Cempra: “GAIN from Drugs for Bad Bugs”
Drug resistance is a growing concern worldwide and Cempra (CEMP) is one of our lead recommendations amongst the innovator companies that offer an attractive investment opportunity in this therapy class. CEMP’s lead drug, 1. Solithromycin (CEM-101, PhIII, CABP; PhII cUTI) is a 4th-generation macrolide, which attempts to address azithromycin-resistance concerns, overcome safety concerns around fluoroquinolones (Levaquin) and, 2. TAKSTA (CEM-102, oral Sodium fusidate, PhIII, aBSSSI; PhII, prosthetic joint infections) is effective against Methicillin-Resistant Staphylococcus Aureus (MRSA) is being developed for long-term treatment of Prosthetic Joint Infection (PJI) and CEMP is seeking an orphan indication in US. Implementation of the Generating Antibiotic Incentives Now (PDUFA-V, effective from Oct. 1, 2012) could add 5 years of market exclusivity in addition to the standard data exclusivity. Both these drugs are unpartnered and clinical data is expected by... For more detail, please read our initiation report released on 2nd July, 2012 on CEMP titled “GAIN from Drugs for Bad Bugs”
COMPANIES MENTIONED
CEMPRA
CEMPRA
