Zeneca Pharmaceuticals has at long last received full marketing approval from the Italian Ministry of Health for its injectable carbapenem antibiotic Merrem/Meronem (meropenem). The product received technical approval in Italy in April.
Meropenem will be launched initially in what Zeneca says is a L230 million ($360 million) per annum market for this type of product in Italian hospitals. The Italian technical approval allowed the company to initiate the Committee for Proprietary Medicinal Products' multistate procedure for other European Union states, for which the total hospital injectable antibiotic market is valued at nearly L1 billion ($1.56 billion). In October last year, Zeneca also submitted Merrem applications to the US Food and Drug Administration; the US injectable antibiotic market is currently valued at around $2 billion a year.
Merrem will enter a crowded market, but one in which there is only one other carbapenem competitor, Merck & Co's Primaxin (imipenem and cilastatin). Zeneca hopes its antibiotic will benefit from not needing to be administered with an enzyme inhibitor, having an easier administration schedule and a slightly broader spectrum of indications (meropenem has won an indication for meningitis in Italy, which Primaxin lacks).
This article is accessible to registered users, to continue reading please register for free. A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.
Login to your accountTry before you buy
7 day trial access
Become a subscriber
Or £77 per month
The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed
Chairman, Sanofi Aventis UK
Copyright © The Pharma Letter 2024 | Headless Content Management with Blaze