• Sinovant’s partner Nabriva Therapeutics Receives U.S. FDA Approval of Lefamulin to Treat Community-Acquired Bacteria Pneumonia (CABP)

    2019-08-19 First New IV and Oral Antibiotic with a Novel Mechanism of Action Approved in Nearly Two Decades Provides Critically Needed Treatment Option for Adult Patients with CABP Aug. 19, 2019 – Sinovant’s partner Nabriva Therapeutics plc (NASDAQ: NBRV), announced today that the U.S. Food and Drug Administration (FDA) has approved Nabriva’s new drug applications for the oral and intravenous (IV) formulations for the treatment of community-acquired bacterial pneumonia (CABP) in adults. As the first IV and oral antibiotic with a novel mechanism of action approved by the FDA in nearly two decades, lefamulin represents an important new empiric monotherapy treatment option for adults with CABP. Both the IV and oral formulations of lefamulin were granted Qualified Infectious Disease Product (QIDP) and Fast Track designation by the FDA. The FDA approval was based on a clinical development program supported by a robust data package, including two pivotal, Phase 3 trials (known as LEAP 1 and LEAP 2). Both trials showed comparable efficacy with moxifloxacin and generally well tolerated safety. CABP is one of the common infectious disease threatening public health. Widespread use of antibiotics has created high resistance to common first line antibiotics among causative pathogens, and industry estimates suggest there are as many as 18 million new cases of CABP each year in China1,2. “With the growing threat of antimicrobial resistance,” said Dr. Rae Yuan, President of Sinovant. “it is urgent to develop a new antibiotic with high targeted spectrum of activity, novel mechanism of action, low propensity for the development of resistance and cross-resistance and convenience for clinical use, so as to provide new and effective treatment for CABP. Sinovant Sciences has an exclusive license to develop and commercialize lefamulin (SNV001) in Greater China region. The Chinese clinical trial application is approved by the National Medical Products Administration, and expected to be initiated on Q4 2019. “We are thrilled about Lefamulin's approval in the United States!” said Dr. Xinan Chen, Executive Chairman of Sinovant. “We look forward to bringing this fist-in-class innovative product to China as soon as possible, to connect Chinese patients with the benefit of global drug innovation.” About Sinovant Sinovant Sciences is an innovative biopharmaceutical company based in Shanghai, China Sinovant is uniquely positioned to bring cutting-edge global medical innovation to China, and transformative Chinese medical innovation to the world. 1Pereyre S et al. Front Microbiol 2016; 7:974 2Leerink Partners research
  • China National Medical Products Administration Approves Sinovant’s Clinical Trial Application for Lefamulin

    2019-06-14 Chinese registrational clinical trial for lefamulin to begin in 2H 2019 BEIJING and SHANGHAI, June 14, 2019 /PRNewswire/ Sinovant Sciences today announced that its Clinical Trial Application (CTA) for lefamulin has been accepted by the Center for Drug Evaluation at the China National Medical Products Administration (NMPA), enabling the initiation of registrational clinical trials for patients with community-acquired bacterial pneumonia (CABP) in the second half of 2019. “The approval of our CTA for lefamulin is a significant moment in the field of antibiotics in China,” said Dr. Rae Yuan, President of Sinovant. “High rates of resistance to existing antibiotics, particularly among the pathogens responsible for CABP, reduce the efficacy of historic first-line therapeutics and compromise millions of patients’ chances of recovery. With its differentiated and novel mechanism of action, lefamulin has the potential to become a preferred first-line empiric monotherapy for CABP, and we are eager to deliver this important new medicine to Chinese patients.” Lefamulin is a novel antibiotic of the pleuromutilin class being developed as a potential treatment for community-acquired bacterial pneumonia (CABP). CABP is one of the leading causes of mortality in China. “This CTA approval is an exciting moment for us,” said Dr. Xinan Chen, Executive Chairman of Sinovant. “We are looking forward to embarking on the next chapter for Sinovant as we advance lefamulin into the clinic.” About Lefamulin Lefamulin is a semi-synthetic pleuromutilin antibiotic which works by selectively inhibiting translation of bacterial protein synthesis. In pre-clinical studies, lefamulin has demonstrated a targeted spectrum of activity against the pathogens that most commonly cause CABP, including multi-drug resistant strains. Due to its novel mechanism of action, low incidence of cross-resistance between other antibacterial agents commonly used to treat CABP, and low propensity for bacterial resistance to develop1, lefamulin has the potential to be used as a first-line empiric monotherapy for the treatment of CABP. Sinovant’s partner Nabriva has completed two global Phase 3 studies of lefamulin in patients with moderate and severe CABP. In both studies, lefamulin was demonstrated to be non-inferior to moxifloxacin, and met both the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) primary and secondary efficacy endpoints for the treatment of CABP. Lefamulin was also shown to be generally well-tolerated when administered either orally or intravenously. New Drug Applications (NDAs) and a Marketing Authorization Application (MAA) for both the oral and intravenous formulations of lefamulin were submitted to the US FDA, and the European Medicines Agency (EMA) in the fourth quarter of 2018 and the second quarter of 2019, respectively. Both NDAs have been granted priority review and the Prescription Drug User Fee Act (PDUFA) goal date for the completion of the FDA’s review is August 19, 2019. About Community-Acquired Bacterial Pneumonia Widespread use of antibiotics has created high resistance to common first line antibiotics among causative pathogens, and industry estimates suggest there are as many as 18 million new cases of CABP each year in China.2,3 About Sinovant Sinovant is a Chinese biopharmaceutical company dedicated to conducting globally innovative biomedical R&D inChinato meet the needs of patients inGreater Chinaand around the world. Sinovant's mission is to develop and commercialize new medicines that address the most pressing public health challenges inChinawhile simultaneously advancing Chinese biopharmaceutical research abroad. For further information, please visit: www.sinovant.com 1 Veve MP, Wagner JL. Pharmacotherapy 2018; 38(9):935-946 2 Pereyre S et al. Front Microbiol 2016; 7:974 3 Leerink Partners research Contact Qi Gu Tel: +86-10-59407070-113 Email:qi.gu@sinovant.com
  • China National Medical Products Administration Approves Sinovant’s Clinical Trial Application for Derazantinib

    2019-04-29 Chinese registrational clinical trial for derazantinib to begin in 2H 2019 BEIJING and SHANGHAI, April 29, 2019 /PRNewswire/ -- Sinovant Sciences today announced that its Clinical Trial Application (CTA) for derazantinib has been accepted by the Center for Drug Evaluation at the China National Medical Products Administration (NMPA), enabling the initiation of a registrational clinical trial in patients with second-line intrahepatic cholangiocarcinoma (iCCA) in the second half of 2019. “iCCA is one of the greatest unmet needs in oncology, particularly in China,” said Dr. Rae Yuan, President of Sinovant. “Patients in the second-line setting are poorly served by existing treatment options, none of which meaningfully extend survival or reduce disease burden. Derazantinib has the potential to be the first approved treatment in China for this devastating disease state, and we look forward to begin enrolling patients in our registrational program later this year.” Derazantinib is an oral pan-FGFR (fibroblast growth factor receptor) inhibitor being developed as a potential treatment for iCCA and other tumor types with high rates of FGFR mutation. The People's Republic of China has one of the world's highest incidence rates of iCCA. “We are very pleased by the approval of this CTA, which brings Sinovant a step closer to delivering derazantinib to Chinese patients,” said Dr. Xinan Chen, Executive Chairman of Sinovant. “Sinovant’s advancement of derazantinib for patients with iCCA underscores our commitment to addressing major public health priorities in China.” About Derazantinib Derazantinib is a potent, orally administered inhibitor of the fibroblast growth factor receptor (FGFR) family, a key driver of cell proliferation, differentiation, and migration. In a Phase 1/2 study in patients with iCCA harboring FGFR2 gene fusions, treatment with derazantinib resulted in an objective response rate of 21%, nearly 3 times higher than standard-of-care chemotherapy.Sinovant’s partner Basileais conducting a similar global registrational study of derazantinib in American and European patients with FGFR2 fusion-positive second-line iCCA. More information on that program is availablehere. About Intrahepatic Cholangiocarcinoma Cholangiocarcinoma (CCA) is the most common biliary malignancy and the second most common malignancy in the liver after hepatocellular carcinoma (HCC).1Depending on the anatomic location, CCA is classified as intrahepatic (iCCA), perihilar (pCCA), and extrahepatic (eCCA). iCCA originates from the intrahepatic biliary ductal system and forms an intrahepatic mass. iCCA is an aggressive cancer, with a median 5-year survival rate of only 15% for patients diagnosed with early-stage disease.2 Reports show that, in China’s most populous cities, the incidence of cholangiocarcinoma is more than 7 cases per 100,000 people, and a majority of cases are intrahepatic.3 About Sinovant Sinovant is a Chinese biopharmaceutical company dedicated to conducting globally innovative biomedical R&D inChinato meet the needs of patients inGreater Chinaand around the world. Sinovant's mission is to develop and commercialize new medicines that address the most pressing public health challenges inChinawhile simultaneously advancing Chinese biopharmaceutical research abroad. For further information, please visitwww.sinovant.com. 1Welzel TM, et al. Impact of classification of hilar cholangiocarcinomas (Klatskin tumors) on the incidence of intra- and extrahepatic cholangiocarcinoma inthe United States.Journal of the National Cancer Institute2006; 98(12), 873-875. 2American Cancer Society 3Banales JM, et al. Cholangiocarcinoma: current knowledge and future perspectives consensus statement from theEuropean Network for the Studyof Cholangiocarcinoma (ENS-CCA).Nature Reviews: Gastroenterology & Hepatology2016; 13, 261-280. Contact Qi Gu Tel: +86-10-59407085 Email:qi.gu@sinovant.com
  • Sinovant and Roivant Launch Cytovant Sciences in Partnership with Medigene to Develop Cellular Therapies in Asia

    2019-04-04 Cytovant licenses East Asian rights for a research-stage T-cell receptor (TCR) against tumor antigen NY-ESO-1 as well as rights for Medigene’s dendritic cell (DC) vaccine for the treatment of patients across East Asia Cytovant and Medigene to collaborate on research and discovery of two additional TCRs tailored for patients in East Asia Medigene receives an upfront payment of USD 10 million as well as potential development, regulatory, and commercial milestones and low double-digit royalties John Xu, PhD, former President and Chief Scientific Officer of Mab-Legend Biotech, named President of Cytovant Hong Kong and Martinsried/Munich, April 4, 2019 /PRNewswire/—Sinovant Sciences and Roivant Sciences today announced the launch of Cytovant Sciences, a biopharmaceutical company focused on developing and commercializing innovative cellular therapeutics in Asia. Cytovant will focus on development programs that have the potential to transform the treatment of diseases that are prevalent in Asian patients. Concurrent with the company’s launch, Cytovant has entered into a multi-program license and collaboration agreement with Medigene AG, a clinical stage biotechnology company focusing on the development of T cell immunotherapies. Medigene has granted Cytovant exclusive licenses to develop, manufacture, and commercialize Medigene’s research-stage T cell immunotherapy targeting NY-ESO-1 as well as a DC vaccine targeting WT-1 and PRAME, in Greater China, South Korea, and Japan. In addition, Cytovant and Medigene have entered into a strategic collaboration and discovery agreement for T-cell receptor (TCR) immunotherapies for two additional targets. Medigene will be responsible for the generation and delivery of the TCR constructs using its proprietary TCR discovery and isolation platform. Following this research collaboration period, Cytovant will assume sole responsibility for the development and commercialization of these TCR therapies in the relevant countries. The TCRs to be generated by Medigene will be tailored specifically to Asian patients. Under the terms of the transaction agreements, Medigene will receive an overall upfront payment of USD 10 million as well as potential development, regulatory, and commercial milestone payments which in aggregate could total over USD 1 billion for the four products across multiple indications. Furthermore, Medigene will be eligible to receive royalty payments on net sales of the products in a low double-digit percentage in the relevant countries. Additionally, Cytovant will reimburse all R&D costs incurred by Medigene within the collaboration. “T cell receptors are the scouts of the immune system,” said Prof. Dolores Schendel, CEO/CSO of Medigene. “They help T cells recognize and destroy cancer cells. We use our sophisticated screening systems to generate tailored TCR therapies for patient populations with specific genetic characteristics. This partnership implements Medigene’s strategy to discover TCRs with various HLA specificities in order to address different populations and markets. Cytovant, with its highly experienced management and scientific team was launched by Sinovant and Roivant to achieve excellence in cell therapies and we are proud to be part of this story of delivering various TCR projects as well as our DC vaccine for development in East Asia.” “The complexities of end-to-end cell therapy manufacturing, development, and commercialization in Asia require regional focus, specialization, and knowledge,” said Benjamin Zimmer, President of Roivant Health. “Roivant and Sinovant have built Cytovant precisely to address these scientific and logistical complexities. We are excited to announce this strategic alliance with Medigene, one of the leading companies in the field of T cell-based therapies, to deliver important new cellular immunotherapies to Asian patients as quickly as possible.” Dr. John Xu, a molecular immunologist by training and translational scientist, has joined Cytovant and will serve as the company’s President. Prior to joining Cytovant, Dr. Xu was President and Chief Scientific Officer of Mab-Legend Biotech, a Shanghai-based antibody discovery company. Previously, Dr. Xu also served as Chief Scientific Officer of Shanghai Benemae Pharmaceutical Corporation and as Head of the Biologics Group at GSK China. He received his B.S. in cell biology and genetics from Peking University and his Ph.D. in biochemistry and molecular biology from Harvard University. “We are thrilled to welcome John to Cytovant,” said Dr. Xinan Chen, Executive Chairman of Sinovant. “John’s deep scientific expertise and knowledge of Asia’s health priorities make him an ideal leader for the company as we prepare to rapidly scale its research and development activities. The launch of Cytovant represents an important milestone in Sinovant’s evolution as a platform for entrepreneurs like John and we look forward to building Cytovant with him.” About Cytovant Cytovant is a clinical-stage biopharmaceutical company focused on developing innovative cellular therapeutics in Asia. Cytovant’s mission is to become Asia’s premier cell therapy company by discovering, developing, and commercializing new medicines that are uniquely suited to Asian patients. About Sinovant Sinovant is a Chinese biopharmaceutical company dedicated to conducting globally innovative biomedical R&D inChinato meet the needs of patients inGreater Chinaand around the world. Sinovant’s mission is to develop and commercialize new medicines that address the most pressing public health challenges inChinawhile simultaneously advancing Chinese biopharmaceutical research abroad. For further information, please visit: www.sinovant.com. About Roivant Roivant aims to improve health by rapidly delivering innovative medicines and technologies to patients. We do this by building Vants – nimble, entrepreneurial biotech and healthcare technology companies with a unique approach to sourcing talent, aligning incentives, and deploying technology to drive greater efficiency in R&D and commercialization. For more information, please visit: www.roivant.com. About Medigene Medigene AG (FSE: MDG1, ISIN DE000A1X3W00, Prime Standard) is a publicly listed biotechnology company headquartered in Martinsried near Munich, Germany. The company is developing highly innovative immunotherapies to target various forms and stages of cancer. Medigene concentrates on the development of personalized T cell-based therapies with the focus on T cell receptor-modified T cells (TCR-Ts) and has projects currently in preclinical and clinical development. For more information, please visit: www.medigene.com. Contractual parties to the agreement are Medigene Immunotherapies GmbH, a wholly owned affiliate of Medigene AG, and Roivant Asia Cell Therapy Holdings Ltd., a wholly owned subsidiary of Roivant Sciences Ltd. Forward-Looking Statements This press release contains forward-looking statements representing the opinion of Medigene as of the date of this release. The actual results achieved by Medigene may differ significantly from the forward-looking statements made herein. Medigene is not bound to update any of these forward-looking statements. Medigene® is a registered trademark of Medigene AG. This trademark may be owned or licensed in select locations only. Contacts: Sinovant Sciences Qi Gu Tel: +86-10-59407085 Email:qi.gu@sinovant.com Roivant Sciences Paul Davis Tel: +1 (646) 495-5310 Email:paul.davis@roivant.com Medigene AG Julia Hofmann, Dr. Robert Mayer Tel.: +49 – 89 – 20 00 33 – 33 01 Email:investor@medigene.com
  • Sinovant Sciences to Present at the 37th Annual J.P. Morgan Healthcare Conference

    2019-01-02 SHANGHAI and BEIJING,Jan. 2, 2019/PRNewswire/ --Sinovant Sciences today announced that Dr.Xinan Chen, Executive Chairman, and Dr.Rae Yuan, President, will present an overview of the business at the 37th Annual J.P. Morgan Healthcare Conference inSan Francisco, CA. The company's presentation is scheduled to begin at8:30 a.m. Pacific TimeonJanuary 10, 2019at the Westin St. Francis. About Sinovant Sinovant is a Chinese biopharmaceutical company dedicated to conducting globally innovative biomedical R&D inChinato meet the needs of patients inGreater Chinaand around the world. Sinovant's mission is to develop and commercialize new medicines that address the most pressing public health challenges inChinawhile simultaneously advancing Chinese biopharmaceutical research abroad. For further information, please visit www.sinovant.com.
  • Sinovant Partner Nabriva Therapeutics Submits New Drug Applications to U.S. Food and Drug Administration for Intravenous and Oral Lefamulin to Treat Community -Acquired Bacterial Pneumonia in Adults

    2018-12-20 DUBLIN, Ireland, Dec. 20, 2018 (GLOBE NEWSWIRE) -- Nabriva Therapeutics plc (NASDAQ: NBRV), a clinical-stage biopharmaceutical company engaged in the research and development of innovative anti-infective agents to treat serious infections, announced the submission of two New Drug Applications (NDAs) to the U.S. Food and Drug Administration (FDA) for the oral and intravenous (IV) formulations of lefamulin, a first-in-class, semi-synthetic pleuromutilin antibiotic, for the treatment of community-acquired bacterial pneumonia (CABP). Both formulations of lefamulin were granted Qualified Infectious Disease Product and Fast Track designation by the FDA, enabling potential Priority Review of the NDAs by the FDA. Nabriva Therapeutics plans to submit a marketing authorization application for lefamulin in Europe in the first quarter of 2019. “The submission of the lefamulin NDAs marks another major milestone for Nabriva Therapeutics, demonstrating our commitment to develop novel anti-infective agents that address the urgent, unmet medical need faced by patients with serious infections,” said Dr. Jennifer Schranz, chief medical officer of Nabriva Therapeutics. “Together with our CONTEPO™ NDA submission, we are one-step closer to offering US clinicians two, novel, first-in-class antibiotics. We believe lefamulin has the potential to provide a much-needed monotherapy treatment option for adults with CABP in both the hospital and ambulatory care settings. We are grateful to the patients and investigative sites who have supported the development oflefamulin for treatment ofCABP.” The two NDAs are supported by two pivotal, Phase 3 clinical trials (known as LEAP 1 and LEAP 2) that evaluated the safety and efficacy of IV and oral lefamulin compared to moxifloxacin in the treatment of adults with CABP, including the option to switch from IV to oral administration and a short course oral treatment with lefamulin. In both LEAP 1 and LEAP 2, lefamulin was demonstrated to be non-inferior to moxifloxacin, and met both the FDA and European Medicines Agency (EMA) primary and secondary efficacy endpoints for the treatment of CABP. Lefamulin was also shown to be generally well-tolerated when administered either orally or intravenously. About CABP Based on Nabriva Therapeutics’ combined analysis of the U.S. Centers for Disease Control and Prevention’s 2007 National Ambulatory Medical Care Survey, the National Hospital Ambulatory Medical Care Survey and 2013 data from the Healthcare Cost and Utilization Project, Nabriva Therapeutics estimates that more than five million adults are treated annually for CABP in the United States. Additionally, based on 2013 data from the Healthcare Cost and Utilization Project, Nabriva Therapeutics estimates that approximately three million of these adult CABP patients are diagnosed in an in-patient hospital and/or emergency department setting, where most are then treated with in-patient IV and oral antibiotics or out-patient oral antibiotics prescribed for use following hospital discharge or release. About Lefamulin Lefamulin is a semi-synthetic pleuromutilin antibiotic with potential to be first-in-class for systemic administration in humans discovered and developed by the Nabriva Therapeutics team. It is designed to inhibit the synthesis of bacterial protein, which is required for bacteria to grow. Lefamulin’s binding occurs with high affinity, high specificity and at molecular sites that are different than other antibiotic classes. Based on results from its two global, Phase 3 clinical trials, Nabriva Therapeutics believes lefamulin is well-positioned for use as a first-line monotherapy for the treatment of CABP due to its novel mechanism of action, targeted spectrum of activity, resistance profile, achievement of substantial drug concentration in lung tissue and fluid, availability of oral and IV formulations and a generally well-tolerated safety profile. Nabriva Therapeutics believes lefamulin represents a potentially important new treatment option for the approximately five to six million adults in the United States diagnosed with CABP each year. About CONTEPO™ CONTEPO™ (fosfomycin for injection, previously referred to as ZTI-01 and ZOLYD) is a novel, potentially first-in-class in the United States, intravenous investigational antibiotic with a broad spectrum of Gram-negative and Gram-positive activity, including activity against most contemporary multi-drug resistant (MDR) strains such as ESBL-producing Enterobacteriaceae. Intravenous (I.V.) fosfomycin has been approved for a number of indications and utilized for over 45 years in Europe to treat a variety of infections, including cUTIs and other serious bacterial infections. CONTEPO utilizes a new dosing approach, originally developed by Zavante (which Nabriva Therapeutics acquired), to optimize its pharmacokinetics and pharmacodynamics. Nabriva Therapeutics believes these attributes, along with the positive clinical experience worldwide, support CONTEPO as a first-line treatment for cUTIs, including acute pyelonephritis, suspected to be caused by MDR pathogens. At least 20 percent of cUTIs are caused by MDR bacteria and limited treatment options are available in the U.S. In addition, non-clinical data have shown that CONTEPO acts in combination with certain other antibiotics to improve bacterial killing. About Nabriva Therapeutics plc Nabriva Therapeutics is a clinical-stage biopharmaceutical company engaged in the research and development of innovative anti-infective agents to treat serious infections. Nabriva Therapeutics has two product candidates that are in late stage development: lefamulin, potentially the first systemic pleuromutilin antibiotic for CABP and CONTEPO (fosfomycin for injection), a potential first-in-class epoxide antibiotic in the United States for complicated urinary tract infections (cUTIs) including acute pyelonephritis (AP). For more information, please visit https://www.nabriva.com. Forward-Looking Statements Any statements in this press release about future expectations, plans and prospects for Nabriva Therapeutics, including but not limited to statements about the development of Nabriva Therapeutics’ product candidates, such as the future development or commercialization of lefamulin and CONTEPO, conduct and timelines of clinical trials, the clinical utility of lefamulin for CABP and of CONTEPO for cUTI, plans for and timing of the review of regulatory filings, efforts to bring lefamulin and CONTEPO to market, the market opportunity for and the potential market acceptance of lefamulin for CABP and CONTEPO for cUTI, the development of lefamulin and CONTEPO for additional indications, the development of additional formulations of lefamulin and CONTEPO, plans to pursue research and development of other product candidates, the sufficiency of Nabriva Therapeutics’ existing cash resources and other statements containing the words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “target,” “potential,” “likely,” “will,” “would,” “could,” “should,” “continue,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the content and timing of decisions made by the U.S. Food and Drug Administration and other regulatory authorities, Nabriva Therapeutics’ ability to realize the anticipated benefits, synergies and growth prospects of its acquisition of Zavante Therapeutics, the uncertainties inherent in the initiation and conduct of clinical trials, availability and timing of data from clinical trials, whether results of early clinical trials or studies in different disease indications will be indicative of the results of ongoing or future trials, whether results of ZEUS will be indicative of results for any ongoing or future clinical trials and studies of CONTEPO, uncertainties associated with regulatory review of clinical trials and applications for marketing approvals, the availability or commercial potential of product candidates including lefamulin for use as a first-line empiric monotherapy for the treatment of CABP and CONTEPO for the treatment of cUTI, the ability to retain and hire key personnel, the sufficiency of cash resources and need for additional financing and such other important factors as are set forth in Nabriva Therapeutics’ annual and quarterly reports and other filings on file with the U.S. Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent Nabriva Therapeutics’ views as of the date of this press release. Nabriva Therapeutics anticipates that subsequent events and developments will cause its views to change. However, while Nabriva Therapeutics may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Nabriva Therapeutics’ views as of any date subsequent to the date of this press release.
  • Angion Biomedica and Sinovant Sciences Enter into Collaboration and License Agreement to Develop BB3 in Greater China

    2018-11-12 HONG KONG,SHANGHAI, andUNIONDALE, N.Y.,Nov. 12, 2018/PRNewswire/ — Angion Biomedica and Sinovant Sciences today announced a collaboration and license agreement for BB3, Angion’s investigational small molecule mimetic of hepatocyte growth factor (HGF), inthe People’s Republic of China,Hong Kong,Macau, andTaiwan(Greater China). Angion is currently developing BB3 in a Phase 3 trial for the treatment of delayed graft function (DGF) following kidney transplantation and in a Phase 2 trial for the treatment of acute kidney injury (AKI) following open-heart surgery requiring cardiopulmonary bypass. “We are very pleased to partner with Sinovant to develop and commercialize BB3 inGreater China,” saidJay Venkatesan, M.D., CEO of Angion. “Our collaboration will help to address the morbidity, mortality, and healthcare costs associated with DGF and AKI in the rapidly growing patient markets inGreater China. Sinovant’s deep knowledge ofChina, experienced management team, and demonstrated commitment to innovation make them the ideal partner for Angion in the region.” “DGF and AKI are each associated with high morbidity and mortality and there are no approved therapies globally,” said Dr.Rae Yuan, President of Sinovant. “There is a pressing need inGreater Chinafor new medicines that can reduce the burden associated with kidney diseases, and we are excited to work with Angion to accelerate the availability of this promising new therapy.” Under the terms of the agreement, Angion has granted Sinovant an exclusive license for the development, commercialization, and manufacture of BB3 inGreater China. Angion will receive significant upfront, regulatory, and commercial milestone payments as well as royalties on sales inGreater China. Sinovant and Angion will cooperate to jointly develop BB3 in DGF and AKI, with Sinovant taking the lead on development activities inGreater China. Sinovant expects to initiate clinical trials with BB3 inGreater Chinaimmediately upon receipt of the necessary regulatory approvals. About DGF and AKI Delayed graft function (DGF) is a form of acute kidney injury (AKI) that manifests postoperatively in 20-30% of renal transplantation patients globally and is associated with a 40% decrease in long-term graft survival.1InGreater China, persistent organ shortages have led to greater use of deceased donor kidneys, which is expected to drive increases in observed rates of DGF. AKI is characterized by an abrupt loss of kidney function and may be caused by a variety of factors. In the surgical setting, AKI is a common complication of open-heart surgery requiring cardiopulmonary bypass. Up to 30% of patients recovering from open-heart surgery experience an AKI-associated complication, resulting in a five-fold increased risk of death during hospitalization2. Risk factors for AKI in the post-surgical setting include existing kidney disease, compromised heart function, exposure to nephrotoxic drugs, advanced age, and diabetes. Advisors T.R. Winston & Company, LLC, served as financial advisor to Angion, and assisted in the negotiations with Sinovant. Morgan, Lewis & Bockius LLP served as legal advisor to Angion. About BB3 BB3 is a potent, small molecule mimetic of HGF which activates the c-Met receptor. Activation of the HGF/c-Met pathway stimulates blood vessel formation, tissue repair, and regeneration, and reduces deposition of extracellular matrix, a non-cellular collection of macromolecules produced in excess by injured tissue leading to organ dysfunction and fibrosis. In a prior Phase 2 study with BB3 in patients with poor kidney function post-transplant, treated patients were shown to have improved renal function, decreased serum creatinine, and reduced need for dialysis relative to patients who received placebo. Angion is currently conducting a Phase 3 study with BB3 in patients presenting with early signs of DGF and a Phase 2 study with BB3 in patients at increased risk for AKI following cardiovascular surgery. About Angion Angion Biomedica Corp. is a biopharmaceutical company discovering and developing novel therapeutic agents for acute and chronic organ diseases and disorders. Angion’s programs are currently focused on renal transplantation, AKI, and chronic kidney disease, with a pipeline of additional indications and product candidates. For further information, please visitwww.angion.com. About Sinovant Sinovant is a Chinese biopharmaceutical company dedicated to conducting globally innovative biomedical R&D inChinato meet the needs of patients inGreater Chinaand around the world. Sinovant’s mission is to develop and commercialize new medicines that address the most pressing public health challenges inChinawhile simultaneously advancing Chinese biopharmaceutical research abroad. For further information, please visitwww.sinovant.com. Contact for Angion Biomedica: Elisha Goldberg Director, Business Development egoldberg@angion.com Contact for Sinovant Sciences: Xinan Chen Executive Director info@sinovant.com 1Siedleckiet al.(2011) 2O’Nealet al.(2016)
  • Sinovant Sciences (仑胜医药), Company Focused on the Development of Innovative Medicines in China, Unveiled at Event in Beijing

    2018-07-17 Backed by Roivant Sciences and CITICPE, a leading Chinese asset management firm Pipeline includes 11 investigational medicines which address significant unmet medical needs in China Sinovant has formed partnership with China Liver Health to accelerate availability of new treatments for liver and infectious diseases in China BEIJING and SHANGHAI, July 17, 2018 /PRNewswire/ —Sinovant Sciences (仑胜医药), a Shanghai-based biopharmaceutical company dedicated to bringing innovative medicines to China and advancing Chinese biopharmaceutical innovation abroad, unveiled its pipeline and leadership team today at an event in Beijing. Sinovant is backed by Roivant Sciences, a global healthcare company focused on reducing the time and cost of drug development, and CITICPE, a leading Chinese private equity firm. Roivant has supported Sinovant in assembling its pipeline and recruiting its senior leadership. “We are very happy to be an investor and long-term partner of Sinovant Sciences,” said CITICPE Managing Director Steven Wang. “We look forward to supporting the company to become a leading new drug research and development company in China, serving patients in China and around the world.” Sinovant began operations in 2017. Sinovant has built a pipeline of 11 investigational biopharmaceutical products for Greater China and other Asian markets, including four therapies suitable for Phase 3 clinical trial application or registration in China.Sinovant’s investigational therapies address several of China’s greatest public health priorities, including liver cancer and drug-resistant bacterial infections. The company’s pipeline today includes: Derazantinib, a fibroblast growth factor receptor (FGFR) inhibitor in global Phase 3 development for the treatment of intrahepatic cholangiocarcinoma (iCCA), a form of liver cancer with high incidence in Greater China and no approved therapies globally. In a prior study in patients with iCCA harboring FGFR2 gene fusions, treatment with derazantinib resulted in an objective response rate of 21%, nearly three times higher than standard-of-care chemotherapy. Lefamulin, an antibiotic that has successfully completed two global Phase 3 studies for community-acquired bacterial pneumonia (CABP), one of the leading causes of mortality in China. Due to its novel mechanism of action, low incidence of cross-resistance with other antibacterial agents commonly used to treat CABP, and low propensity for the development of bacterial resistance, lefamulin has the potential to be used as a first-line empiric monotherapy for the treatment of CABP. Relatedly, lefamulin has been granted Qualified Infectious Disease Product (QIDP) designation from the U.S. Food and Drug Administration (FDA), and is currently in preparation for a New Drug Application submission in the US and a Marketing Authorisation Application filing in Europe. RVT-802, an investigational tissue-based regenerative therapy designed to treat primary immune deficiency resulting from congenital athymia associated with complete DiGeorge Anomaly, a fatal pediatric disorder. RVT-802 has been granted Breakthrough Therapy designation, Regenerative Medicine Advanced Therapy (RMAT) designation, rare pediatric disease designation, and orphan drug designation by the FDA. A rolling Biologics License Application submission with the FDA was initiated earlier this month. Sinovant also announced today that it has received Chinese rights to naronapride, an investigational gastrointestinal prokinetic being developed outside of China by Renexxion. Sinovant intends to initially develop naronapride in irritable bowel syndrome with constipation (IBS-C), a condition that impacts approximately 13 million individuals in China and for which few efficacious treatments are currently available. Naronapride’s low systemic absorption and high specificity for 5HT4 and D2 receptors may differentiate it from other members of the class. Sinovant also plans to expand development into other gastrointestinal disorders. “After meeting the team at Sinovant it became obvious that they were the right company to further naronapride’s development in greater China,” said Dr. Peter Milner, Chief Executive Officer of Renexxion. Sinovant has also formed a partnership with China Liver Health, a leading Chinese public health nonprofit under the management of Ministry of Civil Affairs of China, to accelerate the availability of new treatments for liver disease and infectious diseases in China. “Sinovant is developing a broad array of therapies with the potential to bring significant benefits to patients in China suffering from some of our greatest public health challenges,” said Professor Lai Wei, President of China Liver Health. “We look forward to collaborating with Sinovant on the development of these and other important therapies.” Sinovant Co-Founder Dr. Xinan Chen is a Beijing-born entrepreneur committed to bringing innovation to the Chinese healthcare system. Dr. Chen is a physician and public health professional who has worked with the World Health Organization and Chinese health authorities to improve access and quality of healthcare delivery in China and globally. Dr. Chen received his M.D. from Brown University and his M.P.H. from Harvard University. Prior to Sinovant, Dr. Chen worked at Roivant Sciences on new company formation. About Sinovant Sciences Sinovant Sciences is a Chinese biopharmaceutical company dedicated to conducting globally innovative biomedical R&D in China to meet the needs of patients in China and around the world. Sinovant’s mission is to develop and commercialize new medicines that address the most pressing public health challenges in China while simultaneously advancing Chinese biopharmaceutical research abroad. For more information, please visit www.sinovant.com. About CITICPE CITICPE is a leading asset management firm that manages multiple asset classes, including private equity, mezzanine and public market funds and other products, for a group of over 200 domestic and international investors. The firm was founded in 2008 by a world class team of investment professionals. CITICPE knows China like no one else and is a globally minded long term value investor. The firm uses its sector expertise to generate deal flow and drive the value creation work during the post-investment stage. CITICPE follows a disciplined investment approach to preserve and grow its investors’ capital. The firm’s private equity portfolio of more than 100 companies is highly diversified by sector and stage of investment. CITICPE takes pride in its forward-looking investment philosophy and works hard to create value over the long term for its investors and a better world. For more information, please visit www.citicpe.com. About Roivant Sciences Roivant is a global biopharmaceutical company focused on reducing the time and cost of the drug development process to improve the lives of patients and their families. The Roivant family of companies includes Myovant (women’s health), Axovant (neurology), Urovant (urology), Enzyvant (rare diseases), Dermavant (dermatology), Genevant (RNA therapeutics), Metavant (cardiometabolic diseases), Immunovant (immunology), Altavant (next-generation drug development), Datavant (healthcare data), and Arbutus (hepatitis B). Today there are over 30 investigational drugs in 11 therapeutic areas being tested in over 50 clinical trials across the Roivant family of companies. For more information, please visit www.roivant.com.
  • Nabriva Therapeutics and Roivant Sciences Enter into License Agreement to Develop and Commercialize Lefamulin in Greater China

    2018-03-27 DUBLIN, Ireland, and HONG KONG,March 27, 2018—Nabriva Therapeutics plc(NASDAQ:NBRV), a clinical stage biopharmaceutical company engaged in the research and development of novel anti-infective agents to treat serious infections, with a focus on the pleuromutilin class of antibiotics, and Roivant Sciences, today announced the initiation of a collaboration to develop and commercialize lefamulin in greater China. Lefamulin has completed a pivotal, international Phase 3 clinical trial for the treatment of adults with moderate to severe community-acquired bacterial pneumonia (CABP). Topline data from a second pivotal, international Phase 3 clinical trial are expected in the spring of 2018. As part of the license agreement, Nabriva has granted a Roivant subsidiary an exclusive license to develop and commercialize lefamulin in the greater China region, specifically the People’s Republic of China, Hong Kong, Macau, and Taiwan. The companies will establish a joint development committee to review and oversee all development and commercialization plans. Nabriva will receive a $5 million upfront payment and will be eligible for up to approximately $90 million in additional payments tied to the successful completion of certain regulatory and commercial milestones related to lefamulin for CABP. In addition, Nabriva will be eligible to receive low double-digit royalties on sales upon approval in the covered territories. Roivant’s affiliate will be solely responsible for all clinical development and regulatory filings necessary to secure approval in the covered territories. “Our partnership with Roivant underscores our commitment to ensuring rapid access to lefamulin for adults with CABP around the globe,” said Dr.Colin Broom, chief executive officer ofNabriva Therapeutics. “Roivant has a broad therapeutic portfolio and deep development and commercialization expertise, making the company an excellent partner as we pursue bringing an important and much-needed new treatment option for CABP—and potentially other serious bacterial infections—to China and surrounding territories. The funding from this agreement will also contribute to our efforts to prepare for a successful launch should lefamulin be approved in the United States.” “This partnership demonstrates our commitment to build out a robust pipeline of products in China in addition to derazantinib,” said Vivek Ramaswamy, founder and chief executive officer of Roivant Sciences. “It is also indicative of our desire to develop treatments for infectious diseases beyond hepatitis B virus. Increasing resistance to commonly prescribed anti-infectives represents a significant threat to public health, especially in China, but we believe that lefamulin’s novel mechanism of action represents a promising advance. Our partnership with Nabriva is an important step in our contribution to this area of medicine and this region of the world.” Pneumonia is a leading cause of infectious disease mortality worldwide. In China, pneumonia is the fourth leading cause of death in urban areas and the leading cause of death in rural areas.1Mortality is expected to rise as bacteria become increasingly resistant to currently prescribed treatments. The incidence of multi-drug resistant pneumonia is rising in China and several other Asian countries.2,3,4 About Lefamulin Lefamulin is a semi-synthetic derivative of pleuromutilin that inhibits a key process for bacterial growth. In pre-clinical studies, lefamulin has demonstrated a targeted spectrum of activity against the pathogens that most commonly cause CABP, including multi-drug resistant strains. Due to its novel mechanism of action, low incidence of cross-resistance between other antibacterial agents commonly used to treat CABP, and low propensity for bacterial resistance to develop, lefamulin has the potential to be used as a first-line empiric monotherapy for the treatment of CABP. Furthermore,if approved, the availability of both oral and intravenous (IV) formulations and a favorable tolerability profile make it appropriate for potential use across all three CABP treatment settings, including in-hospital, transition of care, and community-initiated. In the U.S., Nabriva Therapeutics anticipates filing a New Drug Application in the second half of 2018 contingent on positive results from its second, pivotal Phase 3 clinical trial of lefamulin for CABP, which is referred to as LEAP 2. Topline data from LEAP 2 is expected in the spring of 2018. LEAP 2 is designed to assess the efficacy and safety of oral lefamulin compared to oral moxifloxacin in adult patients with moderate CABP. InSeptember 2017,Nabriva Therapeuticsannounced positive topline results from its first Phase 3 clinical trial of lefamulin for CABP, which is referred to as LEAP 1, which evaluated the efficacy and safety of intravenous (IV) to oral lefamulin in adult patients with moderate to severe CABP compared to moxifloxacin with or without adjunctive linezolid. In LEAP 1, lefamulin met both theU.S. Food and Drug Administration(FDA) andEuropean Medicines Agency(EMA) primary endpoints of non-inferiority compared to moxifloxacin with or without adjunctive linezolid. Lefamulin also showed a favorable tolerability profile in the LEAP 1 trial, with no unexpected safety signals or evidence of off-target activity. About Roivant Sciences Roivant is dedicated to transformative innovation in healthcare. Roivant focuses on realizing the full potential of promising biomedical research by developing and commercializing novel therapies across diverse therapeutic areas. Roivant partners with innovative biopharmaceutical companies and academic institutions to ensure that important medicines are rapidly developed and delivered to patients. Roivant advances its drug pipelines through wholly- or majority-owned subsidiary companies, including Myovant (women’s health and endocrine diseases), Axovant (neurology), Urovant (urology), Enzyvant (rare diseases), Dermavant (dermatology) and Metavant (cardiometabolic diseases). Roivant also pursues its mission by incubating and launching innovative healthcare companies operating outside of traditional biopharmaceutical development, including Datavant (healthcare analytics). Roivant’s long-range mission is to reduce the time and cost of developing and delivering new medicines for patients. AboutNabriva Therapeutics plc Nabriva Therapeuticsis a biopharmaceutical company engaged in the research and development of new medicines to treat serious bacterial infections, with a focus on the pleuromutilin class of antibiotics. Nabriva Therapeutics’ medicinal chemistry expertise has enabled targeted discovery of novel pleuromutilins, including both intravenous and oral formulations. Nabriva Therapeutics’ lead product candidate, lefamulin, is a novel semi-synthetic pleuromutilin antibiotic with the potential to be the first-in-class available for systemic administration in humans. The company believes that lefamulin is the first antibiotic with a novel mechanism of action to have reached late-stage clinical development in more than a decade. Nabriva has announced positive topline data for lefamulin from the first of its two global, registrational Phase 3 clinical trials evaluating lefamulin in patients with moderate to severe community-acquired bacterial pneumonia (CABP).Nabriva Therapeuticsbelieves lefamulin is well-positioned for use as a first-line empiric monotherapy for the treatment of moderate to severe CABP due to its novel mechanism of action, targeted spectrum of activity, resistance profile, achievement of substantial drug concentration in lung tissue and fluid, oral and IV formulations and a favorable tolerability profile, with the results of the LEAP 1 trial showing a rate of treatment-emergent adverse events comparable to moxifloxacin with or without linezolid.Nabriva Therapeuticsis evaluating the continued development of lefamulin for additional indications and is developing a formulation of lefamulin appropriate for pediatric use. Outside of the greater China region, Nabriva Therapeuticsowns exclusive rights to lefamulin, which is protected by composition of matter patents issued inthe United States,EuropeandJapan. Guan X, Silk B, Li W, et al. Pneumonia incidence and mortality in mainland China: systematic review of Chinese and English literature, 1985-2008 Liu Y, Chen M, Zhao T, et al. Causative agent distribution and antibiotic therapy assessment among adult patients with community acquired pneumonia in Chinese urban population. BMC Infect Dis 2009;9:31. Cao B, Zhao CJ, Yin YD, et al. High prevalence of macrolide resistance in Mycoplasma pneumoniae isolates from adult and adolescent patients with respiratory tract infection in China. Clin Infect Dis 2010;51:189–94. Qiao M, Ying GG, Singer A, et al. Review of antibiotic resistance in China and its environment. Env Intl 2018;110:160-172
  • Roivant Sciences and ArQule Enter into License Agreement for Derazantinib in China

    2018-02-07 Collaboration will expand the clinical development of derazantinib Roivant Sciences and ArQule, Inc. (NASDAQ: ARQL) today announced the initiation of a collaboration to pursue the development of derazantinib, a pan-FGFR (fibroblast growth factor receptor) inhibitor, in Greater China. As part of the collaboration, ArQule has granted a Roivant subsidiary an exclusive license to develop and commercialize derazantinib in the People’s Republic of China, Hong Kong, Macau, and Taiwan. Deal terms include an upfront payment to ArQule of $3 million and an additional $2.5 million development milestone within the first year. ArQule is also eligible for regulatory and commercial milestones and royalties on future sales of derazantinib in Greater China. ArQule is currently conducting a registrational trial for derazantinib in the United States and Europe as a potential treatment for intrahepatic cholangiocarcinoma (iCCA), a form of biliary tract cancer. The People’s Republic of China has one of the world’s highest incidences of iCCA, where it is the second most common form of liver cancer. Roivant intends to pursue the development of derazantinib in China for the treatment of iCCA while also pursuing further development in other tumor types with high rates of FGFR mutation. “Intrahepatic cholangiocarcinoma is a devastating form of cancer, and there are no approved therapies globally,” said Vivek Ramaswamy, Founder and CEO of Roivant Sciences. “The prevalence of this disease is exceptionally high in China and we will do our part to further the development of derazantinib in that region.” “We are pleased with Roivant’s commitment to develop derazantinib in China, where the need for novel therapies is so pressing,” said Paolo Pucci, CEO of ArQule. “We share their commitment to ensuring broad geographic access to new medicines, and we look forward to developing derazantinib in iCCA and other FGFR-driven cancers.” About Derazantinib Derazantinib is a potent, orally administered inhibitor of the fibroblast growth factor receptor (FGFR) family, a key driver of cell proliferation, differentiation, and migration. In a Phase 1/2 study in patients with iCCA harboring FGFR2 gene fusions, treatment with derazantinib resulted in an objective response rate of 21%, nearly 3 times higher than standard-of-care chemotherapy. ArQule is currently conducting a registrational study with derazantinib in patients with FGFR2 fusion-positive second-line iCCA. The open-label single-arm trial is recruiting in both the United States and Europe with objective response rate as the primary endpoint. More information on that program is available here. About Intrahepatic Cholangiocarcinoma Cholangiocarcinoma (CCA) is the most common biliary malignancy and the second most common hepatic malignancy after hepatocellular carcinoma (HCC).1 Depending on the anatomic location, CCA is classified as intrahepatic (iCCA), perihilar (pCCA), and extrahepatic (eCCA). iCCA originates from the intrahepatic biliary ductal system and forms an intrahepatic mass. iCCA is an aggressive cancer, with a median 5-year survival rate of 15% for patients diagnosed with early-stage disease.2 In China, the incidence of cholangiocarcinoma is more than 7 cases per 100,000 people, and the majority of cases are intrahepatic.3 About ArQule ArQule is a biopharmaceutical company engaged in the research and development of targeted therapeutics to treat cancers and rare diseases. ArQule’s mission is to discover, develop and commercialize novel small molecule drugs in areas of high unmet need that will dramatically extend and improve the lives of our patients. Our clinical-stage pipeline consists of five drug candidates, all of which are in targeted, biomarker-defined patient populations, making ArQule a leader among companies our size in precision medicine. ArQule’s proprietary pipeline includes: Derazantinib, a multi-kinase inhibitor designed to preferentially inhibit the fibroblast growth factor receptor (FGFR) family, in a registrational trial for iCCA and in phase 1b for multiple oncology indications; Miransertib (ARQ 092), a selective inhibitor of the AKT serine/threonine kinase, in a phase 1/2 company sponsored study for Overgrowth Diseases, in a phase 1 study for ultra-rare Proteus syndrome conducted by the National Institutes of Health (NIH), as well as in multiple oncology indications; ARQ 751, a next generation AKT inhibitor, in phase 1 for patients with AKT1 and PI3K mutations; and ARQ 761, a ß-lapachone analog being evaluated as a promoter of NQO1-mediated programmed cancer cell necrosis, in phase 1/2 in multiple oncology indications in partnership with the University of Texas Southwestern Medical Center. In addition, we have advanced ARQ 531, an investigational, orally bioavailable, potent and reversible inhibitor of both wild type and C481S-mutant BTK, in phase 1 for patients with B-cell malignancies refractory to other therapeutic options. ArQule’s current discovery efforts are focused on the identification and development of novel kinase inhibitors, leveraging the Company’s proprietary library of compounds. You can follow us on Twitter and LinkedIn. About Roivant Roivant is dedicated to transformative innovation in healthcare. Roivant focuses on realizing the full potential of promising biomedical research by developing and commercializing novel therapies across diverse therapeutic areas. Roivant partners with innovative biopharmaceutical companies and academic institutions to ensure that important medicines are rapidly developed and delivered to patients. Roivant advances its drug pipelines through wholly- or majority-owned subsidiary companies, including Axovant (neurology), Myovant (women’s health and endocrine diseases), Dermavant (dermatology), Enzyvant (rare diseases), and Urovant (urology). Roivant also pursues its mission by incubating and launching innovative healthcare companies operating outside of traditional biopharmaceutical development. Roivant’s long-range mission is to reduce the time and cost of developing and delivering new medicines for patients. For more information, please visit www.roivant.com. Forward Looking Statements This press release contains forward-looking statements regarding the Company’s clinical trials with derazantinib as well as the potential for future milestone and royalty payments under its License Agreement with Roivant and its subsidiary. These statements are based on the Company’s current beliefs and expectations, and are subject to risks and uncertainties that could cause actual results to differ materially. Positive information about pre-clinical and early stage clinical trial results does not ensure that later stage or larger scale clinical trials will be successful. For example, derazantinib may not demonstrate promising therapeutic effect. In addition, derazantinib may not demonstrate an acceptable safety profile in current or later stage or larger scale clinical trials as a result of known or as yet unanticipated side effects. The results achieved in later stage trials may not be sufficient to meet applicable regulatory standards or to justify further development. Problems or delays may arise during clinical trials or in the course of developing, testing or manufacturing derazantinib that could lead the Company or Roivant and its subsidiary to discontinue its development. Even if later stage clinical trials are successful, unexpected concerns may arise from subsequent analysis of data or from additional data. Obstacles may arise or issues may be identified in connection with review of clinical data with regulatory authorities. Regulatory authorities may disagree with the Company’s or Roivant’s and its subsidiary’s view of the data or require additional data or information or additional studies. In addition, we plan to develop and use a companion diagnostic to identify patients with FGFR2 fusions and possibly other fusions for our future derazantinib clinical trials. We intend to outsource the development of such companion diagnostics to one or more third party collaborators. Such collaborators may encounter difficulties in developing and obtaining approval for such companion diagnostics, including issues relating to selectivity/specificity, analytical validation, reproducibility, concordance or clinical validation. Any delay or failure to develop or obtain regulatory approval of such companion diagnostics could delay or prevent approval of derazantinib. Moreover, the subsidiary of Roivant to which derazantinib has been licensed is a new entity with no track record of drug development or commercialization. If derazantinib is not successfully developed and commercialized in Greater China as a result of any of the foregoing or other issues, risks or uncertainties, ArQule may not receive any future milestones or royalties under the License Agreement. Drug development involves a high degree of risk. Only a small number of research and development programs result in the commercialization of a product. Furthermore, ArQule may not have the financial or human resources to successfully pursue drug discovery in the future. For more detailed information on the risks and uncertainties associated with the Company’s drug development and other activities, see the Company’s periodic reports filed with the Securities and Exchange Commission. The Company does not undertake any obligation to publicly update any forward-looking statements. 1 Welzel TM, et al. Impact of classification of hilar cholangiocarcinomas (Klatskin tumors) on the incidence of intra- and extrahepatic cholangiocarcinoma in the United States. Journal of the National Cancer Institute 2006; 98(12), 873-875. 2 American Cancer Society 3 Banales JM, et al. Cholangiocarcinoma: current knowledge and future perspectives consensus statement from the European Network for the Study of Cholangiocarcinoma (ENS-CCA). Nature Reviews: Gastroenterology & Hepatology 2016; 13, 261-280. Related links www.arqule.com www.roivant.com