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Everest Medicines Announces Regulatory Update and Strategic Partnership for Xerava™ in Taiwan

2022-08-11 08:00 1721

Taiwan FDA accepts New Drug Application for Xerava for treatment of cIAI

Everest enters into strategic partnership with TTY Biopharm for the commercialization of Xerava in Taiwan

SHANGHAI, Aug. 11, 2022 /PRNewswire/ -- 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, announced today 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).

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 https://www.xerava.com/.

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.

About Everest Medicines

Everest Medicines is a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products that address critical unmet medical needs for patients in Asian markets. The management team of Everest Medicines has deep expertise and an extensive track record of high-quality clinical development, regulatory affairs, CMC, business development and operations both in China and with leading global pharmaceutical companies. Everest Medicines has built a portfolio of eleven potentially global first-in-class or best-in-class molecules, many of which are in late stage clinical development. The Company's therapeutic areas of interest include oncology, autoimmune disorders, cardio-renal diseases and infectious diseases. For more information, please visit its website at www.everestmedicines.com

About TTY Biopharm

Established in 1960, TTY Biopharm Company Limited, a publicly listed pharmaceutical company, has transformed in the last sixty years from a production- and sales-oriented generic manufacturing factory into a development- and marketing-focused company of branded generics. With unending self-renovation and transformation, TTY is utilizing the experience, technology, and relationship network accumulated over the decades to redefine itself as a biotech company focusing on developing special formulations and novel drugs. Its mission is to improve the quality of human life with scientific innovation. Additional information can be found at http://eng.tty.com.tw/.

Forward-Looking Statements

This news release may make statements that constitute forward-looking statements, including descriptions regarding the intent, belief or current expectations of the Company or its officers with respect to the business operations and financial condition of the Company, which can be identified by terminology such as "will," "expects," "anticipates," "future," "intends," "plans," "believes," "estimates," "confident" and similar statements. Such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, or other factors, some of which are beyond the control of the Company and are unforeseeable. Therefore, the actual results may differ from those in the forward-looking statements as a result of various factors and assumptions, such as future changes and developments in our business, competitive environment, political, economic, legal and social conditions. The Company or any of its affiliates, directors, officers, advisors or representatives has no obligation and does not undertake to revise forward-looking statements to reflect new information, future events or circumstances after the date of this news release, except as required by law.

Source: Everest Medicines
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