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University Medical Center Utrecht On Behalf Of COMBACTE-NET

11/15/2016 9:34:31 AM

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Da Volterra and The Medicines Company join COMBACTE-NET to combat antimicrobial resistance

Utrecht (the Netherlands), 15 November 2016 – Today the Innovative Medicines Initiative (IMI)-funded New Drugs 4 Bad Bugs (ND4BB) project COMBACTE-NET announces that two new pharmaceutical companies, Da Volterra and The Medicines Company, have joined the project as partners. Together with the existing partners the new partners will closely collaborate to further strengthen the public-private partnership aiming to combat the worldwide growing problem of antimicrobial resistance.

The emergence of antibiotic-resistant bacteria is a global problem, having recently been elevated to the top 3 threats identified by the World Health Organization, and subject of numerous national and international government activities. The estimated costs of antibiotic-resistant bacteria are around € 1.5 billion per year in Europe, with an estimated 25,000 deaths.

COMBACTE-NET (Combatting Bacterial Resistance in Europe) was the first project of the Innovative Medicines Initiative within its ND4BB program. The project aims to develop a broad European network of fully capable and Good Clinical Practice (GCP) compliant clinical investigation sites to execute clinical trials enabling the registration of novel agents to be used in the treatment of patients with bacterial infections. The network currently comprises more than 750 hospitals, 450 laboratories and over 1,000 investigators in 42 European countries.

Da Volterra and The Medicines Company both join the COMBACTE-NET Consortium as a result of an open call launched in March 2015 to follow the early termination of development of GSK1322322. This open call aimed to identify potential replacement antimicrobial agents or approaches developed by EFPIA companies that could fulfill the overall objectives of the COMBACTE-NET project. Three proposals were finally selected, for a total budget of € 87.3 million.

As a result, the COMBACTE-NET project now also includes a study in collaboration with Da Volterra, which aims to determine the incidence of Clostridium difficile infections in hospitalized patients in preparation for a Phase 2/3 trial with Da Volterra’s product that protects the microbiota from the alteration by antibiotics: DAV132. In addition, The Medicines Company will jointly conduct three Phase 1 trials and one Phase 3 trial with the intravenous formulation of minocycline, to support filing of a Marketing Authorisation Application in the EU that will focus on treatment of infections due to Acinetobacter species. Minocycline for Injection is approved by the U.S. FDA for treatment of infections due to Acinetobacter species, but an intravenous formulation of this agent is not available in the EU. Minocycline for Injection is one of the few agents with activity against multi-drug resistant isolates of Acinetobacter species. The open call also resulted in the addition of a Phase 3 trial to the ongoing Phase 2 SAATELLITE study in collaboration with MedImmune. This study aims to test the efficacy and safety of the prophylactic use of MEDI4893, a monoclonal antibody targeting Staphylococcus aureus.

All three partners will work closely with the public partners of the Consortium and employ the clinical and laboratory networks of COMBACTE-NET. Several public institutions will act as academic leaders with the EFPIA companies: the Limoges University Hospital (France) for the Phase 3 trials proposed by MedImmune and The Medicines Company; University of Cologne (Germany) for the Phase 1 trials of The Medicines Company program, and the University Medical Center Utrecht (the Netherlands) for the Da Volterra program.

Clive Meanwell, M.D., Ph.D., Chief Executive Officer of The Medicines Company: “The commitment of IMI to establishing innovative structures to support the development of novel antimicrobial drugs demonstrates their leadership in combatting the growing worldwide public threat of antibiotic resistance. The Medicines Company is pleased to partner with IMI to address the serious public health threat posed by Acinetobacter infections in the European Union. We appreciate the support in making Minocin IV available in the EU.”

Annie Ducher, Chief Medical Officer for Da Volterra, EFPIA WP Co-lead: “Da Volterra is pleased to join the COMBACTE-NET team and through this IMI consortium we envision the development of a confident and efficient relationship to set-up the clinical trial. Realizing clinical studies within the COMBACTE-NET network is a unique opportunity for a SME such as Da Volterra to bring its innovative approach to the forefront. The interactions promise to be clear accelerators for the clinical development of DAV132, our product to prevent Clostridium difficile infections and to protect the intestinal microbiota from alterations induced by antibiotics.”

Hasan Jafri, Senior Director, Clinical Research and Development, Infectious Disease & Vaccines at MedImmune and EFPIA Coordinator of COMBACTE-NET: “Bringing together world-renowned experts within COMBACTE-NET to advance development of novel biologics, such as MEDI4893, may offer a unique opportunity to help prevent serious infections without inducing antimicrobial resistance. The addition of the Global Phase 3 trial to follow the current Phase 2 SAATELLITE study reflects IMI’s and COMBACTE-NET’s commitment to bringing novel molecules to patients. We look forward to leveraging the unique collaborative environment within COMBACTE-NET to work with Da Volterra and The Medicines Company.”

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