SEATTLE, Sept. 17, 2014 /PRNewswire/ -- CTI BioPharma
Corp. (CTI) (NASDAQ and MTA: CTIC) and Servier today jointly
announced that they have entered into an exclusive license and
collaboration agreement to develop and commercialize
PIXUVRI® (pixantrone) in a transaction valued at up to
€103.0 million (approximately $133.5
million) if all milestones are achieved. Under the
agreement, CTI retains full commercialization rights for PIXUVRI in
Austria, Denmark, Finland, Germany, Israel, Norway, Sweden, Turkey, the United
Kingdom and the U.S., with Servier having exclusive rights
to commercialize PIXUVRI in all other countries.
PIXUVRI is conditionally approved in the European Union for
patients with aggressive B-cell non-Hodgkin lymphoma (NHL) who
failed two or three prior lines of therapy. PIXUVRI is the first
monotherapy treatment option for this patient group and the only
therapy licensed for third and fourth line use in aggressive B-cell
NHL patients, which includes diffuse large B-cell lymphoma (DLBCL).
As of this announcement, PIXUVRI was available in 11 countries and
has achieved reimbursement decisions under varying conditions in
England/Wales, Italy,
France, Germany and the
Netherlands. Under the terms of the agreement, CTI will
receive an upfront payment of €14 million (approximately
$18.1 million) and is eligible to
receive additional sales, clinical and regulatory milestone
payments, as well as royalties on sales, such royalty payments
being subject to certain reductions.
"We believe Servier represents the ideal strategic partner to
achieve the full potential of PIXUVRI, particularly in those
regions of the world where CTI does not currently have, or plan to
have a presence," said James A.
Bianco, M.D., President and CEO of CTI. "Our two companies
share a vision for bringing PIXUVRI to patients and believe this
collaboration will not only maximize the development,
commercialization and market potential of PIXUVRI, but will also
help accelerate potential development expansion into new
indications. We believe Servier's development expense contributions
could help us achieve a net positive contribution margin for
PIXUVRI this year and profitability in 2015 and beyond."
"Servier is conducting a comprehensive chemistry and biology
research program in the field of oncology with the aim to develop
and bring novel effective therapies to patients with cancer," said
Jean Pierre Abastado, Head of the
Oncology Therapeutic Innovation Center at Servier. "In addition,
Servier has entered into several scientific collaborations with
Academic Institutions as well as a number of other partnerships in
the field of oncology and hematology. This new partnership will
nicely fit within Servier's portfolio by bringing an immediate
therapeutic solution for patients suffering from aggressive B-cell
non-Hodgkin lymphoma (NHL) who failed two or three prior lines of
therapy."
"This partnership around PIXUVRI will also enable Servier to
build its hemato-oncology capabilities for market access and
medical information in many countries, thereby preparing for the
arrival of an extensive portfolio of innovative treatments that are
currently in clinical development," said Pascal Touchon, Vice President Scientific
Collaboration and Business development at Servier.
Conference Call Information
CTI management will host a conference call and webcast with
slides to review the collaboration agreement with Servier for
development and commercialization of PIXVURI. The event will be
held today at 5:30 a.m. PDT / 8:30 a.m. EDT /
2:30 p.m. CEST. Participants can
access the call at 1-877-718-5111 (domestic) or +1 719-325-4748
(international). To access the live audio webcast with slides or
the subsequent archived recording, visit CTI's website,
www.ctibiopharma.com. Webcast and telephone replays of the
conference call will be available approximately two hours after
completion of the call. Callers can access the replay by dialing
1-888-203-1112 (domestic) or +1 719-457-0820 (international). The
access code for the replay is 6657301. The telephone replay will be
available until Wednesday, September 24, 2014.
About PIXUVRI® (pixantrone)
PIXUVRI is a novel aza-anthracenedione with unique structural
and physiochemical properties. PIXUVRI was structurally designed so
that it cannot bind iron and perpetuate oxygen radical production
or form a long-lived hydroxyl metabolite -- both of which are the
putative mechanisms for anthracycline induced acute and chronic
cardiotoxicity.
In May 2012, the European
Commission granted conditional marketing authorization for PIXUVRI
as a monotherapy for the treatment of adult patients with multiply
relapsed or refractory aggressive NHL. The benefit of PIXUVRI
treatment 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.pixuvri.eu. PIXUVRI does not have marketing approval in
the United States.
About NHL
NHL is caused by the abnormal proliferation of lymphocytes,
cells that are key to the functioning of the immune system. It
usually originates in lymph nodes and spreads through the lymphatic
system. NHL can be broadly classified into two main
forms—aggressive and indolent NHL. Aggressive NHL is a rapidly
growing form of the disease that moves into advanced stages much
faster than indolent NHL, which progresses more slowly.
There are many subtypes of NHL, but aggressive B-cell NHL is the
most common and accounts for about 55 percent of NHL
cases.1 After initial therapy for aggressive NHL with
anthracycline-based combination therapy, one-third of patients
typically develop progressive disease.2 Approximately
half of these patients are likely to be eligible for intensive
second-line treatment and stem cell transplantation, although 50
percent are expected not to respond.2 For those patients
who fail to respond or relapse following second line treatment,
treatment options are limited, and usually palliative
only.2
About Conditional Marketing Authorization
Similar to accelerated approval regulations in the United States, conditional marketing
authorizations are granted in the E.U. to medicinal products with a
positive benefit/risk assessment that address unmet medical needs
and whose availability would result in a significant public health
benefit. A conditional marketing authorization is renewable
annually. Under the provisions of the conditional marketing
authorization for PIXUVRI, CTI will be required to complete a
post-marketing study aimed at confirming the clinical benefit
previously observed.
The European Medicines Agency's Committee for Medicinal Products
for Human Use has accepted PIX306, CTI's ongoing randomized
controlled Phase 3 clinical trial, which compares PIXUVRI-rituximab
to gemcitabine-rituximab in patients who have relapsed after one to
three prior regimens for aggressive B‑cell NHL and who are not
eligible for autologous stem cell transplant.
About CTI BioPharma
CTI BioPharma Corp. (NASDAQ and MTA: CTIC) 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 has a commercial presence in
Europe and a late-stage
development pipeline, including pacritinib, CTI's lead product
candidate that is currently being studied in a Phase 3 program for
the treatment of patients with myelofibrosis. CTI is headquartered
in Seattle, Washington, with
offices in London and Milan under the name CTI Life Sciences
Limited. For additional information and to sign up for email alerts
and get RSS feeds, please visit www.ctibiopharma.com.
About Servier
Servier is an independent French pharmaceutical research
company. Its development is based on the continuous pursuit of
innovation in the therapeutic areas of cardiovascular-, metabolic-,
neurologic-, psychiatric-, bone- and joint diseases as well as
cancer.
In 2013, the company recorded a turnover of 4.2 billion euros.
91 percent of Servier drugs are consumed outside France.
27 percent of turnover from Servier drugs were reinvested in
Research and Development in 2013.
With a strong international presence in 140 countries, Servier
employs more than 21,000 people worldwide.
More information is available at: www.servier.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's securities. Such statements include, but are
not limited to, expectations with respect to milestone and royalty
payments, CTI's ability to achieve a net positive contribution
margin for PIXUVRI this year and profitability in 2015 and beyond,
and 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, including the following, which could cause
actual results to differ materially from those in the
forward-looking statements: satisfaction of regulatory and other
requirements; actions of regulatory bodies and other governmental
authorities; clinical trial results; changes in laws and
regulations; product quality or patient safety issues; product
development risks; the impact of competitive products and pricing
and reimbursement; and other risks identified in CTI's most recent
filings with the Securities and Exchange Commission on Forms 10-K,
10-Q and 8-K. Except as required by law, CTI does not intend to
update any of the statements in this press release upon further
developments.
Note: Under the Agreement, monetary amounts are generally
denoted in euros, whereas monetary amounts are presented herein in
U.S. dollars based upon conversion on September 12, 2014.
PIXUVRI is a registered trademark of CTI BioPharma Corp.
References
- Harris NL, et al. The World Health Organization Classification
of Neoplastic Diseases of the Hematopoietic and Lymphoid Tissues.
Report of the Clinical Advisory Committee Meeting, Airlie House, Virginia, November, 1997. Ann Oncol. 1999
Dec;10(12):1419-32.
- Friedberg JW. Relapsed/refractory diffuse large B-cell
lymphoma. Hematology Am Soc Hematol Educ Program.
2011;2011:498-505. doi: 10.1182/asheducation-2011.1.498.
CTI BioPharma Contact
Monique
Greer
+1 206-272-4343
mgreer@ctibiopharma.com
Servier Contact
Servier Communication Department
+33 1 5572 6037
Email: presse@servier.fr
SOURCE CTI BioPharma Corp.