SHANGHAI, China, March 17, 2020 (GLOBE NEWSWIRE) -- Everest Medicines, a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products that address critical unmet medical needs for patients in Greater China and other parts of Asia, announced today the formation of a strategic partnership with Jiashan National Economic and Technological Development Zone and Jiashan SDIC.
Under the terms of the agreement, Everest Medicines, a company established to develop, manufacture and commercialize innovative drugs in oncology, infectious diseases, cardio-renal diseases and autoimmune diseases, will place its China holding company and global manufacturing site in Jiashan National Economic and Technological Development Zone. Jiashan SDIC will invest US $100 million in Everest Medicines to support several clinical trials for registration and to build good manufacturing practice (GMP) manufacturing and good storage practice (GSP) facilities in the Jiashan National Economic and Technological Development Zone.
Everest will initiate activities in Jiashan in 2020 and will build manufacturing capabilities that comply with US Food and Drug Administration and European Medicines Agency standards to meet both demands in Asia and in the global market. Jiashan is a county in Zhejiang Province that borders Shanghai and allows easy access to downtown Shanghai.
“This partnership with Jiashan will help Everest Medicines meet the growing demand for innovative medicines in China and Asia,” said Neo Zhang, COO of Everest Medicines. “In 2018 the Integrated Development of Yangtze River Delta was highlighted as one of China’s national strategies designed to foster the development of a number of world-class industrial clusters and build the area into a key national innovation hub by 2025. Jiashan is at the forefront of this integration and has established itself as an innovation-driven industrial ecosystem where Everest Medicines can enjoy efficient local manufacturing and research and development. The close proximity to Shanghai is also a great advantage in terms of attracting talent.”
Kerry Blanchard, PhD, MD, CEO of Everest Medicines, said, “Innovative medicines are rapidly becoming a mainstay of Chinese and Asian healthcare. We have built a solid foundation for development and commercialization of our innovative medicines. The establishment of our China holding company in Jiashan strengthens Everest Medicines by providing us the opportunity to manufacture world-class medicines in China.”
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 Greater China and other 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 eight global potentially first in class or best in class molecules, many of which are in late stage clinical development. Our therapeutic areas of interest include oncology, autoimmune disorders, cardio-renal diseases and infectious diseases. Currently four assets are in clinical trials designed for registration in China and two additional assets will start registrational trials in 2020.
About Our Assets
Ralinepag XR is a potential best in class extended release agonist of the IP receptor with improved drug like properties that allow convenient oral dosing. It mimics the action of natural prostacyclins by inducing vasodilation and by blocking platelet aggregation. This class of medicines has been shown to reduce the mortality of pulmonary arterial hypertension (PAH). We are currently enrolling patients in a global registration trial in PAH in collaboration with United Therapeutics.
Etrasimod is a potential best in class oral modulator of the sphingosine 1-phosphate (S1PR) receptor that has improved selectivity and specificity for S1PR1, 4 and 5. Etrasimod induces immunomodulation by trapping lymphocytes in peripheral lymph nodes and blocking their egress into disease sites. The key disease indications for etrasimod include autoimmune diseases such as ulcerative colitis, Crohn’s disease and autoimmune skin disorders. Everest Medicines has initiated a phase 3 registration trial in China based on the positive results of a phase 2 trial performed by our partner, Arena Pharmaceuticals.
Eravacycline is a parenteral, potential best in class, novel, synthetic tetracycline analog that blocks bacterial protein synthesis by binding to the 30S ribosomal subunit. Eravacycline has shown broad in vitro activity against Enterobacteriaceae and Acinetobacter, Gram-negative pathogens that have acquired multidrug resistance (MDR) and are prevalent in China. Everest Medicines initiated a pivotal trial in China for patients with complicated intraabdominal infections (cIAI) in mid 2019. Eravacycline was licensed from Tetraphase Pharmaceuticals.
VNRX5133 is a parenteral, potential best in class, cyclic boronate compound that inhibits both serine and metallo- ß-lactamases. It is combined with cefepime, a 4th generation cephalosporin antibiotic and drives antimicrobial activity against gram-negative bacteria that have acquired MDR via class A, B, C and D ß-lactamase expression. VNRX5133 is the only ß-lactamase inhibitor that blocks class B carbapenemases. Everest Medicines has joined a global phase 3 clinical trial for patients with complicated urinary tract infecetions (cUTI) with our partner VenatoRx Pharmaceutical in 2019.
IMMU132, sacituzumab govitecan, is an antibody–drug conjugate (ADC) that links SN38, the active metabolite of irinotecan, via a cleavable linker to a humanized monoclonal antibody against the human trophoblast cell-surface antigen 2 (TROP-2). TROP2 is a membrane antigen that is frequently over-expressed in many common epithelial cancers. Sacituzumab govitecan delivers high concentrations of the SN38 payload to tumors. Immunomedics, our partner, has been granted break through therapy designation for sacituzumab govitecan by the US FDA and submitted their BLA for 3rd line metastatic triple negative breast cancer (mTNBC) in December 2019. The IND for sacituzumab govitecan in China was accepted by the NMPA in December 2019 and Everest Medicines intends to initiate a pivotal bridging study in 3rd line mTNBC in the first half of 2020.
Nefecon is a potential first in disease product for the treatment of IgA nephropathy, a common cause of glomerulonephritis and chronic kidney disease (CKD) in China. Nefecon is an oral, targeted-release formulation of budesonide, a potent glucocorticoid with an established safety and efficacy profile. The novel formulation delivers the glucocorticoid specifically to the terminal small bowel, a site of production of the offending IgA antibody. Nefecon blocks the formation of the abnormal IgA in the Peyer’s patches and in a phase 2B clinical trial by our partner, Calliditas Therapeutics, reduced proteinuria and stabilized kidney function. Everest Medicines will join the global phase 3 registration trial that began in November 2018.
FGF401 is a potential first in class, ATP-competitive, reversible-covalent inhibitor of FGFR4 for which Everest Medicines obtained global commercial rights from Novartis. Due to specific protein sequence requirements for covalent binding FGF401 does not inhibit other members of the FGFR family or other kinases. FGFR4 is activated by FGF19 and controls bile acid synthesis in the liver. In a murine models ecotopic expression of FGF19 leads to hepatocellular carcinoma (HCC) formation in a high fraction of animals. In humans about 25% of HCC patients aberrantly express FGF19 leading to activation of the FGFR4 signaling pathway, which appears to provide both cell growth and survival signals. The FGF19 gene is located in a genomic region that is frequently focally amplified in a variety of cancers including HCC. FGF401 has undergone a dose escalation study and a phase 1b study in cancer patients and demonstrated single agent responses in HCC patients. The IND for a phase 1b/2 trial in China in patients with HCC was approved in March 2020. China suffers about 365000 incident cases of liver cancer and about 319000 deaths from liver cancer each year.
SPR206 is a potential best in class, novel polymyxin derivative that was designed to reduce the kidney toxicity that is seen clinically with polymyxin B and colistin. Polymyxins bind to the lipopolysaccharides in the outer membrane of gram-negative bacteria leading to derangement and increased permeability of the bacterial cell wall. Polymyxins are last resort antibiotics for MDR gram-negative infections but have significant neurotoxicity and nephrotoxicity. SPR206 inhibits gram-negative pathogens in vitro with high potency and is highly active against Acinetobacter baumannii, one of the more common MDR gram-negative pathogens in China. SPR206 was licensed from Spero Therapeutics and is currently being studied in a phase 1 single ascending dose and multiple ascending dose human clinical trial.
For more information, please visit www.everestmedicines.com.
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