The company is not going to pursue the use of Iplex on their own until after 2018 when there`s no one to share the pie with.Letting others do the research on their dime and then licensing if their successful.I am very disappointed that half a pie isn`t enough for the company to pursue and possibly save a lot of lives in the process but you know they would say it`s just business.After 2018 I`m sure you`ll see INSM pursue several trials for IPLEX including ALS.All share holders can hope for in the meantime is others successful trials and licensing deals.My money is hoping on Arikace right now because that`s what`s on the table,and it appears that Lewis has big plans.
Iplex will be a FOB (follow on biologic) and anyone can make the stuff who develops the process. All the FOB expertise of INSM is gone. That was SG and the crew at Boulder. Also, PCUT could develop same because of previous waiver by Ipsen, Roche for ALS and now Premacure has ROP. So INSM is going to go back after 10 years and pick-up the marbles they spilled on the floor in 2009?!?
We already know about iPlex. Just because another company's drug fails the ALS test does not mean iPlex will make a come back. I really feel sorry for those poor people that have ALS.I wish iPlex really did work. JMO
clinical trial for Iplex in ALS patients was evident in both the Italian and US EAP studies. Even if it was just testimonial clinical data, 39% of the patients had improved swallowing and all the benefits that go along with the preservation of that critical, life saving reflex (better nutrition, maintenance of body weight and body strength, and, most importantly, less aspiration pneumonia). The loss of this reflex makes ALS patients afraid to attempt to eat or drink because of choaking. But while the FDA requested INSM to file a Phase IIb study, INSM rejected the idea and went for a Compassionate IND use instead. Now it is PCUTs turn if they ever generate the funds.
Same for ROP. INSM is at arms distance because "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”." That statement is on the homepage of their website. What is surprising is that it says "with or without binding protein, IGFBP-3." This statement strongly suggests that Premacure has gotten the waiver from Ipsen, Roche and whomever else.
Now Iplex is at best a "royalties only" possibility for INSM's bottom line and that will not be anytime soon.