PARIS and SEATTLE, April
25, 2017 /PRNewswire/ -- 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).i 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.ii
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.iii 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.iv
Around 93,500 new cases of NHL were diagnosed in Europe in 2012, making it the eleventh most
common cancer on the continent.v
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.
Servier Contact
Karine
Bousseau
Servier External Communications
Tel: +33 1 5572 6037
Email: media@servier.com
CTI BioPharma Contact
Ed
Bell
Tel +1 206-272-4345
Email: ebell@ctibiopharma.com
i
http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000925.jsp
[last accessed March 2017]
ii
http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/002055/human_med_001549.jsp&mid=WC0b01ac058001d124
[last accessed March 2017]
iii NHS Conditions webpage. NHL cancer. Available at
http://www.nhs.uk/Conditions/non-hodgkins-lymphoma/Pages/Definition.aspx
[last accessed March 2017]
iv 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]
v 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]
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SOURCE CTI BioPharma Corp.; Servier