On February 24, 2014, Piramal Imaging announced that NeuraCeq™ has received marketing authorization from the European Commission.

NeuraCeq™ is a radiopharmaceutical indicated for Positron Emission Tomography (PET) imaging of beta-amyloid neuritic plaque density in the brains of adult patients with cognitive impairment who are being evaluated for Alzheimer’s disease (AD) and other causes of cognitive impairment. With this authorization, NeuraCeq™ will soon be available to provide valuable information that may give physicians more confidence in their clinical assessment and help them provide more personalized patient management as a negative scan may rule out AD as a cause of a patient’s cognitive decline.

“With the prevalence of dementia predicted to grow dramatically in the coming decades, the global communities are mobilizing to understand the pathology and progression of Alzheimer’s disease and other forms of cognitive impairment,” said Dr. Ludger Dinkelborg, Director of the Board, Piramal Imaging. “The approval of NeuraCeq™ in Europe will give
healthcare providers a new tool to aid in the diagnostic assessment of AD and other causes of cognitive impairment. Our goal from here is to get NeuraCeq™ into the hands of physicians later this year so they can help ensure timely and accurate assessments for patients.”

“Our belief in the diagnostic importance of molecular imaging led us to make a strategic investment in the Bayer research pipeline and create the Piramal Imaging business,” said Dr. Swati Piramal, Vice Chairperson, Piramal Enterprises, Ltd. “In just two years, we are already at the approval milestone in Europe for the first of our compounds setting us up to provide physicians and patients with valuable information about cognitive impairment and decline. Early diagnosis can be powerful knowledge for certain clinicians and families and may lead to faster action and better care – all of which we value to our core at Piramal Enterprises.”

Data from the pivotal phase III autopsy study showed that PET imaging with NeuraCeq™ detects neuritic beta-amyloid in the brains of living subjects. The visual subject-level PET reading proposed for routine clinical practice compared to histopathology for the first 31 brains demonstrated 100 percent sensitivity and 86 percent specificity. In a post-hoc
analysis in a larger population with 74 autopsied subjects, the sensitivity of the visual assessment was 98 percent and specificity was 89 percent.

NeuraCeq™ will be available in select European countries in the second and third quarters of 2014.Piramal Imaging has partnered with IBA Molecular for manufacturing and distribution of NeuraCeq™ upon EU approval. IBA Molecular owns and operates a network of 49 PET isotope facilities worldwide.

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