Td, Surfaxin do work for IRDS (IRDS is a misnomer, it is simply lack of surfactant in premature infants due to prematurity, nothing "idiopathic" about it, also known as HMD-hyaline membrane disease the old name and also a poor choice and better and popularly known as RDS or respiratory distress syndrome of the premature newborn) aka the same RDS that is already very well treated with Survanta, Infasurf and Curosurf all are part animal derived and part semisynthetic and the fully artificial Exosurf in order of sales.
Exosurf is the least effective and the one that shares the most with Surfaxin. Exosurf does work, but despite being first to market loss quickly to Abbott/Ross'Survanta due to the fast short term effect in favor of Survanta. The others are very simmilar to Survanta.
Exosurf is purely synthetic, Surfaxin improvement is the addition of purely synthetic SpB (surfactanct protein B) and the one responsible for the semi-natural ones fast response and also responsible (the lack or deficit of SpB)of sometimes very different responses due to inability to prepare the products with certainty of composition. It is difficult to squeezed the lungs for the product and be the same all the time. The solution is that most of the products doses could be repeated and indeed they are repeated until a good response, the lack of response eventually is more a function of extremely premature lungs (all the good surfactant of the world will not make a difference, only a placenta would and there are no artificial placentas) severe infections or malformations.
So what with Surfaxin steady completly controlled supply of synthetic one by one aminoacid constructed peptide and surprisingly cheap and the even cheaper fosfolipid (the common substance with the market beaten exosurf!)combination?
Well, Surfaxin has a chance of being cheaper as per Dsco, I do not know if it is truely cheaper, Infasurf came to market to beat Survanta in price and Ross has counteract with strong discount prices. Dsco claims that their SpB will make a strong clinical different BUT for the testing they wanted to compare to placebo not again existing products until they were forced to do so by Public Citizens lobby pressure. Actually they are most probably to show a face saving equivalency which is enough to pass the Bush Headless FDA and that will be enough to send the shares to $15.
I most probably exit with the FDA application hype, I am not going to wait for marketing of the product.
The other trial, and actually ahead and shorter number of subjects is needed, just 200, is the MAS trial or meconium aspiration lavage trial. A neat thing, good evidence from current trials using the currently market products, which is an advantage to know it works since all neonatologists in practice are doing it for years off label BUT how are they going to justify the use of Surfaxin exclusively with their "method of use" patent and how are they going to enforce it? well, they will be cheaper, they are going to have the Fda "label" that confers a limited certain "legal" advantage/disadvantage to users (not great pressure) and the mounting evidence that the others do work will make this a mess to make money of. Dsco claims they will sell well in poor countries and still make a profit.
Some Cystic fibrosis trial is slowly developing, the Adult RDS or ARDS is a version that is more doubtful, their claim here is that the very complex and ardous task of 32 bronchi by bronchi branch cleaning with endoscopy help will save lives (so far none of the commercially available surfactants has shown anything but improve oxygenation and ventilator lung mechanics for short time, but less complex use)and I will not bet in ARDS, cause it is a known cemetery field for researcy drugs for decades (like sepsis shock) the most recent demise is Liquivent pIII, and even the moderately success Pafase from Icos abandoned the field for a more possible sepsis shock !!!
Dsco is remarkably well managed and directed with their few resources and extremely limited pipeline.
IRDS and MAS will work well, the problem is market competition.
Drug delivery? Liquivent from ALLp has more advantages in that area, even DNA gene therapy is possible with Liquivent.
Are you out of ALLP? Did you manage to get out? I am in now with the very cheap shares and very high risk.
Regards,
cacaito
Oh, I bought back in Ligand at $9.75, not very cheap but able to move to $15. |
