Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
RTN,
What you say is true, but I am not optimistic that the company can pull it off.
The current privately sponsored trials for Iplex are not sufficient for "Phase III enabling". There will have to be expanded Phase II trials, either at Insmed's expense or with help from a partner. How much chance does Insmed have in obtaining a partner for Iplex given the infamous "settlement"?
You know my views on the company's Biogenerics chances.
Being inately suspicious, I see what looks too much like window dressing coming from Insmed. Maybe I am wrong ... I was once.
At any rate, I do respect your civility.
<Now you are an investor again?>
No, now I am an investor STILL. Everything in that post stands. I wrote it immediately after selling 90% of my INSM position. You can agree with me, disagree with me, or do whatever floats your boat .... but do not question my integrity.
Maybe someone will come to their senses at Insmed and find Dr. Allan a job elsewhere, and maybe this board will someday again be something more than mindless hope/hype ... like maybe a 10% chance ... but I doubt it.
In the meantime, I have better things to do than play to your ego, so do your "delete" thing.
Also from the IV board:
Msg: 3549 of 3549 6/30/2007 10:33:28
By: wjlknew
Posted as a reply to msg 3545 by read_this_n0w
For the record, I am also invested in INSM.
I do think GTCB is the better prospect at this point in time. I hope INSM can find a niche in biogenerics, but it appears all they have to offer is temporary excess capacity in a process that has traditionally had excess capacity throughout the industry. (I say temporary because, if Iplex succeeds, there will be no excess capacity will there?) GTCB on the other hand has a virtual lock on a new process that appears to be a natural fit with biogenerics, and has unlimited capacity. INSM may have a revolutionary new drug. GTCB does has a revolutionary new manufacturing process. I hope they both prosper, but in my opinion INSM has dug themselves into a very large hole and is desperately looking for a way out ... or at least giving the impression there IS a way out.
If you see things differently, so be it.
Afterthought: If you are incapable of anything but mindless drivel, so be that also.
Oh, I see. It is all a big secret which will be revealed in due time.
Nonsense.
This is the most bizarre argument yet. You, and others, completely miss the whole point of "generics" ... which is to make a drug identical to an existing drug, but make it CHEAPER!!
The manufacturing of these drugs is being done now by the patent holders/licensees. The production facilities and expertise already exist and will not be destroyed by patent expiration. The whole idea of generics is to increase competition in order to bring down the price of these products. Dew's point is that Insmed apparently has no advantage over other manufacturing facilities which either already exist or may come on line before FDA rules are implemented ... assuming current legislation will be passed to allow the FDA to develop those rules.
The question which has repeatedly been asked ... and not adequately answered ... is why does Insmed hold any advantage over anyone else interested in entering a possible Biogeneric market? Does Insmed already have a manufacturing facility? Yes, but so do others. Does Insmed have the expertise to manufacture biologics? Yes, but so do others. Etc., etc., etc. The obvious answer is Insmed does not hold any advantage, and probably has some disadvantages because technologies are in existence, or are being developed, which may make Insmed's technology non-competitive. Can Insmed develop new technologies ... like transgenics? I suppose they can, but there is absolutely no indication they are, and they are at best late to the game.
Remember, the manufacturing facilities and expertise already exist to make these products. The purpose of generics is to make the products CHEAPER. Anyone is welcome to enter the fray ... and WILL enter the fray IF THERE IS ADEQUATE PROFIT INCENTIVE. To think Insmed is the only ... or even leading ... competitor is ludicrous.
buy4long,
Anything is possible, but just as good a case can be made for Insmed caving in to the settlement because they knew the jig was up anyway. That EMEA report is not about supplementing and/or supplying a little more data. If it is read in its entirety, it documents a fatally flawed application that was not about to be approved. I was suspicious when Insmed all of a sudden decided to change directions. Now I think I see why.
Dew Dilligence asked a very relevant question that no one has attempted to answer. Why does Insmed think they are in such a fantastic position to take advantage of any possible move in the direction of Biogenerics? To read some of the posts, you would think Congress was considering authorizing the design of automobiles and Insmed has the only wheels in existence.
I said "smokescreen" and I will stand by that opinion.
Well, I hope you are right, but I smell something like you might smell around a large cattle ranch.
Good luck.
Why the big switch to Biogenerics? Read this report from the EMEA. It documents what can only be kindly described as INCOMPETENCE regarding the approval of iPlex for ANY indication. I have sincere doubts as to whether this company can survive with its current management ... maybe with ANY management. In my opinion, all this talk about Biogenerics is nothing more than a smokescreen. I have finally had it with Dr. Allan and company. Good luck to those left standing.
A normal buyout might bring a pps of $1.20 to $1.25. That is a 50% premium, which is higher than average. You will see all kinds of nonsense about $3 and up, but that is just wishful thinking.
I think a more realistic scenario involves one or more surragates acquiring enough shares on the open market (for a lot less money) to effectively control the company, but not enough shares by any one of them to trigger any kind of poison pill. Then, look for a merger of some kind. If this happens, it will probably be before any positive data are released to the public ... which could be awhile.
At least, I hope that is what happens. I would prefer to see Iplex in strong hands. As you can no doubt see, I am not a fan of current management. Apparently, current management bought the science without doing enough DD and we (the stockholders, not management) have paid the price.
I like the science, but not the company.
I think we are saying basically the same thing. When I referred to Insmed's "ability to manufacture" Iplex, of course that includes relevant patents, knowledge, physical plant, etc.
In my opinion, INSM is the partner that matters least. All DNA has to do is stay abreast of ALS results and then (assuming the results are positive) either opt-in for half the cost and half the proceeds, or take out INSM altogether ... which would probably be cheaper than opt-in ... and reap ALL the rewards.
Or, DNA could support TRCA taking INSM out and then deal with TRCA for ALS (and diabetes) per their existing license agreements.
Let's face it, INSM is the weak leg of this trilogy. INSM has only one strong suit ... the ability to manufacture Iplex. When (not IF) DNA finds a way to work around that, INSM is road kill. That's why I think either DNA (or probably TRCA as DNA's surrogate) is acquiring effective control of INSM as we speak. Remember the INSM execs extending their golden parachute to cover them six months BEFORE a change of control, in addition to one year after?
Disclaimer: All the above is assuming Iplex proves effective for indications other than short stature, and assuming the INSM strategy is not to putter and sputter with phase I and II trials until the patents expire ... which I seriously doubt they can do.
I read the opt-in period the same way, and that applies to ALL Iplex indications does it not (including ALS and diabetes)? It appears to me that INSM is allowed to develop Iplex up to phase III for any indication other than short stature (at their own expense of course) and then is relegated to a back seat role with a royalty if the indication looks promising and either DNA or TRCA opt-in. In other words, INSM can never be more than a silent partner and already has all the partners they will probably ever have ... so long as the subject patents are in force. I suppose a thrid party could partner with INSM if DNA and TRCA choose not to opt-in, but why would they?
I guess that's what happens when you willfully infringe someone elses patents. It also explains the current pps.
My previous post was written before I had a chance to read Insmed's latest 10-Q (May 10, 2007). That quarterly report contains the detailed agreement and permanent injunction resulting from the recent legal unpleasantries. Having read the entire agreement, the first paragraph in my previous post (regarding a possible partnership with Cephalon) is wrong. Even that is not a possibility. The relevant sentence from the agreement reads: "It is understood and agreed that Insmed shall not enter into any agreement with a Third Party to develop or commercialize a Product for any Permitted Indication prior to the expiration of the Opt-In Period for such Permitted Indication."
Genentech has opt-in rights for ALS.
The only real bone left for Insmed is generic biologics, and I still think Insmed doesn't have the wherewithal to play successfully in that game ... if the game is played at all.
I really think there is only one outcome to save this mess, and that is for Tercica to acquire Insmed ... by whatever means necessary. I would even be surprised if that is not already in progress.
<where did that nonsense about the 1950'come from and how can the reporter print it and not mention that it was a quote but the info in the quote was nonsense.>
Reporters are generally interested in controversy and are happy to report any controversial statement ... regardless of its accuracy ... so long as the statement is a quote. (They can always attribute the statement to someone else if its accuracy is questioned.) A very good reporter once told me, "The press will sell ammunition to both sides and then report on the war."
I think PLH3465 makes a good point. Outside of Cephalon, assuming Iplex proves effective in ALS and assuming DNA and/or Tercica have no opt-in rights for ALS (which may not be the case), the only thing a partner can expect is a piece of half a pie. To me, that sounds like a bad deal for any prospective additional partner ... as well as a bad deal for Insmed. I would think any prospective additional partner would be better off buying Insmed out.
I wouldn't place much hope on any other partnerships.
Also, expecting a windfall from generic biologics is just wishful thinking. IF everything fall into place between Congress and the FDA, other (pronounced larger and richer) companies will step in to reap the profits. Perhaps a partner there, but the same logic applies regarding a buyout.
Let's face it. Half the farm is gone, but Dr. Allan's salary is intact regardless of what happens.
That's a relief! For awhile there, I was afraid Geoffrey Allan might have to take a pay cut.
Now we know why the pps failed to rise on the recent news. The "investors" were shorting 20 million shares into the PIPE.
rod,
Thanks, can't believe I haven't noticed the Hide Board Info before. I've been scrolling down and cussing for months.
rod,
This is the first post in several days and only the sixth this month. Has this board become irrelevant? Has INSM become irrevelant?
On a more serious note, while things are quiet is there any chance of placing all the information on this site behind a message number ... like is done on the Biotech Values board? It is a nuisance to have to scroll through all that to get to the posts ... or lack of posts as the case may be. Some of the information is also out-of-date now.
In a word, yes. Withdrawing the MAA for short stature was part of the court settlement, and Insmed has no Phase III data at this point to support an MAA for any other application.
Rod,
Thanks for the information. I was surprised to learn the origin of "INSM-18". NDGA has the reputation for being a snake oil and has been effectively banned in the U.S. for some time. Over the years, it has been promoted to cure about everything, but some who ingested it developed serious kidney and liver problems ... some died I believe.
Now, Insmed has licensed the stuff to a questionable (to me at least) company for a variety of indications, making the deal public a couple of months later through an obscure paragraph in the 10-K. Combine that, the revised COC agreements being made public late on a Friday, the obviously scripted latest CC being cutoff before any probing questions could be taken, and I am reminded of the old saying: "Those who have nothing to hide, hide nothing".
On the other hand, .....
What is going on here?
"Some thought it was written off by the company, however it seems it did find some renewed interest"NDGA, aka masoprocol, aka INSM-18 "
It appears it HAS been written off ... or more accurately licensed off. Did I fail to take note of an 8-K making public this material event?
Masoprocol is reported to no longer be available in the United States. Masoprocol is described as a topical cream for sun induced skin growths. Is this the source of INSM-18?
Help.
This is standard with most all companies, but I was referring to the "six months prior to" language. That is a little strange, and sounds like someone has something specific in mind.
"There was an 8-K issued last year pertaining to INSM officers and it means absolutely nothing."
There were actually several 8-K's filed last year on the subject of executive terminations AFTER a change in control, but this one adds: "... during the SIX MONTHS PRIOR TO or one-year period following a change in control ....." (Emphasis added.)
Now, I have no idea what that means, but I would certainly not characterize it as "absolutely nothing". The BOD had something in mind.
"It will take a very measured approach to see vision that will probably be laid out, but I would certainly expect the caliber of board members ..."
Either there is something wrong with my vision, or I am the wrong caliber, or both.
"Several questions remain, but this may get interesting."
Expanding:
- the ALS Italy indication being addressed distinctly in the settlement,
- the rather odd statement showing up yesterday in the TRCA 8-K that either Genentech or Tercica can go it alone for some indications with Insmed supplying the IPLEX (like Insmed may have bigger fish to fry), and
- Cephalon's history of acquiring small biotechs and incorporating their science.
"This is the one indication with the most research data via IGF-1. Phase III completed, waiting for results. IGF-1 given at doseage 0.05-0.10 which is half what Iplex has shown in numerous other trials to be safe. I still maintain ALS changed the landscape for Insmed and could have been a driving factor in Insmed giving up short stature and making the deal."
Rod,
More and more it is looking as if you are right. The Phase III trial to which you refer is being conducted by the Mayo Clinic. It follows two previous trials (the first in 1997 in the U.S. which showed efficacy, and the second in 1998 in Germany which did not). The drug being tested is Myotrophin (IGF-1) from Cephalon. However, Cephalon is not sponsoring the trial, and apparently gave up on Myotrophin for ALS.
Since Insmed and Cephalon have "partnered" for the ALS trial in Italy, I am curious if Cephalon has a renewed interested in ALS using IPLEX instead of Myotrophin. Several things point in that direction, not the least of which is the ALS indication being effectively left out of the DNA/TRCA/INSM settlement. Several questions remain, but this may get interesting.
Rod, if I'm not mistaken one of the posters from the USA says he is now receiving IPLEX off label at $72 per dose from Insmed. He says he is injecting one dose per day, but plans to up that to two doses per day soon, and eventually will go to four doses per day (the maximum recommended)... if his physician sees no adverse effects. He also sets out the procedure to obtain IPLEX, but cautions it is too early for him to assess its effectiveness.
The Tercica 8-K filed today fleshes out some of the details of the agreement, but the last paragraph states:
"The foregoing description is a summary of the material terms and is qualified in its entirety by the Settlement Agreement, a copy of which will be filed as an exhibit to Tercica’s next quarterly report on Form 10-Q."
It looks like we may have to wait a while longer for the real nitty-gritty.
There is one sentence though that appears for the first time:
"Alternatively, such opt-in party may elect to obtain the sole right to promote IPLEX for such indication and Insmed has agreed to supply IPLEX to such party under a separate supply agreement."
That sentence raises more questions than it answers, but it appears there may be some wiggle room for Tercica to obtain IPLEX from Insmed for the kids?
recurveman, great post. A couple of additional thoughts:
"They are now an R&D company with no power because they ceded it to TRCA-DNA. Read the settlement prelminaries. Even after either one would opt to enter into an agreement on any indication they would assume all commercialization powers if or after FDA approval."
This may play out to be the best course for Insmed ... and us. I shudder to think of Insmed's current management making any more ruinous decisions going forward. My thoughts are that Genentech realizes they bet on the wrong horse (Tercica) originally, but they had about as much confidence in Insmed management then as we have now, so they went with Tercica as the better option at the time.
"The BS about a partnership with DNA is not what this is about. It is a dictatorial relationship by any stretch and in the end the arrogance of INSM gave the science away to a predator and a dupe."
I actually feel better with Genentech making the business decisions.
Insmed painted itself into a corner and had to get out any way it could. Insmed can now retire to its lab and Genentech can commercialize whatever of value it develops. The 50/50 split looks fair to me when you consider it applies to costs as well as profits. (Genentech actually has the same arrangement with Tercica but their opt-in period begins AFTER Phase III trials.) The lions share of development costs are from Phase III through manufacture and distribution. If the 50/50 split applied only to profits, it would be an entirely different story. It does look like a partnership. Time will tell if it quacks like one.
I would like to see Genentech go one step furtner and buy half the Colorado facility from Insmed. That would give Genentech more control of commercialization, and would give Insmed needed cash.
I also think Genentech threw Tercica a bone and hopes they will go away eventually. Genentech has always been primarily interested in the diabetes indication, although Genentech's arrangement with Tercica excludes any indication for diseases of the central system also.
No, I wasn't involved. My only confidence in these, or any, lawyers is that they know how to dot their i's and cross their t's ... sometimes to a fault.
My point in this discussion is only that it's silly to endlessly speculate on what is meant by "provide", and other things, in the PR. When the final agreement is signed and filed, it will no doubt have several pages of just definitions. Nothing will be left to interpretation (except in the context of any controlling law). Did you ever read a mortgage? If a PR was released on a mortgage, it would probably say: "If the buyer doesn't pay for the property as agreed, the lender can foreclose." The actual document is a little more specific!
No one will have to wonder what the definition of "is" is, and no one will have to speculate on who is allowed to do what, when, where, etc.
I'm about as sure as it's possible to be. However, when I say "agreement", I mean the detailed document itself. I have no idea who agreed to (or dictated) the broad terms.
beachgal, I fully understand that. However, your previous post begs just the kind of questions that will be covered in detail in the document. I suppose speculation on those kinds of questions give something to write about ... and raise doubts about if that is your intent ... but accomplish little else. In post #4855 I supplied the link to the existing DNA/TRCA agreement. Read it and you will see the kind of detail to which I refer.
There is no such thing as a written document that is not subject to differing interpretations (if there were there would not be need for lawyers, and of course the lawyers are not going to let that happen), but most of these agreements come close.
I would put the odds at more like 60%, at least until Genentech is heard from. There is nothing wrong with optimism though, so long as it is tempered with reason.
I agree. For now, that's all we have to go by. However, the lawyers hammered out the agreement, and I'm not sure the two respective managements understand (or even know) the details.
The confusion will probably continue for awhile. The PR is not the final word on the subject, and different people have different interpretations. Even the two companies seem confused as to details of the settlement (Genentech has not been heard from). We will have to wait for the actual settlement agreement to be filed with the SEC. That document will define who can, or cannot, do what and will be quite specific ... a contract.
At this time, we are still speculating on almost everything.
The next question might be, "Why did Insmed not design the studies to meet FDA criteria for a full blown Phase II test?" The answer is that Insmed did not design the studies ... although they probably had input. The investigators designed their own studies to meet their own criteria. I used the words "studies", as opposed to "tests" purposely. That is how I keep my confusion to a minimum.
"are those studies real Phase II or not???"
Yes, the studies are Phase II in that they are not Phase I or Phase III. However, they do not meet the criteria for a FDA approved Phase II that could enable a Phase III if successful. That doesn't mean they are a waste. They will probably provide data to assist Insmed in designing a "qualified" Phase II ... and I think they may provide data that will allow a combination Phase II/III. That will be up to the FDA.
That probably added to your confusion, but there are simply Phase II studies, and there are Phase II studies. An analogy might be a house that was built to FHA specifications and a house that was not. They are both houses, and both may be quality houses, but one will not qualify for a FHA loan.
Comments re your proposed letter:
CEO Allan didn't give away the short stature market. If you recall, a jury (right or wrong) determined that Insmed infringed the patent. Faced with the possibility of an injunction or substantial monetary damages, what would you have done ... "give away" the indication or pay several times what you could ever hope to earn by appealing the verdict (and possibly bankrupting the company in the process).
I have seen several statements to the effect that Insmed was only banned from "marketing" Iplex for short stature. Although it is not the definitive document, the PR is all we have at this juncture and that is simply not true. The PR states: "As a consequence of the court's finding that Tercica's patents were infringed, Insmed will no longer be able to provide IPLEX in the U.S. for severe Primary IGF-1 Deficiency and the following indications: Primary IGF-1 Deficiency, Noonan's Syndrome, Laron Syndrome, Growth Hormone Deficiency, and all other short stature indications; and Adult Growth Hormone Deficiency." NO LONGER ABLE TO PROVIDE means no longer able to PROVIDE. You can argue all day that "provide" means "market", but it does not. The final document will no doubt define "provide" very precisely.
I do agree with one thing. The CEO is overpaid.
Has anyone read the DNA/TRCA Licensing Agreement? It probably offers insight into what what form INSM's agreement may take, including these definitions:
"1.62 “Phase II Clinical Trial” means those tests and studies in humans required by the FDA which generate sufficient data as to safety, dose ranging and efficacy of a Licensed Product to permit commencement of a Phase III Clinical Trial.
1.63 “Phase II/III or Phase III Clinical Trial” means a controlled study in humans that is prospectively designed, using predetermined endpoints, to demonstrate clinically and statistically the efficacy and safety of a Licensed Product for one or more Indications as a pivotal study intended to lead to FDA Approval of such Licensed Product for such Indication(s)."
Also, how many knew that DNA has opt-in rights to any commercial development of a TRCA drug that is not an orphan designation or for diabetes?
Interesting read.
http://contracts.onecle.com/tercica/genentech.lic.2002.04.15.shtml