It's sort of funny, but Insignificance posts so many times, over and over under multiple ID's that iPLEx is dead, iPLEX is dead, iPLEX is dead........ one gets the feeling that if anything positive ever does develop with iPLEX it will be the worse single day of Insignificance's life....
And then there is rehvdm...... nearly three years ago Premacure finally started a website. It has never, ever changed.....at all. From day one this is what the companies home page has stated: Premacure AB, located in Uppsala, Sweden owns exclusive worldwide rights to develop and commercialize Insulin-Like Growth Factor 1 (IGF-I) together with or without its natural binding protein, IGFBP-3, as a product for the “prevention of complications of preterm birth”.
Rehvdm discovered this website a few weeks ago, and posted that same sentence as if it was brand new information! Then he repeated it again today! Honest. This is the same guy that yesterday put up a post with the words phagotycized, and nidus!!!
The bottom line is this: The Swedish group that still lists Insmed as a commercial partner on the University website has been working with iPLEX for ROP for several years now. During that time they also developed WINROP, which they say is 100% effective at predicting which preemies will develop ROP.
From birth ROP can be diagnosed.
So, apparently preemies that were 100% likely to develop ROP, after receiving premiplex treatment, did NOT develop ROP!!!
Otherwise why would trial leader Ann Hellstrom make this comment: " Our preliminary results show that by returning IGF1 levels to those normally observed during pregnancy we can prevent the condition and probably also other complications that can affect premature infants."
"...owns exclusive worldwide rights to develop and commercialize Insulin-Like Growth Factor 1 (IGF-I) together with or without its natural binding protein, IGFBP-3..."
There is only one IP barrier to Premicure (or anyone else for that matter) with respect to IGF-1 in the EU; i.e., Insmed's patents. Insmed IP is also protected under the same patents in the EU. Unlike other companies, Insmed is bound by the settlement to recognize (until 2018) the patents that are not recognized/in force in the EU. The settlement also forbids Insmed from enabling any other entity's commercialization of IGF-1 without specific authority granted. So the license from Insmed grants "...exclusive worldwide rights..."
Ipsen and Roche do not want to be viewed as obstructionists to the very limited and important use of recombinant IGF-1 (with or without BP-3) to treat otherwise untreatable diseases. These two companies have granted waivers to INSM before there were outlicenses for ROP and/or ALS. Why would they want to get branded as obstructionists now?
Also, with the potential benefits to (totally innocent) premature babies, why would Ipsen and/or Roche want to inhibit those clinical trials? The answer is they would not. However much problem they are having getting Increlex batches from passing QC/QA at Lonza, they are still going to do as much as they can to promote the IGF-1 aura for clinical use. If you do not believe me, go to ClinicalTrialsDOTgov, click on "Advanced Search", select Phase II, III and IV clinical studies (2/3 down the menu) and put in the key word "IGF-1" and see what pops up. Two-hundred and 68 studies. That is 268!
"268 studies found for: igf-1 | Phase 2, 3, 4"
Unfortunately, none of that is going to benefit INSM's bottom line for years. They had the IP and their chance to bring a highly safe and efficacious product into the biopharma regimen of products and failed. Now they have outlicensed the opportunity to others.
Sad but totally true. Particularly for INSM Longs.