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Biopharmaceuticals Oncology Regulatory

 News Release - June 23, 2017

EUSA Pharma Receives Positive CHMP Opinion for Tivozanib for the First-Line Treatment of Advanced Renal Cell Carcinoma in Europe

HEMEL HEMPSTEAD, England, June 23, 2017 -- (Healthcare Sales & Marketing Network) -- EUSA Pharma (EUSA), a specialty pharmaceutical company with a focus on oncology and oncology supportive care, today announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the approval of FOTIVDA« (tivozanib) for the management of adult patients with advanced renal cell carcinoma (RCC). EUSA's marketing authorisation application included data from the TiVO-1 pivotal study, which included over 500 patients with advanced RCC. Following the positive CHMP opinion, the European Commission will now issue a formal decision on approval, and if granted, tivozanib will be indicated for use in the 28 countries of the European Union plus Norway and Iceland, for the first-line treatment of adult patients with advanced RCC and for adult patients who are VEGFR and mTOR pathway inhibitor-na´ve following disease progression after one prior treatment with cytokine therapy for advanced RCC.

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."

About renal cell carcinoma and tivozanib

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.

About EUSA Pharma

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.


Source: EUSA Pharma

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