biospectrumasiaJuly 28, 2019
Tag: Cipla USA , UTI drug , worldwide rights
Cipla USA Inc., a wholly-owned subsidiary of the leading global pharmaceutical company Cipla Limited, announced the acquisition of the prescription drug ZEMDRI (Plazomicin) from Achaogen Inc. in a Chapter 11, U.S. Bankruptcy Code auction of Achaogen's assets. Cipla USA has acquired worldwide rights of ZEMDRI™ (excluding Greater China) with its allied assets and limited liabilities.
ZEMDRI™ is a once-daily novel intravenous (IV) aminoglycoside for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis, in adults who are unresponsive to currently available treatment options. ZEMDRI™ was approved by the United States Food & Drug Administration (USFDA) in June 2018, and was launched in the same year, with patent protection expected to continue until 2031 or 2032. It has been granted a new technology add-on payment (NTAP) by the Centers for Medicare & Medicaid Services (CMS), for its administration in a hospital in-patient setting. The product has also been filed for approval in the European Union (EU).
ZEMDRI™ is the latest milestone in Cipla's history of proactive and humanitarian leadership in enabling access to life-saving drugs. In 2001, at the height of the global HIV movement, Cipla changed the treatment paradigm with its offer of a triple combination anti-retroviral therapy at less than a dollar a day in Africa against the prevailing price of around USD 12,000 a year for one patient. With anti-microbial resistance (AMR) today being an urgent global healthcare challenge, Cipla has been at the forefront of AMR stewardship. Plazomicin is a novel antibiotic effective against some of the cUTI-causing gram-negative bacteria that are resistant to beta-lactam antibiotics including carbapenems. Clinical studies have shown sustained microbiological eradication of the bacteria with Plazomicin.
Cipla is a signatory to the Industry Declaration on AMR at the World Economic Forum in Davos in 2016 that laid out a roadmap to combat AMR.
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