Business Wire

Servier and CTI BioPharma Expand License and Collaboration Agreement to Develop and Commercialize PIXUVRI®

Del

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.

About NHL

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.

About Servier

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.

More information is available at: www.servier.com and www.servier-oncology.com

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.

Forward-Looking Statements

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]

2 http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/002055/human_med_001549.jsp&mid=WC0b01ac058001d124 [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]

Contact information

Servier Contact
Karine Bousseau
Servier External Communications
Tel: +33 1 5572 6037
Email: media@servier.com
or
CTI BioPharma Contact
Ed Bell
Tel: +1 206 272 4345
Email: ebell@ctibiopharma.com

Om Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

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

(c) 2018 Business Wire, Inc., All rights reserved.

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

Loxam Announces a Conditional Agreement to Acquire UK Platforms20.7.2018 14:51Pressemelding

Loxam Group (“Loxam”) announces that its wholly-owned subsidiary Nationwide Platforms Limited (“Nationwide”) has entered into a conditional agreement with HSS Hire Group plc (“HSS”) with respect to the acquisition of UK Platforms Limited (“UKP”). UKP specializes in renting powered access equipment from its 12 branches located throughout the United Kingdom. The company has approximately 130 employees and operates a fleet of 3,000 units. UKP is controlled by HSS since 2013. As part of this transaction, Nationwide has entered into a commercial agreement with HSS to provide powered access equipment to complement HSS’ existing fleet. The closing of the transaction is subject to the approval by HSS’ shareholders and the confirmation that it will not be referred to the Competition and Mergers Authority. The transaction is expected to close before year end 2018. Don Kenny, CEO of Loxam’s Powered Access Division states: “I am delighted with the acquisition of UKP which will further reinforce NW

Schlumberger Announces Second-Quarter 2018 Results20.7.2018 11:00Pressemelding

Schlumberger Limited (NYSE: SLB) today reported results for the second quarter of 2018. (Stated in millions, except per share amounts) Three Months Ended Change Jun. 30, 2018 Mar. 31, 2018 Jun. 30, 2017 Sequential Year-on-year Revenue $8,303 $7,829 $7,462 6% 11% Pretax operating income $1,094 $974 $950 12% 15% Pretax operating margin 13.2% 12.4% 12.7% 75 bps 45 bps Net income - GAAP basis $430 $525 $(74) -18% n/m Net income, excluding charges & credits* $594 $525 $488 13% 22% Diluted EPS - GAAP basis $0.31 $0.38 $(0.05) -18% n/m Diluted EPS, excluding charges & credits* $0.43 $0.38 $0.35 13% 23% *These are non-GAAP financial measures. See section below entitled "Charges & Credits" for details. n/m = not meaningful Schlumberger Chairman and CEO Paal Kibsgaard commented, “The second quarter was both busy and exciting for Schlumberger as we completed a number of major milestones in preparation for the broad-based global activity upturn that is now emerging. We delivered solid top-line gro

H.I.G. Capital Announces the Sale of KidsFoundation19.7.2018 19:50Pressemelding

H.I.G. Capital (“H.I.G.”), a leading global private equity investment firm with more than €21 billion of equity capital under management, announced today that one of its affiliates has entered a definitive agreement to sell the KidsFoundation Group (“KidsFoundation”), the Dutch market leader in childcare services, to Onex Corporation (“Onex”)(TSX:ONEX). Terms were not disclosed. Headquartered in Almere, the Netherlands, KidsFoundation provides high-quality childcare to nearly 30,000 children between the ages of six weeks and 12 years. H.I.G. created KidsFoundation in 2014 through the acquisition of assets from the estate of Estro Group. During H.I.G.’s ownership, the company has developed strongly with significant capital invested by H.I.G. to create a high-quality childcare offering. H.I.G. worked with KidsFoundation management to optimise the footprint of the company by exiting loss-making locations, introduce new IT systems to drive operational improvement and develop an internal M&

SIG Combibloc Group Holdings S.à r.l.: 2018 Second Quarter Results19.7.2018 16:01Pressemelding

We are pleased to announce our quarterly conference call to discuss the results of SIG Combibloc Group Holdings S.à r.l. for the second quarter ended June 30, 2018. Date: Monday, July 23, 2018 Time: 15.00 CEST / 14.00 BST / 9.00 EDT The call information will be distributed on our secure site. If you would like access to our call, please contact investor.relations@sig.biz . Regards, SIG Combibloc Group Holdings S.à r.l. View source version on businesswire.com: https://www.businesswire.com/news/home/20180719005634/en/ Contact information SIG Combibloc Group Holdings S.à r.l. Jennifer Gough investor.relations@sig.biz

NEORIS Announces Creation of Innovation Labs Worldwide to Create a Smarter Future19.7.2018 15:32Pressemelding

NEORIS, a global digital consulting services company, announced today it is consolidating the most innovative solutions it has developed in different geographies and allocating unprecedented resources to deploy a network of Innovation Labs worldwide. The main objective is to lay the foundation for the continuous development of disruptive solutions for its four core industries: Manufacturing, Financial Services, Healthcare and Telecommunications. Due to its disruptive nature, NEORIS decided that its first Innovation Lab should be housed in the Monterrey Digital Hub, which today is the first-of-its-kind as it is a space where entrepreneurs, companies, universities and investors converge to foster an ecosystem for Digital Transformation. The lab inaugurated in Monterrey, Mexico is the first of a series of Innovation Labs that will open in the different countries that NEORIS operates, and is a space where customers can experience emerging technologies through real-life scenarios. One such

CORRECTING and REPLACING Albar Capital Deploys FlexNOW19.7.2018 15:29Pressemelding

Subhead of release should read: Out-of-the-Box Multi-Asset Execution Management System (instead of Easy-to-Install Multi-Asset Execution Management System). The corrected release reads: ALBAR CAPITAL DEPLOYS FLEXNOW Out-of-the-Box Multi-Asset Execution Management System FlexTrade (@FlexTrade) today announced that Albar Capital Ltd., a new hedge fund led by Javier Velazquez (formerly of Millennium Capital Partners LLP), is now trading equities and futures using FlexNOW, FlexTrade’s new execution management system. “The FlexNOW team was instrumental in solving several of our problems,” said Jason Ruder, Trader at Albar Capital. “Not only are they helping us with our compliance requirements, they are also responsive to requests that improve my workflow.” According to Rhyd Lewis, FlexNOW Product Manager, FlexNOW’s quick onboarding and easy installation process was critical for Albar Capital’s launch on 2 July. “We had no problem integrating FlexNOW with Albar’s portfolio and risk managemen