Burton-on-Trent, UK – 8 January 2014 – Clinigen Group plc (AIM: CLIN) today announced the initiation of an early access program, managed by Clinigen Global Access Programs (Clinigen GAP), to provide the anti-bacterial VIBATIV® (telavancin) to patients in Europe with hospital-acquired bacterial pneumonia (HAP) known or suspected to be caused by MRSA. HAP is an area of considerable unmet need; for the first time VIBATIV® will be available to physicians in Europe to treat eligible patients on an individual named patient basis.
In March 2013 Clinigen in-licensed VIBATIV® into its Specialty Pharmaceuticals business, Clinigen SP, from Theravance, Inc. for commercialization in Europe. Although the product had been approved in Europe in 2011 by the European Commission, its use was suspended in 2012 following a halt in operations at the previous contract manufacturer. Between approval and suspension the drug was not launched into the market and therefore has never previously been available in Europe. With the technical transfer to a new contract manufacturer completed by Theravance, Clinigen is working closely with the European Medicines Agency (EMA) to remove the Marketing Authorization suspension and to make the product commercially available in 2014.
Clinigen SP has drawn on the Group’s unique business model, enabling it to provide early access to VIBATIV® utilizing its dedicated Global Access Programs business, Clinigen GAP. With the time between a patient contracting pneumonia and receiving VIBATIV® a critical factor, Clinigen will use its comprehensive European logistics network to ensure that the drug reaches patients swiftly, providing 24/7 access to the drug for individual named patients.
Shaun Chilton, Chief Operating Officer, Clinigen Group said, “VIBATIV® is a drug that can be used when other alternatives for HAP are not suitable. Our ability to provide access to VIBATIV® on a named patient basis addresses a key unmet need and could make a huge difference to critically ill patients. While we are working with the EMA to lift the Marketing Authorization suspension for VIBATIV®, the Group is able to respond to unmet medical need and provide access to this drug through our Clinigen GAP division.”
Mark Corbett, Senior Vice President, Clinigen GAP added: ‘’We are pleased to be able to implement an access program for the newest of Clinigen’s portfolio products, as we already do for Foscavir® and Cardioxane® in markets where they are not commercially available, in addition to the 30+ other programs we are already managing for other leading pharmaceutical and biotech companies.”
Clinigen GAP will continue to provide access to VIBATIV® via an access program on a named patient basis until Marketing Authorization is restored across the European markets. For information or enquiries about the access program contact Clinigen GAP:
Tel: +44(0) 1283 494 340
Fax: +44(0) 1283 494 341
Notes to Editors
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 (US) 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 September 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 the previous single-source drug product supplier did not meet the current Good Manufacturing Practice ("cGMP") requirements for the manufacture of VIBATIV®. Theravance is currently working on re-establishing consistent product supply that will meet European Commission requirements.
In June 2013, US Food and Drug Administration (FDA) approved VIBATIV® (telavancin) for the treatment of adult patients with hospital-acquired and ventilator-associated bacterial pneumonia (HABP/VABP) caused by susceptible isolates of Staphylococcus aureus when alternative treatments are not suitable. In addition, the US FDA approved Hospira (McPherson, Kansas, US) as the manufacturer of VIBATIV®, 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 named patient programs
Named patient programs provide controlled, pre-approved access to unapproved medicines in response to requests from physicians on behalf of specific or ‘named’ patients before those medicines are licensed in the patients’ home country.
The Clinigen Group is a specialty global pharmaceutical company 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).
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.
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.
For more information, please visit www.clinigengroup.com
Issued for and on behalf of Clinigen Group.
To contact the Clinigen team at College Hill, email email@example.com
Melanie Toyne-SewellManaging Partner