The Taiwan Food and Drug Administration (FDA) has accepted a New Drug Application (NDA) for Everest Medicines’ xerava (eravacycline) to treat complicated intra-abdominal infections (cIAI).
The new fully synthetic fluorocycline intravenous antibiotic, xerava has been developed to use as a first-line empiric monotherapy to treat multidrug resistance (MDR) infections, such as MDR Gram-negative infections.
Currently, it is approved in the UK, US, EU, and Singapore to treat cIAI and is now under review for cIAI treatment in Greater China.
Simultaneously, Everest Medicines has also signed an exclusive partnership deal with TTY Biopharm (TTY) to commercialise Xerava in Taiwan.
Under the terms of the agreement, TTY will handle the commercialisation of the antibiotic in the country.
The deal also includes further ten-year period following the launch of the product in Taiwan along with the option to extend the term.
Everest Medicines CEO Kerry Blanchard said: “The acceptance of our New Drug Application for Xerava and our agreement with TTY are key steps towards bringing this important and novel therapy to Taiwan.
“With a robust organisation that includes expert functions in regulatory, medical, marketing and sales, and a successful record of commercializing other important anti-infective products in the region, TTY was a clear partner of choice as we continue our work to expand the regional reach and access of this critical therapy for patients with complicated intra-abdominal infections and other potentially life-threatening infections.”
In Taiwan, TTY has also led the commercialisation of other new anti-infective products, including Cubicin (daptomycin), Colistin (colimycin), and Brosym (cefoperazone+sulbactam).