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Piramal Imaging to present data at Society for Nuclear Medicine Annual Meeting

Research from more than a dozen studies across multiple compounds in molecular imaging portfolio, including amyloid imaging agent florbetaben, will be presented

2012-06-11
(Press-News.org) Miami Beach, Fla., June 8, 2012: Piramal Imaging SA, a subsidiary of Piramal Healthcare Limited [NSE: PIRHEALTH, BSE: 500302], will present data on several compounds from its molecular imaging portfolio at the Society of Nuclear Medicine's 59th annual meeting in Miami Beach, Fla., from June 9 - 13. Data from five florbetaben studies will be featured, including results from a pivotal Phase III trial which will provide the basis for regulatory submission later this year.

Earlier this spring, Piramal Imaging was formed through the acquisition of worldwide rights to the molecular imaging research and development portfolio of Bayer Pharma AG. Florbetaben, a late-stage amyloid imaging agent being studied as a potential tool to aid in the diagnosis and assessment of Alzheimer's disease, is the lead compound in the portfolio.

Historically, the only way to definitively diagnose Alzheimer's disease has been after death – at autopsy – through analysis and identification of beta-amyloid in brain tissue. The global Phase III trial employed a unique and rigorous study design comparing in vivo brain positron emission tomography (PET) imaging with florbetaben to post-mortem analysis of the brain tissue. Another study compared florbetaben scans of people with mild cognitive impairment (MCI) over time to assess their risk of developing Alzheimer's disease.

"What better way to introduce Piramal Imaging to the nuclear medicine community," says Dr. Ludger M. Dinkelborg, CEO Piramal Imaging. "We believe we have the richest molecular imaging portfolio in the industry today, and the range of research we are presenting here reflects the depth, diversity and clinical relevance of our pipeline." Before co-founding Piramal Imaging, Dr. Dinkelborg served as Head of Diagnostic Imaging Research and Head of Molecular Imaging at Bayer Healthcare.

Piramal Imaging is developing an innovative and proprietary tracer portfolio to address major clinical needs in Alzheimer's disease, prostate cancer, lung cancer, liver cancer, and cardiovascular disease.

"Our goal is to be a leader in molecular imaging through increased diagnostic accuracy of serious medical conditions to improve patient care," says Dr. Swati A. Piramal, Director, Piramal Healthcare Limited. "On a parallel track with our aggressive clinical development program, we are taking the necessary steps toward bringing our tracers to market through the formation of strategic partnerships." Dr. Piramal was recently elected to the Harvard Board of Overseers and also serves on the Dean's Advisory Board of both the Harvard School of Public Health and Harvard Business School.

At this meeting, research on several of the company's pipeline compounds will be featured, including:

NOTE TO EDITORS: All data is embargoed until the date/time of presentation.

Florbetaben

Multicentre phase 3 trial on florbetaben for β-amyloid brain PET in Alzheimer disease [Abstract #41]
Oral Presentation: Neuroscience Miscellaneous & New Approaches
Sunday, June 10, 1:57 PM - 2:09 PM, Room B217/218
Presenter: Osama Sabri, University of Leipzig, Leipzig, Germany

Longitudinal assessment of cerebral amyloid-β deposition in APP-Swe mice with [18F]florbetaben PET [Abstract #92]
Oral Presentation: Brain Imaging Council Young Investigator Award Symposium
Sunday, June 10, 5:03 PM - 5:15 PM, Room B217/218
Presenter: Axel Rominger, University of Munich, Munich, Germany

Partial volume effect correction of florbetaben β-amyloid (Aβ) PET data improves discrimination between Alzheimer's disease (AD) patients and healthy volunteers (HVs) [Abstract #146]
Oral Presentation: Quantifying Brain Amyloid Signal - Methods & Challenges
Monday, June 11, 10:24 AM - 10:36 AM, Room B217/218
Presenter: Henryk Barthel, University of Leipzig, Leipzig, Germany

A two-year longitudinal assessment of Aβ deposition in MCI with 18F-Florbetaben [Abstract #148]
Oral Presentation: Quantifying Brain Amyloid Signal - Methods & Challenges
Monday, June 11, 10:48 AM - 11:00 AM, Room B217/218
Presenter: Kevin Ong, Centre for PET, Austin Health, Melbourne, VIC, Australia

In vivo PET imaging of β-amyloid plaques in an APP/PS1 mouse model of Alzheimer's disease: Comparison of [18F]FIBT and [18F]Florbetaben with [11C]PiB [Abstract #1630]
Poster Presentation: Probes for Neuroimaging
Sunday, June 10, 7:04 PM - 7:06 PM, Exhibit Hall A-B
Presenter: Behrooz Hooshyar Yousefi, Technische Universität München, Munich, Germany

FSPG Correlation of (4S)-4-(3-[18F]fluoropropyl)-L-glutamate ([18F]FSPG) uptake by positron emission tomography (PET) with immunohistochemical expression of system xC- and CD44 in cancer patients [Abstract #219]
Oral Presentation: Basic Science (Oncology); Tumor Characterization & Microenvironment
Monday, June 11, 5:18 PM - 5:30 PM, Room B118/119
Presenter: Dae Hyuk Moon, University of Ulsan College of Medicine, Seoul, Republic of Korea

Evaluation of the 18F L-glutamate derivative 18F-FSPG (BAY 94-9392) in lymphoma and colon cancer patients [Abstract #1126]
Poster Presentation: Meet the Author Poster Session; Basic Science (Oncology)
Monday, June 11, 2:30 PM - 4:00 PM, Exhibit Hall A-B
Presenter: Meena Kumar, Stanford University Medical Center, Palo Alto, California, USA

Evaluation of the 18F-labeled L-glutamate derivative 18F-FSPG (BAY 94-9392) in brain and head and neck cancer patients [Abstract #274]
Oral Presentation: Basic Science (Oncology); Novel Imaging Agents - Clinical
Tuesday, June 12, 8:36 AM - 8:48 AM, Room B118/119
Presenter: Meena Kumar, Stanford University Medical Center, Palo Alto, California, USA

Characterization of physiological 18F-FSPG uptake in healthy volunteers: Kinetics and biodistribution [Abstract #555]
Oral Presentation: Technological Advances, Methodology, Quantification
Wednesday, June 13, 10:33 AM - 10:45 AM, Room B118/119
Presenter: Camila Mosci, Stanford University, Palo Alto, California, USA

Ga68-Bombesin
Preclinical validation of the Ga-68-Bombesin Antagonist BAY 86-7548 for a Phase I Study in Prostate Cancer Patients [Abstract #177]
Oral Presentation: Prostate
Monday, June 11, 12:30 PM - 12:42 PM, Room B214
Presenter: Sandra Borkowski, Global Drug Discovery, Bayer Healthcare, Berlin, Germany

Radiosynthesis and pre-clinical evaluation of Al18F labeled bombesin antagonist: Promising tracer for prostate cancer imaging [Abstract #1732]
Poster Presentation: Special Meet the Author Poster Session; Probes for Oncology
Sunday, June 10, 6:30 PM - 8:00 PM, Exhibit Hall A-B
Presenter: Svetlana Selivanova, Center for Radiopharmaceutical Sciences, ETH Zurich, Zurich, Switzerland

DFMT

Clinical investigation of dynamic PET/CT imaging using O-([18F]fluoromethyl)-D-tyrosine (D-18F-FMT, BAY 86-9596) in oncological patients [Abstract #1676]
Poster Presentation: Special Meet the Author Poster Session; Probes for Oncology
Sunday, June 10, 6:30 PM - 8:00 PM, Exhibit Hall A-B
Presenter: Irene Burger, University Hospital, Zurich, Switzerland

Comparison of PET/CT images with a novel tracer O-([18F]fluoromethyl)-D-tyrosine (D-18F-FMT, BAY 86-9596) with LAT1 immunohistochemical staining in patients with non-small cell lung cancer or head and neck squamous cell carcinoma [Abstract #1677]
Poster Presentation: Special Meet the Author Poster Session; Probes for Oncology
Sunday, June 10, 6:30 PM - 8:00 PM, Exhibit Hall A-B
Presenter: Irene Burger, University Hospital, Zurich, Switzerland

### For investor enquiries, please contact: Sagar Gokani/Prasad Mhatre
Investor Relations Team, Piramal Healthcare Limited
Tel: +91 (0) 22 3046 6474/6489
investor.relations@piramal.com

For media enquiries, please contact: PIRAMAL GROUP PUBLIC RELATIONS AGENCY
Akansha Pradhan
Corporate Communications, Piramal Group
Tel: +91 (0) 22 3351 4082/4083
akansha.pradhan@piramal.com

Amy Losak - Tel: +1 646 935 3917
amy.losak@ketchum.com

On site at SNM meeting:
Julie Armour - Mobile: +1 908 656 5887
julie.armour@ketchum.com

Note to the Editors: About Florbetaben (BAY 94-9172) Florbetaben is an 18F-labeled PET tracer that specifically binds to deposition of beta-amyloid. These depositions (plaques) consist of proteins that accumulate in the brain and are a pathological hallmark of Alzheimer's disease. As the aggregation of the beta-amyloid protein in the brain is also a key target for new therapeutic treatments under development, florbetaben might also be able to support the development of these new treatment approaches. A Phase II study showed that patients with clinical diagnosis of Alzheimer's disease could be differentiated from age-matched healthy volunteers on the basis of florbetaben uptake pattern in the brain. The results of the Phase II study were presented at the International Conference on Alzheimer's diseases (ICAD) in Vienna, Austria in July 2009 and published in the Lancet Neurology in April 2011.

About Piramal Healthcare Ltd Piramal Healthcare, is an innovation led company with a growth track record of above 25% CAGR since 1988. Piramal Healthcare had consolidated revenues of US $450million in FY2012. With assets across North America, Europe and Asia, Piramal Healthcare is one of the largest pharmaceutical custom manufacturing companies across the world. It has significant presence in the global critical care space with sales of anesthesia products to over 100 countries. Piramal Healthcare has a robust pipeline of 16 new molecules with its cartilage repair gel – BST-CarGel having received European CE mark approval recently. In 2010, Piramal Healthcare sold its domestic formulation business to Abbott for a consideration of US $3.8 billion. Piramal Healthcare has in June 2012 completed its acquisition of one the fastest growing healthcare information leaders, Decision Resources Group, which is a reflection of the strategy to continue investing in strong intellectual property in the healthcare space. Piramal Healthcare also has a growing presence in the financial services sector with an NBFC focusing on lending to the real estate sector and IndiaReit – a real estate focused private equity fund.

About the Piramal Group The Piramal Group, led by Ajay G. Piramal, is one of India's foremost business conglomerates. Driven by the core values of Knowledge Action Care, the Piramal Group has interests in a myriad of industries that encompass healthcare, drug discovery & research, diagnostics, glass, real estate and financial services. The Piramal Group steadfastly pursues inclusive growth while adhering to ethical and value driven practices. The Group's turnover exceeded $ 900 million in FY2011.



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[Press-News.org] Piramal Imaging to present data at Society for Nuclear Medicine Annual Meeting
Research from more than a dozen studies across multiple compounds in molecular imaging portfolio, including amyloid imaging agent florbetaben, will be presented