Thursday, September 18, 2014 - 01:00

Clinigen Group launches New First-in-Class Antibiotic VIBATIV® (telavancin) for MRSA related Hospital-Acquired Pneumonia across Europe.

Burton-on-Trent, UK - 18 September 2014 - Clinigen Group plc ('Clinigen' or the 'Group') (AIM: CLIN), the specialty global pharmaceutical company, today announced that the new first-in-class bactericidal, once-daily, injectable antibiotic VIBATIV® (telavancin), is now available to prescribe in Europe for the treatment of adults with nosocomial pneumonia (also known as hospital acquired pneumonia - HAP), including ventilator associated pneumonia (VAP), known or suspected to be caused by methicillin-resistant Staphylococcus aureus (MRSA) when other alternatives are not suitable.

In March 2013, Clinigen, in-licensed V IBATIV® from Theravance, Inc. for commercialization in Europe, however, at that time the European Marketing Authorisation for the drug was suspended due to stopped operations at the previous manufacturer.  Clinigen worked closely with a new contract manufacturer and the relevant European authorities to have the suspension lifted. The European Commission (EC) confirmed this in March 2014 enabling Europe-wide, licensed supply to commence.  This will be the first time the licensed product will be available in Europe.

VIBATIV® is an innovative treatment for HAP, the most common cause of death among infections acquired in a hospital setting, in that it offers a dual mechanism of action enabling it to kill even drug resistant strains of Staphylococcus aureus.[1]The drug's dual mechanism of action means that even a strain resistant to one of the mechanisms of action may still be affected by the other mechanism, suggesting that VIBATIV® may be less prone to resistance than other antibiotics.  HAP caused by MRSA is a considerable unmet need, recognised as a public health priority in the EU.  MRSA is estimated to cost EUR380 million every year in extra hospital costs.[2] As a result of these high costs, both economic and human, there is increasing demand for new tools to combat infections caused by drug-resistant bacterial strains and the availability of new antibacterial agents is recognised as playing an important role in treating MRSA.

30-70% of patients who acquire HAP currently die despite early and appropriate treatment, and the condition places a large burden on healthcare systems.[3] There is a limited choice of licensed antibiotic therapies able to treat HAP/VAP caused by MRSA and therefore this launch provides an important, alternative, effective agent in the fight against the growing problem of resistance by bacteria.

"HAP caused by MRSA is often more serious and difficult to treat than similar infections with more drug susceptible strains," said Professor Matteo Bassetti,  Professor of Infectious Diseases, School of Medicine and Postgraduate School of Infectious Diseases, University of Udine, Italy. "We are increasingly seeing bacteria acquire resistance to antibiotics previously considered last resort treatments; we need more options to treat these extremely serious infections. The widespread availability of a new and effective antibiotic such as VIBATIV® is therefore very good news for Europe."

"The emergence of so-called 'super bugs' and increasing resistance among microbes to existing antibiotics has been recognised internationally as a major clinical challenge," said Peter George, Group Chief Executive Officer at Clinigen Group plc. "We are therefore extremely proud to be making this potentially life-saving medicine available across Europe for people who may have no other suitable option to fight a life-threatening infection."

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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®  is approved in the United States (US) for the treatment of adult patients with (i) 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, and (ii) hospital-acquired and ventilator-associated bacterial pneumonia (HAP/VAP) caused by susceptible isolates of Staphylococcus aureus when alternative treatments are not suitable. 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. VIBATIV® was discovered and developed by Theravance, Inc., and transferred to Theravance Biopharma, Inc. in connection with the separation of the two companies in June 2014.

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®. In March this year the European Commission reinstated the marketing authorisation for VIBATIV® as consistent product supply was re-established in accordance with European Commission requirements. Theravance Biopharma Antibiotics, Inc. has granted Clinigen exclusive commercialization rights to VIBATIV® in the EU and certain other European countries (including Switzerland and Norway).

For further information, for healthcare professionals please visit www.vibativ.eu

About Clinigen

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 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.

 

Contact Details

 

Clinigen Group plc                                                                                          Tel: +44 (0) 1283 495 010

Peter George, Group Chief Executive Officer

Shaun Chilton, Chief Operating Officer

 

Instinctif Partners (media relations)

Tel: +44 (0) 20 7457 2020

Melanie Toyne-Sewell/Jen Lewis/ Emma Barlow

Email: clinigen@instinctif.com

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