The Skinny on INSM, TRCA and DNA
by: esrdpatient
Long-Term Sentiment: Strong Buy 04/19/06 01:10 am
Msg: 87673 of 87732
Those who know the history of Genentech (DNA) know that it corporately decided to get rid of its research and findings on IGF-1 so that it could restrict its time, efforts and personnel to finding cancer cures.
In divesting itself of this unwanted molecule, it sold to TRCA a whole gunny-sack of know-how and anything that seemed to be germane to IGF-1. By this time IGF-1 was old 1970's technology and the patent to make IGF-1 had expired.
Whether Genentech sold TRCA a pig in a polk, only litigation will decide. Genentech will officially stand by TRCA on the basis that whatever it sold to TRCA was merchantable.
Genentech purportedly had a large old batch of IGF-1 which is rumored to have been sent out for a number of years for clinical trials by endocrinologists who were trying to help children. They recorded results sometimes in good scientific fashion and sometimes more anecdotally from reports by parents. Many of these were foreign children seen twice a year by an endocrinologist or an assistant.
TRCA summarized these results and submitted them to the FDA as the basis for an approval of the drug Increlex.
Prior to this, other companies had produced IGF-1 and had hopes of marketing it. One such company is part of Pfizer. Another company actually filed in Europe for drug approval of IGF-1 many years ago but abandoned the application.
Although we may never know all of the details, in my humble opinion companies probably got rid of their IGF-1 aspirations because of negative clinical results when using only IGF-1 in its naked form.
INSM, over a long number of years, developed its own techniques and a large number of patents, and eventually developed IPLEX by its own methods.
The technique of INSM in successfully manufacturing the binding protein and successfully pairing it with IGF-1, resulted in a patented application whereby quite unexpectedly the paired product could be administered in unexpectedly higher doses than IGF-1 alone and with fewer injections per day and with decidedly fewer major side effects.
The mere idea that IGF-1 could be combined with its binding protein was not patentable since the two proteins occur naturally one bound to the other so that the idea of combining them is self-evident.
INSM, however, was entitled to patent the use of the two together as a novel drug which unexpectedly could be given in larger doses than IGF-1 alone and could be administered only once daily with fewer major problems.
In other words, the unexpectedly beneficial nature of IPLEX could not have been self-evident before the discovery and invention and clinical success by Insmed and its assignees.
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AI
