Cipla USA acquires anti-infective ZEMDRI( IV Plazomicin)

Cipla USA has announced the acquisition of the prescription drug ZEMDRI (Plazomicin) from Achaogen 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 and 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 and 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).

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.

Umang Vohra, Managing Director and Global Chief Executive Officer, Cipla, said, “The acquisition of ZEMDRI deepens our pipeline of specialty products in the US in our identified focus areas of central nervous system, lung delivery of medicines and institutionally-administered products. With a robust front-end commercial infrastructure for the US hospital sales in place, we expect to extract strong synergy from our IV Plazomicin and IV Tramadol assets. Cipla has been a leading industry voice in the fight against AMR and our expertise in manufacturing, marketing and conducting educational programmes in the antibiotic segment makes us well-placed to take ZEMDR globally to expand our leadership position.”