Melinta Therapeutics and Xediton Pharmaceuticals have entered an exclusive commercialisation and licensing agreement for four novel anti-infective products.
The products include Baxdela (delafloxacin), Vabomere (meropenem and vaborbactam), Orbactiv (oritavancin), and Kimyrsa (oritavancin).
Under the terms of the deal, Xediton Pharmaceuticals will handle the registration and commercialisation works of these products in Canada.
Melinta Therapeutics president and CEO Christine Ann Miller said: “Xediton shares our commitment to ensure that all patients who need our life-saving therapies can get them.
“We are confident that Xediton brings the right amount of energy and experience to effectively bring our novel anti-infective portfolio to market throughout this region.”
Baxdela is indicated to treat acute bacterial skin and skin structure infections (ABSSSI) and community-acquired bacterial pneumonia (CABP), which is caused by designated susceptible bacteria in adult patients.
Vabomere will be used to treat complicated urinary tract infections (cUTI), including pyelonephritis, that are caused by the susceptible microorganisms, in patients aged 18 years and above.
Kimyrsa and Orbactiv are indicated to treat ABSSSIx, which is caused or suspected to be caused by susceptible isolates of the gram-positive microorganisms, in adult patients.
Xediton Pharmaceuticals president George Gafrey said: “We are very pleased to partner with Melinta to bring these life-saving products to Canada.
“We believe these products will address unmet needs and will be of tremendous benefit to Canadian patients, particularly in our fight to combat the global threat of antimicrobial resistance.
“We look forward to the approval and commercialisation of Baxdela, Kimyrsa, Orbactiv and Vabomere.
“These products have been approved by the United States Food and Drug Administration for indications that include the treatment of infections caused by organisms on Canada’s Pathogens of Interest List.
“This will make our subsequent submissions to Health Canada potentially eligible for Priority Review, an expedited regulatory pathway here in Canada.”