Clinigen Group plc Acquires Oncology Support Therapy Cardioxane® from a World-Leading Pharmaceutical Company

  Clinigen Group plc Acquires Oncology Support Therapy Cardioxane® from a
  World-Leading Pharmaceutical Company

Business Wire

BURTON-ON-TRENT, England -- March 26, 2013

Clinigen Group plc (‘Clinigen’ or the ‘Group’) (LSE: CLIN) (AIM: CLIN) today
announced the acquisition of Cardioxane® (dexrazoxane) from Novartis for US$33
million in cash, payable in two tranches. Under the terms of the agreement,
Clinigen will assume responsibility for manufacturing, registration,
distribution, and commercialization of the product in countries where current
marketing authorizations exist, including key European, Asian and Latin
American territories.

Cardioxane, an oncology support therapy, is a cardioprotective agent used to
prevent the cardiotoxicity of anthracycline chemotherapy for patients with
advanced and/or metastatic breast cancer.

Clinigen believes there is an opportunity to revitalize Cardioxane, which has
no direct licensed competition in the anthracycline therapy cardioprotection
space, by utilizing new commercialization, market and indication strategies
over the next five years. Historic revenues for Cardioxane have been
c.US$11-12 million per annum. Latin America is a strong market for Cardioxane
which is of particular interest to Clinigen, being a territory in which the
Group wishes to expand its reach and which may improve access routes for
existing portfolio products such as Foscavir®, as well as products that
Clinigen may acquire in the future.

Cardioxane is the third addition to Clinigen’s Specialty Pharmaceuticals (SP)
business complementing Foscavir, its anti-viral active against Cytomegalovirus
(CMV) and commonly used in the support of leukemia patients undergoing bone
marrow transplants, acquired from AstraZeneca in March 2010. Recently, the
Group in-licensed VIBATIV®, an anti-bacterial for the treatment of nosocomial
pneumonia caused by MRSA, for commercialization in the EU from Theravance. All
three are highly specialized, hospital-only drugs which Clinigen SP supplies
into licensed markets and Clinigen Global Access Programs (GAP) supplies into
pre- or unlicensed markets on a named patient basis.

“Acquiring Cardioxane from Novartis is another major step forward for us,”
said Peter George, Chief Executive Officer of Clinigen. “Cardioxane fits
particularly well within our portfolio. We have been looking for medicines
that complement Foscavir and Cardioxane does this by extending our role in
oncology support. Together with our recent addition of VIBATIV, which further
builds on our anti-infective capability, we are delivering on our mission to
supply the right drug to the right patient at the right time.”

About Cardioxane® (dexrazoxane)

Cardioxane is a cardioprotective agent used to prevent chronic cumulative
cardiotoxicity caused by doxorubicin or epirubicin in advanced and/or
metastatic adult breast cancer patients who have received a prior cumulative
dose of 300mg/m2 of doxorubicin or 540mg/m2 of epirubicin when further
chemotherapy treatment is required. Cardioxane is administered by intravenous
infusion. It is believed to work by binding to metal ions, thus decreasing the
formation of intracellular superoxide radicals and preventing cardiotoxicity.
Cardioxane was initially licensed in 1992. Subsequently, Novartis acquired the
product as part of the 2006 acquisition of Chiron. The product is currently
licensed for sale in 43 markets around the world, including 18 in Latin
America.

Within the European Union Cardioxane underwent a revision to its label in
2011, restricting its licensed use to advanced and/or metastatic breast
cancer. The change brought the EU label in line with the dexrazoxane
indication that exists within the United States.

About Clinigen Group

Clinigen is a specialty global pharmaceutical products and services business
headquartered in the UK, with offices in the US and Japan. The Group has three
operating businesses; Specialty Pharmaceuticals (Clinigen SP), Clinical Trials
Supply (Clinigen CTS), and Global Access Programs (Clinigen GAP). The SP
business focuses on acquiring and in licensing specialist, hospital-only
medicines worldwide and commercializing them within niche markets. For more
information, please visit www.clinigengroup.com.

Forward-looking statement

This announcement contains certain projections and other forward-looking
statements with respect to the financial condition, results of operations,
businesses and prospects of Clinigen Group plc (“Clinigen”). These statements
are based on current expectations and involve risk and uncertainty because
they relate to events and depend upon circumstances that may or may not occur
in the future. The forward-looking statements include statements regarding
Cardioxane, its development, potential and financial performance. There are a
number of factors which could cause actual results or developments to differ
materially from those expressed or implied by these forward-looking
statements. Any of the assumptions underlying these forward-looking statements
could prove inaccurate or incorrect and therefore any results contemplated in
the forward-looking statements may not actually be achieved. Recipients are
cautioned not to place undue reliance on any forward-looking statements
contained herein. Clinigen undertakes no obligation to update or revise
(publicly or otherwise) any forward-looking statement, whether as a result of
new information, future events or other circumstances.

Contact:

Clinigen Group plc
Peter George
Group Chief Executive Officer
or
Robin Sibson
Group Chief Financial Officer
or
Anton Jenkins
Chief Operating Officer
David Bryant
Global Business Director
Tel: +44 (0) 1283 495 010
or
Numis Securities Limited
Michael Meade/Freddie Barnfield
(Nominated Adviser)
or
James Black/Tom Ballard
(Corporate Broking)
Tel: +44 (0) 20 7260 1000
or
College Hill (media relations)
Melanie Toyne-Sewell/Stefanie Bacher/Jen Lewis
Tel: +44 (0) 20 7457 2020
Email: clinigen@collegehill.com
 
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