Piramal Imaging ( Subsidiary of Piramal Enterprises) has made two major acquisitions, BST CarGel for 30cr in 2011 from BioSynTech and a molecular imaging Portfolio from Bayer in 2012 for an undisclosed amount.
CarGel received approval in the EU in 2012 and is still awaiting approval from the FDA. For an acquisition price of 30cr and developmental expenses, its looks like Piramal Imaging will reap long lasting benefits.
With the current approval of FDA for Neuraceq(a.k.a Florbetaben), a market for a new class of PET imaging agents with a potential unto 1.5Billion USD per year has been unlocked.
Looks like the LifeSciences division will start contributing cash flows from Fy14-15 itself.
Exciting times ahead.
BERLIN and BOSTON, March 20, 2014
Piramal Imaging today announced that the U.S. Food and Drug Administration (FDA) has approved Neuraceq™. This approval comes only four weeks after receiving marketing authorization for Neuraceq™ from the European Commission.
Neuraceq™ is indicated for Positron Emission Tomography (PET) imaging of the brain to estimate beta-amyloid neuritic plaque density in adult patients with cognitive impairment who are being evaluated for Alzheimer’s disease (AD) and other causes of cognitive decline.
There are an estimated 7.7 million new cases of dementia each year worldwide.1 Alzheimer’s disease accounts for 60-80% of all dementia diagnoses.2 However, a clinical diagnosis of probable AD is incorrect upon post-mortem histological investigation in 10-30% of cases.3
The Centers for Medicare & Medicaid Services (CMS) has declared it will cover a beta-amyloid PET scan for patients under Coverage with Evidence Development (CED) programs. The objective of these programs is to assess the impact of beta-amyloid scans on improving patient outcomes or advancing patient treatment options.
“Alzheimer’s disease or any form of cognitive impairment is a daunting diagnosis,” said Dr. Ludger Dinkelborg, Director of the Board, Piramal Imaging. “For the patients and caregivers, the concern centers around understanding what the future holds. For physicians, the challenge is properly assessing the patient and determining the best care path.”
“The FDA’s approval of Neuraceq™ is a significant milestone for Piramal Imaging and demonstrates our dedication to advancing innovation in molecular imaging globally,” said Dr. Swati Piramal, Vice Chairperson, Piramal Enterprises, Ltd. “The rising prevalence of Alzheimer’s disease and cognitive impairment is being felt individually and collectively around the world. Our goal as a company is to usher in a new era of imaging that helps paint clearer pictures of the physiology of such conditions and helps improve patient outcomes.”
The FDA approval of Neuraceq™ is based on safety data from 872 patients who participated in global clinical trials as well as three studies that examined images from adults with a range of cognitive function, including 205 end-of-life patients who had agreed to participate in a post-mortem brain donation program. Images were analyzed from 82 subjects with post-mortem confirmation of the presence or absence of beta-amyloid neuritic plaques. Correlation of the visual PET interpretation with histopathology in these 82 brains demonstrated that Neuraceq™ accurately detects moderate to frequent beta-amyloid neuritic plaques in the brain and is a useful tool to estimate the density of these plaques in life.
Piramal Imaging has partnered with IBA Molecular for manufacturing and distribution of Neuraceq™. IBA Molecular owns and operates a network of 49 PET isotope facilities worldwide, a network that is unique in both size and scope.
One thought on “Piramal Enterprises – FDA Approves Florbetaben”
Well done man. Good posts. Hope AP is good at allocating the Vodafone cash. That’s usually the tricky bit.