Date: 2018-10-01
Type of information: Licensing agreement
Compound: Vabomere™ (meropenem and vaborbactam), Orbactiv® (oritavancin) and Minocin® (minocycline)
Company: Melinta Therapeutics (USA - CT) Menarini (Italy)
Therapeutic area: Infectious diseases
Type agreement: licensing - development - commercialisation
Action mechanism:
Disease: acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible designated gram-positive bacteria including methicillin-resistant Staphylococcus aureus (MRSA), complicated intra-abdominal and urinary tract infections, hospital-acquired pneumonia, bacteraemia that occurs in association with any of these infections and infections due to aerobic Gram-negative organisms, infections due to susceptible strains of important designated gram-positive and gram-negative pathogens, including infections due to Acinetobacter species
Details:
- • On October 1, 2018, Melinta Therapeutics and Menarini Group announced that they have entered into an agreement under which Menarini will acquire the exclusive rights to co-develop and commercialize Vabomere™ (meropenem and vaborbactam), Orbactiv® (oritavancin) and Minocin® (minocycline) for Injection in 68 countries in Europe, Asia-Pacific including China, South Korea, and Australia (Japan excluded), and the Commonwealth of Independent States (CIS) including Russia for a total consideration of up to $265 million.
- The agreement builds on Melinta and Menarini’s existing commercial and co-development agreement for Baxdela® (delafloxacin) – announced in 2017 – in the same 68 markets.
- Melinta will maintain its rights for Vabomere, Orbactiv and Minocin for Injection in the U.S., where all three products are currently marketed. A marketing authorization application for Vabomere is currently under review by the EMA. On September 20, 2018, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorization for Vabomere, intended for the treatment of complicated intra-abdominal and urinary tract infections, hospital-acquired pneumonia, bacteraemia that occurs in association with any of these infections and infections due to aerobic Gram-negative organisms where treatment options are limited. Orbactiv is approved by the EMA for the treatment of adults with acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible designated gram-positive bacteria including methicillin-resistant Staphylococcus aureus (MRSA).
Financial terms:
- Under the terms of the agreement, Melinta will receive an upfront licensing fee, additional approval and sales-based milestone payments, and potential royalty payments based on a percentage of net sales of the three products. Proceeds from the agreement will more than satisfy Melinta’s milestone payment obligation related to Vabomere’s European marketing approval.
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Is general: Yes
