When I recently countered the woefully-clueless suggestion by Rehdvm that Insmed had agreed to sell, for a mere $11.5 million, the only significant value remaining in iPlex, I pointed out that preemies need only a tiny amount of drug - and that Insmed retains the rights to the substantial revenue-generating opportunities (now with the guarantee of a manufacturing source).
Apart from the original FDA-approved use of iPlex (short stature unresponsive to growth hormone therapy) iPlex has shown promise in early clinical studies for a number of indications. But arguably the most important finding has been the improvement in insulin sensitivity seen in almost every iPlex study, including the "failed" studies.
Insmed never at any time had access to sufficient funding to take the early program through to a Diabetes pivotal clinical trial. But it's well worth noting the developments regarding the overall iPlex intellectual property portfolio.
After the patent infringement setback, and the subsequent Settlement Agreement which granted Genentech or Tercica the option of becoming a 50% owner of any promising development, Insmed stopped paying the annual renewal fees in the major European countries for almost all of its iPlex-related patents, allowing those patents to lapse. By 2010 I believe Insmed was only keeping three patents valid in Europe - two manufacturing patents, and this patent -
EP1183042 - METHODS FOR TREATING DIABETES
Insmed has continued to keep this patent valid. The renewal fees were paid in eleven European countries last year.
And perhaps Insmed now has a more effective means of delivery than subcutaneous bolus injection?
"This new analysis shows that the global type 2 diabetes therapeutics market was worth $23.7 billion in 2011. Between 2002 and 2011, the market grew at a rate of 11.8%. By 2020, the market is expected to be worth $45.1 billion"
Those here familiar with European patent law might see the funny side of a European patent entitled METHODS FOR TREATING DIABETES - given that methods of treatment are not patentable in Europe.
However, a method of manufacture of a substance intended as a treatment is patentable.
Which begs the question - what does Insmed gain from keeping that patent in force, in view of the patent issued in 2011 covering the manufacture of the high-purity (at least 96% free of mass and charge variants) protein complex?
Here's the main claim of the Diabetes patent -
"Use of a complex comprising IGF-1 and IGFBP-3 for the manufacture of a medicament for treating or alleviating diabetes mellitus in a subject suffering from the symptoms or complications associated with diabetes mellitus."
All that immediately springs to mind is that this earlier patent covers a small theoretical gap - the use of a low-purity protein complex to treat diabetes. If that is indeed the only significant return from paying the annual renewal fees, it would seem to suggest that Insmed considers the Diabetes opportunity to have significant value.
Any ideas Terry? From your reaction it's obvious that my reminder of the Diabetes opportunity meant a lot to you.
In case you are wondering what FUD is talking about, read the release from 2004 (See Below). You can also google the information FUD mentioned....interesting.
Fud....could you provide a link or information on where to find verification about Insmed making the renewal fees? Thanks
November 9, 2004
Insmed Announces Expansion of Patent Portfolio in the Treatment of Diabetes; New European Patent Granted for SomatoKine
RICHMOND, Va., Nov 9, 2004 (BUSINESS WIRE) -- Insmed Incorporated (NASDAQ: INSM) today announced issuance by the European Patent Organization of patent EP1183042 entitled "Methods for Treating Diabetes", covering the use of SomatoKine(R) (rhIGF-I/rhIGFBP-3) for the treatment of diabetes mellitus, including type 1 diabetes, type 2 diabetes and insulin resistant diabetes such as Type A insulin resistance. This European patent corresponds to the Company's United States patent US 6,040,292 also entitled "Methods for Treating Diabetes". According to the World Health Organization (WHO), approximately 170 million people have diabetes worldwide, and that this number may double by the year 2025. WHO estimates that there are 33 million patients in Europe with theses conditions and an additional 18 million patients in the United States.
"This patent is important to further strengthen our expansive intellectual property position surrounding our novel IGF-I replacement therapy, SomatoKine(R)," commented Philip J. Young, Chief Business Officer and Executive Vice President. "This new patent complements our United States patent covering the same patient types. Based on data we have generated to date, we believe SomatoKine(R) has the potential to enhance the treatment of diabetes as well as insulin resistant conditions."
Over the past several years Insmed has conducted four Phase II clinical trials with SomatoKine in type 1 and type 2 diabetes patients demonstrating SomatoKine can significantly reduce daily insulin consumption, improve blood sugar and contro