close

Products

Date: 2012-03-02

Type of information:

Product name: EV-035

Compound: EV-035

Therapeutic area:

Action mechanism: EV-035 is a bacterial type II topoisomerase inhibitor, belonging to the chemical class of 2-pyridones. EV-035 shows potent broad-spectrum activity, including pathogens such as: Burkholderia pseudomallei, Burkholderia mallei, Yersinia pestis, Bacillus anthracis, Francisella tularensis, Coxiella burnetti and Brucella abortus. Superior activity over reference antibiotics was observed in vitro and in mammalian intracellular infection models.
EV-035 retains activity on multidrug-resistant strains including pathogens resistant to quinolones and other topoisomerase inhibitors. Early in vivo work indicates an efficacy comparable or better than gold standard drugs against both Gram+ and Gram- strains, including E. coli and MRSA as well as other multidrug-resistant pathogens.

Company: Evolva (Switzerland)

Disease:

Latest news: * On February 29,  2012, Evolva announced that its project with the US Army Research Office (ARO), conducted as part of the Transformational Medical Technology Initiative’s mission to prevent and address biowarfare threats, has been completed successfully. EV-035, one of the compounds studied under the ARO program, has been found to be a promising novel antibiotic with good activity in preclinical models against a range of select agents and other bacterial pathogens.
During 2012 data on EV-035 will be presented at various scientific congresses, commencing with the 2012 ASM Biodefense and Emerging Diseases Research Meeting, taking place 26 – 29 February in Washington, DC, USA.
Evolva has been working with ARO since 2008 and the US Defense Threat Reduction Agency (DTRA) since September 2006. Evolva’s work for ARO focused on finding molecules that inhibit the growth of the Gram-negative bacterial pathogen Burkholderia pseudomallei.
The compound has good oral bio-availability and exhibits a favorable safety profile. Data generated to date indicate that EV-035 is an excellent candidate for further characterization and promotion as broad-spectrum bio-defense agent. Apart from the potential defense use, Evolva owns all rights to EV-035 and has patent applications covering this portfolio.

Patents:

Submission of marketing authorization application USA :

Submission of marketing authorization application UE:

Withdrawal of marketing authorization application USA:

Withdrawal of marketing authorization application UE:

US authorization:

UE authorization:

Favourable opinion UE:

Favourable opinion USA:

Orphan status USA:

Orphan status UE:

Pediatric exclusivit _USA:

Pediatric exclusivity UE:

OTC status:

Other news:

Is general: Yes