Premacure was sold and is being taken private,anyone have any thoughts on how this might affect INSMED? I tried to call Brian Ritchie but the website format has changed and Brian`s contact info is no longer under Investor relations. Comments---
Sentiment: Strong Buy
This deal all but guarantees a new manufacturing source of the protein complex.
The obvious benefit to Insmed is in being one step closer to royalty payments from the treatment of babies born pre-term.
It seems a reasonable assumption that all babies (including full-term) will in future be tested for GH and IGF-1 serum levels. A certain proportion will have an ongoing deficiency, which if untreated will lead to Short stature, diabetes(?) and other complications.
Most children will be treatable with Growth Hormone. The rest will require IGF-1 treatment.
Insmed could supply either (or both) in an injected liposome, gradually releasing the hormone throughout the course of the day (or week / month) so that serum levels are where they would be in a normal individual.
Research suggests that a pre-term baby also needs IGFBP-3. But if the IGF-1 is being administered gradually to a child, would there necessarily be any need for the binding protein?
The binding protein is certainly necessary to prevent retinopathy. That has been well documented by Premacure, as slow serum levels of IGFBP-3 is relevant in complications of premature birth and studies have shown that it is in fact the IGFBP-3 that plays the most direct role in correct development of vision.
Sentiment: Strong Buy
Btw - picking up on Terry's lie about a five-year wait for shareholder value from Premiplex, clearly this is an indication which would qualify under the new legislation for FDA approval on the basis of firm evidence of safety together with a strong likelihood of efficacy.
All the research conducted and results obtained so far by Premacure are based on treatment with Premiplex, if I am not mistaken. However, in public press releases, a lot of emphasis is placed on IGF-1, without much mention of the binding protein. In today's PR put out by Shire, they state, "With the acquisition of Premacure, Shire HGT will continue the ongoing Phase II study, the primary goal of which is to restore the IGF-1 levels in the preterm infant to those found during normal in utero development."
However they also state this, "In preterm infants (born before 31 weeks of gestation), the early separation from the maternal circulation results in a loss of specific growth factors, such as insulin-like growth factor 1 (IGF-1), that are believed to result in lifelong complications, including ROP." Note the plural growth factors.
Articles such as this one: "IGFBP3 suppresses retinopathy through suppression of oxygen-induced vessel loss and promotion of vascular regrowth," that conclude with: "IGFBP3 suppresses retinopathy through suppression of oxygen-induced vessel loss and promotion of vascular regrowth." lead me to believe that these researchers consider IGFBP3 to be an important contributor inthe treatment of ROP with Premiplex.
b_leaguered IGFBP-3 is IGF-1's best friend, necessary to extend to life of IGF-1 so it can reach its target and as you posted, part of the process of correct vision development. And Insmed is the supplier of the protein complex for all of Premacure's studies. So, no chance this is going to change midstream! From the PR:
"ROP is a devastating eye disorder that can severely impact preterm infants for the rest of their lives," said Flemming Ornskov, MD, CEO Designate, Shire. "This investigational protein has the potential to provide a first-in-class treatment that may minimize the development and impact of complications arising from ROP. We will build on the work that Premacure has done and will apply Shire's proven ability in developing protein replacement therapies for rare disorders to bring this much needed therapy to the market."
"The acquisition of Premacure by Shire further underscores the potential to change the long-term outlook for preterm infants with ROP and their families," said Jan Borg, founding CEO of Premacure. "We are excited that this program will become part of the innovative pipeline at Shire and believe that their experience and resources may accelerate the development of a product that seeks to prevent some of the devastating long-term consequences of ROP."
Sentiment: Strong Buy
Shire has a 17 Billion dollar market cap., and they have purchased Premacure whose only drug is covered by IP owned by Insmed.
That simply can't be considered a bad thing for INSM.
Seems we have a new partner. Marker cap of $17 billion, with approaching $5 billion in annual sales.
Would have preferred an acquisition by a company with an established network in China. Haven't been in to the Shire web site yet, but a quick search didn't reveal any link with China.