"On May 25, 2012, the Company entered into an agreement with Premacure ... pursuant to which the Company agreed to grant 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 license is subject to the Company's receipt of a consent and waiver from Tercica ... and from Genentech ... of certain rights granted by the Company to Tercica and Genentech ... The Premacure License Agreement includes diligence milestones and royalty payments on prospective product sales.
In September 2012, we entered into an amended and restated license agreement with Premacure ... and received the waiver from Genentech. The license remains subject to the Company's receipt of the waiver from Tercica."
"Premacure (now Shire plc) ...
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."
Relevant historical events -
Tercica was originally created in order to develop IGF-1 under an outlicensing agreement with Genentech.
Insmed had incurred royalty obligations to Genentech and Tercica (in settlement of a patent infringement law suit) in respect of the use of the IGF-1/IGFBP-3 protein complex.
Genentech had little to lose by waiving its rights, but Tercica (now part of Ipsen) presumably held out for a share of the profits.
Insmed has given Shire and Ipsen the option to sort it out between themselves provided Insmed is paid $11.5 million up front.
Preemies only need tiny amounts of IGF-1/IGFBP-3. Insmed retains the rights to the substantial revenue-generating opportunities - and now has a manufacturer.
Iplex is morphing into a biological for premature infants, which is a patented use by two doctors (one US and one Swedish) to promote normal development and prevent ROP in premature babies. It will be "reborn" under the trade name Premiplex and will be developed by the Premacure subsidiary of Shire. They have to get a c GMP CMO to make Premiplex from scratch (per GA in 2009, an 18 month project) and get through the Phase IIb clinical trial. Dr. M Ley, et al, published his data about how 2 - 7 days of continuous IV infusions could achieve the 20 -60 micrograms per liter of circulating recombinant IGF-1/BP-3. But INSM gave up on development of Iplex for any purpose at the time the FOB business and a couple of files were sold to Merck. If Premiplex is going anywhere it is in the hands of Premacure/Shire. They will be the first to have a new supply of the recombinant drug. INSM wanted the $11.5 million ot facilitate Arikace and (probably) the master file for the liposome. Iplex is not dead, it is in the domain of Premacure and Shire. There is no backdoor here for INSM. I do not think the PCUT association has much merit because they are non-profit. The top royalty they hypothesized back in the ALS days of 2008-2009 was a 43% royalty if INSM put up $25 million in development costs. That fell off quickly without the up front $$$ to around 20%, if that.
INSM is an investment in Arikace and other drugs, biologicals, etc. where macrophage capture will either have a pharmacological effect, or potentiate the immune system to down regulate (asthma) or up regulate (infectious disease vaccination). We shall see.