Astellas Receives Positive Opinion From CHMP for European Approval of VIBATIV(TM) for Nosocomial Pneumonia Caused by MRSA

Staines, England (ots/PRNewswire) - Astellas Pharma Europe
Ltd., announced today that the Committee for Medicinal Products for
Human Use (CHMP) of the European Medicines Agency (EMA) adopted a
positive opinion, recommending the granting of marketing
authorisation for VIBATIV (telavancin hydrochloride) for the
treatment for adults with nosocomial (hospital-acquired) pneumonia,
including ventilator associated pneumonia known or suspected to be
caused by MRSA (methicillin resistant Staphylococcus aureus). VIBATIV
should be used only in situations where it is known or suspected that
other alternatives are not suitable. VIBATIV is a bactericidal,
once-daily injectable lipoglycopeptide antibiotic developed by
Theravance, Inc..

The CHMP, on the basis of quality, safety and efficacy data
submitted, considered there to be a favourable benefit to risk
balance for VIBATIV and therefore recommended the granting of the
marketing authorisation.

The CHMP's positive opinion is a critical step in the approval
process, and it is expected that the European Commission will follow
the advice of the CHMP and grant marketing authorisation in
approximately two to three months. If approved, it would allow
Astellas to make the product available to healthcare professionals
trying to meet the challenge of treating serious hospital-acquired
lung infections caused by MRSA.

"This positive opinion from the CHMP for VIBATIV is great news
for both doctors and patients who continue to battle serious
life-threatening nosocomial pneumonia, including ventilator
associated pneumonia caused by MRSA," said Ken Jones, President and
CEO, APEL. "It means healthcare professionals will soon have a new,
effective hospital antibiotic with potent bactericidal activity
against Gram-positive bacteria and potentially a higher likelihood of
generating successful clinical outcomes in certain critically ill
patients who increasingly fail to respond to established therapy(1),"
he added.

The European Centre for Disease Prevention and Control (ECDC)
estimate that each year more than 4 million patients in Europe
acquire an infection in hospital. At least 37,000 Europeans die as a
direct result of hospital-acquired infections.(2) Risk factors for
contracting a hospital-acquired infection due to MRSA include older
age, prolonged hospitalisation, intravenous drug use and diabetes.(3)
MRSA is the most frequent cause of ventilator-associated pneumonia
and the second highest cause of mortality in these critically ill
patients.(4)

Across Europe there is a high unmet need for new drugs which are
active against MRSA and other Gram-positive pathogens particularly
with poor susceptibility to more commonly used antibacterials.(5)

VIBATIV, licensed from Theravance, Inc. for global
commercialisation, is a bactericidal, once-daily, injectable
lipoglycopeptide antibiotic with a dual mechanism of action against
Gram-positive bacteria including resistant pathogens such as
MRSA(6,7). In Phase 3 clinical trials, more than 750 patients with
nosocomial pneumonia, including a subset of patients with ventilator
associated pneumonia, have been treated with VIBATIV.

In phase 3 clinical trials ATTAIN I and ATTAIN II VIBATIV has
demonstrated non-inferiority to vancomycin in the primary endpoint of
clinical cure, with better outcomes in certain patient populations.
(7-9)

VIBATIV was approved in the United States in September 2009, and
in Canada in October, 2009 for adult patients with complicated skin
and skin structure infections (cSSSI) caused by susceptible
Gram-positive bacteria.10

Astellas has an ongoing commitment to combating infectious
diseases through the worldwide launch of its injectable antifungal
echinocandin, MYCAMINE(R) (micafungin), which has been used to treat
over 750,000 patients worldwide.(11) In addition, Astellas has
entered into a global partnership with Basilea Pharmaceuticals Ltd.
to co-develop and co-promote isavuconazole, an azole antifungal for
the treatment of invasive fungal infections, including
Aspergillosis, currently in Phase 3 trials; and with Optimer
Pharmaceuticals Inc. to develop and commercialise fidaxomicin, an
investigational antibiotic under regulatory review as a novel
treatment for Clostridium difficile infection in Europe and certain
other countries.(12)

About Astellas Pharma Europe Ltd.

Astellas Pharma Europe Ltd., located in the UK, is a European
subsidiary of Tokyo-based Astellas Pharma Inc. Astellas is a
pharmaceutical company dedicated to improving the health of people
around the world through the provision of innovative and reliable
pharmaceuticals. The organisation is committed to becoming a global
company by combining outstanding R&D and marketing capabilities and
continuing to grow in the world pharmaceutical market. Astellas
Pharma Europe Ltd. is responsible for 21 affiliate offices located
across Europe, the Middle East and Africa, an R&D site and three
manufacturing plants. The company employs approximately 3,900 staff
across these regions. For more information about Astellas Pharma
Europe, please visit http://www.astellas.eu.

1. Matteo Bassetti M, Mikulska M, Righi E et al. The role of
telavancin in the treatment of MRSA infections in hospital. Expert
Opin Investig. Drugs 2009; 18:521-529

2. European Centre for Disease Control: http://ecdc.europa.eu/en/
healthtopics/healthcare-associated_infections/pages/index.aspx
Accessed 17 May 2011

3. Ratnaraja & Hawley. Current challenges in treating MRSA: what
are the options? Expert Rev Anti Infect Ther 2008;6:601-18.

4. Kollef MH, Morrow LE, Niederman MS et al. Clinical
Characteristics and Treatment Patterns Among Patients with
Ventilator-Associated Pneumonia.Chest 2006;129:1210-8

5. ECDC/EMEA Joint Technical Report: The bacterial challenge:
time to react. 17 September 2009. http://ecdc.europa.eu/en/publicati
ons/Publications/0909_TER_The_Bacterial_Challenge_Time_to_React.pdf
Accessed 17 May 2011

6. Higgins DL, Chang R, Debabov DV, et al. Telavancin, a
multifunctional lipoglycopeptide, disrupts both cell wall synthesis
and cell membrance integrity in methicillin-resistant Staphylococcus
aureus. Antimicrob. Agents Chemother 2005;49:1127-1134

7. Rubinstein E, Lalani T, Corey GR, et al. Telavancin versus
vancomycin for hospital-acquired pneumonia due to gram-positive
pathogens. Clin Infect Dis 2011; 52:31-40

8. Shorr AF, Niederman M, Kollef MH, et al. Telavancin: a novel
agent for ventilator-associated pneumonia due to Staphylococcus
aureus. Oral presentation at the Annual Meeting of the ACCP; Chest
2008, abstract.

9. Rubinstein, E, Barriere, SL, Genter, FC, et al. Late
ventilator-associated pneumonia (VAP): analysis of baseline
characteristics and clinical outcomes in the ATTAIN studies. Poster
823. SCCM 2010

10. VIBATIV US prescribing information May 2011

11. IMS Midas sales 12/02 to 12/10, Astellas Pharma Ltd

12. Astellas press release on partnership with Optimer for
fidaxomicin, 7th Feb 2011

http://www.astellas.eu

ots Originaltext: Astellas Pharma Europe Limited
Im Internet recherchierbar: http://www.presseportal.de

Contact:
For additional information: Astellas Pharma Europe Ltd,
CorporateCommunications, Mindy Dooa, Tel: +44-(0)1784-419408