On August 10, 2022 Everest Medicines (HKEX 1952.HK, "Everest", or the "Company"), a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products to address critical unmet needs in Asia Pacific markets, reported that the Taiwan Food and Drug Administration (TFDA) has accepted the submission of a New Drug Application (NDA) for Xerava (eravacycline) for the treatment of complicated intra-abdominal infections (cIAI) (Press release, Everest Medicines, AUG 10, 2022, View Source [SID1234618070]).
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In addition, the Company has entered into an exclusive partnership agreement with TTY Biopharm (TTY) for commercialization of Xerava in Taiwan. TTY is one of the largest local pharmaceutical companies in Taiwan and has led the successful commercialization of other novel anti-infective products in the region, such as Brosym (cefoperazone+sulbactam), Colistin (colimycin) and Cubicin (daptomycin).
"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," said Kerry Blanchard, MD, PhD, Chief Executive Officer of Everest Medicines. "With a robust organization 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."
"TTY Biopharm has been dedicated in the fields of cancer and critical care for many years. It is not only being one of the top pharmaceutical companies in Taiwan, but also focuses on international marketing. Through this partnership, TTY may provide more options and better solutions to both patients and medical professionals in the near future," said Sara Hou, Chief Executive Officer of TTY Biopharm.
Under the partnership, which includes a 10-year term upon the launch of Xerava in Taiwan with possibility of extension, TTY will be responsible for all commercialization of the product in Taiwan.
Everest Medicines has exclusive rights to develop and commercialize Xerava in Greater China, South Korea, and the key markets of South East Asia, under a licensing agreement with Tetraphase Pharmaceuticals (a wholly owned subsidiary of La Jolla Pharmaceutical Company). Xerava was approved for the treatment of cIAI in adults in Singapore in April 2020 and is currently under regulatory review for cIAI in mainland China and the Hong Kong region.
About Xerava (eravacycline)
Xerava (eravacycline) is a novel, fully synthetic, broad-spectrum, fluorocycline, parenteral antibiotic of the tetracycline class that has shown broad in vitro activity against Gram-negative and Gram-positive pathogens that have acquired multidrug resistance (MDR) and are prevalent in China. Xerava is currently approved for the treatment of complicated intra-abdominal infections (cIAI) in the US, EU, UK and Singapore and the medicine is currently under review for cIAI in Greater China. Everest is also developing Xerava for the treatment of community-acquired bacterial pneumonia (CABP). Xerava was licensed from Tetraphase Pharmaceuticals, a wholly owned subsidiary of La Jolla Pharmaceutical Company. For more information, please visit View Source
About Complicated Intra-Abdominal Infections
Complicated intra-abdominal infections (cIAI) is a type of major hospital- or community-acquired infection which extend beyond the source organ into the peritoneal space and can result from perforation of or damage to the gastrointestinal tract. cIAI diagnoses include intra-abdominal abscess, stomach or intestinal perforation, peritonitis, appendicitis, cholecystitis, or diverticulitis. cIAI is caused by different bacterial pathogens, including Gram-negative aerobic bacteria, Gram-positive bacteria, and anaerobic bacteria. In 2018, there were 2.9 million cIAI patients in China alone, with increasing rates of infections caused by drug-resistant bacteria, which limits the effectiveness of currently available antibiotics.