- Servier will commercialize PIXUVRI
in all markets except the US
- CTI BioPharma will retain rights to
commercialize PIXUVRI in the US
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]
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version on businesswire.com: http://www.businesswire.com/news/home/20170424006233/en/
Servier ContactKarine BousseauServier External
CommunicationsTel: +33 1 5572 6037Email: media@servier.comorCTI
BioPharma ContactEd BellTel: +1 206 272 4345Email:
ebell@ctibiopharma.com
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