Everest Medicines Announces Financial Results for Full Year Ended December 31, 2021


SHANGHAI, March 28, 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, today announced its financial results for full year ended December 31, 2021, along with a corporate progress update.

“Despite a challenging backdrop for the biopharmaceutical industry in 2021, we propelled the Company forward by achieving an impressive number of accomplishments across our business, including fostering key strategic partnerships, expanding its global presence by building teams in South Korea, Singapore, and the Taiwan region, receiving the first of several expected drug approvals for Trodelvy in Singapore and investing in COVID-19 vaccines and therapeutic candidates to address the world’s ongoing public health crisis,” said Kerry Blanchard, MD, PhD, Chief Executive Officer of Everest Medicines.

“As 2022 progresses, we look forward to building on the momentum established last year to position our company for sustained future growth. We will persist in growing our clinical capabilities, pursuing our global expansion strategy and building a commercial-ready biopharmaceutical company in order to provide innovative medicines to patients in need. We will strive to accomplish these goals, committed as always to the highest standards of quality and integrity,” said Blanchard.

Recent Product Highlights and Anticipated Milestones

Sacituzumab govitecan-hziy (Trodelvy™), our anchor drug candidate in the oncology therapeutic area, is a first-in-class TROP-2 directed antibody-drug conjugate (ADC).

  • Clinical and regulatory development achievements during the Reporting Period:

    –  In January 2021, we submitted a New Drug Application (“NDA”) to the Health Sciences Authority (“HSA”) of Singapore for sacituzumab govitecan for the treatment of patients with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease, and the indication was subsequently amended to second-line and later lines metastatic TNBC.

–  In January 2021, the Center of Drug Evaluation (“CDE”) of the China National Medical Products Administration (“NMPA”) approved a China clinical trial application (“CTA”) for sacituzumab govitecan for the treatment of patients with metastatic urothelial cancer (“mUC”).

–  In March 2021, the CDE of the China NMPA approved a CTA for a phase 2 basket trial for a variety of cancers with high TROP-2 expression. The trial is designed to evaluate sacituzumab govitecan monotherapy in 180 patients with relapse/refractory esophageal squamous cell carcinoma, gastric cancer, and cervical cancer at select sites in China.

–  In April 2021, the Company’s partner, Gilead Sciences, Inc. (Gilead), received full approval from the US FDA for Trodelvy for the treatment of adult patients with second-line metastatic triple-negative breast cancer (mTNBC).

–  In April 2021, Gilead received accelerated approval from the US FDA for Trodelvy for the treatment of adult patients with locally advanced or metastatic urothelial cancer (mUC) who have previously received a platinum-containing chemotherapy and either a programmed death receptor-1 (PD-1) or a programmed death-ligand 1 (PD-L1) inhibitor.

–  In May 2021, NMPA accepted the Biologics License Application (“BLA”) for sacituzumab govitecan for the treatment of second-line and later lines metastatic TNBC in adult patients. Following the BLA acceptance, sacituzumab govitecan was granted priority review by the CDE of China NMPA in May 2021.

–  In May 2021, the Ministry of Food and Drug Safety (“MFDS”) of South Korea had granted Fast Track Designation and Orphan Drug Designation to sacituzumab govitecan for the treatment of later line metastatic TNBC.

–  In July 2021, Taiwan Food and Drug Administration (“TDFA”) granted Pediatric and Rare Severe Disease Priority Review Designation for adult patients with second-line metastatic TNBC.

–  In November 2021, the Company announced the topline results of its bridging study, EVER-132-001, a single-arm, multi-center Phase 2b study of sacituzumab govitecan conducted in China on patients with unresectable locally advanced or metastatic TNBC who have received two or more prior systemic therapies, at least one for metastatic disease.

–  In December 2021, MFDS of South Korea accepted the Company’s NDA for sacituzumab govitecan for the treatment of second-line and later lines metastatic TNBC in adult patients.

–  In December 2021, TFDA accepted the NDA submission of sacituzumab govitecan for the treatment of second-line and later lines metastatic TNBC in adult patients.

–  The phase 3 Asia study was ongoing, which is designed to assess and compare the efficacy and safety of sacituzumab govitecan versus treatment of physician’s choice in Asian patients with hormone receptor positive, HER2 negative metastatic breast cancer (“HR+/HER2- mBC”) who have failed at least two prior chemotherapy regimens. The trial will enroll approximately 330 HR+/HER2- mBC patients in Greater China and South Korea. The enrollment of this study is expected to complete enrollment by the first half of 2022.

  • Post-Reporting Period milestones and expected achievements:

 –  In January 2022, the Company announced it will participate in a study pursuant to a clinical trial collaboration between Gilead and Merck & Co., Inc. (MSD) to evaluate the combination of sacituzumab govitecan and MSD’s anti-PD-1 therapy Keytruda® (pembrolizumab) in first-line metastatic non-small cell lung cancer (NSCLC).

–  In January 2022, the HSA of Singapore approved the Company’s NDA for sacituzumab govitecan for the treatment of second-line and later lines metastatic TNBC.

 –  In March 2022, our partner Gilead announced results from the Phase 3 TROPiCS-02 study evaluating Trodelvy in patients with HR+/HER2- mBC who received prior endocrine therapy, CDK4/6 inhibitors and two to four lines of chemotherapy. The study met its primary endpoint with a statistically significant improvement in progression-free survival versus physician’s choice of chemotherapy.

–  We anticipate receiving the BLA decision from China NMPA and NDA decision from the TDFA for sacituzumab govitecan for the treatment of second-line metastatic TNBC in 2022.

Nefecon (TARPEYO™), our anchor drug candidate in cardio-renal therapeutic area, is a novel oral formulation of budesonide (budesonide delayed release capsules) in the development for the treatment of primary immunoglobulin A nephropathy (“IgAN”).

  • Clinical and regulatory development achievements during the Reporting Period:

–  The Company completed the Chinese patient enrollment into the NefIgArd Phase 3 global registrational study evaluating NEFECON as a treatment for primary IgAN.

–  Our partner Calliditas Therapeutics AB, (“Calliditas”) in April, 2021 granted an accelerated assessment procedure on its marketing authorization application (“MAA”) for Nefecon in IgAN and submitted the MAA in May of 2021. In September 2021, Calliditas announced that the European Medicine Agency’s (“EMA”) Committee for Human Medicinal Products (“CHMP”) has decided to continue the assessment of the MAA for Nefecon under standard procedure assessment timelines, with potential conditional approval in second quarter of 2022.

– In December 2021, our partner Calliditas, announced that the US FDA approved TARPEYO (developed under Project name NEFECON) delayed release capsules the first and only treatment indicated to reduce proteinuria in adults with primary IgAN at risk of rapid disease progression.

  • Post-Reporting Period milestones and expected achievements:

–  In March 2022, the Company entered into a license agreement with Calliditas to develop and commercialize NEFECON for the treatment of primary IgAN in South Korea, expanding its license in addition to rights held in Greater China and Singapore.

–  We expect to conduct an interim analysis of the Chinese patients in the global phase 3 NefIgArd study and this is expected to lead to a regulatory submission in China in second half of 2022.

PTX-COVID19-B, a potentially best-in-class lipid nanoparticle-formulated mRNA COVID-19 vaccine with a strong immunogenicity and tolerability profile.

  • Clinical and regulatory development achievements during the Reporting Period:

–  In December 2021, we announced jointly with Providence Therapeutics (“Providence“) that scientists from both companies had analyzed the sequence of the SARS-CoV-2 Omicron variant, selected viral sequences and designed plasmid clones to develop a new version of the COVID-19 vaccine specifically targeting the new Omicron variant.

–  In December 2021, PTX-COVID19-B was selected to be part of a World Health Organization (WHO) Solidarity Trial Vaccines (STV) clinical trial, an international, randomized clinical trial designed to rapidly evaluate the efficacy and safety of promising new candidate vaccines.

  • Post-Reporting Period milestones and expected achievements: 

–  Providence will readout the data for the phase 2 trial of PTX-COVID19-B around mid-2022 and initiate a phase 3 trial for booster indication in mid-2022 as well.

Eravacycline (Xerava™), is a novel, fully synthetic fluorocycline intravenous antibiotic developed for use as first-line empiric monotherapy for the treatment of multidrug resistant (MDR) infections, including MDR Gram-negative infections.

  • Clinical and regulatory development achievements during the Reporting Period:

–  In March 2021 and September 2021 respectively, the China NMPA and the Department of Health of Hong Kong accepted an NDA for eravacycline for the treatment of complicated intra-abdominal infections (cIAI).

–  In August 2021, the CDE of the China NMPA approved the CTA for eravacycline for the treatment of community-acquired bacterial pneumonia (CABP).

  • Post-Reporting Period milestones and expected achievements:

–  We expect NDA approval for eravacycline for the treatment in cIAI in China within 2022.

Other clinical-stage assets

  • Clinical and regulatory development achievements during the Reporting Period:

–  In August 2021, the Phase 1b/2 study evaluating FGF401 in combination with PD-1 inhibitor, pembrolizumab, in patients with advanced solid tumors, such as hepatocellular carcinoma (HCC) reached recommended Phase 2 dose. The trial is ongoing.

 –  In September 2021, we received the approval from the CDE of the China NMPA for the Investigational New Drug application under the Class One category for SPR206 (also known as EVER206), a novel, intravenous next-generation polymyxin product candidate in development for the treatment of MDR Gram-negative bacterial infections.

–  Ralinepag is a potentially best-in-class oral, selective potent, once-daily IP receptor agonist intended for the treatment of…



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