Piramal Imaging Announces the Acceptance for Review of [18F] florbetaben by the FDA and EMA for the Visual Detection of beta

 Piramal Imaging Announces the Acceptance for Review of [18F] florbetaben by
   the FDA and EMA for the Visual Detection of beta-amyloid in Alzheimer's
                                   Disease

  PR Newswire

  BOSTON and MUMBAI, India, March 21, 2013

BOSTON and MUMBAI, India, March 21, 2013 /PRNewswire/ --

Piramal Imaging SA, a division of Piramal Enterprises, today announced that
the Food and Drug Administration (FDA) and the European Medicines Agency (EMA)
have accepted its applications for review of the investigational PET amyloid
imaging agent [ ^18 F] florbetaben. A New Drug Application (NDA) was submitted
to the U.S. Food and Drug Administration (FDA) and a Marketing Authorization
Application to the EMA for [ ^18 F] florbetaben use in the visual detection of
beta-amyloid in the brains of adults with cognitive impairment who are being
evaluated for Alzheimer's disease and other causes of cognitive decline. [ ^18
F] florbetaben binds to beta-amyloid plaques in the human brain, a hallmark
characteristic in Alzheimer's disease.

 (Logo: http://photos.prnewswire.com/prnh/20120516/531613 )

Today, Alzheimer's disease is usually diagnosed after a person with a
cognitive impairment undergoes an extensive clinical examination which
typically includes family and medical history, physical and neurological
examinations, laboratory tests, and imaging procedures such as computed
tomography (CT) and magnetic resonance imaging (MRI) scans. Still, a
definitive diagnosis of Alzheimer's disease can only be made after death where
an autopsy can reveal the presence of beta-amyloid plaques and neurofibrillary
tangles in the brain. However, post-mortem studies looking for accumulations
of beta-amyloid in the brain have shown that 10 to 30 percent of diagnoses
based on clinical examinations are incorrect. [ ^18 F] florbetaben is being
studied to determine its potential ability to detect beta-amyloid plaques in
living subjects with cognitive impairment.

The submission of [ ^18 F] florbetaben is based on the results of a broad
clinical program including a pivotal multi-center Phase III trial. This was
the first study of a direct comparison between in-vivo PET imaging of the
brain using [ ^18 F] florbetaben and the post-mortem analysis of brain tissue.
The study was performed to confirm that [ ^18 F] florbetaben binds to
beta-amyloid in the brain at the regional level and is diagnostically useful
on the subject to exclude Alzheimer's disease. The presence of beta-amyloid in
histopathological sections taken from the brains of deceased subjects was
directly matched to [ ^18 F] florbetaben uptake in the identical regions of
interest. The visual assessment procedure proposed for routine clinical
practice demonstrated 100% sensitivity, 92% specificity, and excellent
inter-reader agreement (kappa = 0.88). In addition, a subsequent study looked
across 461 images from Phase I, II, and III studies to validate that the
visual assessment method, taught by an electronic tool, is reliable (kappa =
0.87).

"The acceptance for review of [ ^18 F] florbetaben marks an important
milestone in our clinical research on Alzheimer's disease. The addition of [
^18 F] florbetaben PET imaging to the current clinical evaluation of people
suffering from cognitive decline may help to increase the diagnostic
confidence of physicians addressing a significant medical need by providing
earlier and more robust information to people and their caregivers. We also
see a potential for our product to contribute in the future to the early
detection of Alzheimer's disease and facilitate specific treatment decisions,"
said Dr. Ludger Dinkelborg, Director of the Board, Piramal Imaging SA. Renaud
Dehareng, Chief Executive Officer of IBA Molecular, also welcomed the
acceptance for review of [ ^18 F] florbetaben. In 2012 IBA Molecular and
Piramal Imaging signed an agreement to the effect that IBA Molecular would
manufacture and distribute [ ^18 F] florbetaben upon regulatory approval in
both the United States and Europe. The company owns and operates a network of
54 PET isotope facilities worldwide, a network that is unique in both size and
scope. Dehareng said, "We believe our network of PET isotope facilities is
well positioned to maximize patient access to [ ^18 F] florbetaben and is
strongly committed to providing our customers and their patients with the best
quality product and service possible."

Notes to the editors:

About florbetaben

[ ^18 F] florbetaben is an ^18 F-labeled tracer for use in positron emission
tomography (PET) which specifically binds to beta-amyloid deposits in the
brain, a key pathological hallmark in Alzheimer's disease. A Phase III trial
presented for the first time at the annual meeting of the American Academy of
Neurology in 2012 showed that PET imaging with [ ^18 F] florbetaben detects
beta-amyloid in the brains of living subjects. The visual assessment procedure
proposed for routine clinical practice demonstrated 100% sensitivity and 92%
specificity.

About Alzheimer's disease

Alzheimer's disease is a progressive neurodegenerative disease which primarily
affects people over the age of 60 and is the most common cause of dementia. In
2009 estimates suggested that more than 36 million people worldwide were
suffering from Alzheimer's. This figure could exceed 115 million by 2050. At
present there is no cure for the disease, although treatments which may help
with certain symptoms, combined with the right services and support, can
improve the quality of life for the millions of people living with
Alzheimer's.

About Piramal Enterprises Ltd.

Piramal Enterprises is one of India's largest diversified companies with
operations in pharmaceuticals, financial services and information management.
Piramal Enterprises generated consolidated revenues of $500 million in the
2012 financial year. In pharmaceuticals field, Piramal Enterprises is one of
the leading custom manufacturing players in the world and operates in the
global critical-care segment with a portfolio of inhalation and injectable
anesthetics. Its OTC business is ranked number 7 in India. PEL is also
involved in drug discovery & research and has strong pipeline of development
products. In the financial services field, PEL has a real-estate-focused PE
fund called Indiareit, and an NBFC that focuses on lending to the real-estate
and education sector. Recently, PEL also entered the global
information-management industry by acquiring the US-based company Decision
Resources Group. PEL acquired the global rights to a molecular-imaging
research and development portfolio from Bayer AG. The portfolio includes the
rights to [ ^18 F] florbetaben, a highly specialized molecule used in PET
imaging to detect beta-amyloid in the brain, a widely recognized marker for
Alzheimer's disease.

About Piramal Imaging SA

Piramal Imaging SA, a division of Piramal Enterprises Ltd., was formed in 2012
with the acquisition of the molecular imaging research and development
portfolio of Bayer Pharma AG. By developing novel PET tracers for molecular
imaging, Piramal Imaging is focusing on a key field of modern medicine.
Piramal Imaging strives to be a leader in the Molecular Imaging field by
developing innovative products that improve early detection and
characterization of chronic and life threatening diseases leading to better
therapeutic outcomes and improved quality of life.

http://piramalenterprises.com .

About IBA Molecular

IBA Molecular is a global group of companies that develops, manufactures and
distributes radiopharmaceutical products and supporting services used in
molecular imaging. IBA Molecular has engineered a strong and unique product
portfolio and pipeline of diagnostic and therapeutic tracers aimed at
advancing the global movement towards personalized medicine and making
molecular imaging/therapy a major discipline in healthcare. The company also
provides educational, technical and marketing support to medical specialists
worldwide to help them respond better to patient needs. For more information,
please visit http://www.ibamolecular.com or contact IBA Molecular North
America, Inc., 21000 Atlantic Boulevard, Suite 730, Dulles, Virginia 20166.

For media enquiries please contact: Tammy Best Marketing Communications
Manager Piramal Enterprises - Imaging Division Contact: +1-1-617-557-1750
tammy.best@piramal.com Akansha Pradhan Corporate Communications Piramal Group
Contact: +91-3351 4082 akansha.pradhan@piramal.com
 
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