infectious disease resistant to multiple drugs

Xerava approval marks the first product to be commercialized by Everest in China Everest plans to commercially launch Xerava in China in Q3, 2023 SHANGHAI, March 16, 2023 /PRNewswire/ -- Everest Medicines (HKEX 1952.HK, "Everest", or the "Company"), a biopharmaceutical company focused on the development, manufacturing and commercialization of innovative medicines and vaccines, announced today that the National Medical Products Administration (NMPA) of China has approved its New Drug Application (NDA) for Xerava (eravacycline) for the treatment of complicated intra-abdominal infections (cIAI) in adult patients. The Company plans to commercially launch Xerava in China in the third quarter this year. "We are very excited to receive NMPA approval for Xerava and launch the product as the first product Everest will commercialize in China," said Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines. "This will lead Everest's transformation from a biotech to a fully-integrated biopharmaceutical company. We expect to have three or more product approvals in 2023-2024, including Nefecon to be approved and commercialized later this year. Together with Xerava, these products will help Everest develop into a full commercial-stage company." "The approval of Xerava by NMPA reinforces the importance of addressing the urgent need for innovative antibiotic treatment options in China as multidrug-resistant bacteria infection continues to pose clinical challenges in China," said Sunny Zhu, Chief Medical Officer for Infectious Diseases at Everest Medicines. "We are encouraged by the continued regulatory success of Xerava across our territories in Asia, demonstrating Everest's superior capabilities to effectively advance innovative treatment options on behalf of patients in need. In the infectious disease space, we have other best-in-class product candidates in the pipeline. We plan to for Taniborbactam in China this year for complicated urinary tract infection and we plan to initiate phase III clinical study in the second half of this year for EVER206, a novel polymyxin derivative with potentially better safety pro to current options. We hope to advance these two drug candidates quickly so that our portfolio of three innovative antibiotics could help address the significant unmet medical needs in China." Xerava has been approved and commercialized in Singapore. It was also approved in Hong Kong and is currently under regulatory review for cIAI in the Taiwan region. Since 2020, Xerava has been recommended in multiple global treatment guidelines issued by Infectious Disease Society of America's (IDSA) and European Society of Clinical Microbiology and Infectious Diseases (ESCMID) as a treatment choice for multi-drug resistant gram-negative bacterial infections including Carbapenem resistant organisms. In addition, it was included in an expert consensus on the multi-disciplinary management of intra-abdominal infections by the Chinese Society of Surgery of Chinese Medical Association, Infectious Diseases Society for Evidence-based and Translational Medicine of Chinese Research Hospital Association and the Editorial Board of Chinese Journal of Surgery. In Feb. 2023, Xerava was also recommended in the Guidelines for the diagnosis, treatment, prevention and control of infections caused by carbapenem-resistant gram-negative bacilli. "Xerava, with a broad bacterial spectrum coverage, shows high antibacterial potency in vitro, and has strong antibacterial activity against major clinical resistant pathogens such as ESBLs, CRE, CRAB, VRE, MRSA, etc.," said Professor Wang Minggui, head of the Institute of Antibiotics at Huashan Hospital affiliated to Fudan University. "Xerava has been recommended by many guidelines in China and abroad, and its domestic launch will definitely help the treatment of resistant pathogens' infections in China." Everest Medicines has exclusive rights to develop and commercialize Xerava in Greater China, South Korea, and certain markets of South East Asia, under a licensing agreement with Tetraphase Pharmaceuticals, Inc. (a wholly owned subsidiary of Innoviva, Inc.). 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, Singapore and Hong Kong and the medicine is currently under review for cIAI in Taiwan region. Xerava was licensed from Tetraphase Pharmaceuticals, Inc., a wholly owned subsidiary of Innoviva, Inc. About Complicated Intra-Abdominal Infections Complicated intra-abdominal infections (cIAI) are 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, manufacturing and commercializing transformative pharmaceutical products and vaccines 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 from both leading global pharmaceutical companies and local Chinese pharmaceutical companies in high-quality discovery, clinical development, regulatory affairs, CMC, business development and operations. Everest Medicines has built a portfolio of potentially global first-in-class or best-in-class molecules in the company's core therapeutic areas of renal diseases, infectious diseases and autoimmune disorders. For more information, please visit its website at . 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. Company Codes: HongKong:1952

Just shy of four months ago, Gilead’s next-gen HIV drug candidate lenacapavir got hit with a CRL over CMC issues involving the type of vials planned for use. Now, the pharma is headed back to the FDA for round two. Gilead announced Monday afternoon that it had refiled its NDA submission filled with new CMC data after the FDA essentially balked at borosilicate glass vials, originally used for the non-oral form of lenacapavir. The drug candidate, which recently won a positive opinion from Europe’s CHMP, is being developed for HIV-1 infection “in heavily treatment-experienced (HTE) people with multi-drug resistant (MDR) HIV-1 infection.” Many companies have run into particulate contamination issues, and this is not the first time Gilead has such a problem on its hands. Just last December, Gilead had to recall two lots of Veklury due to glass contamination issues. Regulators previously slapped a clinical hold on 10 trials — also last December — while studying injectable versions of the experimental HIV-1 capsid inhibitor, due to concerns that vials made of borosilicate glass could lead to the formation of tiny glass particles seeping into the solution. Gilead CMO Merdad Parsey said at the time that “We are committed to working diligently with FDA to resolve this glass vial compatibility quality issue and resume injectable lenacapavir dosing in the affected studies in a timely fashion.” That hold was lifted in May, two months after the drug was initially rejected and after Gilead found a new solution with which the regulatory agency was content. Gilead’s VP of HIV clinical development Jared Baeten said in a statement that “There are people with HIV who have severely limited treatment options due to resistance to multiple antiretroviral therapy classes,” adding that the California company is committed to unmet needs. Baeten tells Endpoints News that Gilead currently has no plans at looking at lenacapavir outside of HIV treatment and prevention. And with the new progress, Gilead has started re-dosing patients in multiple clinical trials for HIV treatment — the basis of Gilead’s NDA, according to Baeten. On top of that, the restarted clinical trials include lenacapavir in participants as a pre-exposure prophylaxis, testing the drug as a method of HIV prevention. As for what makes the resubmitted NDA different from the first, Gilead said in a statement that “the NDA resubmission contains comprehensive CMC data to support the compatibility of lenacapavir with an alternative vial type made from aluminosilicate glass,” plus pre-clinical and clinical data. And now, the company is playing the waiting game to hear what FDA thinks, and whether the changes made are enough for the application to be accepted, analyzed and run through a new, yet-undisclosed PDUFA date. If it gets approved, lenacapavir will be the first HIV-1 capsid inhibitor on the market. Lenacapavir has been billed as Gilead’s next big thing in its HIV arsenal, given the drug’s potential to not only allow dosing just once every six months but block HIV-1 at multiple stages of the virus’s lifecycle and work to both treat and prevent infection. GSK’s ViiV Healthcare is also in the long-acting HIV treatment game, with its pre-prophylaxis injectable cabotegravir being the first HIV treatment to provide an alternative to a once-commonplace daily pill regimen.

June 24, 2022 12:00 UTC – Recommendation is Based on Week 26 Data from the CAPELLA Trial Showing Twice-Yearly Lenacapavir Achieved High Rates of Virologic Suppression in Heavily Treatment-Experienced People with HIV – – If Authorized, Lenacapavir Could Offer a New, Every Six-Month Treatment Option for People with Limited Treatment Choices – FOSTER CITY, Calif.--(BUSINESS WIRE)--Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion for investigational lenacapavir for the treatment of HIV-1 infection, in combination with other antiretroviral(s), in adults with multi-drug resistant HIV-1 infection for whom it is otherwise not possible to construct a suppressive anti-viral regimen. The CHMP positive opinion is a scientific recommendation to the European Commission (EC) to grant marketing authorization in Europe and will be reviewed by the EC, which has the authority to authorize medicines in the 27 Member States of the European Union, as well as Norway, Iceland and Liechtenstein. The final European Commission decision is expected later this year. “Treatment options are extremely limited for people living with HIV whose virus is no longer effectively controlled by their current regimen. We are encouraged by this CHMP positive opinion for lenacapavir, as it is an important step toward a potential new treatment option for individuals with multi-drug resistant HIV,” said Jared Baeten, MD, PhD, Vice President, HIV Clinical Development, Gilead Sciences. “We look forward to the final decision by the European Commission and the potential for lenacapavir to help fill a critical unmet need for persons living with HIV with complex prior treatment histories.” The positive opinion is supported by data from the Phase 2/3 CAPELLA trial, a double-blinded, placebo-controlled global multicenter study designed to evaluate the antiviral activity of lenacapavir administered every six months as a subcutaneous injection, in combination with other antiretroviral(s), in heavily treatment-experienced people with multi-drug resistant HIV-1 infection. In this patient population of high unmet medical need, 81% (n=29/36) of participants receiving lenacapavir in addition to an optimized background regimen achieved an undetectable viral load (<50 copies/mL) at Week 26. Additionally, CAPELLA participants achieved a mean increase in CD4 count of 81 cells/µL. The New England Journal of Medicine published the primary outcome results of the CAPELLA trial in its May 11, 2022 issue - Capsid Inhibition with Lenacapavir in Multidrug-Resistant HIV-1 Infection. Through Week 26, lenacapavir was generally well tolerated, with no serious adverse events related to lenacapavir as determined by the study investigator. The most common adverse events observed in the trial were injection-site reactions. Lenacapavir is an investigational compound and is not approved by any regulatory authority for any use and its safety and efficacy are not established. There is no cure for HIV or AIDS. About Lenacapavir Lenacapavir is Gilead’s potential first-in-class, investigational long-acting HIV-1 capsid inhibitor in development for the treatment of HIV-1 infection. The safety, efficacy and dosing of Gilead’s investigational, long-acting HIV-1 capsid inhibitor lenacapavir are being evaluated in multiple ongoing clinical studies. Lenacapavir's multi-stage mechanism of action is distinguishable from currently approved classes of antiviral agents and is designed to provide a new avenue for the development of long-acting therapy options for people with or at risk for HIV-1. While most antivirals act on just one stage of viral replication, lenacapavir is designed to inhibit HIV-1 at multiple stages of its lifecycle and has no known cross resistance to other existing drug classes. If authorized, lenacapavir would be the only HIV-1 treatment option administered twice yearly. About CAPELLA (NCT04150068) CAPELLA is a Phase 2/3, double-blinded, placebo-controlled global multicenter study designed to evaluate the antiviral activity of lenacapavir administered every six months as a subcutaneous injection in heavily treatment-experienced people with multi-drug resistant HIV-1 infection. CAPELLA includes men and women with HIV-1 and is being conducted at research centers in North America, Europe and Asia. In CAPELLA, 36 participants with multi-class HIV-1 drug resistance and a detectable viral load while on a failing regimen were randomly allocated to receive oral lenacapavir or placebo in a 2:1 ratio for 14 days, in addition to continuing their failing regimen (functional monotherapy). An additional 36 participants were enrolled in a separate treatment cohort. Both cohorts are part of the ongoing maintenance period of the study evaluating the safety and efficacy of subcutaneous lenacapavir administered every six months in combination with an optimized background regimen. The primary endpoint was the proportion of participants randomly allocated to receive lenacapavir or placebo for 14 days, in addition to continuing their failing regimen, achieving ≥0.5 log10 copies/mL reduction from baseline in HIV-1 RNA at the end of the functional monotherapy period. Following the 14-day functional monotherapy period, participants randomly allocated to receive lenacapavir or placebo, in addition to continuing their failing regimen, started open-label lenacapavir and an optimized background regimen, while those enrolled in a separate treatment cohort received open-label lenacapavir and an optimized background regimen on Day 1. This ongoing maintenance period of the study is evaluating the additional trial endpoints of safety and efficacy of subcutaneous lenacapavir administered every six months in combination with an optimized background regimen. For further information, please see . About Gilead Sciences Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. For 35 years, Gilead has been a leading innovator in the field of HIV, driving advances in treatment, prevention and cure research. Gilead researchers have developed 11 HIV medications, including the first single-tablet regimen to treat HIV and the first antiretroviral for pre-exposure prophylaxis (PrEP) to reduce the risk of acquiring HIV infection. These advances in medical research have helped to transform HIV into a preventable, chronic condition for millions of people. Gilead is committed to continued scientific innovation to provide solutions for the evolving needs of people affected by HIV around the world. Through partnerships and collaborations, the company also aims to improve education, expand access and address barriers to care, with the goal of ending the HIV epidemic for everyone, everywhere. Gilead was recognized as the number one philanthropic funder of HIV-related programs in a report released by Funders Concerned About AIDS. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California. Forward-Looking Statements This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including Gilead’s ability to initiate, progress and complete clinical trials involving lenacapavir in the anticipated timelines or at all; the possibility of unfavorable results from ongoing and additional clinical trials involving lenacapavir; uncertainties relating to regulatory applications and related filing and approval timelines, including the risk that the EC may not grant marketing authorization for lenacapavir for the treatment of HIV-1 infection in a timely manner or at all; the risk that any regulatory approvals, if granted, may be subject to significant limitations on use; the possibility that Gilead may make a strategic decision to discontinue development of lenacapavir and as a result, lenacapavir may never be successfully commercialized; and any assumptions underlying any of the foregoing. These and other risks, uncertainties and factors are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2022, as filed with the U.S. Securities and Exchange Commission. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The reader is cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, and is cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation and disclaims any intent to update any such forward-looking statements. GILEAD and the GILEAD logo are trademarks of Gilead Sciences, Inc. All other trademarks are the property of their respective owners. For more information about Gilead, please visit the company’s website at , follow Gilead on Twitter (@Gilead Sciences) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.