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Yep, your right (of course ). In hinsight, my comment was not very usefull there. Lev looks definetly in pole position, However Pharming seems to have a few opportunities to break orphan, if I did my homework well
http://www.fda.gov/orphan/oda.htm provides some leadway:
"...PROTECTION FOR DRUGS FOR RARE DISEASES OR CONDITIONS
SEC. 527 [360cc]. (a) Except as provided in subsection (b), if the Secretary--- ...."
and then after that read subsection b.
My free interpretation is that if the constant supply of product by Lev is questioned by the FDA (for one reason or the other), the FDA could grant Pharming a license as well.
There is also an interesting FDA page on Orphan Drug Regulations, which you probably know much better than I do:
http://www.fda.gov/orphan/odreg.htm
It seems that if it can be proven that the product of Pharming is either of a higher quality (more pure), less prone to possible contamination, or otherwise safer in use, this could be a reason to declare Pharmings product clinical superior and grant a subsequent license to Pharming.
I don't know what Pharming will do, but I suppose it will be along these lines. I am not sure whether the difference in post translation modifications of both products will be enough to declare them non equivalent for the purpose of the orphan designation act. Probably not.
Regards,
Elmono
Just for your information, but Pharming already received an orphan designation more than a year ago. It also has been given fast track from the FDA for acute HAE.
http://www.pharming.com/index.php?act=show&pg=304&hl=orphan
It is only in the prophylactic indication that LEV might be the first:
What does this line in the article mean exactly:
"The jury said infringement of one of the patents was willful, allowing Wilkin to as much as triple any damage award.
"
Triple as compared to what? To what would the term 'damage award' specifically refer? To royalties...? Or to the upfront payment already set by the jury?
gelukkig maar
Please look at the jury instructions, page 6, line 8-10. Judge will deal with willfull infringement later. Not for the jury to take that in consideration when determining damages/royalties.
http://www.xs4all.nl/~surg3on/2006-nov-INSMvsTRCA_trial_motions-Read_this_n0w/975%20jury%20instructi...
Looks pretty clear to me. More to come on this from Judge. Correct me if I am wrong
judge will rule on the amount of damages because of willful infringment. This was something the jury was not instructed to determine.
Is INSMED allowed to produce in the US and ship finished goods to Europe and sell it there? Or is this also subject to royalties under the current verdict?
I will put this topic to rest now, since I believe my point is not being understood by most of the posters. So no point in argueing anymore. The science is great, now the company has to show that it is good in making money too and that it can live up to expectations and be able to achieve its own (internal) targets. First test: Q4 numbers
Regards,
No that's one of the things that didn't change, since INSMED projected at that time a (partial) loss of the law suit and 15 % royalties as a consequence
Appreciate your response and yes there might be many reasons that explain 'low' initial uptake and also lower revs.
Remember that the 33 or 66 patient number I referred were not invented by me, but calculated by another poster.
The facts are that
1) INSMED expected to have 200 patient*years worth of revs for 2006. (200*40.000 gives you 8 million)
2) INSMED now states during trial that revs for 2006 are less than 1 million.
So what changed that could not have been foreseen by INSM when they made their initial calculations?
I guess we'll just have to patiently wait for Q4 figures to come in and provide us with more guidance as to were we stand and what the real potential of the current approved indication is.
Regards,
Elmono
( I appreciate that you directed your warning to all 'off topic' posters
CHM,
Thanks for sharing your thoughts with me. They do provide some insight, but not all of it. I do agree that these figures were probably made well before 2006, actualy when INSMED was apparently talking to Paul Capital for additional funding (At least that is what I learned from the various documents).
I do not completely agree to your views, because I think INSMED must have been able to roughly calculate a launch date, based on expected approval date and what work needed to be done afterwards. So I believe that they have taken this into account when making the original projections. If you calculate that we will have roughly 33 patient*year revs for 2006, whereas INSMED originally projected 200 patient*year revs, the difference is not explained by the fact that INSMED might have calculated with a slightly different launchdate (although I doubt it whether they realy thought that they were going to launch on or before 1 jan 2006)
And you'are right they are just projections and a lot is still to come and can changes in future years. By the way have you taken a look at Lazards projected penetration percentages for Iplex by year end 2006? All I am saying is that they might have been a little overoptimistic and let's hopen that doesn't back fire.
Finally I don't believe you hire a large expensive sales force and put them on the backburner until after the trial is over.
As for me personally, I have been in and out INSMED the last years and find it a fascinating company with great potential and great risks (for investors). I currently have a small stake, but I think I will temporary get out before the trial verdict and will look for a nice entry moment again later on.
Thanks again for taking my observation (a little) serious, unlike some others
This was not exactly the answer I was looking for, mfetish. You still haven't given me the explanation as to why the experts in the field were so wrong about their own sales projections
My friend, I am not gonna lower myself to your standards. You can have the last say. You are absolutely clueless. Feel sorry for you, being a person without any substance with a need to attack others with a different or just a critical view.
Good luck, you're on ignore
Great to see a reply like this instead of explaining why management overestimated their own projections. Shows your own 'profound' knowledge and true identity.
Just as a reminder:
"TOU Refresher
Off-topic: Any off-topic discussion is a violation of TOU. If your post is not about the stock for the board you're posting to, do not post it. Use email, private message, or post it to a board where it is on-topic.
"
Anyway, maybe somebody more civilised can do the explaining. Anybody who read the doc I referred to, should have questionmarks about potential revenues from this approved indication (sofar the only approved indication that is)
still believe that if the company (INSM) heavily overestimated its own future sales (2006), this is not a good sign and might be indicative for years to come, as far as the current approved indication is concerned. I find it realy strange that the experts in the field where so dead wrong about this. But hey, what do we care, because everything will turn rosy next year or so
One thing I am worried about is that uptake of IPLex is much slower than expected.
http://www.xs4all.nl/~surg3on/2006-november-INSMvsTRCA_trial_motions/967%209.pdf
Instead of 8 mil rev for 2006, less than 1 mil is expected. Any ideas on what the investment community (analists and so on) predicted for 2006 revs?
Is this internal new projection already made public? (other than through a trial doc??)
I got this from one of the docs posted on surg3on site
http://www.xs4all.nl/~surg3on/2006%20november%20INSMvsTRCA%20trial%20motions/897%20memorandum%20in%2...
"
Finally, the Court should deny Defendants motion because the 2006 sales information
they seek to add now includes very limited data. Insmed has reported merely four months sales
data because it started selling iPlex on May 26, and its latest disclosure ends September 30. In
contrast, the reasonable royalty is mainly based on long-term projections because the hypothetical
license will last until 2018. It is improper to rely heavily on merely four months data to
determine the reasonable royalty of such a long-term license.
Defendants argue that Plaintiffs damage expert included later events in his testimony.
However, the limited evidence to which he testified, such as the royalty rates included in
Tercicas recently-announced agreement with Ipsen, simply confirm that the royalty rates Dr.
Hausman said would arise from the hypothetical negotiation (20% to 30%) are in fact reasonable.
This testimony was not offered to suggest in any way that these facts would have affected the
state of mind of the parties in December 2005."
Seems like Tercica/DNA was going for a 20-30% royalty and INSMED not.
Any thoughts?
DD,
To be honest and no disrespect, but I would hardly consider INSM a value play. Not even at this level. I also believe that the 120 million in shares might not be enough. It just won't bring in enough cash. As for partners: yes, probably a necessity, but will lead to either additional dilution or revenue sharing.
About the current approved indication: think about how many people ar born yearly in the US (or EU), about the prevalence of the indication and till what age persons are (still) suitable for treatment. Also think about the under diagnosing percentage and I am sure you will figure out the maximum sustained revenuestream for this indication. So yes, in the longterm we will definetely need approved broader indications. For now: highly speculative, despite the one approved indication.
I am not a trader, but definetly not a person who invests and leaves the stock on the shelf for the years to come, keeping fingers crossed.
GL
Even as a smart long, I am sure you are not willing to invest in a stock that will not appreciate substantially in the next 6 to 12 months, or will you? Knowing that there are much better opportunities around. Surely with every bit of good news, the share price will jump 10-20, maybe even 30 or 40%. The problem is, that to finance broader indications, a lot more cash is needed. Even with a partner or without further expansion, I believe more cash is needed to finance the operations and will be attracted in the next 3-6 months (think about the legal costs, the sales force and the new hot shots in town). So what we will likely see is some very good (trial)news, followed by a not so nice shelf.
Also the legal dispute is like a sufficating dark blanket that will stop any substantial and lasting upside movement, until it is resolved. I would be very very surprised if in the next weeks a full and final settlement will be reached.
Although I believe in the potential of the product Iplex, I think it will take a while before INSM takes of. Hell it might even take a year or two. I prefer to be invested for the time being in other assets. That having said, I do and have been closely monitor(ing) INSM developments the past years.
For the record: I was invested in INSM for quiet some time and bailed out a couple of months ago, with a substantial loss.
- 5-10 % could be easily 25 % for all we know.
- MMD market entrance at least 4 years away, if ever.
INSM is currently definetely not taking the whole primary IGF defiency market. Endo's still interested in TRCA product.
Definetely more dilution in the future to finance broader indications. Nice products, nice prospects for the company despite the trial issues, but not much permanent upside for the stock in the short term, the way I see it.
Nice trading on some good news and then settling down again.
Please don't hype this stock too much, it's not very credible
Because revenue suck and stay way behind expectations. That's why! I am actualy surprised there wasn't a steeper decline
Coming back to this, would the IP of GTCB be valued or taken into consideration when we are talking about sharing the costs of development? I mean a lot of research and investment was put on the table to get to the point where we are now. Or you think this is not part of the deal and GTCB was not able to put this into play. What's your take on this?
Yep, you are right. I guess I only read the shortened press releases and judged too fast. My mistake
It's a pitty GTCB didn't put this in the press release, which probably mislead a whole lot of people. I wonder why it wasn't mentioned there. Any idea?
I don't think this is such good news', since the objective wasn't met:
Objective of the study:
Young adults with type 1 diabetes mellitus (T1DM) have increased glomerular filtration rate (GFR), which may mediate progressive renal disease and microalbuminuria. This may be secondary to low concentrations of insulin-like growth factor (IGF)-I and GH hypersecretion. We tested the hypothesis that restoration of circulating IGF-I concentrations in young adults with T1DM might suppress GH secretion, GFR and urinary albumin excretion.
Conclusion:
.....but there was no effect on glomerular hyperfiltration or albumin excretion rates......
Which indication are you referring to, Coinstarz?
With all due respect, but if TRCA would put INSM out of business, TRCA would take over the whole market that could be covered by Increlex (not necessary limited to short stature. So it has a lot to gain. If it would settle for a small royalty percentage, it would indeed put itselve (very slowly) out of business, since in the end the product with the most competitive edges will prevail.
In my opinion, TRCA will try and do anything to put INSM out of business and or negotiate a substantial higher percentage than the mere 10% if it gets the chance to do so. I wonder whether bad publicity is such an issue if it would only be Increlex on the market and no serious alternative. Patients need to be treated, right?
I do not believe getting 10% royalty in a settlement is a win-win situation for TRCA (at this point).
After reading the ruling I got the strong impression that INSM tried to do anything in its power to narrow the scope of the patents at issue (especially with regard to the 414) and that to a significant extend didn't succeed in doing so.
There is some light at the end of the tunnel for INSM, because it also scored some points on the matter of bio-activeness (basically, in my opinion, TRCA/DNA will now need to prove that it was capable of producing a bioactive protein at the moment the 414 was issued, which is something different than a polypeptide with just the right aminoacid sequence) and definition of human IGF-1 (the definition now specifically excludes fusion proteins. I am not sure about the consequences yet)
I am long on INSM and have taken a few hits recently, so I am not particulary happy with the outcome. I will wait for the INSM Q2 results and CC before even considering extending my position.
(and reread the ruling a couple of times more
Try the following link which sheds some light on the meaning of (partial)summary judgements. As specialy the bottom part is interesting:
http://www.ladas.com/Litigation/PreliminaryInjunctions/Prelim04.html
thanks!
coinstarz,
any info on the european population for severe IGFD? or is it just a matter of extrapolating the 6000 number?
Just wondering if there are any numbers circulating
elmono
Hi Dew,
I haven't found out the 'reply to none' trick, so I will add some info on GTCB and antithrombin this way.
You probably know that plasma derived antithrombin is made commercially available in Europe under the trade name ATnativ by Baxter. What I just learned is that another big, but to me relatively unknown company, by the name of Grifols is marketing plasma derived antithrombin under three different brand names. Their most advanced en newest product (in terms of safety, side effects and shelf-live)is called Abinex (You can check out their website). This made me wonder about the real marketpotential for Atryn in Europe, since Abinex can probably be used off-label for the same indications as Atryn. I believe that Grifols might also want to target the US market with this product. I am curious about your view on this.
Another thing I learned is that the EMEA CHMP Blood Group Working Party will probably evaluate the MA application of GTCB and those guys will not convene as early as half september (you can check out the EMEA website for this), so I find it very hard to believe that the CHMP will make a recommendation before half october, first awaiting the opinion of their most important working group.
The last thing you should check out is the following site:
http://www.fda.gov/cber/summaries.htm
Please take a look at the presentations of Dick Scotland, Chris Healey and Rainer Seitz and let me know if you found these informative. I did. There are also some other interesting presentations. Some DD for the weekend I should say
Regards,
Elmono
Dew,
I have read both documents and I no too little details about what infomation GTCB provided the EMEA with, to make a really good assessment. I do however give you my gut feeling and thoughts:
My guess is that the additional questions will not require a new trial. If an extra trial was needed, that would have been clear from the first set of questions already, and at that time there was no indication whatsoever (also judging by the comments GTCB made) that that was the case.
I do however believe that given the small set of data acquired from the trial(s) and the fact that a market approval of a product based on an entirely new production platform is at stake, combined with the new (more stringent) guidelines to be put in place, the EMEA will do everything in its power to address in particular the tiniest safety & quality concerns it can think of.
Also it doesn't help in my opinion that Atryn does not provide a cure for a disease that affects a large group of persons and for which no cure is available. That certainly would have meant more presssure on the shoulders of the EMEA when it comes to an approval.
Instead I believe the EMEA will take all the time it needs to gain knowledge about the particular aspects of this new platform, knowing that there will be a lot more to come in the future. Sadly so it is GTCB who has to take all the hits first.
In conclusion I am very curious about the nature of the new round of questions. I am not so concerned about there being an extra trial necessary (my guess would be less than 10 % chance), but I do believe that it will take GTCB considerable extra time to provide the answers and that approval will not be anywhere near dec 2005 earliest. I do believe GTCB will require additional funding at the expense of the current shareholders and I hope there will be some positive news from GTCB that could lift the shareprice a little before that event will occur.
Regards,
Elmono
Dew,
You may find this document, although from 2002, also very worthreading. I do not know if you already have read it.
http://www.emea.eu.int/pdfs/human/bpwg/222099en.pdf
The title is:
"Note for guidance on the clinical investigation of plasma derived antithrombin products"
It gives some interesting insides.
Could it be that the EMEA just treats ATryn as if it is a substitution for the plasma derived alternative? Ifso, the new guidelines could have lead to the additional questions, wouldn't you think so?
Looking forward to your thoughts,
Rgeards,
Elmono
I found a link to a new EMEA guideline regarding biotech-derived proteins, that especifically deals with quality issues. Hypothetically, since we are talking about a recombinant product here, GTCB has to deal with all the issues described in this document and the EMEA wants to already put this guideline into full practice. Personally I found the requirements described in the document pretty intimidating
Could it just be that the main reason for the additional questions that the EMEA is planning on asking, might have to do with intensified regulations? Or are my thoughts very much 'off track'.
This is the link:
http://www.emea.eu.int/pdfs/human/bwp/4934805en.pdf
elmono
The document's title is:
GUIDELINE ON SIMILAR BIOLOGICAL MEDICINAL PRODUCTS CONTAINING BIOTECHNOLOGY-DERIVED PROTEINS AS ACTIVE SUBSTANCE: QUALITY ISSUES
Happy to hear comments from the specialists regarding this document