Production of pyocyanin, water-soluble green pigment of Pseudomonas aeruginosa. (left tube) Ps. aeruginosa cultured on heart infusion soft agar medium. The aerobic bacteria grow only on the surface of the medium (forming whitish biofilm) , and water-soluble green pigment diffuses down. (right tube) Uninnoculated medium (as control). (Photo credit: Wikipedia)
INSM
NASDAQ : US$10.87 BUY
Target: US$18.00
COMPANY DESCRIPTION:
Insmed is focused on developing novel, targeted inhaled therapies for the treatment of serious orphan lung diseases. Its lead product candidate is Arikace, a liposomal formulation of FDA approved antibiotic, amikacin.
All amounts in US$ unless otherwise noted.
Investment recommendation
Reiterate BUY, $18 price target on Arikace potential in two orphan indications: CF P. aeruginosa and nontuberculous
mycobacteria (NTM) lung infections. INSM’s lead drug Arikace is a liposomal formulation of potent, FDA-approved antibiotic
amikacin. We expect positive data from a Phase 2 US NTM trial (data Q1/14E). Our $18 target is based on a pNPV analysis.
Investment highlights
We continue to see the NTM as the value drive of the stock and think a clear path forward will crystallize after Q1 date
and formal FDA meeting along with ongoing QIDP dialogue.
INSM believes a single point change in the NTM endpoint scale would be clinically meaningful. We think if a one-point
change on the 7-point, semi-quant scale is supported by improvements in QoL measures, this combination of data
could be meaningful to FDA and clinicians. Data from the Ph2 open label trial should be available mid-2014.
We think Ph3 CF sub-population analysis could support European health technology assessments. Sub-population
analysis from CF Ph3, to be presented at NACFC, could support Arikace use in certain select patient populations either instead of or in combination with Tobi.
Related articles
- Insmed to Present at the 8th Annual JMP Securities Healthcare Conference (virtual-strategy.com)
- Upcoming Catalyst Could Spark Another Run for Insmed (biomedreports.com)
