Clinigen Group Acquires Oncology Support Therapy SAVENE® (dexrazoxane) from SpePharm AG

  Clinigen Group Acquires Oncology Support Therapy SAVENE® (dexrazoxane) from
  SpePharm AG

      Acquisition strengthens Clinigen’s position in dexrazoxane market

Business Wire

BURTON-ON-TRENT, England -- March 31, 2014

Clinigen Group plc (‘Clinigen’ or the ‘Group’) (LSE: CLIN) (AIM: CLIN) the
specialty global pharmaceutical company today announces the acquisition of
SAVENE^® (dexrazoxane) from SpePharm AG, a majority owned affiliate of Norgine
B.V. The Financial terms of the acquisition are not being disclosed.

SAVENE is indicated for the treatment of extravasation in anthracycline
chemotherapy in adults. Extravasation occurs when anticancer drugs, normally
injected into a vein, leak or are accidentally injected into tissue
surrounding the vein where they can cause serious damage. SAVENE is the only
authorized treatment of its kind available. Its use within the first six hours
of extravasation occurring is crucial and enables affected patients to
continue their anticancer treatment.

SAVENE has Orphan Drug status and protection until late 2016 with a worldwide
method of use patent until 2020. In 2013 the sales were approximately
€3.8million.

Under the terms of the agreement, Clinigen will assume full responsibility for
SAVENE’s manufacturing, registration, distribution, and commercialization in
all markets globally excluding the Americas, Israel and South Africa. In
Japan, Clinigen will provide SAVENE through an existing supply and license
agreement with Kissei Pharmaceutical Co. Ltd, the marketing authorization
holder.

In 2013 the Group also acquired Cardioxane^® from Novartis which, like SAVENE,
has dexrazoxane as its active substance and is also an oncology support
therapy; used to prevent the cardiotoxicity of anthracyclines for patients
with advanced and/or metastatic breast cancer. The acquisition of SAVENE
allows Clinigen to exploit synergies between the two products.

Peter George, Chief Executive Officer, Clinigen Group, said: “In acquiring
both SAVENE and Cardioxane, Clinigen will expand its strategic options in
oncology support and consolidate its supply chain. The acquisition was a
natural move for us and is in line with our stated strategy to expand our
specialty pharmaceuticals portfolio.”

David Bryant, Senior Vice President, Clinigen SP, said: “This is the fourth
product to be added to our specialty pharmaceuticals portfolio. This
acquisition has helped strengthen our position in the oncology support area,
adding SAVENE to Cardioxane and Foscavir^®. We continue to focus on the
acquisition of niche, hospital-only therapies which have the potential to save
the lives of critically ill patients.”

                                   - Ends -

Notes to Editors

About SAVENE^® (dexrazoxane)

SAVENE^® is a powder and diluent that are made up into a solution for
infusion. It contains the active substance dexrazoxane. SAVENE is used to
treat extravasation of anthracyclines in adults.

Anthracycline extravasation refers to the inadvertent infiltration of
chemotherapy into the subcutaneous or sub dermal tissues surrounding the
intravenous or intra-arterial administration site. Management and treatment of
anthracycline extravasation should be initiated as soon as possible to
minimise potential tissue damage and ensure best possible treatment outcomes
for patients.

SAVENE has two major mechanisms of action:

  *Chelation of iron
  *Inhibition of DNA topoisomerase II.

Dexrazoxane binds to iron and prevents the formation of free radicals, which
are considered to play a major role in the development of
extravasation-induced tissue necrosis. In addition, dexrazoxane binds to DNA
topoisomerase II at a different step in the catalytic cycle than
anthracyclines and locks the enzyme in a form that is no longer affected by
the anthracyclines. SAVENE was designated an ‘orphan drug’ in 2001.

About Clinigen Group

The Clinigen Group is a specialty global pharmaceutical company headquartered
in the UK, with offices in the US and Japan. The Group, dedicated to
delivering ‘the right drug, to the right patient at the right time’, has three
operating businesses; Specialty Pharmaceuticals (Clinigen SP), Clinical Trials
Supply (Clinigen CTS), and Global Access Programs (Clinigen GAP). Clinigen SP
is focused on acquiring its own intellectual property in licensed, niche,
hospital-only critical care medicines, increasing the value of these medicines
by developing new formulations and indications, then registering and marketing
them in defined global markets.

SAVENE^® is the fourth product to be added to Clinigen’s Specialty
Pharmaceuticals business. In addition to its close strategic fit with
Cardioxane^® (dexrazoxane hydrochloride), SAVENE complements Foscavir^®
(foscarnet sodium), Clinigen’s anti-viral active against Cytomegalovirus (CMV)
commonly used in the support of leukemia patients undergoing bone marrow
transplants, acquired from AstraZeneca in March 2010. In addition VIBATIV^®
(telavancin), an anti-bacterial for the treatment of nosocomial pneumonia
caused by MRSA was in-licensed for commercialization in the EU from Theravance
in March 2013. All four drugs in Clinigen’s portfolio are highly specialized,
hospital-only drugs which Clinigen SP markets into licensed markets and
Clinigen GAP supplies into pre- or unlicensed markets on a named patient
basis.

For more information, please visit www.clinigengroup.com.

About SpePharm AG

SpePharm AG is a joint venture between Norgine B.V. and the former
shareholders of SpePharm Holding B.V. which was formed in 2012 to
commercialize SpePharm’s Specialty Pharmaceutical products through Norgine’s
European infrastructure.

About Norgine B.V

Norgine is a leading independent European specialty pharmaceutical company
that has been established for over 100 years and has a presence in all major
European markets. In 2013, Norgine’s total revenue was €274 million and the
company employs over 1,000 people.

Norgine’s focus is the development and marketing of pharmaceutical products
that address significant unmet clinical needs in therapeutic areas such as
gastroenterology, hepatology, critical and supportive care. Norgine owns a
manufacturing and development site in Hengoed, UK and a manufacturing site in
Dreux, France. For more information, please visit www.norgine.com.

NORGINE and the sail logo are trademarks of the Norgine group of companies.

Contact:

Clinigen Group plc
Peter George, Group Chief Executive Officer
Robin Sibson, Group Chief Financial Officer
Shaun Chilton, Group Chief Operating Officer
Tel: +44 (0) 1283 495 010
or
Norgine B.V.
Paul Pay (Corporate and Business Development)
Tel: +44 (0) 1895 826 660
or
Isabelle Jouin (Media)
Tel: +44 (0) 1895 453 643
or
Numis Securities Limited
Michael Meade/Freddie Barnfield (Nominated Adviser)
James Black/Tom Ballard (Corporate Broking)
Tel: +44 (0) 20 7260 1000
or
Peel Hunt LLP - Joint Broker
James Steel / Jock Maxwell Macdonald
Tel: +44 (0) 20 7418 8900
or
Instinctif Partners (media relations)
Melanie Toyne-Sewell/Stefanie Bacher/Jen Lewis
Tel: +44 (0) 20 7457 2020
Email: clinigen@instinctif.com
 
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