IBA Molecular to Manufacture and Distribute 18F-Florbetaben in Europe and US
DULLES, Va. and MUMBAI, India, Aug. 6, 2012 /PRNewswire/ -- IBA Molecular and Piramal Imaging SA (Piramal) have announced an agreement whereby IBA Molecular will manufacture and distribute 18F-Florbetaben, Piramal's new diagnostic imaging agent, in the European and US markets. 18F- Florbetaben is a radiopharmaceutical currently in development for use with positron emission tomography (PET) for the detection of beta-Amyloid plaque deposition in the brain, a pathological feature associated with Alzheimer's disease and other neurologic conditions.
Recently announced results from Phase III studies (presented at the American Academy of Neurology's 64th Annual Meeting) indicate that PET imaging with 18F-Florbetaben reliably detects beta-amyloid in the brain with great accuracy and may have potential as an aid in the diagnosis and assessment of Alzheimer's disease. The visual assessment procedure proposed for routine clinical practice demonstrated 100% sensitivity and 92% specificity with excellent inter-reader agreement (kappa=0.88). This pivotal trial was the first to overlay MRI and PET data to accurately match Florbetaben gray matter uptake with disease in six defined regions of the brain. This was done to confirm that Florbetaben binds to beta-Amyloid on both a regional (brain sections) and subject (whole brain) level. This combination provided considerably more data points than any other beta-Amyloid tracer trial to date.
"We are committed to creating a strong global pharma business based on intellectual property. 18F-Florbetaben is our lead compound in the molecular imaging business, and we are confident that it has the potential to increase clinicians' accuracy and confidence. IBA Molecular and Piramal share a common vision and dedication towards fulfilling unmet medical needs and investing in superior discovery and research," said Mr. Ajay Piramal, Chairman, Piramal Group.
"IBA Molecular is deeply committed to the future of nuclear medicine, and the 18F-Florbetaben distribution agreement with Piramal will allow us to provide, upon its approval, one of the most anticipated compounds in nuclear medicine to our network of customers. We have seen data from the global phase III results of 18F-Florbetaben, and recognize the significant potential of this compound. We are looking forward to joining forces with the Piramal team in their worldwide launch of the product," said Mr. Renaud Dehareng, Chief Executive Officer of IBA Molecular.
Piramal recently acquired the intellectual property (including patents, trademarks and know-how), worldwide development, marketing and distribution rights of the lead compound 18F-Florbetaben as well as other clinical and pre-clinical assets of Bayer Healthcare's molecular imaging business to form its imaging subsidiary, Piramal Imaging SA.
IBA Molecular is a world leader in the Nuclear Medicine market with a network of manufacturing sites in Europe, the US and Asia, providing customers with high quality PET and SPECT diagnostic and therapeutic products.
About 18F-Florbetaben (BAY 94-9172)
18F-Florbetaben is an 18F-labeled PET tracer currently under development that has proven to specifically bind 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 and other neurologic conditions. As the aggregation of the beta-amyloid protein in the brain is also a key target for new therapeutic treatments under development, 18F-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 18F-Florbetaben uptake pattern in the brain. Results from a global Phase 3 trial indicate that PET imaging with 18F-Florbetaben reliably detects beta-amyloid deposition in the brain. The visual assessment procedure proposed for routine clinical practice demonstrated 100% sensitivity and 92% specificity with excellent inter-reader agreement (kappa = 0.88).
About Alzheimer's Disease
Alzheimer's disease is a devastating neuro-degenerative disease and the most common cause of dementia. Most cases of Alzheimer's affect people over the age of 60. It is a progressive disease that can lead to premature death. In 2006, estimates suggested that more than 26 million people worldwide were suffering from Alzheimer's disease. By 2050, this number could reach more than 100 million. At present there is no cure for Alzheimer's, but treatment for symptoms, combined with appropriate services and support, can make life better for the millions of people living with the disease.
About Piramal Enterprises
Piramal Enterprises is an innovation led company with a growth track record of above 25% CAGR since 1988, and consolidated revenues of US $450 million in FY2012. With assets across North America, Europe and Asia, Piramal Enterprises is one of the largest pharmaceutical custom manufacturing companies across the world. It has a robust pipeline of 16 new molecules with its cartilage repair gel – BST-CarGel having recently received European CE mark approval. In 2010, Piramal Enterprises sold its domestic formulation business to Abbott for a consideration of US $3.8 billion. Piramal Imaging SA, part of Piramal Enterprises, was formed in 2012, with the acquisition of the molecular imaging research and development portfolio of Bayer Pharma AG.
For more information, please visit www.piramalhealthcare.com.
About IBA Molecular
IBA Molecular is a global developer, manufacturer and distributor of 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 better respond to patient needs.
For more information, please visit http://www.iba-molecular.com.
SOURCE IBA Molecular