Servier and CTI BioPharma Expand License and Collaboration Agreement to Develop and Commercialize PIXUVRI®
Servier and CTI BioPharma Corp. (CTI BioPharma) (NASDAQ and MTA: CTIC) today jointly announced that they agreed to expand their existing license and development collaboration agreement for PIXUVRI® (pixantrone). Under this expanded agreement, Servier will have rights to PIXUVRI in all markets except the US, where CTI BioPharma will retain the commercialization rights. Servier will pay CTI BioPharma €12 million with the potential for CTI BioPharma to receive €76 million in additional sales and regulatory milestone payments as well as royalties on net product sales.
PIXUVRI has been granted conditional marketing authorization from the European Commission for the treatment of adult patients with multiply relapsed or refractory aggressive non-Hodgkin B-cell lymphoma (NHL).1 As a specific post-authorization requirement, PIXUVRI is currently being investigated in a Phase III clinical trial, PIX306. If positive, the results from this trial will confirm the treatment’s current indication and could support broader indications.
In 2014, CTI granted Servier rights to commercialize the drug globally except in Austria, Denmark, Finland, Germany, Israel, Norway, Sweden, Turkey, UK and the US. With this expanded agreement, which provides Servier’s rights to all markets except the US, the companies will continue to work closely together to build the efficacy and safety evidence for PIXUVRI and to ensure that as many eligible patients as possible are benefitting from it.
“Over the past three years, we have worked hand in hand with our partner, CTI BioPharma, to bring new treatment options to patients in Europe”, said U. Marion Schrenk, MD, Head of Therapeutic Area Oncology of Servier. “We are looking forward to leveraging our expertise in these additional markets to ensure more eligible patients have access to PIXUVRI. Oncology is an important focus for us, and we are fully committed to working with our partners, researchers and scientists to provide patients with novel therapeutic options in areas with high unmet needs.”
“Servier is an important strategic partner for us and has helped bring PIXUVRI to many patients," said Adam R. Craig, President and CEO of CTI BioPharma. “We look forward to our expanded partnership as we aim to complete the PIX306 trial in the near-term.”
About PIXUVRI (pixantrone)
PIXUVRI is a cytotoxic medicine that works by interfering with the DNA within cells and preventing them from making more copies of DNA. This means that the cancer cells in B-cell NHL cannot divide and eventually die.2
PIXUVRI is conditionally approved in the EU as monotherapy for the treatment of adult patients with multiply relapsed or refractory aggressive B-cell NHL. The benefit has not been established in patients when used as fifth line or greater chemotherapy in patients who are refractory to last therapy.
The Summary of Product Characteristics (SmPC) has the full prescribing information, including the safety and efficacy profile of PIXUVRI in the approved indication. The SmPC is available at www.servier.com.
NHL is an uncommon type of cancer that affects the lymphatic system, which is defined as a network of vessels and glands that run throughout the body. 3 The lymphatic system is a key component of the immune system, as it plays a role in destroying old or abnormal cells and fighting bacteria and other infections.4
Around 93,500 new cases of NHL were diagnosed in Europe in 2012, making it the eleventh most common cancer on the continent.5
NHL comprises more than 60 subtypes, with each requiring a different diagnostic evaluation and treatment approaches. Lymphoma patient groups around the world, led by the umbrella group Lymphoma Coalition, have been recently calling for accurate subtype reporting to allow patients to clearly understand their subtype and have better communication with their doctors. Given the complexities of the condition, access to information is essential to empower patients.
Servier is an international pharmaceutical company governed by a foundation and headquartered in Suresnes (France). With a strong international presence in 148 countries and a turnover of 4 billion euros in 2016, Servier employs 21,000 people worldwide. Corporate growth is driven by Servier’s constant search for innovation in five areas of excellence: cardiovascular diseases, diabetes, cancers, immune-inflammatory diseases, and neurodegenerative diseases, as well as by its activities in high-quality generic drugs. Being completely independent, the Group reinvests 25% of turnover (excluding generics) in research and development and uses all its profits for growth.
Becoming a key player in oncology is part of Servier’s long-term strategy. Currently, there are nine molecular entities in clinical development in this area, targeting gastric and lung cancers and other solid tumors, as well as various leukemias and lymphomas. This portfolio of innovative cancer treatments is being developed with partners worldwide, and covers different cancer hallmarks and modalities, including cytotoxics, proapoptotics, targeted, immune and cellular therapies, to deliver life-changing medicines to patients.
About CTI BioPharma
CTI BioPharma Corp. is a biopharmaceutical company focused on the acquisition, development and commercialization of novel targeted therapies covering a spectrum of blood-related cancers that offer a unique benefit to patients and healthcare providers. CTI BioPharma has a late-stage development pipeline, including pacritinib for the treatment of patients with myelofibrosis. CTI BioPharma is headquartered in Seattle, Washington. For additional information and to sign up for email alerts and get RSS feeds, please visit www.ctibiopharma.com.
This press release includes forward-looking statements within the meaning of the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995. Such statements are subject to a number of risks and uncertainties, the outcome of which could materially and/or adversely affect actual future results and the trading price of CTI BioPharma's securities. Such statements include, but are not limited to, expectations with respect to milestone and royalty payments, the expected benefits and potential of the collaboration and PIXUVRI, including with respect to possibly expanding PIXUVRI into new indications. The statements are based on assumptions about many important factors and information currently available to us to the extent we have thus far had an opportunity to fully and carefully evaluate such information in light of all surrounding facts, circumstances, recommendations and analyses. Risks that contribute to the uncertain nature of the forward-looking statements include, among others, risks associated with the biopharmaceutical industry in general and with CTI BioPharma and its product and product candidate portfolio in particular including, among others, risks associated with the following: satisfaction of regulatory and other requirements; actions of regulatory bodies and other governmental authorities; changes in laws and regulations; product quality or patient safety issues; product development risks; the impact of competitive products and pricing and reimbursement; that CTI BioPharma cannot predict or guarantee the outcome of preclinical and clinical studies, as well as other risks listed or described from time to time in CTI BioPharma's most recent filings with the SEC on Forms 10-K, 10-Q and 8-K. Except as required by law, CTI BioPharma does not intend to update any of the statements in this press release upon further developments.
1 http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000925.jsp [last accessed March 2017]
3 NHS Conditions webpage. NHL cancer. Available at http://www.nhs.uk/Conditions/non-hodgkins-lymphoma/Pages/Definition.aspx [last accessed March 2017]
4 Cancer Research UK. Lymphatic System. Available at http://www.cancerresearchuk.org/about-cancer/what-is-cancer/body-systems-and-cancer/the-lymphatic-system-and-cancer [Last accessed March 2017]
5 Cancer Research UK. Non-Hodgkin lymphoma incidence statistics. Available at http://www.cancerresearchuk.org/health-professional/cancer-statistics/statistics-by-cancer-type/non-hodgkin-lymphoma/incidence#GCwFbl4szbj1GQxD.99 [last accessed March 2017]
Om Business Wire
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
Celltrion Receives Positive CHMP Opinion for Herzuma® for Trastuzumab Biosimilar15.12.2017 22:13 | Pressemelding
Celltrion, Inc. (KOSDAQ: 068270) announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion recommending that Herzuma® (trastuzumab biosimilar) be granted marketing authorization in the European Union (EU) for the treatment of patients with early breast cancer, metastatic breast cancer, or metastatic gastric cancer whose tumors have either HER2 overexpression or HER2 gene amplification. The CHMP’s opinion will now be sent to the European Commission (EC) for final review. Herzuma® is a biosimilar to Herceptin®i, a breast cancer and gastric cancer treatment antibody biologic drug developed by Genentech and marketed by Roche. Herceptin® is a blockbuster drug which had worldwide sales of CHF 6.8 billionii (US$6.8 billion) in 2016, of which CHF 2.1 billioniii (US$2.1 billion) was in
Takeda and TiGenix announce that Cx601 (darvadstrocel) has received a positive CHMP opinion to treat complex perianal fistulas in Crohn’s disease15.12.2017 12:34 | Pressemelding
Takeda Pharmaceutical Company Limited (TSE: 4502) (“Takeda”) and TiGenix NV (Euronext Brussels and NASDAQ: TIG) (“TiGenix”) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), in conjunction with the Committee for Advanced Therapies (CAT), has adopted a positive opinion recommending a marketing authorization (MA) for investigational compound Cx601 (darvadstrocel). Cx601 is expected to be indicated for the treatment of complex perianal fistulas in adult patients with non-active/mildly active luminal Crohn’s disease, when fistulas have shown an inadequate response to at least one conventional or biologic therapy.2 This recommendation marks the first allogeneic stem cell therapy to receive a positive CHMP opinion in Europe. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/201712
Bitcoin Romania and Twispay Announce Integration Partnership Providing Users with the Ability to Purchase Bitcoin with Bank Cards15.12.2017 12:21 | Pressemelding
Bitcoin Romania, leading Eastern European Bitcoin exchange & brokerage firm, and Twispay, Swiss-owned European payment processor and FinTech pioneer, today announced the availability of a payment integration that allows a global clientele to acquire Bitcoin and Ethereum cryptocurrencies using Visa and Mastercard bank cards. Unprecedented in Romania, this is one of the first East-Central European integration partnerships that allow consumers to use their cards to purchase cryptocurrency. Until recently, investors could only acquire cryptocurrencies through bank transfers and cash deposits, but the volatility of cryptocurrency markets dictates the need for additional operational flexibility. Investors require faster, safer, more reliable, and more comfortable ways to complete purchases. “One minute can make the difference between a million lost and a million earned. That is pr
Upon Conclusion of the Fourth Annual Forum for Promoting Peace in Muslim Societies, Scholars and Intellectuals Visit the Louvre Abu Dhabi Museum15.12.2017 11:38 | Pressemelding
A high-level delegation of dignitaries, scholars and intellectuals participating in the fourth annual Forum for Promoting Peace in Muslim Societies, visited the Louvre Abu Dhabi museum. The delegation was headed by H.E Mustafa Ceric, former Grand Mufti of Bosnia; alongside Sheikh Mohammad Mukhtar Ould Imbala, Head of Mauritania’s Fatwa & Grievances Supreme Council; H.E Amar Mirghani Hussein, Sudanese Minister of (religious) Guidance and Endowments; and H.E Salho Jay, Imam of the Juma Masjid in South Africa. The Forum was held in Abu Dhabi from 11-13 December 2017, with the participation of more than 700 scholars, intellectuals and religious dignitaries from around the world. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20171215005255/en/ Group Photo of the Scholars and Intellectuals during their visit to the L
Kennedy Wilson Acquires 124-Unit Northbank Apartments in Dublin, Ireland for €45 Million15.12.2017 11:00 | Pressemelding
Global real estate investment company Kennedy Wilson (NYSE: KW) announces that it has acquired Northbank Apartments, a wholly-owned 124-unit apartment community in Dublin’s North Docks, for €45 million from Jarmar Properties Limited (In Receivership) acting through David Carson of Deloitte as Statutory Receiver, the lender being the National Asset Management Agency (“NAMA”). Situated in Dublin’s North Docks, Northbank is located just 50 meters from Kennedy Wilson’s existing 84-unit Liffey Trust apartments. The two buildings benefit from great transport links as the LUAS Red line is immediately adjacent connecting to Dublin’s city centre and main train stations in five minutes. “The successful acquisition of Northbank in such close proximity to our Liffey Trust asset allows us to leverage our existing presence and implement our value-add asset management strategy, including a
AML BitCoin Enters Phase II of ICO15.12.2017 09:00 | Pressemelding
NAC Foundation, LLC announces today that the initial coin offering for the AML BitCoin – the world’s only patent-pending compliant digital currency – has been extended for another month to accommodate a torrent of last minute, new coin purchasers and the demands of thousands of current owners of the coin, who have had difficulty navigating the process of establishing the specialized wallet required to hold the innovative digital currency. This second phase of the AML BitCoin initial coin offering will see an increase in the price of the coin, from US $1.00 to US $1.25. The company has already been contacted by prospective purchasers in the slightly higher priced Phase II, and anticipates a further price increase to US $1.50 within a week or two. HitBTC, one of the world’s largest and most active digital currency exchanges, was prepared to list the AML BitCoin for trading on
I vårt presserom finner du alle våre siste saker, kontaktpersoner, bilder, dokumenter og annen relevant informasjon om oss.Besøk vårt presserom