Business Wire

EUSA Pharma Receive Positive Opinion from The CHMP For tivozanib For The First-Line Treatment of Advanced Renal Cell Carcinoma In The European Union

Del

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.

-ENDS-

NOTES TO EDITORS

About tivozanib and renal cell carcinoma (RCC)

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.

About EUSA Pharma

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.

For more information visit www.eusapharma.com.

About AVEO

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.

References

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)

7 http://www.cancerresearchuk.org/health-professional/cancer-statistics/statistics-by-cancer-type/kidney-cancer/incidence#heading-Ten. Last accessed June 2017.

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.

Contact information

EUSA Pharma
Lee Morley
Chief Executive
Tel +44 (0) 330 5001140

Om Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982http://www.businesswire.co.uk

Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.

Følg saker fra Business Wire

Registrer deg med din epostadresse under for å få de nyeste sakene fra Business Wire på epost fortløpende. Du kan melde deg av når som helst.

Siste saker fra Business Wire

The Listing of Money Trade Coin on Cryptocurrency Exchange and the Rising Promise of a New Era in Dubai21.9.2017 17:45Pressemelding

MONEY TRADE COIN, the new age cryptocurrency, dazzled its investors’ expectations by listing on NovaExchange. Immediate trading began post the launch by Money Trade Coin’s founder and CEO, Mr. Amit Lakhanpal and H.E. Sheikh Saqer Al Nahyan. The listing event held on September 17 at Burj Al Arab was witnessed by a list of 40 VIP businessmen including H.E. Sheikh Jumaa Al Maktoum, Mr. Faisal Almaazmi, his principal advisor and director of Greenland Capital Properties, Mr. Charles Said Kiwan founder of MVP Tech and Mr. Khaled Abdulla, Head of Communications MENA at Barclays PLC. This Smart News Release features multimedia. View the full release here: http://www.businesswire.com/news/home/20170921006013/en/ Amit Lakhanpal greets H.E. Sheikh Saqer Al Nahyan (Photo: AETOS Wire) Money Trade Coin, the propagator of the “Cryptocurrency correct knowledge” l

Triaconta Announces a New Safe Way to Invest in Cryptocurrencies21.9.2017 16:18Pressemelding

Triaconta wants to minimize the risks of investing in cryptocurrencies with Combicoin to make the cryptocurrency market accessible for a larger audience. CombiCoin is 100% asset backed by the top 30 cryptocurrencies with the highest market cap. Because of this the CombiCoin will not suddenly plunge and investors will have less risks when there are major fluctuations. There are over 1000 cryptocurrencies on the market and together they represent a value of 130 billion USD. However, all these coins are very volatile. For example, the value of bitcoin grew from 1000 to 4000 USD within six months. The value of Ethereum, the second largest cryptocurrency, rose from 150 to 400 USD within 6 months but plunged to 150 USD 4 weeks later. In the first six months of 2017 the top 30 of cryptocurrencies grew with 1200 percent. The value of CombiCoin is determined for 3.3

TIP Trailer Services Announces the Successful Refinancing of its ABS program21.9.2017 15:16Pressemelding

On 21 September 2017, TIP Trailer Services announced that it had successfully refinanced its Asset Backed Securitisation (ABS) program. The Pan-European program was originally established in 2014 and is a securitisation structure common under Dutch law for operating leases. The new program will run until March 2019. This Smart News Release features multimedia. View the full release here: http://www.businesswire.com/news/home/20170921005815/en/ At the official signing of the TIP ABS refinancing were: From left to right: Jorrit Achterberg (Legal Counsel, TIP Trailer Services), Patrick Vergouwen (International Investor Relations Manager, TIP Trailer Services), Bart de Boo (Director, Asset Based Finance, Rabobank), Gert Huizing (Quality Assurance Manager Capital Market Services, Intertrust), Leo van der Sman (Legal Counsel, Intertrust) (Photo: Business Wire) “The extra funding and improved co

Tohatsu, Major Outboard Manufacturer, to Launch Global Brand Campaign Targeting Millennial Generation Boat Users21.9.2017 14:30Pressemelding

On September 21, 2017, Tohatsu Corporation (headquartered in Tokyo, Japan; hereinafter &quot;TOHATSU&quot;) announced the outline of its global brand campaign at the 57th Genoa International Boat Show held in Genova, Italy. TOHATSU’s global brand campaign based on a new branding strategy will be deployed at boat shows around the world, starting from the Genoa International Boat Show in September 2017. This Smart News Release features multimedia. View the full release here: http://www.businesswire.com/news/home/20170921005018/en/ Feel the Wind (Photo: Business Wire) The campaign sets “SMARTS” millennials as its core target, revealing TOHATSU’s new brand logo, “Blue Wings” and its unique “Simpliq™ Technology” The feature of the new branding strategy is its target demographic called “SMARTS”, millennial boat owners (born between 1977 and 199

Sigma Systems Chief Technology Officer to Address CSPs at Futurecom 201721.9.2017 14:00Pressemelding

Sigma Systems, the global leader in catalog-driven software, has today announced that its Chief Technology Officer, Catherine Michel, will be speaking at Futurecom 2017 – the largest ICT event in Latin America. Catherine will address communications service providers (CSPs) and industry professionals at the Sao Paulo event on what’s driving the digitalization mandate for operators. Ahead of her presentation, Catherine commented: “The digitalization of the CSP is about transforming business operations, based on a thorough understanding of customer needs, behaviours and experiences. This requires a shift in corporate culture, and many CSPs are not making the changes necessary to embrace digital innovation and become market leading digital service providers. To deliver on a digital transformation, operators must embrace digital innovation and enable the rapid launch a

Encanto Potash Corp Secures CAD $100 Million Capital Commitment from GEM Global21.9.2017 13:00Pressemelding

Encanto Potash Corp. (&quot;Encanto&quot; or the &quot;Company&quot;) the TSX-V listed Potash development; Mining and Operating company (TSX-V: EPO) is pleased to announce that it has secured a commitment for a CAD $100 million funding facility. Under the funding agreement signed 15th September, 2017 (the &quot;Agreement&quot;), GEM Investments America, LLC and GEM Global Yield LLC SCS undertake to invest up to CAD $100,000,000 over the next three years. The proceeds will be used to commence the engineering and design phase of the mine in anticipation of a shovel-ready construction date of September 2019. Under a joint venture agreement with Muskowekwan Resources Ltd and Chief Reginald Bellerose of the First Nation’s Muskowekwan tribe, Encanto has secured the mineral rights for the mine and completed preliminary studies. In the interim, proceeds will also be used for the procurement an

I vårt presserom finner du alle våre siste saker, kontaktpersoner, bilder, dokumenter og annen relevant informasjon om oss.

Besøk vårt presserom