India’s Piramal Buys Bayer’s Molecular Imaging Research Portfolio To Bulk Up Innovative Pipeline
This article was originally published in PharmAsia News
Executive Summary
Piramal steadily carving out a pipeline that will give it a niche in the global pharma business.
MUMBAI – As part of its evolution to become an innovation-driven company, India’s Piramal Enterprises Ltd. said it acquired worldwide rights to Bayer HealthCare Pharmaceuticals AG’s molecular imaging research and development portfolio via its newly created subsidiary Piramal Imaging SA.
Of the total acquired assets, the biggest attraction for Piramal is florbetaben – an intravenous positron emission tomography (PET) diagnostic tool used for early diagnosis of Alzheimer’s disease. Florbetaben is in confirmatory Phase III clinical trials.
Piramal estimates the new class of PET imaging agents for Alzheimer's has a global market potential of up to $1.5 billion. Alzheimer's disease is known to be a devastating neurodegenerative disease and the most common cause of dementia. Most cases of Alzheimer's disease affect people over the age of 60. By 2050, Piramal estimates the number of people affected by the disease could reach more than 100 million.
Early Diagnosis – A Differentiator
Florbetaben is a PET tracer for the detection of beta amyloid plaque deposition in the brain, which is the pathological hallmark of disease in probable Alzheimer’s disease patients, according to Piramal. “Detection of beta amyloid depositions is expected to result in earlier diagnosis and more specific treatment of Alzheimer’s disease,” the company said in an April 16 statement.
Phase III trials showed that PET imaging with florbetaben reliably detects beta amyloid in the brain and shows value as a potential tool to aid in the diagnosis and assessment of Alzheimer’s disease. All study endpoints were met and Phase III results will be presented April 25 at the American Academy of Neurology Annual Meeting in New Orleans.
The group is establishing a dedicated global team to commercialize florbetaben. The core members of Bayer’s research and development team comprising about 20 scientists who are working on the portfolio will be joining Piramal Imaging in Berlin and will carry forward the development work, through global regulatory approvals.
“Personalized medicine is seen as an important component of future diagnosis and we will be working more and more on this area through our new subsidiary” - Ajay Piramal.
The senior Piramal management declined to share the value of the deal but said the company expects to file for European and U.S. regulatory approvals by the third quarter of 2012. Piramal Group Chairman Ajay Piramal said the launch timeline depends on approvals from regulatory agencies.
In addition to florbetaben, Bayer’s portfolio of molecular imaging agents include early-stage diagnostic imaging tools for detection of diseases in CNS, cardiology and oncology.
Win-win Deal
On its part, Roland Turck, head of Specialty Medicine at Bayer HealthCare said the transaction provides a clear strategic benefit for both Piramal and Bayer.
“For Bayer, the transaction enables us to free up resources to concentrate and accelerate the development of our exciting late stage pipeline. And Piramal will be better able to leverage the existing clinical, regulatory and marketing investments in florbetaben,” he noted.
Ajay Piramal said Bayer intends to concentrate on a narrower area of research, and that provided an opportunity for Piramal to step into the imaging business.
“Personalized medicine is seen as an important component of future diagnosis and we will be working more and more on this area through our new subsidiary,” Piramal said, adding that the company will be following a “string of pearls strategy” to selectively identify niche areas and grow its presence in the global pharmaceutical market.
Piramal will, however, have to contend with some serious competition as larger global companies like Eli Lilly & Co. recently secured an approval for Amyvid (florbetapir F18 ) (Also see "Amyvid Approval Just The Start Of A Critical Year For Alzheimer’s" - Pink Sheet, 16 Apr, 2012.). GE Healthcare Technologies Inc. is also known to be working on tracers for Alzheimer’s disease.
Similarly, Navidea Biopharmaceuticals Inc. licensed exclusive worldwide rights to AstraZeneca PLC’s mid-stage fluorine-18-labeled agent AZD4694 [See Deal
]. Navidea plans to start a Phase III trial of ‘4964 in early 2013 (Also see "Radiopharm Specialist Navidea Steps Up Licensing Activity, Opens Boston Office In Anticipation Of Key Approval Decision" - Pink Sheet, 28 Feb, 2012.).
Last week, Piramal announced European approval of its regenerative cartilage repair product BST CarGel, calling it a breakthrough technology with superior outcomes over existing options (Also see "Disruptive Technology? Piramal Gets EU Nod For Regenerative Cartilage Repair Therapy" - Scrip, 11 Apr, 2012.).
With sales at $650 million in 2011, Piramal hopes to have a significant portion of its future revenues to funnel from innovative compounds that it is acquiring or developing internally. In 2010, Piramal sold its India prescriptions business to Abbott Laboratories Inc. for over $3.8 billion.