ARIAD
Pharmaceuticals, Inc. (NASDAQ: ARIA) and Angelini Pharma, through
the Austrian subsidiary CSC Pharmaceuticals, today announced that ARIAD
has granted Angelini exclusive rights to commercialize Iclusig®
(ponatinib) for the indications approved by the European Medicine Agency
(EMA) in Central and Eastern Europe. These countries include Bulgaria,
the Czech Republic, Hungary, Poland, Romania, Slovakia and Slovenia.
With this distributorship in place, Iclusig will be available to
patients with resistant and intolerant Philadelphia-positive leukemias
in more than 23 countries in Europe.
Under the terms of the agreement, ARIAD will remain the Marketing
Authorization Holder of Iclusig, and ARIAD will manage this
distributorship out of its European headquarters in Lausanne,
Switzerland.
Angelini will be responsible for sales and marketing, medical affairs,
regulatory and reimbursement support. Angelini will book sales of
Iclusig while ARIAD will supply packaged drug to Angelini. An upfront
payment to ARIAD and milestones associated with commercial launches will
total approximately $7.3 million. Additionally, Angelini will provide
ARIAD with a substantial share of Iclusig sales in the region.
“With this agreement, we continue to move towards having Iclusig
available to patients in geographies outside of our own commercial
footprint,” said Marty J. Duvall, executive vice president and chief
commercial officer of ARIAD. “Angelini will be an important partner for
us in this region where, according to the EMA, there are approximately
8,000 patients living with chronic myeloid leukemia (CML) who may become
resistant or intolerant to other approved tyrosine kinase inhibitors.
Angelini has the experience and geographic reach to market and
distribute Iclusig in Central and Eastern Europe.”
ARIAD received Marketing Authorization Approval for Iclusig from the
European Medicine Agency in July 2013. The commercial launches of
Iclusig in these Central and Eastern European countries are expected to
begin in 2015.
“By partnering with ARIAD, we will be able to provide this important
cancer medicine to patients in Central and Eastern Europe who have
difficult-to-treat CML or Ph+ ALL and few options available to them,”
said Gianluigi Frozzi, CEO of Angelini Pharma Division. “We look forward
to a successful collaboration with ARIAD and to making Iclusig available
to refractory CML and Ph+ ALL patients.”
About Iclusig® (ponatinib)
Iclusig is a kinase inhibitor. The primary target for Iclusig is
BCR-ABL, an abnormal tyrosine kinase that is expressed in chronic
myeloid leukemia (CML) and Philadelphia-chromosome positive acute
lymphoblastic leukemia (Ph+ ALL). Iclusig was designed using ARIAD’s
computational and structure-based drug design platform specifically to
inhibit the activity of BCR-ABL. Iclusig targets not only native BCR-ABL
but also its isoforms that carry mutations that confer resistance to
treatment, including the T315I mutation, which has been associated with
resistance to other approved TKIs.
About Angelini
Angelini is a privately-held, mid-sized international manufacturer and
marketer of pharmaceutical and healthcare products in the pharmaceutical
and mass-market sectors.
Founded in Italy in 1919, the group employs about 4,000 people. The
pharmaceutical sector is the core business of the group, representing
over 50% of the company's €1.4 billion 2013 revenue.
Angelini has branches in Italy, Spain, Austria, Portugal, Poland, Czech
Republic, Slovak Republic, Hungary, Romania, Bulgaria, Slovenia,
Croatia, Greece, Turkey, Russia, USA, Pakistan; its products are
available in over 60 countries through an extensive network of licensees
and strategic agreements with local pharmaceutical companies.
At an international level, the company focuses mainly on pain relief,
inflammation, CNS, anti-infectives, gynecology and has a strong position
in the OTC market. The R&D department is currently focused on
pain/inflammation, CNS and infectious diseases areas. In the latter, R&D
is active with program in discovery, including private-public projects
with New Chemical Entities, as well as clinical programs with already
marketed products fully developed in Europe by Angelini.
Angelini also operates in Personal Care and Machinery sectors, in joint
venture with Procter & Gamble, and in Perfumery and Winegrowing.
About ARIAD
ARIAD Pharmaceuticals, Inc., headquartered in Cambridge, Massachusetts
and Lausanne, Switzerland, is an integrated global oncology company
focused on transforming the lives of cancer patients with breakthrough
medicines. ARIAD is working on new medicines to advance the treatment of
various forms of chronic and acute leukemia, lung cancer and other
difficult-to-treat cancers. ARIAD utilizes computational and structural
approaches to design small-molecule drugs that overcome resistance to
existing cancer medicines. For additional information, visit http://www.ariad.com or
follow ARIAD on Twitter (@ARIADPharm).
This press release contains “forward-looking statements” which are based
on management's good-faith expectations and are subject to certain
factors, risks and uncertainties that may cause actual results, outcome
of events, timing and performance to differ materially from those
expressed or implied by such statements. These factors, risks and
uncertainties include, but are not limited to the Company’s ability to
manufacture, and supply Angelini with Iclusig; the ability of Angelini
to perform the contracted services, such as obtaining pricing and
reimbursement approval for Iclusig in central and eastern European
countries; Angelini’s ability to distribute, promote, market and sell
Iclusig in those countries; the reimbursed price levels obtained; the
use of Iclusig for patients under named patient access schemes in those
countries; and the timing and success of sales of Iclusig in those
countries. These factors, risks and uncertainties also include, but are
not limited to: the costs associated with ARIAD’s development and
manufacturing, commercial and other activities; the adequacy of capital
resources and the availability of additional funding; and other factors
detailed in the Company's public filings with the U.S. Securities and
Exchange Commission. The information contained in this press release is
believed to be current as of the date of original issue. After the date
of this document, the Company does not intend to update any of the
forward-looking statements to conform to actual results or to changes in
the Company's expectations, except as required by law.
Copyright Business Wire 2014