Burton-on-Trent,UK – 16 September 2013 – Following the acquisition of Cardioxane® from Novartis and the in-licensing of VIBATIV® from Theravance, Inc. in March 2013, Clinigen Group plc (‘Clinigen’ or the ‘Group’) (AIM: CLIN) today reported significant progress in the handover of these products with the transfer of key Marketing Authorizations in Europe to Clinigen. The transfers have progressed according to internally agreed timelines both projects are continuing on schedule.
For oncology support therapy Cardioxane® (dexrazoxane), Marketing Authorizations in France, the UK, the Netherlands, and Poland have been transferred from Novartis to Clinigen. As Marketing Authorization holder Clinigen has assumed responsibility for manufacturing, registration, distribution, and commercialization of Cardioxane® in these countries, ensuring a smooth transition and an uninterrupted supply of the drug to patients. Clinigen plans to transfer all Marketing Authorizations from Novartis and fully manage supply globally by the end of 2014, which is a similar timeline to Foscavir® when it transferred from AstraZeneca to Clinigen.
Furthermore, the European Commission has approved the transfer of Marketing Authorization for the anti-bacterial VIBATIV® (telavancin) from Theravance, Inc. to Clinigen. VIBATIV® has been suspended for use in the European Union since 2012 following a suspension of operations at the contract manufacturer. Having completed the technical transfer to a new contract manufacturer, Clinigen is working closely with the European Medicines Agency to remove the marketing suspension and expects to have European product available, as planned, in the first quarter of 2014.
For countries where Cardioxane® and VIBATIV® do not have Marketing Authorization, Clinigen will leverage the capabilities of its Global Access Programs business (Clinigen GAP) to supply the medicines on a named patient basis.
“The transfer of the European Marketing Authorizations to Clinigen marks an important step in the integration of both Cardioxane® and VIBATIV® into our Specialty Pharmaceuticals business,” said Peter George, Chief Executive Officer, Clinigen Group. “Clinigen has now assumed full control of all key commercialization activities and will provide further updates as we begin to realize the benefit of supplying Cardioxane® directly. In addition, our priority for the remainder of the year is to work towards lifting the current suspension of the Marketing Authorization for VIBATIV®.”
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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 VIBATIV® (telavancin)
VIBATIV® is a bactericidal, once‐daily, injectable lipoglycopeptide antibiotic with a dual mechanism of action whereby VIBATIV® both inhibits bacterial cell wall synthesis and disrupts bacterial cell membrane function. VIBATIV®, discovered and developed by Theravance, is approved in the United States for the treatment of adult patients with complicated skin and skin structure infections (cSSSI) caused by susceptible isolates of Gram‐positive bacteria, including Staphylococcus aureus, both methicillin‐ susceptible (MSSA) and methicillin‐resistant (MRSA) strains, since 2009. In 2011, the European Commission granted Marketing Authorization for VIBATIV® for the treatment of nosocomial pneumonia (hospital-‐acquired), including ventilator‐associated pneumonia, known or suspected to be caused by MRSA when other alternatives are not suitable.
In May 2012, the European Commission suspended Marketing Authorization for VIBATIV® because of a suspension of operations at the contract manufacturing site. Theravance is currently working on re‐ establishing consistent product supply that will meet European Commission requirements.
In June 2013, the United States (US) FDA approved Hospira Worldwide, Inc. as a VIBATIV® drug manufacturer, and in August 2013 Theravance announced that it had re‐established reliable product supply in the US. Clinigen and Theravance are currently working together with the relevant European Commission authorities to remove the Marketing Authorization suspension and introduce commercial supply of VIBATIV® to the EU at the earliest opportunity.
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.
Clinigen GAP develops and implements global access programs for biotechnology and pharmaceutical companies and has provided access to unlicensed, licensed and end‐of‐lifecycle products to thousands of patients. Clinigen has experience in the implementation of more than 30 access programs worldwide.
For more information, please visit www.clinigengroup.com.
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® and VIBATIV®, their 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.
Clinigen Group plc
Tel: +44 (0) 1283 495 010
Peter George, Group Chief Executive Officer
Shaun Chilton, Chief Operating Officer
College Hill (media relations)
Tel: +44 (0) 20 7457 2020
Melanie Toyne-Sewell/Stefanie Bacher/Jen Lewis