The out-licensing programs will still be developing
For those here unhappy about the fact that the new web site doesn't mention iPlex it's worth noting that it doesn't mention Inhaled Cisplatin Lipid Complex either. Seems to me that the redesign is focussed primarily upon optimising sales of Arikace. Others can worry about optimising sales of products where Insmed has out-licensed its IP.
Potential investors will soon discover via the 10-K that Insmed has a lot more going for it than Arikace. It won't tell them the recent news that somebody has committed to manufacturing a new supply of iPlex for the Premacure and PCUT programs, but those wanting to dig deeper will doubtless check out the Premacure, PCUT and Eleison sites in order to discover how soon Insmed is likely to benefit from out-licensing revenue streams.
Investors new to Insmed should be aware that the Company has several out-licensing irons in the fire, not least of which is this -
"Inhaled Cisplatin Lipid Complex is a novel sustained-release formulation of cisplatin in a lipid-based complex designed specifically for administration via inhalation for cancers affecting the lung. It is in pre-clinical development and we are not actively pursuing development at this time. We have recently out-licensed the rights to Eleison Pharmaceuticals, a privately-held Company focused on developing compounds for orphan indications."
Here is the description from Eleison's Phase II clinical trial (currently recruiting at two of three listed locations) -
ILC is a novel formulation of cisplatin, designed for inhalation by nebulization. The anticipated pulmonary benefits of ILC over systemic cisplatin therapy are threefold:
..... Increased local cisplatin concentrations
..... Sustained release of cisplatin in the lungs
..... Minimal systemic exposure to cisplatin
In this study, patients currently in surgical complete remission (CR) following one or two prior relapses of osteosarcoma involving pulmonary disease will be treated with ILC every two weeks for up to one year. ILC will be administered via nebulization."
Estimated enrollment is fifty participants, and the estimated primary completion date is currently December 2014.
Cisplatin is already an FDA-approved therapy for cancer, and one would imagine that the potential for lipid accumulation must be of little relevance when the disease is cancer, the liposomes are delivering a cancer inhibitor, and the liposomal delivery keeps the toxic cisplatin out of the bloodstream.
From the CDC site -
"In 2008 (the most recent year numbers are available) -
..... 208,493 people in the United States were diagnosed with lung cancer, including 111,886 men and 96,607 women.
..... 158,592 people in the United States died from lung cancer, including 88,541 men and 70,051 women."
The WHO site indicates 1,370,000 deaths from lung cancer worldwide in 2008.
It's worth noting though that Insmed's out-licensed therapy is targeted at individuals perceived to be particularly at risk of developing lung cancer.
I've never claimed to have any more medical knowledge than has the average layman, but I'm under the impression that when malignant cancer anywhere in the body reaches a given stage of development there's a significant risk of it spreading to the lungs. The ongoing study is restricted to patients who have undergone surgery for lung cancer, as one would expect given the serum toxicity traditionally associated with chemotherapy. But if delivery via liposome inhalation is accompanied by negligible systemic toxicity one wonders if that might warrant a wider role as a proactive therapy. Perhaps give the therapy to any patient for whom an operation for cancer is planned?
As always - constructive input would be appreciated.