The Medicines Company MDCO got some good news on the pipeline front with its experimental antibiotic, Carbavance meeting FDA as well as EMA pre-specified primary endpoints in a late-stage study (TANGO I) conducted in patients with complicated urinary tract infections (cUTI).
Top-line results from the multi-center, randomized, double-blind, double-dummy study showed that Carbavance achieved statistical superiority over piperacillin-tazobactam (trade name: Zosyn) with overall success being observed in 98.4% of patients treated with Carbavance. Carbavance’s safety and tolerability was comparable to the control treatment.
The company believes that this data is sufficient to seek regulatory approval in both the U.S. and the EU next year with the U.S. submission expected in early 2017. Full results from the study will be presented at an upcoming infectious disease conference.
Carbavance has been designated a Qualified Infectious Disease Product by the FDA and has fast track status as well. Antibiotic resistance, especially to carbapenems, is a rapidly growing problem with carbapenem-resistant enterobacteriaceae (CRE) infections being one of the deadliest given the mortality rate of 40%. As a result, there is urgent need for antimicrobials that can effectively treat CRE and other resistant organisms.
Carbavance is one of the four potential blockbuster candidates in The Medicines Co.’s pipeline. It is currently in the phase III multi-center, randomized, open-label TANGO 2 study in which it is being compared to “best available therapy” in subjects with selected serious infections due to CRE. Interim analysis from this study is expected to provide supportive data for the regulatory application in the U.S.
Meanwhile, The Medicines Co. expects important news flow on its three other blockbuster potentials – ABP-700 (IV anesthetic and sedation agent), ALN-PCSsc (hypercholesterolemia), and MDCO-216 (lipid modulating agent) – in the second half of the year.
The Medicines Co. is a Zacks Rank #4 (Sell) stock. With its flagship product Angiomax going generic, the company has entered a challenging period where driving top-line growth will become increasingly difficult. In such a scenario, investor focus will remain on the company’s pipeline.
Some better-ranked stocks in the healthcare sector include ANI Pharmaceuticals, Inc. ANIP, ArQule Inc. ARQL and Apricus Biosciences, Inc. APRI – while ANI is a Zacks Rank #1 (Strong Buy) stock, ArQule and Apricus are Zacks Rank #2 (Buy) stocks.
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