Date: 2017-03-02
Type of information: Development agreement
Compound: Baxdela® (delafloxacin)
Company: Melinta Therapeutics (USA - CT) Menarini (Italy)
Therapeutic area: Infectious diseases
Type agreement: development - commercialisation
Action mechanism:
- antibiotic. Delafloxacin is an investigational anionic fluoroquinolone antibiotic currently in Phase 3 clinical development for hospital-treated skin infections, known as acute bacterial skin and skin structure infections (ABSSSI). In clinical trials, delafloxacin is being tested in both IV and oral formulations.
- In June 2017, the FDA has approved Baxdela™ (delafloxacin), indicated in adults for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible bacteria.
Disease: acute bacterial skin and skin structure infections (ABSSSI), hospital-treated community-acquired bacterial pneumonia (hCABP)
Details:
- • On March 2, 2017, Melinta Therapeutics and Menarini announced the signing of a development and commercialization agreement. As part of this agreement, Melinta has granted the Menarini Group exclusive rights to commercialize delafloxacin (known as Baxdela® in the US) under their own brands in 68 countries in Europe, Asia-Pacific including China, South Korea, and Australia (Japan excluded), and the Commonwealth of Independent States (CIS) including Russia.
- Menarini will be responsible for submitting regulatory applications and pursuing pricing approvals for delafloxacin in the countries being licensed. Currently, the companies expect that a Marketing Authorization Application (MAA) for Delafloxacin would be submitted to the European Medicines Agency (EMA) in the second half of 2017.
- Melinta and Menarini have further agreed to co-develop delafloxacin for additional indications beyond its initial indication of acute bacterial skin and skin structure infections (ABSSSI), including hospital-treated community-acquired bacterial pneumonia (hCABP). The ongoing Phase 3 clinical study of delafloxacin in patients with hCABP will continue to enroll patients globally. Going forward, Melinta and Menarini will collaborate in the design and share in the cost of clinical trials for this and other indications.
Financial terms:
- Under the terms of the collaboration, Melinta will be receiving an upfront payment and near-term development and regulatory milestone payments, as well as sales milestones and royalties from Menarini Group.
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Is general: Yes
