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Neuroblastoma is the second most common solid tumour in childhood, following brain tumours[2], and predominantly affects children under five years old[3]. Every year in Europe, around 1,200 children are diagnosed with neuroblastoma[4], a rare cancer arising from neural crest cells, which are involved in the foetal development of the nervous system and other tissues.[2] Because neuroblastoma can spread very quickly, almost half of children are initially diagnosed at an advanced stage of their disease and are recognised as 'high-risk' and with a poor prognosis. Approval of dinutuximab beta brings new hope to these 'high-risk' children who have previously received induction chemotherapy and achieved at least a partial response, followed by myeloablative therapy and stem cell transplantation, as well as those with history of relapsed or refractory neuroblastoma, with or without residual disease.[1] "Today's announcement is a leap forward for the children and families affected by neuroblastoma, particularly those who have keenly followed the positive clinical trial results for dinutuximab beta and long anticipated its approval in Europe," commented Dr Juliet Gray, Associate Professor and Consultant in Paediatric Oncology at University of Southampton, UK. "As a clinician working in a highly specialised disease area with limited treatment options, I greatly welcome the availability of this targeted immunotherapy treatment that offers improved results for high-risk neuroblastoma patients used alone or in combination with existing therapies." Steve Richards, CEO of the neuroblastoma charity Solving Kids' Cancer Europe, added: "In the absence of any other targeted immunotherapy for children with high-risk neuroblastoma, the European regulatory body that approves medicines to be marketed in Europe, expedited the review of dinutuximab beta. Today's approval means that EUSA Pharma who manufactures dinutuximab beta is able to make it available for use by hospitals across Europe, improving access for thousands of children and their families to this new treatment, with proven improved survival rates. The next challenge will be for EUSA Pharma to engage with relevant access bodies throughout Europe, including NICE in the UK, to ensure timely review through the new drugs processes and secure access to this medicine for patients. The young innocent victims of this cruel and devastating disease deserve nothing less." Lee Morley, CEO of EUSA Pharma, commented, "We are delighted that the EC has recognised the urgent need to accelerate approval of dinutuximab beta in order to provide an effective and targeted treatment for this debilitating disease. EUSA Pharma in partnership with Apeiron and SIOPEN has believed strongly in the potential of this treatment throughout the clinical trial process and today's announcement is final acknowledgement of its value to address the serious unmet need of children and their families affected by high-risk neuroblastoma." Dinutuximab beta is a monoclonal chimeric antibody developed to target a specific antigen, GD2, on neuroblastoma cells. It has been investigated in clinical trials for high-risk neuroblastoma, with more than 1000 patients having received treatment to date. Dinutuximab beta has orphan drug designation in the US and EU, and EUSA plans to file the product for approval in the United States in 2017. Founded in March 2015, EUSA Pharma is a specialty pharmaceutical company with commercial operations across Europe and the USA, and a wider distribution network in approximately 40 further countries. The management team comprises highly experienced pharmaceutical professionals with a broad experience and proven track record of successfully identifying, developing and commercializing innovative medicines that advance patient care and improve their wellbeing. For more information visit: http://www.eusapharma.com.


Dinutuximab beta, originally developed by the Vienna-based biotech company Apeiron Biologics, was previously available in Europe under a managed access program, and following the positive CHMP opinion issued in March 2017 was granted expedited EU approval. Dinutuximab beta forms a core element of the treatment guidelines for high-risk neuroblastoma. The marketing authorization is based on data developed from multiple clinical trials conducted across Europe that included over 1,000 patients receiving Dinutuximab beta. Lee Morley, EUSA Pharma's Chief Executive Officer, said, "We are delighted with this expedited EU approval for Dinutuximab beta as it provides an important new therapeutic option for children with high-risk neuroblastoma who currently have limited treatment choices. Neuroblastoma is a devastating disease that is responsible for up to 10% of childhood tumors, and EUSA is working hard to bring this life-saving therapy to children around the world. As part of this mission we plan to launch Dinutuximab beta immediately across the EU with our own team. In parallel we will file Dinutuximab beta with the FDA for approval in the United States as well as work with selected partners in other territories to secure access to Dinutuximab beta for patients worldwide." Neuroblastoma is an orphan oncology condition with significant unmet medical need.  It accounts for up to 10% of childhood tumors and affects approximately 1,200 children in Europe each year.  Dinutuximab beta has been used extensively across Europe under a managed access scheme and is included in a number of treatment protocols for high-risk neuroblastoma. Dinutuximab beta is an anti-GD2 monoclonal antibody that significantly improves event-free and overall survival in children with high- risk neuroblastoma, with a favorable safety profile compared with other immunotherapies. Dinutuximab beta forms an important part of treatment regimens for high-risk neuroblastoma and its novel features offer the potential for further development to expand its current role. Dinutuximab beta has orphan drug designation in the US, and EUSA plans to file the product for approval in the United States in 2017. Dinutuximab beta is approved in Europe for use in children aged 12 months and above who have previously received induction chemotherapy and achieved at least a partial response, followed by myeloablative therapy and stem cell transplantation, as well as patients with a history of relapsed or refractory neuroblastoma, with or without residual disease.  In patients with previous relapsed / refractory disease and in patients who have not achieved a complete response after first line therapy, Dinutuximab beta should be combined with interleukin-2 (IL-2).  Prior to the treatment of relapsed neuroblastoma, any actively progressing disease should be stabilised by other suitable measures. Founded in March 2015, EUSA Pharma is a specialty pharmaceutical company with commercial operations in the US and Europe, and a wider distribution network in approximately 40 further countries.  Currently, EUSA has a broad portfolio of approved and named-patient specialty hospital products, which the company has ambitious plans to expand through acquisition and in-licensing.  EUSA is led by an experienced management team with a strong record of building successful specialty pharmaceutical companies, and is supported by significant funding raised from leading life science investor Essex Woodlands. In addition to Dinutuximab beta, EUSA Pharma's products include: Caphosol® for the treatment of oral mucositis, a common and debilitating side-effect of radiation therapy and high-dose chemotherapy; Collatamp®, a gentamicin-collagen implant licensed either in hemostasis or for the prevention and treatment of surgical site infection; Custodiol® solution for use in the preservation of organs for transplantation; Fomepizole® for the treatment of ethylene glycol poisoning; and Xenazine® for the treatment of abnormal movements associated with Huntington's chorea and hemiballismus.  EUSA also has exclusive European, Latin American, North and South African and selected Middle East and Asian rights to tivozanib, which is currently under review by EMA for the treatment of advanced renal cell carcinoma.  For more information visit http://www.eusapharma.com.


BEIJING--(BUSINESS WIRE)--CANbridge Life Sciences and Amoy Diagnostics announced that they have entered into a strategic partnership to develop a companion diagnostic assay for CANbridge’s lead candidate, CAN008, a fully human Fc fusion protein. Previous clinical work, in a Phase II trial conducted in Europe, demonstrated a significant overall survival benefit for recurrent glioblastoma multiforme (GBM) patients with high expression of the CD95 ligand, or low methylation of CD95L promotor, CpG2. CAN008 is currently in a Phase I/II clinical study in GBM patients in Taiwan. CANbridge plans to initiate a CAN008 Phase II trial in GBM in China in 2018. The patients will be screened for the CAN008 biomarkers to determine trial enrollment eligibility. “We are pleased to partner with AmoyDx, a leader in providing highly-reliable and effective diagnostic solutions to clinical practices in China,” said James Xue, CANbridge Chairman and CEO. “AmoyDx’s diagnostic CD95 IHC and CpG2 qPCR kits will provide CANbridge with personalized medicine tools in the Phase II trial to deliver optimized treatment to GBM patients as early as possible.” “We are excited that our diagnostic technology will play a key role in the CAN008 clinical development,” said Dr. Li-Mou Zheng, Chairman and CEO of AmoyDx. “We believe that the joint effort by CANbridge and AmoyDx could help to realize the therapeutic potential of CAN008 in critically-ill GBM patients in China sooner. AmoyDx has multiple existing strategic partnerships with multi-national corporations providing diagnostic products and services in China and other countries. The CANbridge – AmoyDx collaboration is the first in which both parties are innovative Chinese companies with leadership positions in their respective fields.” CAN-008 is a fully human fusion protein which consists of the extracellular domain of CD95, fused to the Fc region of human IgG that inhibits the CD95 ligand, a member of the tumor necrosis factor (TNF) family. By blocking it, CAN-008 restores the immune system’s anti-tumor response and inhibits invasive tumor cell growth. In a European Phase II trial in patients with recurrent glioblastoma, conducted by the drug’s previous developer, privately-held Apogenix, patients with biomarkers for the CD95 ligand experienced the greatest benefits. In July 2015, CANbridge acquired an exclusive license to develop, manufacture and commercialize CAN-008 for GBM and other indications, in China, Hong Kong and Macau, which was recently expanded to include Taiwan. Amoy Diagnostics Co., Ltd. (AmoyDx) focuses on molecular diagnostics for oncology precision medicine. With completely independent intellectual property rights to ADx-ARMS and Super-ARMS technologies, AmoyDx has a market-leading portfolio of molecular diagnostic kits, including, but not limited to, EGFR, RAS, ALK, BRAF, PIK3CA and ROS1 testing kits, approved by the CFDA and CE certified as well. In European EMQN and Chinese PQCC programs, AmoyDx has been the No.1 test kit supplier for multiple years with the highest accuracy rate. Currently, AmoyDx serves an extensive domestic and international oncology network, reaching over 300 hospitals in China and 50 countries all over the world. Every year, hundreds of thousands of cancer patients benefit from AmoyDx products. AmoyDx is strategic partner of AstraZeneca, Boehringer-Ingelheim, Pfizer, Merck and Illumina, providing diagnostic products and services for medicine development and clinical studies in gene tissue and blood testing. For more information, please visit the website: www.amoydx.com. CANbridge Life Sciences, Ltd. is a clinical-stage bio-pharmaceutical company accelerating development and commercialization of specialty healthcare products for serious and critical medical conditions in China and North Asia (Korea and Taiwan). CANbridge develops partnerships with Western bio-pharmaceutical companies, with clinical-stage pharmaceutical, medical device or diagnostic products, that are either unavailable in China/North Asia or address medical needs that are underserved in the region. CANbridge also licenses, or obtains exclusive rights to develop drug and device products that are approved in their home markets for commercialization in China and North Asia. CANbridge has an agreement with EUSA Pharma to commercialize Caphosol® in China for the prevention and treatment of oral mucositis caused by cancer treatments, and a license with Apogenix to develop, manufacture and commercialize immune-oncology therapy, APG101, for the treatment of glioblastoma multiforme in China, Macao, Hong Kong and Taiwan, where it will be developed as CAN008. CANbridge also holds a worldwide license (ex-North America) with AVEO Oncology to develop, manufacture and commercialize clinical-stage ErbB3 (HER3) inhibitory antibody candidate AV-203, renamed by CANbridge as CAN017. Led and backed by a highly-seasoned executive team, with extensive Chinese drug development experience, CANbridge has the capability to select, acquire, develop and commercialize future therapeutics and diagnostics targeting the unmet medical needs of Chinese and East Asian patients with serious or critical conditions. CANbridge is privately-held and headquartered in Beijing, China. For more on CANbridge Life Sciences, please go to www.canbridgepharma.com.


CAMBRIDGE, Mass.--(BUSINESS WIRE)--AVEO Oncology (NASDAQ:AVEO) today announced its European licensee for tivozanib, EUSA Pharma, has completed an oral explanation to the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA), as part of the Marketing Authorization Application (MAA) review process for tivozanib as a treatment for patients with first-line renal cell carcinoma (RCC). It is expected that with the oral explanation complete, the CHMP will proceed to an opinion which they will submit to the European Commission (EC), which has the authority to approve medicines for use in the 28 countries in the European Union. The opinion is expected to be announced at a future CHMP meeting. “We are pleased that the file continues to progress through the CHMP review process with EUSA having completed an oral explanation for tivozanib,” said Michael Bailey, president and chief executive officer of AVEO. “We believe tivozanib’s unique tolerability profile, together with the longest progression free survival from a Phase 3 first line RCC study, demonstrates its potential to enhance treatment options for RCC patients.” RCC is the most common form of kidney cancer,i which accounts for an estimated 49,000 deaths in Europe each year.ii It is expected to be one of the fastest increasing cancers over the next ten years.iii Tyrosine Kinase Inhibitor (TKI) vascular endothelial growth factor (VEGF) inhibitors are the gold standard treatment for advanced RCC in Europe, however, patients on current treatments can often experience significant side effects.iv,v Tivozanib is an oral, once-daily, vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI). It is a potent, selective and long half-life inhibitor of all three VEGF receptors and is designed to optimize VEGF blockade while minimizing off-target toxicities, potentially resulting in improved efficacy and minimal dose modifications. Tivozanib has been investigated in several tumors types, including renal cell, colorectal and breast cancers. AVEO Oncology (AVEO) is a biopharmaceutical company dedicated to advancing a broad portfolio of targeted therapeutics for oncology and other areas of unmet medical need. The Company is focused on seeking to develop and commercialize its lead candidate tivozanib, a potent, selective, long half-life inhibitor of vascular endothelial growth factor 1, 2 and 3 receptors, in North America as a treatment for renal cell carcinoma and other cancers. AVEO is leveraging multiple partnerships aimed at developing and commercializing tivozanib in oncology indications outside of North America, and at progressing its pipeline of novel therapeutic candidates in cancer and cachexia (wasting syndrome). For more information, please visit the company’s website at www.aveooncology.com. This press release contains forward-looking statements of AVEO that involve substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. The words “anticipate,” “believe,” “expect,” “intend,” “may,” “plan,” “potential,” “could,” “should,” “would,” “seek,” “look forward,” “advance,” “goal,” “strategy,” or the negative of these terms or other similar expressions, are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements include, among others, statements about: the Company’s expectation that the CHMP will proceed to an opinion in connection with its review process for tivozanib as a treatment for RCC, that they will announce such opinion at a future CHMP meeting and will submit such opinion to the EC; AVEO’s beliefs about the potential therapeutic benefits of tivozanib as a treatment, including for RCC; AVEO’s strategy, prospects, plans and objectives, including those that relate to advancing therapeutics, including tivozanib, and for leveraging collaborations. AVEO has based its expectations and estimates on assumptions that may prove to be incorrect. As a result, readers are cautioned not to place undue reliance on these expectations and estimates. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements that AVEO makes due to a number of important factors, including risks relating to: whether the tivozanib file will continue to progress through the CHMP on the time frame and manner currently expected; AVEO’s ability to enter into and maintain its third party collaboration agreements; the ability of AVEO and its licensees and other partners to achieve development and commercialization objectives under these arrangements, including, in the case of EUSA’s, its plans to advance the development and commercialization of tivozanib in the European Union; AVEO’s ability, and the ability of its licensees, to demonstrate to the satisfaction of applicable regulatory agencies the safety, efficacy and clinically meaningful benefit of AVEO’s product candidates, including without limitation risks relating to the ability of EUSA to successfully obtain approval of its MMA for tivozanib in the European Union. AVEO faces other risks relating to its business as well, including its ability to successfully enroll and complete clinical trials, including the TIVO-3 and TiNivo studies; AVEO’s ability to achieve and maintain compliance with all regulatory requirements applicable to its product candidates; AVEO’s ability to obtain and maintain adequate protection for intellectual property rights relating to its product candidates and technologies; developments, expenses and outcomes related to AVEO’s ongoing shareholder litigation; AVEO’s ability to successfully implement its strategic plans; AVEO’s ability to raise the substantial additional funds required to achieve its goals, including those goals pertaining to the development and commercialization of tivozanib; unplanned capital requirements; adverse general economic and industry conditions; competitive factors; and those risks discussed in the section titled “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations—Liquidity and Capital Resources” included in AVEO’s Annual Report on Form 10-K for the year ended December 31, 2016, its quarterly reports on Form 10-Q and in other filings that AVEO may make with the SEC in the future. The forward-looking statements in this press release represent AVEO’s views as of the date of this press release. AVEO anticipates that subsequent events and developments may cause its views to change. While AVEO may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. You should, therefore, not rely on these forward-looking statements as representing AVEO's views as of any date other than the date of this press release.


News Article | May 15, 2017
Site: www.prlog.org

-- On May 8, 2017, The European Commission has granted marketing authorization for "Dinutuximab beta Apeiron", an antibody-based immunotherapy of the rare pediatric cancer neuroblastoma. Thanks to the Vienna-based Biotech company Apeiron Biologics AG ("Apeiron") patients in Europe are now offered an additional treatment option with a promising therapy – a result of a collaborative effort of management and employees, academic institutions, Austrian private investors, business angels as well as public and private research initiatives.The drug "Dinutuximab beta Apeiron" improves the survival and chances for cure in the severe pediatric cancer neuroblastoma. The biological agent, an antibody, causes clinically relevant effects in both early and advanced stages of this aggressive disease. Based on the European Commission's marketing authorization Apeiron and its marketing partner EUSA Pharma will now be able to provide an immunotherapy for neuroblastoma in Europe and subsequently worldwide.Chief Executive Officer Hans Loibner, who set up and managed the company since 2005 and is considered the "father" of this success notes: "After years of hard work we have achieved an extraordinary medical and commercial success with this marketing approval, which is a rare event with only very few comparable biotech companies in Europe having achieved such a milestone over the past 10 years. 'We' refers to a remarkably small team of fewer than 20 employees who, together with excellent external partners, have shown what is possible with the right spirit, entrepreneurship and experience. I would like to mention some: Oliver Mutschlechner has led the team for all regulatory activities at Apeiron. Without Prof. Ruth Ladenstein from the St. Anna Children's Hospital in Vienna, the entire project would not exist. Prof. Holger Lode from the University Hospital Greifswald in Germany has provided key clinical contributions. Ulrich Granzer and his team in Munich have fundamentally supported us with their expertise in the regulatory process. Thanks to all."Apeiron was founded in 2003 by Josef Penninger, an internationally renowned Austrian researcher, scientific director of the Institute for Molecular Biotechnology Austria (IMBA) and member of the Supervisory Board of Apeiron. He added: "The most beautiful thing first: We save lives of children with this product! On top, it is now apparent that the Austrian biotech research scene is competitive in the global market place. The future tax revenue originating from this success should justify public investment into this future technology."The chairman of the Supervisory Board, Manfred Reichl, who acted as lead investor for the first time in 2007, emphasizes, "Apeiron is probably the only European biotech company having achieved such an outstanding success based exclusively private funding. Finding the required double-digit million Euro capital from private investors in Austria requires a high credibility of all persons involved." Reichl adds, "The worldwide annual sales of this product, which Apeiron will participate in significantly, are expected to reach triple digit million Euro amounts, demonstrating that the local entrepreneurial start-up culture can also be scientifically and commercially successful on an international level."The development of the antibody in Europe was initiated by Prof. Ruth Ladenstein at the St. Anna Children's Hospital and Children's Cancer Research Institute in Vienna. For more than 15 years, relevant academic clinical studies were conducted by her and by Prof. Holger Lode (University of Greifswald). She comments, "We recognised the potential of this antibody for neuroblastoma therapy at an early stage and have been working on its development together with the pan-European academic consortium SIOPEN and associated hospitals for many years. In Apeiron we have found a congenial industry partner."Neuroblastoma is an orphan oncology condition with significant unmet medical need. It accounts for up to 10% of childhood tumours and affects approximately 1,200 children in the EU5 and US each year. Dinutuximab beta was already widely used across Europe and abroad under a managed access program and was included in a number of treatment protocols for high risk neuroblastoma.Dinutuximab beta Apeiron (ch14.18/CHO;APN311) is a mouse-human chimeric anti-GD2 monoclonal antibody produced in a state-of-the art process in Chinese Hamster Ovary (CHO) cells that significantly improves event-free and overall survival in children with high risk neuroblastoma, with a favourable safety profile compared to other antibody-based neuroblastoma immunotherapies. The antibody forms an important part of treatment regimens for high risk neuroblastoma. Furthermore, its features offer the potential for further development in other malignancies to expand its current role. It has orphan drug designation for neuroblastoma treatment in the US and EU, and EUSA plans to file the product for approval in the United States in 2017.Apeiron is a private biotech company based in Vienna, Austria, engaged in innovative projects in immuno-oncology. In addition to "Dinutuximab beta Apeiron" (, ch14.18/CHO)the company is developing additional cancer immunotherapy projects:is a humanized anti-GD2 antibody-IL-2 fusion protein in clinical stage. Focus of clinical development presently is on melanoma by unique intratumoral application. A broad program is pursued to develop therapies aiming at stimulation of the immune system via novel checkpoint blockade mechanisms to fight cancer:is a preclinical project for orally available drugs, performed together with Sanofi and Evotec.is a novel individual cellular immunotherapy targeting the intracellular checkpoint cbl-b. A Phase I study in advanced cancer patients was successfully performed in the US (Wake Forest University, NC), Phase II is in planning stage.For more information visit www.apeiron- biologics.com Dr. Hans Loibner, CEOCampus-Vienna-Biocenter 51030 Vienna, AustriaT +43 / (0) 664 926 3820E hans.loibner@apeiron-biologics.comW www.apeiron-biologics.com


News Article | May 23, 2017
Site: www.businesswire.com

BEIJING--(BUSINESS WIRE)--CANbridge Life Sciences, a clinical-stage biopharmaceutical company focused on developing Western drug candidates in China and North Asia, announced that it raised $25 million in a Series B round with lead investor, Lapam Capital, a Beijing-based life science venture capital firm, with a portfolio that includes Betta Pharm. Several other institution investors also participated, including: Qiming Venture Partners, Yuanming Capital, Yanyuan Capital, Biossom Investment Management and Wuxi App Tec. Haoyue Capital provided professional services. CANbridge will use the proceeds to fund the clinical trial development of its two lead compounds, CAN008 and CAN017, in China.xs CAN008, a fully-human fusion onco-immunotherapy, is currently in a Phase I/II for the treatment of glioblastoma multiforme (GBM), in Taiwan. The company plans to initiate a Phase II CAN008 GBM trial in China in 2018. CAN017, an antibody inhibitory onco-immunotherpy, will target esophageal squamous cell cancer (ESCC), the prevalent form of esophageal cancer in Asia. CANbridge has raised a total of over $40M in Series A and B financing rounds combined, and has plans for additional strategic transactions in 2017. “We are delighted with the strong response from the market in this round of financing,” said James Xue, PhD, CANbridge Chairman and CEO. “We welcome the new institutional investors, as well as appreciate the continuing support from Qiming and endorsement of our vision, strategy and programs. These funds will bolster CANbridge’s financial position and strategy to build a pipeline of leading candidates in solid-tumor oncology in China. It enables us to advance our clinical trial program in our two lead candidates, CAN008 and CAN017, in China, where we hope to address the serious needs of patients with glioblastoma multiforme and esophageal squamous cell cancer, diseases with almost no effective treatment options.” CANbridge Life Sciences, Ltd. is a clinical-stage bio-pharmaceutical company accelerating development and commercialization of specialty healthcare products for serious and critical medical conditions in China and North Asia (Korea and Taiwan). CANbridge develops partnerships with Western bio-pharmaceutical companies, with clinical-stage pharmaceutical, medical device or diagnostic products, that are either unavailable in China/North Asia or address medical needs that are underserved in the region. CANbridge also licenses, or obtains exclusive rights to develop, drug and device products that are approved in their home markets, for commercialization in China and North Asia. CANbridge has an agreement with EUSA Pharma to commercialize Caphosol® in China for the prevention and treatment of oral mucositis caused by cancer treatments, and a license with Apogenix to develop, manufacture and commercialize immune-oncology therapy, APG101, for the treatment of glioblastoma multiforme in China, Macao, Hong Kong and Taiwan, where it will be developed as CAN008. CANbridge also holds a worldwide license (ex-North America) with AVEO Oncology to develop, manufacture and commercialize clinical-stage ErbB3 (HER3) inhibitory antibody candidate, AV-203, renamed by CANbridge as CAN017. Led and backed by a highly-seasoned executive team, with extensive Chinese drug development experience, CANbridge has the capability to select, acquire, develop and commercialize future therapeutics and diagnostics targeting the unmet medical needs of Chinese and East Asian patients with serious or critical conditions. CANbridge is privately-held and headquartered in Beijing, China. For more on CANbridge Life Sciences, please go to www.canbridgepharma.com.


HEMEL HEMPSTEAD, Angleterre--(BUSINESS WIRE)--EUSA Pharma (EUSA), une société de spécialités pharmaceutiques axée sur l'oncologie et les soins oncologiques de soutien, a annoncé aujourd'hui que le Comité des médicaments à usage humain (CHMP) de l'Agence européenne des médicaments (EMA) a émis un avis favorable recommandant l'autorisation de mise sur le marché de FOTIVDA (tivozanib) pour la prise en charge des adultes atteints de carcinome à cellules rénales (CCR) avancé dans l'Union européenne, ainsi qu'en Norvège et en l'Islande. Si ce médicament est approuvé, il sera indiqué pour le traitement de première intention des adultes atteints de CCR avancé et des adultes naïfs des inhibiteurs du VEGFR et de la voie mTOR, à la suite de l'évolution de la maladie après un traitement préalable à base de cytokines pour le CCR avancé1. Le CCR est la forme la plus courante de cancer du rein2 et serait responsable d'environ 49 000 décès en Europe chaque année3. On estime qu'il sera l'un des cancers qui connaîtra la plus forte croissance au cours des dix prochaines années4. Les inhibiteurs de l'activité tyrosine-kinase des récepteurs du facteur de croissance de l'endothélium vasculaire (VEGFR-TKI) sont actuellement le traitement de première intention de référence du CCR avancé en Europe, mais les patients ainsi traités présentent souvent des effets secondaires significatifs5,6. La recommandation du CHMP est basée sur des données issues de l'essai international de phase III multicentrique, ouvert, randomisé (TiVO-1)1,5 qui a évalué l'efficacité et la tolérabilité du tivozanib par rapport à un traitement comparatif à base de VEGFR-TKI (sorafénib) offert actuellement pour le traitement de plus de 500 patients atteints de CCR avancé. L'essai a atteint son critère d'évaluation principal, démontrant la survie sans progression (SSP) médiane la plus longue observée avec un VEGFR-TKI dans une étude clinique de phase III sur un traitement de première intention du CCR avancé. Les patients traités par le tivozanib ont présenté une meilleure SSP (11,9 contre 9,1 mois parmi la population générale [RR, 0,797 ; IC à 95 %, 0,639 à 0,993 ; P = 0,042] et 12,7 contre 9,1 mois parmi les patients naïfs de traitement [RR, 0,756 ; IC à 95 %, 0,580 à 0,985 ; P = 0,037]) par rapport au sorafénib1,5. On a également constaté une amélioration du profil d'effets secondaires du tivozanib, c'est-à-dire que 86 % des patients ont pu continuer à prendre la dose complète (contre 57 % avec le sorafénib, P = < 0,001) et seulement 14 % (contre 43 % avec le sorafénib) ont dû recevoir une dose réduite en raison d'événements indésirables (EI). En outre, un nombre inférieur de patients traités par le tivozanib ont présenté les effets secondaires défavorables couramment associés aux autres VEGFR-TKI, comme la diarrhée (23 % contre 33 %) et le syndrome d'enflure douloureuse des mains et des pieds (14 % contre 54 %)5. Le docteur Bernard Escudier, oncologiste médical et membre du comité des tumeurs génito-urinaires à l'Institut Gustave Roussy (France), a déclaré : « C'est une bonne nouvelle pour les patients atteints de CCR métastatique. Les effets de cette maladie se sont considérablement améliorés avec l'introduction de traitements ciblés. Les patients vivent plus longtemps bien que les traitements offerts actuellement puissent être associés à des toxicités significatives. Nous sommes toujours à la recherche de nouveaux traitements efficaces et bien tolérés du CCR métastatique et de ce fait, le tivozanib sera une addition bienvenue. Nous avons aussi hâte de poursuivre nos recherches sur des approches combinées potentielles avec d'autres agents thérapeutiques. » « L'avis rendu aujourd'hui par le CHMP en faveur de l'autorisation de mise sur le marché du tivozanib dans l'Union européenne est une étape importante dans l'expansion des options thérapeutiques pour les patients atteints de cancer à cellules rénales avancé chez qui, malgré les progrès réalisés, les taux de survie au stade avancé de la maladie restent faibles et les traitements existants peuvent être associés à des toxicités limitant l'effet thérapeutique », a indiqué le docteur Jon Morgan, directeur médical chez EUSA Pharma. « L'avis rendu est étayé par les résultats solides et fiables de l'étude pivot TiVO-1 qui ont démontré l'efficacité probante du tivozanib comme traitement de première intention et, notamment pour cette classe d'agents, un profil de tolérance très favorable et avantageux. » Le cancer du rein est le septième cancer le plus fréquent en Europe, 115 000 nouveaux cas étant diagnostiqués chaque année7. Le CCR est la forme de cancer du rein la plus courante2, représentant environ 80 % de tous les cancers du rein8. On estime qu'il sera l'un des cancers qui connaîtra la plus forte croissance au cours des dix prochaines années, en raison du vieillissement de la population en Europe, le tabagisme et la progression de l'obésité jouant également un rôle important4. Une expression excessive de la protéine VEGF et l'augmentation de l'irrigation sanguine (angiogenèse) de la tumeur qui en résulte sont des caractéristiques courantes du CCR5. Les VEGFR-TKI réduisent l'irrigation sanguine de la tumeur et sont le traitement de première intention de référence du CCR avancé en Europe. Cependant, les patients actuellement traités présentent souvent des effets secondaires significatifs, y compris éruptions cutanées, diarrhée et syndrome d'enflure douloureuse des mains et des pieds. Dans l'essai international de phase III (TiVO-1)5 sur le CCR avancé, le tivozanib a démontré un avantage significatif de la SSP par rapport au sorafénib (11,9 contre 9,1 mois parmi la population générale [RR, 0,797 ; IC à 95 %, 0,639 à 0,993 ; P = 0,042] et 12,7 contre 9,1 mois parmi les patients naïfs de traitement [RR, 0,756 ; IC à 95 %, 0,580 à 0,985 ; P = 0,037])1,5. On a également constaté une amélioration du profil d'effets secondaires par rapport au sorafénib, moins de patients traités par tivozanib (14 % contre 43 %) ayant dû recevoir une dose réduite en raison d'EI ; et moins de 5 % des patients présentant les effets secondaires sévères (grades 3 et 4) généralement associés à d'autres VEGF-TKI, comme la diarrhée, l'asthénie (faiblesse physique) et le syndrome d'enflure douloureuse des mains et des pieds. L'hypertension (44 %) et la dysphonie (21 %) étaient les EI les plus fréquemment signalés avec le tivozanib5. Aux termes de l'accord de licence d'EUSA avec AVEO PHARMACEUTICALS, INC, annoncé en décembre 2015, la société détient les droits de commercialisation exclusifs sur le tivozanib dans le traitement du CCR en Europe et dans un certain nombre d'autres territoires en dehors de l'Amérique du Nord, y compris en Amérique du Sud et en Afrique du Sud, en plus d'une gamme d'autres indications. Selon les termes de cet accord, EUSA Pharma entreprendra et financera la commercialisation du produit dans ses territoires, sous réserve de son approbation. AVEO PHARMACEUTICALS, INC conserve les droits de commercialisation du produit en Amérique du Nord. Fondée en mars 2015, EUSA Pharma est une société pharmaceutique spécialisée qui exerce des activités commerciales aux États-Unis et en Europe et possède un vaste réseau de distribution couvrant environ 40 pays dans le monde. EUSA détient actuellement un portefeuille de spécialités hospitalières approuvées et plusieurs destinées à des patients nommément désignés, que la société a pour ambition de développer en procédant à des acquisitions ainsi qu'à l'obtention de droits de distribution sous licence. EUSA est dirigée par une équipe composée de professionnels expérimentés, ayant fait leurs preuves à la tête de sociétés de spécialités pharmaceutiques performantes, et est financée par des fonds importants levés par le grand investisseur dans le domaine des sciences de la vie, EW Healthcare Partners. EUSA Pharma compte parmi ses produits : la solution dispersable Caphosol® pour le traitement de l'inflammation de la muqueuse buccale, un effet secondaire courant et débilitant de la radiothérapie et de la chimiothérapie à doses élevées ; Collatamp®, un implant de gentamicine-collagène homologué pour l'hémostase ou la prévention et le traitement de l'infection du site opératoire ; la solution Custodiol® utilisée dans la préservation des organes de transplantation ; Fomepizole pour le traitement de l'intoxication à l'éthylène glycol ; Xenazine® pour le traitement des troubles moteurs associés à la maladie de Huntington ; et le dinutuximab bêta pour le traitement des patients atteints de neuroblastome à risque élevé. AVEO PHARMACEUTICALS, INC est une société biopharmaceutique qui cherche à établir un vaste portefeuille de traitements ciblés pour l'oncologie et d'autres secteurs où les besoins médicaux restent à satisfaire. La société est spécialisée dans le développement et la commercialisation de son principal candidat, le tivozanib, un inhibiteur puissant, sélectif, à longue demi-vie des récepteurs 1, 2 et 3 du facteur de croissance de l'endothélium vasculaire, en Amérique du Nord, pour le traitement du carcinome des cellules rénales et d'autres cancers. AVEO a établi plusieurs partenariats pour développer et commercialiser le tivozanib pour des indications non oncologiques sur le plan international et pour des indications oncologiques en dehors de l'Amérique du Nord, ainsi que pour élargir son pipeline de candidats thérapeutiques innovants contre le cancer et la cachexie (syndrome de dépérissement). Pour de plus amples informations, veuillez vous rendre sur le site de la société à www.aveooncology.com. 4 Cancer Research UK. Kidney cancer rates are increasing, so what’s fuelling the surge? Disponible sur le site http://scienceblog.cancerresearchuk.org/2017/04/24/kidney-cancer-rates-are-increasing-so-whats-fuelling-the-surge/. Consulté en juin 2017. 5 Motzer R.J; Nosov D et al. Tivozanib Versus Sorafenib As Initial Targeted Therapy for Patients With Metastatic Renal Cell Carcinoma: Results From a Phase III Trial. Journal of Clinical Oncology. Volume 31. 2013: 30:3791 6 Wong MKK, Mohamed AF et al. Selecting renal cell carcinoma therapy: Ranking of patient perspective on toxicities. J Clin Oncol 30: 303s, 2012 (suppl; abstr 4608) 8 Escudier B; Porta C et al. Renal cell carcinoma: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Annals of Oncology 27 (Supplement 5). 2016: v58–v68. Disponible sur le site http://www.esmo.org/Guidelines/Genitourinary-Cancers/Renal-Cell-Carcinoma. Consulté en juin 2017.


This positive CHMP opinion follows the European Commission's recent expedited approval of EUSA's dinutuximab beta, which is the only immunotherapy indicated for the treatment of high risk neuroblastoma in Europe.  The approval followed a positive CHMP opinion issued at the end of March 2017. "Today's opinion by the CHMP to recommend marketing authorization of tivozanib in the EU is an important step in expanding treatment options for patients with advanced renal cell carcinoma, where, despite advancements in therapy, survival rates in advanced disease remain low and existing treatments can be associated with therapy-limiting toxicities," said Dr Jon Morgan, Medical Director, EUSA Pharma. "The opinion is supported by robust and consistent results from the TiVO-1 pivotal study which demonstrated compelling efficacy of tivozanib as a first-line treatment, and importantly for this class of agents, a highly favorable and advantageous tolerability profile." Lee Morley, EUSA Pharma's Chief Executive Officer said, " Tivozanib has the potential to become an important new first-line therapy and this positive CHMP outcome represents a great achievement for the EUSA team.  Along with the recent EU approval of dinutuximab beta, EUSA is making great strides in building a leading specialty pharmaceutical business. In our short history we have made significant progress in expanding our portfolio of specialist medicines, and we look forward to further strengthening our portfolio focused in the oncology field." Kidney cancer is responsible for 5% of malignancies in men and 3% in women, making it the 7th and 10th most common type of cancer respectively. Of these kidney cancers, approximately 80% are renal cell carcinoma (RCC). Known risk factors for RCC include cigarette smoking, obesity and hypertension. Tivozanib is an oral, once-daily, vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor. It is a potent, selective and long half-life inhibitor of all three VEGF receptors and is designed to optimize VEGF blockade while minimizing off-target toxicities, potentially resulting in improved efficacy and minimal dose modifications. Tivozanib has been investigated in several tumor types, including renal cell, colorectal and breast cancers.  EUSA holds exclusive commercialization rights to tivozanib in RCC in Europe, and in a number of other territories, including South America and South Africa, in addition to a range of further indications. Founded in March 2015, EUSA Pharma is a specialty pharmaceutical company with commercial operations in the US and Europe, and a wider distribution network in approximately 40 further countries. Currently, EUSA has a broad portfolio of approved and named-patient specialty hospital products, which the company has ambitious plans to expand through acquisition and in-licensing. EUSA is led by an experienced management team with a strong record of building successful specialty pharmaceutical companies, and is supported by significant funding raised from leading life science investor EW Healthcare Partners. In addition to tivozanib, EUSA Pharma's products include: Dinutuximab beta for the treatment of high-risk neuroblastoma; Caphosol® for the treatment of oral mucositis, a common and debilitating side-effect of radiation therapy and high-dose chemotherapy; Collatamp®, a gentamicin-collagen implant licensed either in hemostasis or for the prevention and treatment of surgical site infection; Custodiol® solution for use in the preservation of organs for transplantation; Fomepizole® for the treatment of ethylene glycol poisoning; and Xenazine® for the treatment of abnormal movements associated with Huntington's chorea and hemiballismus.  For more information visit http://www.eusapharma.com.


HEMEL HEMPSTEAD, England--(BUSINESS WIRE)--EUSA Pharma (EUSA), ein Spezialpharmaunternehmen, das sich auf Onkologie und onkologische Betreuung konzentriert, gab heute bekannt, dass der Ausschuss für Humanarzneimittel (CHMP) der Europäischen Arzneimittelbehörde (EMA) eine positive Beurteilung abgegeben hat und die Genehmigung für das Inverkehrbringen von FOTIVDA (Tivozanib) zur Behandlung erwachsener Patienten mit fortgeschrittenem Nierenzellkarzinom (RCC) in der Europäischen Union sowie in Norwegen und Island empfiehlt. Im Falle der Zulassung wird das Medikament bei einer Erstlinienbehandlung erwachsener Patienten mit fortgeschrittenem RCC und für erwachsene Patienten, die VEGFR- und mTOR-Signalweg-Hemmer-naiv sind, nach Krankheitsprogression im Anschluss an eine vorherige Behandlung mit einer Zytokin-Therapie bei fortgeschrittenem RCC indiziert sein.1 Die Beurteilung des CHMP basiert auf Daten aus der globalen, offenen, randomisierten multizentrischen Phase-III-Studie (TiVO-1)1,5, welche die Wirksamkeit und Verträglichkeit von Tivozanib im Vergleich zu der gegenwärtig verfügbaren VEGFR-TKI-Behandlung (Sorafenib) anhand der Behandlung von mehr als 500 Patienten mit fortgeschrittenem RCC evaluierte. Die Studie erreichte ihren primären Endpunkt, indem sie das längste mittlere progressionsfreie Überleben (PFS) bei einem VEGFR-TKI im Rahmen einer klinischen Phase-III-Studie zur Untersuchung der Erstlinientherapie bei fortgeschrittenem RCC nachweisen konnte. Die mit Tivozanib behandelten Patienten verzeichneten ein längeres PFS (11,9 Monate im Vergleich zu 9,1 Monate in der Gesamtpopulation [Hazard-Ratio 0,797; Konfidenzintervall zum Niveau 95%; 0,639 bis 0,993; p = 0,042] und 12,7 Monate im Vergleich zu 9,1 Monate bei therapienaiven Patienten [Hazard-Ratio 0,756; Konfidenzintervall zum Niveau 95%, 0,580 bis 0,985; p = 0,037]) im Vergleich mit Sorafenib.1,5 Es besteht darüber hinaus ein verbessertes Nebenwirkungsprofil bei der Anwendung von Tivozanib. Dies bedeutet, dass 86% der Patienten in der Lage waren, bei der vollen Dosismenge zu bleiben (im Vergleich zu 57% bei Gaben von Sorafenib, p =< 0,001) und lediglich 14% (im Vergleich zu 43% bei Sorafenib) eine Dosisreduzierung aufgrund von unerwünschten Ereignissen (AEs) erforderten. Darüber hinaus berichteten weniger Patienten bei Gaben von Tivozanib über belastende Nebenwirkungen, die oftmals in Zusammenhang mit anderen VEGFR-TKIs stehen. Hierzu gehören Diarrhoe (23% im Vergleich zu 33%) und das Hand-Fuß-Syndrom (14% im Vergleich zu 54%).5 „Die heutige Beurteilung durch den CHMP mit der Empfehlung der Genehmigung des Inverkehrbringens von Tivozanib in der EU ist ein bedeutender Schritt auf dem Weg zur Erweiterung der Behandlungsoptionen für Patienten mit fortgeschrittenem Nierenzellkarzinom, bei denen bislang trotz Fortschritten in der Therapierung die Überlebensraten bei fortgeschrittenem Krankheitsverlauf niedrig bleiben und die bestehenden Behandlungsformen mit therapiehemmenden Toxizitäten in Zusammenhang gebracht werden müssen”, so Dr Jon Morgan, Medical Director, EUSA Pharma. „Die Beurteilung wird durch belastbare und konsistente Ergebnisse aus der Zulassungsstudie TiVO-1 unterstützt, die eine überzeugende Wirksamkeit von Tivozanib zur Erstlinienbehandlung und ein besonders günstiges und vorteilhaftes Verträglichkeitsprofil zeigte, was für diese Klasse von Wirkstoffen von besonderer Bedeutung ist.” Nach der positiven Beurteilung des CHMP wird die Europäische Kommission nun eine formale Entscheidung zur Zulassung veröffentlichen und falls die Zulassung erfolgt, wird Tivozanib zur Anwendung in 28 Ländern in der Europäischen Union sowie in Island und Norwegen indiziert sein. Im Rahmen der im Dezember 2015 angekündigten Lizenzvereinbarung von EUSA mit AVEO PHARMACEUTICALS, INC hält das Unternehmen exklusive Vermarktungsrechte an Tivozanib zur Anwendung bei RCC in Europa und mehreren anderen Regionen außerhalb Nordamerikas, darunter Südamerika und Südafrika sowie für eine Reihe weiterer Indikationen. Gemäß den Vertragsbedingungen wird EUSA Pharma unter der Voraussetzung der formalen Zulassung die Vermarktung des Produkts in seinen Regionen durchführen und finanzieren. AVEO PHARMACEUTICALS, INC behält das Recht, das Produkt in Nordamerika zu vermarkten. AVEO PHARMACEUTICALS, INC ist ein biopharmazeutisches Unternehmen, das bestrebt ist, ein breites Portfolio an zielgerichteten Therapeutika für die Onkologie und andere Bereiche mit ungedecktem medizinischem Bedarf voranzubringen. Das Unternehmen konzentriert sich auf die Entwicklung und Vermarktung seines Hauptkandidaten Tivozanib, ein wirksamer, selektiver Half-Life-Inhibitor der vaskulären endothelialen Wachstumsfaktoren 1-3 zur Behandlung von Nierenzellkarzinomen und anderen Krebserkrankungen in Nordamerika. AVEO nutzt mehrere Partnerschaften zur Entwicklung und Vermarktung von Tivozanib für nicht onkologische Indikationen weltweit und onkologische Indikationen außerhalb Nordamerikas sowie für die Weiterentwicklung seiner Pipeline neuartiger therapeutischer Produktkandidaten zur Behandlung von Krebs und Kachexie (Wasting-Syndrom). Weitere Informationen finden Sie auf der Website des Unternehmens unter www.aveooncology.com. 1 Committee for Medicinal Products for Human Use (CHMP). Summary of opinion to be made. Verfügbar unter: http://www.ema.europa.eu 4 Cancer Research UK. Kidney cancer rates are increasing, so what’s fuelling the surge? Verfügbar unter: http://scienceblog.cancerresearchuk.org/2017/04/24/kidney-cancer-rates-are-increasing-so-whats-fuelling-the-surge/. Letzte Aktualisierung: Juni 2017. 5 Motzer R.J; Nosov D et al. Tivozanib Versus Sorafenib As Initial Targeted Therapy for Patients With Metastatic Renal Cell Carcinoma: Results From a Phase III Trial. Journal of Clinical Oncology. Volume 31. 2013: 30:3791 6 Wong MKK, Mohamed AF et al. Selecting renal cell carcinoma therapy: Ranking of patient perspective on toxicities. J Clin Oncol 30: 303s, 2012 (suppl; abstr 4608) 8 Escudier B; Porta C et al. Renal cell carcinoma: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Annals of Oncology 27 (Supplement 5). 2016: v58–v68. Verfügbar unter: http://www.esmo.org/Guidelines/Genitourinary-Cancers/Renal-Cell-Carcinoma. Letzte Aktualisierung: Juni 2017.


HEMEL HEMPSTEAD, England--(BUSINESS WIRE)--EUSA Pharma (EUSA), a specialty pharmaceutical company with a focus on oncology and oncology supportive care, today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending marketing authorisation of FOTIVDA (tivozanib) for the management of adult patients with advanced renal cell carcinoma (RCC) in the European Union plus Norway and Iceland. If approved, it will be indicated for the first-line treatment of adult patients with advanced RCC and for adult patients who are VEGFR and mTOR pathway inhibitor-naïve following disease progression after one prior treatment with cytokine therapy for advanced RCC.1 RCC is the most common form of kidney cancer,2 which accounts for an estimated 49,000 deaths in Europe each year.3 It is expected to be one of the fastest increasing cancers over the next ten years.4 Vascular endothelial growth factor receptor tyrosine kinase inhibitors (VEGFR-TKIs) are currently the gold standard first-line treatment for advanced RCC in Europe, however, patients on existing treatments can often experience significant side effects.5,6 The CHMP’s recommendation is based on data from the global, open-label, randomised, multi-centre Phase III trial (TiVO-1)1,5 which evaluated the efficacy and tolerability of tivozanib compared to a currently available comparator VEGFR-TKI treatment (sorafenib) in the treatment of over 500 patients with advanced RCC. The trial met its primary endpoint demonstrating the longest median progression-free survival (PFS) seen with a VEGFR-TKI in a first-line phase III clinical study in advanced RCC. Patients treated with tivozanib experienced superior PFS (11.9 vs. 9.1 months in the overall population [HR, 0.797; 95% CI, 0.639 to 0.993; P =.042] and 12.7 vs. 9.1 months in treatment-naïve patients [HR, 0.756; 95% CI, 0.580 to 0.985; P =.037]) versus sorafenib.1,5 There was also an improved side effect profile with tivozanib, meaning 86% of patients were able to remain on full dose (versus 57% with sorafenib, P = <0.001), with only 14% (versus 43% with sorafenib) requiring a dose reduction due to adverse events (AEs). In addition, fewer people on tivozanib experienced the burdensome side effects, commonly associated with other VEGFR-TKIs, such as diarrhoea (23% vs 33%), and hand-foot syndrome (14% vs 54%).5 Dr Bernard Escudier, Medical Oncologist and member of the Genitourinary Tumour Board of Gustave Roussy, France, commented “This is excellent news for patients with metastatic RCC. Outcomes in this disease have greatly improved with the introduction of targeted therapies, meaning that patients are living for longer, although currently available therapies can be associated with burdensome toxicities. We are still in need of effective and well tolerated new treatments in metastatic RCC and thus, tivozanib will be a welcomed addition. We also look forward to continuing our investigations of potential combination approaches with other therapeutic agents.” Tivozanib is an oral, once-daily, potent and highly-selective VEGFR-TKI. Current first-line VEGFR-TKIs block the action of a broad range of Tyrosine Kinases (TKs), in addition to the VEGFR targets, which can lead to patients experiencing burdensome side effects.5,6 “Today’s opinion by the CHMP to recommend marketing authorisation of tivozanib in the EU is an important step in expanding treatment options for patients with advanced renal cell carcinoma, where, despite advancements in therapy, survival rates in advanced disease remain low and existing treatments can be associated with therapy-limiting toxicities,” said Dr Jon Morgan, Medical Director, EUSA Pharma. “The opinion is supported by robust and consistent results from the TiVO-1 pivotal study which demonstrated compelling efficacy of tivozanib as a first-line treatment, and importantly for this class of agents, a highly favourable and advantageous tolerability profile.” Lee Morley, EUSA Pharma’s Chief Executive Officer said, “Tivozanib has the potential to become an important new first-line therapy and this positive CHMP outcome represents a great achievement for the EUSA team. Along with the recent EU approval of dinutuximab beta, EUSA is making great strides in building a leading specialty pharmaceutical business. In our short history we have made significant progress in expanding our portfolio of specialist medicines, and we look forward to further strengthening our portfolio focused in the oncology field.” Following the CHMP positive opinion, the European Commission will now issue a formal decision on approval, and if approved, tivozanib will be indicated for use in the 28 countries in the European Union plus Iceland and Norway. Kidney cancer is the seventh most common cancer in Europe, with more than 115,000 new cases diagnosed each year.7 RCC is the most common form of kidney cancer2 with RCC accounting for around 80% of all kidney cancers.8 Kidney cancer is expected to be one of the fastest increasing cancers over the next ten years, as a result of Europe’s ageing population, with smoking and a rise in obesity also playing a part.4 An over-expression of VEGF protein, and a resulting increase in tumour blood supply (angiogenesis), is a common feature of RCC.5 VEGFR-TKIs reduce the supply of blood to the tumour and are the gold standard first-line treatment for advanced RCC in Europe, however, patients on current treatments often experience significant side effects, including skin rashes, diarrhoea, and hand-foot syndrome. In the global Phase III trial (TiVO-1)5 in advanced RCC, tivozanib demonstrated a significant PFS benefit versus sorafenib (11.9 vs. 9.1 months in the overall patient population [HR, 0.797; 95% CI, 0.639 to 0.993; P =.042], and 12.7 vs. 9.1 months in treatment-naïve patients [HR, 0.756; 95% CI, 0.580 to 0.985; P =.037]).1,5 There was also an improved side-effect profile versus sorafenib, with significantly fewer patients on tivozanib (14% versus 43%) requiring a dose reduction due to AEs; and less than 5% of patients experiencing the severe side effects (grade 3&4) commonly associated with other VEGF-TKIs, such as diarrhoea, asthenia (physical weakness) and hand-foot syndrome. Hypertension (44%) and dysphonia (21%) were the most commonly reported AEs on tivozanib.5 Under EUSA’s license agreement with AVEO PHARMACEUTICALS, INC, announced in December 2015, the company holds exclusive commercialisation rights to tivozanib in RCC in Europe and in a number of other territories outside North America, including South America and South Africa, in addition to a range of further indications. Under the terms of the agreement, EUSA Pharma will undertake and fund the commercialisation of the product in its territories, assuming approval. AVEO PHARMACEUTICALS, INC retains the rights to commercialise the product in North America. Founded in March 2015, EUSA Pharma is a specialty pharmaceutical company. The company has commercial operations in the US and Europe, and a wider distribution network in approximately 40 countries around the world. Currently, EUSA has a portfolio of approved and several named-patient specialty hospital products, which the company has ambitious plans to expand through acquisition and in-licensing. EUSA is led by an experienced management team with a strong record of building successful specialty pharmaceutical companies, and is supported by significant funding raised from leading life science investor EW Healthcare Partners. EUSA Pharma’s products include: Caphosol® dispersible for the treatment of oral mucositis, a common and debilitating side-effect of radiation therapy and high-dose chemotherapy; Collatamp®, a gentamicin-collagen implant licensed either in haemostasis or for the prevention and treatment of surgical site infection; Custodiol® solution for use in the preservation of organs for transplantation; Fomepizole for the treatment of ethylene glycol poisoning; Xenazine® for the treatment of movement disorders associated with Huntington's chorea; and Dinutuximab beta for the treatment of patients with high-risk neuroblastoma. AVEO PHARMACEUTICALS, INC is a biopharmaceutical company dedicated to advancing a broad portfolio of targeted therapeutics for oncology and other areas of unmet medical need. The company is focused on developing and commercialising its lead candidate tivozanib, a potent, selective, long half-life inhibitor of vascular endothelial growth factor, 1, 2 and 3 receptors, in North America as a treatment for renal cell carcinoma and other cancers. AVEO is leveraging multiple partnerships to develop and commercialise tivozanib in non-oncologic indications worldwide and oncology indications outside of North America, as well as to progress its pipeline of novel therapeutic candidates in cancer and cachexia (wasting syndrome). For more information, please visit the company’s website at www.aveooncology.com. 1 Committee for Medicinal Products for Human Use (CHMP). Summary of opinion to be made. Available at: http://www.ema.europa.eu 2 Cancer Research UK. Kidney Cancer, Types and Grades. Available at: http://www.cancerresearchuk.org/about-cancer/kidney-cancer/stages-types-grades/types-grades. Last accessed June 2017. 3 Cancer Research UK. Kidney Cancer Statistics. Available at: http://www.cancerresearchuk.org/health-professional/cancer-statistics/statistics-by-cancer-type/kidney-cancer/mortality#heading-Five. Last accessed June 2017. 4 Cancer Research UK. Kidney cancer rates are increasing, so what’s fuelling the surge? Available at: http://scienceblog.cancerresearchuk.org/2017/04/24/kidney-cancer-rates-are-increasing-so-whats-fuelling-the-surge/. Last accessed June 2017. 5 Motzer R.J; Nosov D et al. Tivozanib Versus Sorafenib As Initial Targeted Therapy for Patients With Metastatic Renal Cell Carcinoma: Results From a Phase III Trial. Journal of Clinical Oncology. Volume 31. 2013: 30:3791 6 Wong MKK, Mohamed AF et al. Selecting renal cell carcinoma therapy: Ranking of patient perspective on toxicities. J Clin Oncol 30: 303s, 2012 (suppl; abstr 4608) 8 Escudier B; Porta C et al. Renal cell carcinoma: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Annals of Oncology 27 (Supplement 5). 2016: v58–v68. Available at: http://www.esmo.org/Guidelines/Genitourinary-Cancers/Renal-Cell-Carcinoma. Last accessed June 2017.

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