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Results of Phase III (PIX306) Study Evaluating Progression-Free Survival of PIXUVRI® (pixantrone) Combined with Rituximab in Patients with Aggressive B-cell Non-Hodgkin Lymphoma

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CTI BioPharma Corp. and Servier today announced that the pivotal Phase III study (PIX306) evaluating PIXUVRI® (pixantrone) combined with rituximab in comparison to gemcitabine combined with rituximab in patients with aggressive B-cell non-Hodgkin lymphoma (NHL) did not meet its primary endpoint of improvement of progression-free survival (PFS).

“We are disappointed with the outcome of the PIX306 study and will proceed to conduct a thorough review of the clinical data to assess the next steps for the PIXUVRI program,” commented Adam Craig, MD, PhD, CEO of CTI BioPharma. “We would like to express our appreciation to the patients, families and investigators who participated in the study.”

Results will be submitted for presentation at a major scientific meeting by the end of the year and for publication in a peer-reviewed journal.

#ENDS#

About PIX306

The PIX306 study is a randomized, multicenter study comparing pixantrone combined with rituximab versus gemcitabine combined with rituximab in patients with aggressive B-cell non-Hodgkin lymphoma (NHL).

The PIX306 study enrolled 312 patients who had relapsed after therapy with CHOP-R or an equivalent regimen and were ineligible for stem cell transplant. The primary endpoint was progression-free survival (PFS) while overall survival (OS), complete response rate (CR), overall response rate (ORR) and safety were secondary endpoints.

For more information about the PIX306 study, please visit
https://www.clinicaltrials.gov/ct2/show/NCT01321541.

The ClinicalTrials.gov identifier is NCT01321541.

About Non-Hodgkin Lymphoma (NHL)
NHL is a blood cancer that affects the lymphatic system, which is defined as a network of vessels and glands that run throughout the body.1 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.2

NHL can occur in different parts of the body from the lymph nodes in the neck to the liver or spleen, but also in other organs such as the stomach, small bowel, bones, brain, testicles or skin.3 Around 168,000 new cases of NHL are diagnosed in the United States and Europe every year.

About PIXUVRI ® (pixantrone)
PIXUVRI® is the only treatment in the European Union indicated as monotherapy for the treatment of adult patients with multiply relapsed or refractory aggressive non-Hodgkin B-cell lymphoma (NHL).4 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 cannot divide and eventually die.5

PIXUVRI® has not been approved by the U.S. Food and Drug Administration in the United States (US).

PIXUVRI® has conditional marketing authorization from the European Commission for prescription in the European Union (EU) as a monotherapy for the treatment of adult patients with multiply relapsed or refractory aggressive NHL.6 Conditional marketing authorizations are granted in the EU if all the following requirements are met: the benefit-risk balance of the product is positive, it is likely that the applicant will be able to provide comprehensive data, unmet medical needs will be fulfilled, the benefit to public health of the medicinal product's immediate availability on the market outweighs the risks due to need for further data.7 The PIX306 report will be submitted to the EMA for evaluation by the end of December 2018.

PIXUVRI® is mentioned in the ESMO guidelines as an anthracycline-like drug with reduced cardiotoxicity, which demonstrated some efficacy in heavily treated patients.8

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.ema.europa.eu

CTI granted Servier rights to commercialize the drug globally in all markets except the US. The two companies continue to work closely to build the efficacy and safety evidence for PIXUVRI® and to ensure that as many eligible patients as possible are benefitting from it.

About Servier
Servier is an international pharmaceutical company governed by a non-profit foundation, with its headquarters in France (Suresnes). With a strong international presence in 148 countries and a turnover of 4.152 billion euros in 2017, Servier employs 21,600 people worldwide. Entirely independent, the Group reinvests 25% of its turnover (excluding generic drugs) in research and development and uses all its profits for development. Corporate growth is driven by Servier’s constant search for innovation in five areas of excellence: cardiovascular, immune-inflammatory and neuropsychiatric diseases, cancer and diabetes, as well as by its activities in high-quality generic drugs. Servier also offers eHealth solutions beyond drug development.

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 different types of leukemia and lymphomas. This portfolio of innovative cancer treatments is being developed with partners worldwide, and covers different cancer hallmarks and modalities, including cytotoxics, proapoptotics, immune, cellular and targeted therapies, to deliver life-changing medicines to patients.

More information: www.servier.com

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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 contains forward-looking statements, which are generally statements that are not historical facts. Forward-looking statements can be identified by the words "expects," "anticipates," "believes," "intends," "estimates," "plans," "will," “outlook” and similar expressions, including those related to the potential therapeutic potential of PIXUVRI®, the submission of the study to a peer-reviewed journal, and the timing, scope and outcome of interactions with and submissions to regulators. Forward-looking statements are based on management’s current plans, estimates, assumptions and projections, and speak only as of the date they are made. Servier and CTI BioPharma undertake no obligation to update any forward-looking statement in light of new information or future events, except as otherwise required by law. Forward-looking statements involve inherent risks and uncertainties, most of which are difficult to predict and are generally beyond the control of either company. Actual results or outcomes may differ materially from those implied by the forward-looking statements as a result of the impact of a number of factors, many of which are discussed in more detail in the public reports of CTI BioPharma filed with the Securities and Exchange Commission.

1 NHS Conditions webpage. NHL Cancer. Available at http://www.nhs.uk/Conditions/non-hodgkins-lymphoma/Pages/Definition.aspx [last accessed July 2018].

2 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 July 2018].

3 Cancer Research UK. What is NHL cancer. Available at http://www.cancerresearchuk.org/about-cancer/type/non-hodgkins-lymphoma/about/what-is-lymphoma [last accessed July 2018]

4 Pixuvri Summary of Product Characteristics, Available at: https://www.medicines.org.uk/emc/medicine/29829 [last accessed July 2018]

5 European Medicines Agency. About Pixuvri. Available at: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/002055/human_med_001549.jsp&mid=WC0b01ac058001d124 [last accessed July 2018].

6 Evaluate Group. NICE Publishes Final Guidance on PIXUVRI® (pixantrone). Available at http://www.evaluategroup.com/Universal/View.aspx?type=Story&id=490415 [last accessed July 2018].

7 European Medicines Agency. Authorisation details. Available at http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/002055/human_med_001549.jsp&mid=WC0b01ac058001d124 [last accessed July 2018]

8 Tilly H et al. Diffuse large B-cell lymphoma (DLBCL): ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Annals of Oncology (2015). Volume 26 (suppl 5); v116-v125. Available at http://www.esmo.org/Guidelines/Haematological-Malignancies/Diffuse-Large-B-Cell-Lymphoma [last accessed July 2018]

Contact information

Servier Media Relations
Sonia MARQUES
media@servier.com
Tel: +33(0)1 55 72 40 21/+33(0)7 84 28 76 13
or
Karine BOUSSEAU
media@servier.com
Tel: +33(0)1 55 72 60 37
or
CTI BioPharma
Julia Balanova (investors)
jbalanova@troutgroup.com
Tel: +1 646 378 2936
or
Rich Allan (media)
rallan@troutgroup.com
Tel: +1 646 378 2958

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