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Drug Development


Tuznue® is a trastuzumab biosimilar treatment to


Roche’s Herceptin® which is used to treat patients with HER2-overexpressing breast


cancer, HER2-overexpressing metastatic gastric cancer or gastroesophageal junction adenocarcinoma


resulting in more than 1.5 million deaths annually and mortality rates ranging from 15% to 65%. These infections continue to be a global health issue, especially for critically ill patients in hospi- tals and patients with compromised immune sys- tems, including cancer and transplant patients. Approximately 90% of all reported fungal-related deaths are associated with Candida, Cryptococcus, Aspergillus and Pneumocystis. Rezafungin is a novel, once-weekly echinocan-


din antifungal being developed for the first-line treatment of candidemia and invasive candidiasis as well as for the prophylaxis of invasive fungal infections in patients undergoing allogeneic blood and marrow transplantation, for which there have


been limited advances in the last 13 years. It has a characteristic pharmacokinetic profile with a pro- longed half-life and front-loaded plasma exposure which, in contrast to all other echinocandin anti- fungals, we believe allows rezafungin to be devel- oped for once-weekly intravenous therapy for inpatient and outpatient use. The US Food and Drug Administration (FDA)


has designated rezafungin as a Qualified Infectious Disease Product (QIDP) with Fast Track status related to its use in the treatment of candidemia and invasive candidiasis and for pro- phylactic use, and has granted orphan drug desig- nation for the treatment of candidemia and inva- sive candidiasis.


54


Drug Discovery World Winter 2019/20


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