Clinigen Appointed by AZ to Manage Global Access Program for New Combination Antibiotic, CAZ-AVI

Clinigen Group plc announces the initiation of a global access program for AstraZeneca’s investigational antibiotic, CAZ-AVI (ceftazidame-avibactam)

Online PR News – 19-February-2015 – Burton-on-Trent, UK – Clinigen Group plc (‘Clinigen’ or the ‘Group’, AIM: CLIN) announced today the initiation of an international global access program for AstraZeneca’s investigational antibiotic, CAZ-AVI (ceftazidame-avibactam), through its specialist Clinigen GAP division.

CAZ-AVI is being developed to treat a broad range of Gram-negative bacterial infections which are becoming resistant to antibiotics and pose an increasing risk to public health. It is being investigated as a new treatment option for patients with complicated urinary tract infections (cUTIs), complicated intra-abdominal infections (cIAIs) and nosocomial pneumonia. Complicated urinary tract and intra-abdominal infections are often attributed to drug-resistant bacteria. Gram-negative bacteria such as Escherichia coli (E. coli) are particularly adaptive. E.coli commonly causes urinary tract infections affecting nearly three million people per year and has become resistant to an increasing number of antibiotics. cIAI is an important cause of morbidity and mortality, and is the second most identified cause of severe sepsis in intensive care units.

The program is the first for Clinigen GAP with AstraZeneca and will provide access to CAZ-AVI to eligible patients for all countries world-wide with the exception of the US and Canada.
Healthcare Professionals will be able to request the drug for patients who have no other licensed therapeutic alternatives.

CAZ-AVI consists of ceftazidime, a well-established third generation injectable cephalosporin antimicrobial agent, and avibactam, a next generation non-beta lactam beta-lactamase inhibitor. Increasingly, infections have reduced the activity of ceftazidime. However, the addition of avibactam protects ceftazidime from breakdown, restoring the activity and enabling CAZ-AVI to better meet current and future needs for tackling serious gram-negative infections. CAZ-AVI has been granted a Qualified Infectious Disease product (QIDP) designation by the USA FDA which enables priority review and fast track status.

Shaun Chilton, Chief Operating Officer, Clinigen Group said, “I am very pleased to announce the launch of this first program for AstraZeneca, further strengthening the relationship with Clinigen. We now work with AstraZeneca across all our operating businesses. The continued growth within Clinigen GAP demonstrates the increasing need for early access to drugs in areas of critical unmet need."

Mark Corbett, Senior Vice President, Clinigen GAP said, “The war on antimicrobial resistance relies on the development of novel and improved therapies effective against serious infections, such as CAZ-AVI. We are pleased to be able to use our experience in the provision of international access programs to supply patients with what could be a very important drug. We look forward to working with AstraZeneca to provide access to CAZ-AVI and meeting this area of unmet need.”

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CAZ-AVI (ceftazidime-avibactam) is an investigational antibiotic being developed to treat serious Gram-negative bacterial infections. It consists of ceftazidime, a third-generation, antipseudomonal cephalosporin, that is an established treatment for serious Gram-negative bacterial infections, and avibactam, a next generation, non-beta lactam beta-lactamase inhibitor.

The addition of avibactam to ceftazidime protects ceftazidime from breakdown by serine-beta-lactamases. CAZ-AVI offers a differentiated profile versus existing treatment options in serious Gram-negative infections through its activity against a broad range of isolates of carbapenem-resistant Enterobacteriaceae and difficult to treat Pseudomonas aeruginosa combined with robust coverage of extended spectrum beta-lactamase-expressing pathogens.

CAZ-AVI is being jointly developed with Forest Laboratories, a wholly-owned subsidiary of Actavis. AstraZeneca holds the global rights to commercialise CAZ-AVI, with the exception of North America where the rights are held by Forest Laboratories.

About Clinigen Group
The Clinigen Group is a specialty global pharmaceutical company headquartered in the UK, with offices in the US and Japan. The Group, dedicated to delivering ‘the right drug, to the right patient at the right time’, has three operating businesses; Specialty Pharmaceuticals (Clinigen SP), Clinical Trials Supply (Clinigen CTS), and Global Access Programs (Clinigen GAP). Clinigen GAP develops and implements global access programs for biotechnology and pharmaceutical companies and has provided access to unlicenced, licenced and end-of-lifecycle products to thousands of patients. Clinigen has experience in the implementation of more than 30 access programs worldwide.

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