creates inhaled therapies for a number of different lung diseases including chronic lung infections in which there are no approved therapies. What is interesting about the therapy is how it's delivered. Their patented eFlow Electric Nebulizer is a hand-held device that allows the patient to easily inhale from it, so that the antibiotic is delivered directly to the site of infection and into the lungs. The antibiotic agent is a liposomal form of Amikacin called Arikace. Arikace is an antibiotic commonly used by hospitals for severe infections.
Amikacin is an aminoglycoside antibiotic that is most often used to treat hospital acquired infections with multi-drug resistant Gram negative bacteria. Insmed is testing Arkiace in several trials for the treatment of Pseudomonas and Non-Tuberculosis Mycobacteria (NTM). The company is currently undergoing a Canadian and European Phase III (CLEAR 108) study for CYSTIC FIBROSIS patients Pseudomonas lung infections, initiated in the 2nd quarter of 2012.
In a Phase II extension study recommended by the DSMB for Arkiace, 560 mg were administered once daily for 28 day periods, for 6 cycles and was well tolerated. No adverse effects were observed with longer term dosing. Data showed statistically significant reduction from baseline in Pseudomonas Aeruginosa density, including mucoid strains. Inhalation of Arikace also showed statistically significant sustained improvement in lung function. Top-line data is expected to be released mid 2013, so investors should be very aware of the therapy's potential. This is an orphan status therapy that uses an already approved drug for Cystic Fibrosis patients, so the stock price could run significantly to data.
It's a shame he didn't mention that unless catastrophic news arrives before the end of May, INSM will also be included in the Russell 3000 in June.
If the news expected mid-year from the Phase III pivotal study is strongly supportive of approval, and we see an increase in market cap in proportion to that triggered by the results for the Vertex CF drug, the share price should immediately go to at least $37. Our market cap at that point would still only be around half that of HGSI on the day after its Phase III news in 2009.
The Russell tracker funds are likely to need three or four million shares this June. Who is going to sell them those shares at anywhere near the current price - shorts or otherwise?