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.
For ARIAD InvestorsKendra Adams, (617)
503-7028Kendra.adams@ariad.comorFor ARIAD MediaLiza Heapes,
(617) 621-2315Liza.heapes@ariad.comorFor
AngeliniMediaFabio Pieroni, +39 06
78053760f.pieroni@angelini.it
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