15% of the first $100 million of PAST sales and 20% of over $100 million of PAST sales when past sales are less than $1 million and cannot increase ... because they are PAST.
<I think the PR only talks about short stature because it is the only approved drug they have for that indication.>
You are probably right. And, some seem to be losing sight of the fact that it will probably be a couple of years before Iplex is approved for anything BUT short stature. During that time, Insmed's net sales will probably not even approach $100 million ... much less $200 million ... so the royalty paid will neither be a windfall for TRCA nor a killer for INSM. By that time, the appeal will be settled.
The bottom line is that TRCA will receive (and INSM will pay) very little from the royalty for some time ... if ever.
<Too bad INSM didn't agree to 30% and put this behind them.>
Considering it will be several years before INSM sees over $100 million in net sales, I would say 15% is about twice as good as agreeing to 30%.
<If the injunction were granted, how would INSM survive while awaiting the appeal process to run it's course?>
It's not probable that an injunction will be granted, but INSM would survive the same way it did prior to launching Iplex ... with no royalties to pay. INSM is not a one trick pony.
The fact of the matter is INSM is in a better position now than a year ago, with a promising future.
jellybean, thank you for your clear and concise explanation of the patent implications and applications. I have been trying to wrap my non-scientific mind around the subject for months ... with limited success. You supplied a common sense explanation in a minute. (The "literal infringement" ruling now makes sense to me. I wish the jury had been supplied with your post.)
buy4long, did you get an answer to your question? On July 31,2006, Insmed entered into an agreement with Phyton Biotech to develop a different production method.
http://www.insmed.com/updates/secondary.asp?title=Press%20Releases§ion=ir
I am a believer in the concept of presenting the TRUTH, the WHOLE TRUTH, and NOTHING BUT THE TRUTH. To do otherwise is perhaps an honest oversight, but is often a deliberate attempt to deceive.
Your post is an example of presenting the TRUTH, but not the WHOLE TRUTH. Perhaps you failed to notice that only footnotes 5,6,7,8,9 apply to the CEUT report in question?