Melinta Therapeutics and Hikma sign exclusive licensing agreement for two novel anti-infectives for the Middle East and North Africa region

MORRISTOWN, N.J. – April 29, 2021 – Melinta Therapeutics (Melinta) and Hikma Pharmaceuticals PLC (Hikma) today announced they have entered into an exclusive licensing agreement for Vabomere^®(meropenem and vaborbactam) and Orbactiv^®(oritavancin), two novel anti-infective injectable products, for the Middle East and North Africa (MENA) region.

In the United States, Orbactiv^® is indicated for the treatment of adult patients with acute bacterial skin and skin structure infections due to designated susceptible Gram-positive pathogens and Vabomere^® is indicated for the treatment of patients 18 years of age and older with complicated urinary tract infections, including pyelonephritis, caused by designated susceptible Gram-negative pathogens.

Under the terms of the agreement, Hikma is responsible for the registration and commercialization of these two products across its 18 MENA markets. This extends Hikma’s existing partnership with Melinta for their intravenous and oral formulations of Baxdela^® (delafloxacin), a novel antibiotic product. The addition of these two innovative products to Hikma’s portfolio builds on its hospital anti-infective franchise and provides healthcare professionals with more treatment options.

“We are excited to be extending our partnership with Melinta and bring Vabomere^® and Orbactiv^® to our patients in MENA,” said Mazen Darwazah, Hikma’s Executive Vice Chairman and President of MENA. “As one of the leading suppliers in the region, it is our responsibility to equip doctors with the latest and most innovative developments to treat their patients. This agreement supports our strategy of establishing a global network of partners to strengthen our portfolio and improve availability of treatment options in the MENA region.”

“Hikma shares our commitment to ensure that all patients who need our life-saving therapies can get them,” said Christine Ann Miller, President and Chief Executive Officer of Melinta. “We’re thrilled to extend our partnership to reach patients in need in the MENA region with Vabomere® and Orbactiv^®.”

Enquiries

Melinta Therapeutics

Susan Blum
Interim Chief Financial Officer
+1 312 767 0296
info@melinta.com

Hikma Pharmaceuticals PLC

Susan Ringdal
EVP, Strategic Planning and Global Affairs
+44 (0)20 7399 2760/ +44 7776 477050
uk-investors@hikma.uk.com

Dana Alhusseini
Communication Manager
+962 6 580 2900
Dalhusseini@hikma.com

About Melinta Therapeutics

Melinta Therapeutics, LLC provides innovative therapies to people impacted by acute and life-threatening illnesses. Our portfolio currently includes five commercial-stage antibiotics: Baxdela® (delafloxacin), Kimyrsa™ (oritavancin), Minocin® (minocycline) for Injection, Orbactiv® (oritavancin), and Vabomere® (meropenem and vaborbactam). With an unsurpassed commitment to providers and the patients they serve, we work to ensure that all people who need our therapies can receive them. We focus our expanding portfolio on serving patients with an unmet need because that’s how we make the most meaningful impact. At Melinta, we’re visionaries dedicated to innovation while staying grounded in what matters most: patients. Visit www.melinta.com for more information.

About Hikma
(LSE: HIK) (NASDAQ Dubai: HIK) (OTC: HKMPY) (rated BBB-/stable S&P and BBB-/stable Fitch)

Hikma helps put better health within reach every day for millions of people around the world. For more than 40 years, we’ve been creating high-quality medicines and making them accessible to the people who need them. Headquartered in the UK, we are a global company with a local presence across the United States (US), the Middle East and North Africa (MENA) and Europe, and we use our unique insight and expertise to transform cutting-edge science into innovative solutions that transform people’s lives. We’re committed to our customers, and the people they care for, and by thinking creatively and acting practically, we provide them with a broad range of branded and non-branded generic medicines. Together, our 8,600 colleagues are helping to shape a healthier world that enriches all our communities. We are a leading licensing partner, and through our venture capital arm, are helping bring innovative health technologies to people around the world. For more information, please visit: www.hikma.com

READ FULL TEXT

Michael N. Dudley, Pharm.D.

President and Chief Executive Officer
Qpex Biopharma, Inc.

Dr. Dudley has over 30 years of experience in antiinfective drug research, development, and commercialization. In 2018, he co-founded Qpex Biopharma which raised $33M in Series A financing and acquired the preclinical infectious disease programs from The Medicines Company. He has overseen the development and regulatory approval of 3 antibiotics, most recently a beta-lactamase inhibitor combination product from a new chemical class (vaborbactam) discovered in the company laboratories. The antibiotic product Vabomere™ advanced from discovery to FDA approval in 2017 in less than 8 years. He lead the negotiation for multiple contracts from public-private partnerships (e.g., BARDA of the US Government; Innovative Medicines Initiative for the EU) for a combined total of over $190 million funding to advance antimicrobial agents in development in the US and Europe. Prior to co-founding Qpex, he was Chief Scientific Officer and co-founder of Rempex Pharmaceuticals that was acquired by the Medicines Company (MDCO) in 2013, where he remained as the co-leader of the Infectious Disease Business Unit of MDCO. Prior to Rempex, he held VP/SVP/CSO positions of increasing responsibility at the biotech companies Mpex Pharmaceuticals (acquired by Aptalis in 2011), Diversa Corporation, and Microcide Pharmaceuticals. Prior to his career in pharmaceutical industry, he held full-time academic appointments that included Professor of Pharmacy and Chairman of the Department of Pharmacy Practice at the University of Rhode Island College of Pharmacy (URI), and Adjunct Professor of Medicine, Brown University School of Medicine at Roger Williams Medical Center in Providence, RI. As an academic researcher, he conducted preclinical and clinical research in antibacterial, antifungal, and antiviral agents, including pioneering work on PK-PD approaches for several classes of antiinfectives. Dr. Dudley has published over 130 scientific papers and book chapters describing the evaluation and clinical use of antiinfective agents and treatment of infectious diseases. He has served as an invited speaker at several FDA and EMA workshops, international meetings on infectious diseases, and advisor to several companies. He has served as an Editor for the journal Antimicrobial Agents and Chemotherapy and numerous other editorial and advisory boards. He completed undergraduate work at Pepperdine University and his Doctor of Pharmacy (PharmD) from the University of California San Francisco (UCSF), completed at residency at UCSF, and a fellowship in infectious diseases at Hartford Hospital.

Melinta Therapeutics and Hikma sign exclusive licensing agreement for two novel anti-infectives for the Middle East and North Africa region

René Russo, PharmD, BCPS

René Russo, PharmD, BCPS

Roger J. Pomerantz, M.D., F.A.C.P.

Christine Ann Miller

Graham G. Lumsden

Marco Taglietti, M.D.

Ankit Mahadevia

Jeffrey Stein, Ph.D.

Evan Loh, M.D.

Michael Dunne, M.D

Ciara Kennedy, Ph.D.

Ted Schroeder

Kevin Finney

Manos Perros, Ph.D.

David Roblin

Stephen Conafay

Christopher J. Burns, Ph.D.

Michael N. Dudley, Pharm.D.

Ramani Varanasi

Corey Fishman

Felix Faupel

Adrian Nivoliez