Everest Medicines Announces Interim Results for First Half of 2023
Thursday, 24 August 2023
Shanghai, China – August 24, 2023 – Everest Medicines (HKEX 1952.HK, “Everest”, or the "Company"), a biopharmaceutical company focused on the development, manufacturing and commercialization of innovative medicines and vaccines, today announced its interim results for the first half of 2023, along with a corporate update.
“We are pleased to have achieved a number of critical milestones during the first half of 2023, propelling Everest to a commercial stage biopharma,” commented Rogers Yongqing Luo, CEO of Everest Medicines. “At the end of July, we successfully took the critical step of launching our first therapeutic drug in China, Xerava®, which is the world's first fluocycline antibiotic for the treatment of multi-drug resistant infections. To support Xerava’s launch, we have built a lean and efficient commercial team of highly experienced professionals, which we will gradually scale up as we prepare for additional product debuts. Over the next 18-24 months, we expect to have three additional products approved in China.”
“Being one of very few biotech companies with a substantial lineup of products prepared for launch over the next two years clearly demonstrates our expertise in selecting and commercializing promising drug candidates. We expect to receive NDA approvals from both China and Singapore in the second half of 2023 for Nefecon®, our first-in-disease treatment for adults with primary immunoglobulin A nephropathy (IgAN) and launch Nefecon® broadly in China in early 2024. We will also continue to broaden our product pipeline through our dual approach of in-licensing and internal discovery, targeting underserved conditions and areas of high unmet need with innovative and differentiated therapies. Through a series of measures to improve operational efficiency and restructure our strategic focus, we have significantly reduced expenses across different functions and narrowed net loss in the first six months of this year by more than a third compared to a year ago. This will allow Everest to continue to generate value for our stakeholders and shareholders,” said Mr. Luo.
*Recent Product Highlights and Anticipated Milestones*
*INFECTIOUS DISEASE PORTFOLIO*
*Eravacycline (Xerava®), *is the world’s first Fluorocycline antibiotic for the treatment of infections caused by gram negative, gram positive and anaerobic pathogens including multidrug-resistant (“MDR”) isolates. Its current approved indication is cIAI in adult patients.
· Achievements during the Reporting Period:
- On March 16, 2023, the Company announced that China’s NMPA approved its NDA for Xerava® in the treatment of cIAI in adult patients, marking it the first product to be commercialized by the Company in China.
· Post-Reporting Period achievements and expected milestones:
- On July 26, 2023, Xerava® was successfully launched in China with its first prescriptions issued at Huashan Hospital affiliated to Fudan University. The commercialization of Xerava® in China marks the Company’s transformation into a commercial-stage innovative biopharmaceutical company.
- We expect NDA approval for eravacycline for the treatment of cIAI in the Taiwan region in 2023.
*Taniborbactam* is a beta-lactamase inhibitor (“BLI”) that, in combination with cefepime, may offer a potential treatment option for patients with serious bacterial infections caused by difficult-to-treat resistant gram-negative bacteria, most notably carbapenem-resistant Enterobacterales (“CRE”) and carbapenem-resistant Pseudomonas aeruginosa (“CRPA”).
· Post-Reporting Period achievements and expected milestones:
- On 15 August 2023, our partner Venatorx Pharmaceuticals announced that the US FDA has accepted the NDA for cefepime-taniborbactam, an investigational beta-lactam/beta-lactamase inhibitor (BL/BLI) antibiotic for the potential treatment of adult patients with complicated urinary tract infections(“cUTI”), including pyelonephritis. The FDA has granted priority review of the NDA with a Prescription Drug User Fee Act (“PDUFA”) target action date of February 22, 2024.
*EVER206 (also known as SPR206)*, is a potentially best-in-class, novel polymyxin derivative designed to reduce toxicity, especially nephrotoxicity, compared to levels observed clinically with polymyxin B and colistin.
· Achievements during the Reporting Period:
- On January 18, 2023, the Company announced topline results from a China phase 1 study on healthy subjects demonstrating that EVER206 is well-tolerated with no evidence of acute kidney injury and no new safety signals on healthy subjects with dose ranges applied in the study. The pharmacokinetics of healthy subjects in China were comparable to the results of the overseas phase I study (SPR206-101) and the safety profile was also similar to the results from the overseas Phase I trial, supporting the Company’s plans to initiate next-phase clinical development in China.
* *
*RENAL PORTFOLIO*
*Nefecon®*, our anchor drug candidate in the renal therapeutic area, is a patented oral, delayed release formulation of budesonide in development for the treatment of IgAN.
· Achievements during the Reporting Period:
- On February 10, 2023, South Korea’s Ministry of Food and Drug Safety (“MFDS”) granted Global Innovative product on Fast Track (“GIFT”) designation to Nefecon® for the treatment of primary IgAN. South Korea’s GIFT program was launched in September 2022 to further accelerate review timeframes, especially for groundbreaking products. Nefecon® is the second product overall and the first non-oncology product included in MFDS’s GIFT program. Inclusion in the GIFT program is expected to accelerate regulatory review time by 25% and allow for rolling review.
- On March 12, 2023, our partner Calliditas Therapeutics AB (“Calliditas”) reported positive topline results from a Phase 3 NefIgArd Trial evaluating Nefecon® in the treatment of IgAN. The trial met its primary endpoint with Nefecon® demonstrating a highly statistically significant benefit over placebo (p value
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