Melinta Therapeutics, a privately held company developing novel antibiotics to treat serious bacterial infections, and Menarini Group, an Italian biopharmaceutical group, has 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), an investigational anionic fluoroquinolone, 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. 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.
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 Delafloxacin’s 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.
“We are very pleased to have the Menarini Group as our partner in these major territories. Their strong presence, reputation, and breadth of experience in over 130 countries in Europe, Asia and CIS countries, including in fast-growing markets like China and Russia, will be a significant advantage in driving the global success of Delafloxacin,” stated Eugene Sun, MD, CEO of Melinta. “With this agreement and our existing collaborations, we have established commercial partnerships on six continents. Pending approvals in these geographies, we will be well positioned to make Delafloxacin available worldwide.”
“This collaboration with Melinta is directly in line with our mission of bringing high-quality pharmaceuticals to patients all over the world,” added Dr. Pio Mei, General Manager of The Menarini Group. “We believe that Delafloxacin has an important role to play in the treatment of severe, life-threatening bacterial infections. We will work with Melinta to bring Delafloxacin to hospitals in Europe, Asia and CIS, and to develop it for additional indications.”
In the US, Melinta will retain rights to Delafloxacin, where the product has completed Phase 3 clinical trials for the treatment of patients with ABSSSI. Melinta submitted New Drug Applications to the FDA for the intravenous and oral formulations of Delafloxacin for this indication in October 2016, and a PDUFA date of June 19, 2017 has been set. Should the FDA approve Delafloxacin for sale in the US, Melinta intends to conduct a commercial launch with a dedicated sales and marketing team.