Bayer sells molecular imaging development portfolio to Piramal Healthcare
Monday, April 16 2012 | Comments
sold the worldwide rights to its molecular imaging research and development portfolio to India-based Piramal Healthcare Ltd.
The transaction includes the development, marketing and distribution rights to florbetaben, a positron emission tomography (PET) imaging agent for the detection of beta-amyloid plaques in the brain that is in Phase III development.
Beta-amyloid plaques are a hallmark feature in the brains of patients with probable Alzheimer's disease (AD), Piramal noted. Historically, the only way to definitively diagnose AD has been with a postmortem analysis of brain tissue to confirm the presence of these plaques, the firm added.
In a Phase III trial of florbetaben, which compared in vivo PET imaging with florbetaben versus postmortem analysis of brain tissue, the imaging agent met all study endpoints. The visual assessment procedure of PET scans that is the proposed procedure for routine clinical practice had a sensitivity of 100 percent, a specificity of 92 percent and excellent interreader agreement, according to Piramal.
The results of this trial are scheduled to be presented later this month in New Orleans at the American Academy of Neurology's 64th Annual Meeting
Piramal has established a new subsidiary, Piramal Imaging SA, to manage the development of the newly acquired portfolio, which includes certain preclinical and clinical assets in addition to florbetaben.
Additionally, the company is creating a global commercial team dedicated to florbetaben and plans to file for regulatory approvals of the imaging agent later this year. Piramal estimated that florbetaben's class of PET imaging agents for AD has a global market potential of as much as $1.5 billion.
Financial terms of the transaction between Bayer and Piramal were not disclosed.
With this acquisition, Piramal joins several companies, such as Eli Lilly and Co.
and GE Healthcare
, in the pursuit of an AD imaging agent that could be used to help diagnose the disease.
GE recently reported that its investigational PET amyloid imaging agent, [18F]flutemetamol, met the primary endpoints of two Phase III trials that evaluated the agent's ability to detect or exclude the presence of beta-amyloid plaques in the brain. The company plans to file for regulatory approval of flutemetamol later this year.
In addition, earlier this month, the Food and Drug Administration
approved Lilly's Amyvid (florbetapir F 18) injection, a radioactive diagnostic agent, for brain imaging of beta-amyloid plaques in patients with cognitive impairment who are being evaluated for AD and other conditions that lead to cognitive decline. Amyvid is the first and only radioactive diagnostic agent approved for PET imaging of beta-amyloid neuritic plaques in the living brain, according to Lilly.