"Premacure (now Shire plc) - In May 2012, we entered into an agreement with Premacure pursuant to which we granted to Premacure an exclusive, worldwide license to develop manufacture and commercialize IGF-1, with its natural binding protein, IGFBP-3, for the prevention and treatment of complications of preterm birth (the “Premacure License Agreement”). In March 2013, we amended the Premacure License Agreement
to provide Premacure with the option, exercisable by Premacure any time prior to April 30, 2013, to pay us $11.5 million and assume any of our royalty obligations to other parties in exchange for a fully paid license. If Premacure exercises this option, we would not be entitled to future royalties from Premacure."
For a total of $11.5 megs, INSM will "cut the strings on any royalty due INSM for developing ROP" provided Premacure/Shire ". . . and assume any of our royalty obligations to other third parties (what are the third parties other than Ipsen and Roche until 2018?) in exchange for a fully paid license." This of course is written in lay discourse for shareholders and does not parallel the language in the amended Premacure License Agreement, but think for one moment what the intent has to be. INSM is giving up future rights to royalties from Premacure if they assume any royalties to third parties for . . . what??? ROP (yes). MMD (no). ALS (no). Any other uses covered by the Settlement Agreement (no).
But let's see what happens on April 30. According to the "Spumps", the SP will be quadrupled (or more), PCUT will be in a royalty deal with INSM and the FDA will roll and not require an NDA to be filed.
INSM investors get real. The slow, highly regulated path in the middle of all this nonsense is what will carry WL, INSM and Longs forward to a reasonable payday. Nothing more.
How are you going to get $billion from outlicensing to PCUT? A non-profit company. Answer that question and you can suggest WL ment more than "continued opportunities for outlicensing."
The opportunities in INSM's future scientifically center on the liposome that penetrates the biofilm and is phagocytized by the fixed airway and alveolar macrophages. The macrophages present to the immune system of the lungs, BTW, which is not a systemic immune system. It is what medical people call "mucosal immunity." Every organ system that has a mucous membrane has its own immune system - gi tract, urogenital tract, lungs, eyes, to produce a local defense against foreign substances and infectious agents that have evolved to infect a very limited site on the mammalian body. That is what INSM will focus upon. They now view Iplex outlicensing as a means to a liposome/Arikace end.
BTW - just so you do not feel picked on, you were the first guy on this MB to mention Duchenne MD back in 2009. I looked it up and you were correct. Now there are lots of Phase II trials and one Phase III on Duchenne. INSM could have been among the front runners if they had not gone with Moxley and DM1. Now Sarepta has a RNA dystrophin drug (reverses Duchenne mutation) like Kalydeco reverses some forms of CF. These companies cannot sit on their hands for years and hope to keep ahead, or catch up.
Rehd, so you see ROP as a foot-in-the door for future Iplex development as well? I'm not convinced that Shire budgeted to pay the 11.5 (could be a higher number based on the CEO's comment on the CC) in addition to the Premacure buyout and Iplex production costs. In their PR, they announced future milestones and royalties, which could be their plan all along. Premacure may have wanted to pay the 11.5 and assume the entire risk of future success in ROP, while larger companies like like Shire limit their investment in each indication in case it doesn't pan out, and divirsify to other indications for the same treatment to reduce the risk.