Melinta Therapeutics & Menarini Group Enter Commercial Agreement

Melinta Therapeutics, Inc. and Menarini Group recently announced 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.

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.

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.

“We are excited to expand our partnership with the Menarini Group and significantly increase global access to our dynamic antibiotic portfolio,” said Dan Wechsler, President and CEO of Melinta. “Menarini has been an excellent partner with us on Baxdela, and with this agreement, we will unite all of our products under a single partner in these key global markets, allowing for significant commercial synergies. Menarini’s strong presence, reputation, and breadth of experience will continue to be integral as we work to drive the global success of our products and bring these important treatment options to patients around the world.”

“As Menarini, after our recent collaboration on delafloxacin, we feel very proud to keep working with Melinta to strengthen our value proposition in infectious disease. The addition of meropenem/vaborbactam, oritavancin and minocycline IV to our current portfolio, gives us the opportunity to build a high-value antibiotics platform supporting our infection in focus mission to fight life-threatening bacterial infections,” added Pio Mei General Manager of the Menarini Group.

Melinta will maintain its rights for Vabomere, Orbactiv and Minocin for Injection in the US, 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 the medicinal product 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).

Melinta Therapeutics, Inc. is the largest pure-play antibiotics company, dedicated to saving lives threatened by the global public health crisis of bacterial infections through the development and commercialization of novel antibiotics that provide new therapeutic solutions. Its four marketed products include Baxdela (delafloxacin), Vabomere (meropenem and vaborbactam), Orbactiv (oritavancin), and Minocin (minocycline) for Injection. It also has an extensive pipeline of preclinical and clinical-stage products representing many important classes of antibiotics, each targeted at a different segment of the anti-infective market. Together, this portfolio provides Melinta with the unique ability to provide providers and patients with a range of solutions that can meet the tremendous need for novel antibiotics treating serious infections. For more information, visit www.melinta.com.

The Menarini Group is an Italian pharmaceutical company, 13th in Europe out of 5,345 companies, and 35th in the world out of 21,587 companies, with a turnover of more than 3,7 billion Euro and more than 17,000 employees. The Menarini Group has always pursued two strategic objectives: Research and Internationalisation offering high quality solutions in many of the most important therapeutic areas such as Cardiology, Respiratory, Infectious Disease, Gastroenterology, Diabetology and Inflammation/Reumathology. With 16 Manufacturing Sites and 7 Research and Development centers, the Menarini Group has a strong presence throughout Europe, Asia, Africa, Central and South America. Menarini’s products are available in 136 countries worldwide. For more information, visit www.menarini.com.