AZ signs antibiotic deal with Forest Laboratories
pharmafile | August 13, 2009 | News story | Research and Development, Sales and Marketing |Â Â Antibiotics, ForestÂ
AstraZeneca has struck a deal with Forest Laboratories to co-develop and commercialise ceftaroline, an anti-infective drug in phase III.
The companies aim to meet the demand for new drugs in this area, which is driven by the increasing development of bacterial resistance to available antibiotics.
Under the agreement, AZ will market ceftaroline in all areas outside the US, Canada and Japan, and Forest will retain rights to the drug in the US. The companies expect to file it in the US by the end of 2009 and will seek European approval by the end of 2010.
AstraZeneca's chief executive David Brennan said: "AstraZeneca and Forest Laboratories, through a successful partnership, aim to battle the growing problem of antibiotic resistance.
"This collaboration complements our existing antibiotic Merrem, and our significant investment in antibiotic research, as well as agents in development such as CytoFab. We are excited to be partnering with Forest and to be part of ceftaroline's future."
In the UK, infections account for about 10% of all deaths and cost 10% of the NHS budget, according to research commissioned by parliament last year.
The efficacy of current anti-infectives is threatened by the spread of drug resistance factors, with some already made ineffective. As a result, there is a pressing need for new anti-infective drugs.
Many bacterial infections have few satisfactory treatment options and rates of pneumonia and skin infections being caused by MRSA are increasing.
Ceftaroline is being investigated for the treatment of complicated skin and skin structure infections (cSSSI) and community-acquired bacterial pneumonia (CABP).
It has shown to prevent infection against a broad range of pathogens commonly implicated in cSSSI and CABP, including methicillin-resistant Staphylococcus aureus (MRSA) and multi-drug resistant Streptococcus pneumoniae (MDRSP).
So far Forest has conducted four phase III trials with ceftaroline to assess its efficacy and safety profile in treating the conditions. Results showed that against current market comparators, ceftaroline exhibited activity against gram-positive pathogens (including MRSA and MDRSP) and common gram-negative pathogens and was generally well tolerated.
If approved, ceftaroline could be used as a first-line treatment for both CABP and cSSSI.
AZ will pay Forest an undisclosed signing fee, milestone payments and sales-related royalties in the deal.
Other anti-infective research
Elsewhere the UK's Wellcome Trust 'Seeding Drug Discovery' initiative recently supported a number of pharmaceutical companies in pursuing anti-infective research.
It is funding a variety of drug discovery programmes, including those that may be less profitable. Prolysis received £3.5 million to take an anti-MRSA chemical through to phase I clinical trial, and GlaxoSmithKline has £4 million to test part of its current anti-bacterial portfolio in search of a novel class of anti-Gram negative agents.
Forest's Daxas deal
Meanwhile, Forest recently signed another deal, this time with private Swiss company Nycomed. The pair have partnered over Nycomed's Daxas, an experimental treatment for respiratory condition COPD, with Forest gaining rights to develop and market the drug in the US.
Daxas is the first pill for the disease, and could compete with GSK's Advair and also Spiriva, which is marketed by Pfizer and Boehringer Ingelheim.
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