What's your read on INSM PPS upon successfull P3 results come mid this year ? Interesting to see reputed Ayer Capital recently took a large stake in INSM.
Current pps is also below the price many of the insiders bought. Also like the automatic insiders buy program CEO has instituted.
Insmed (INSM) creates inhaled therapies for a number of different lung diseases including chronic lung infections for which there are no approved therapies. What is interesting about the therapy is how it's delivered. Its 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 Arikace 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 with Pseudomonas lung infections, initiated in the 2nd quarter of 2012.
In a Phase II extension study recommended by the DSMB for Arikace, 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.
Amikacin, and ingredient in Arikace, is the FDA approved antibiotic for CF. But it wasn't delivered well in the lung. Insmed's Liposome technology solves this delivery problem by placing amikacin into a liposome, which allows an extension duration of drug efficacy. Amikacin efficacy suggests that the drug is potentially better than TOBI which brings in annual revenues around $400m.With a market cap near $295M, Insmed appears to be undervalued by at least $100M, if not more.
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