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

By Astellas Pharma Europe Ltd., PRNE
Thursday, May 19, 2011

New Treatment Option for Adult Patients With Nosocomial Pneumonia, Including Critically ill Patients With Ventilator Associated Pneumonia

STAINES, England, May 20, 2011 - 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

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

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:
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

5. ECDC/EMEA Joint Technical Report: The bacterial challenge: time to
react. 17 September 2009.
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

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

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