INDIANAPOLIS—With an upfront payment of $300 million on the table, plus as much as $500 million more for potential future regulatory and commercial milestones, Eli Lilly and Co. announced Nov. 8 that it had signed a definitive merger agreement to acquire Philadelphia-based Avid Radiopharmaceuticals Inc., a company developing novel molecular imaging compounds for the detection and monitoring of chronic human diseases.
Avid's lead program in development is florbetapir F 18 (18F-AV-45), a molecular imaging agent under investigation for detecting the presence of amyloid plaque in the brain, and for which a marketing application was recently been submitted to the U.S. Food and Drug Administration (FDA). The potential half-billion in milestone payments in the Lilly-Avid deal are all related to florbetapir.
Avid also brings to Lilly a diagnostics development platform delving into other disease areas, including Parkinson's disease and diabetes.
"The acquisition of Avid Radiopharmaceuticals aligns well with Lilly's innovation-based strategy, offers a potential near-term revenue opportunity, leverages our neuroscience expertise and will immediately bolster our diagnostics capabilities," says Dr. John Lechleiter, Lilly's chairman and CEO. "We look forward to partnering with Avid's experts during the regulatory process for florbetapir, and are intent on gaining FDA approval for this promising diagnostic intended to help clinicians and researchers identify the presence of beta-amyloid plaque in the brain."
Beta-amyloid plaque is widely believed to play an important role in the development and progression of Alzheimer's disease, Lilly notes, a disease that currently affects more than five million Americans alone. Despite advances in understanding Alzheimer's there is still no definitive way to diagnose the disease until after death, making good diagnostic candidates very desirable.
Dr. Daniel M. Skovronsky, founder and CEO of Avid, describes his company's relationship with Lilly as "productive and long-standing" and looks forward to not only moving florbetapir forward but work with Lilly's scientific team to "continue our work to develop new molecular imaging agents capable of changing the medical management of significant chronic human diseases."
Reportedly, Avid will continue to operate from its current Philadelphia location, and it will provide uninterrupted support for ongoing academic clinical trials, including the Alzheimer's Disease Neuroimaging Initiative (ADNI), as well as ongoing clinical trials for other pharmaceutical companies.
Florbetapir is used in conjunction with positron emission tomography (PET) technology and is being assessed for the ability to detect beta-amyloid plaque deposits in living patients. Avid notes that the agent was the first beta-amyloid imaging compound to enter multicenter, IND clinical studies in the United States, and has now been studied in more than a dozen trials in more than 700 subjects ranging from cognitively normal individuals to those with Alzheimer's dementia. In addition to a pivotal Phase III image-to-autopsy study, other clinical studies are also being conducted in the European Union, North America, South America, Australia and Asia.
The acquisition, should it make it through all the customary closing conditions, could be a significant gain for Lilly on the regulatory approval front. The company sustained a setback in Alzheimer's disease research in August when it halted development of semagacestat, a gamma secretase inhibitor, because preliminary results from two ongoing long-term Phase III studies showed it did not slow disease progression and was associated with worsening of clinical measures of cognition and the ability to perform activities of daily living. (However Lilly's solanezumab, another compound in Phase III trials as a potential Alzheimer's treatment, was unaffected by that setback, as its mechanism of action is different.)
The company has also been buffeted in other therapeutic areas recently.
In late October, Moody's Investors Service made rumblings about downgrading Lilly's A-1 rating after the FDA called for a new study on the experimental diabetes drug Bydureon, which Lilly developed with Amylin Pharmaceuticals. FDA wants Lilly to assess cardiac risks the drug may pose, and that will likely push potential approval of the drug into 2012.
Adding to Lilly's recent woes is a looming patent cliff, with Bloomberg noting that by 2013, the company will lose patent protection for drugs that account for half its revenues. One of the most notable of those drugs is Zyprexa, used to treat such conditions as schizophrenia and bipolar disorder, which loses patent protection in April 2011, and was one of Lilly's biggest-selling drug last year, boasting revenue of $4.9 billion.
Avid's lead program in development is florbetapir F 18 (18F-AV-45), a molecular imaging agent under investigation for detecting the presence of amyloid plaque in the brain, and for which a marketing application was recently been submitted to the U.S. Food and Drug Administration (FDA). The potential half-billion in milestone payments in the Lilly-Avid deal are all related to florbetapir.
Avid also brings to Lilly a diagnostics development platform delving into other disease areas, including Parkinson's disease and diabetes.
"The acquisition of Avid Radiopharmaceuticals aligns well with Lilly's innovation-based strategy, offers a potential near-term revenue opportunity, leverages our neuroscience expertise and will immediately bolster our diagnostics capabilities," says Dr. John Lechleiter, Lilly's chairman and CEO. "We look forward to partnering with Avid's experts during the regulatory process for florbetapir, and are intent on gaining FDA approval for this promising diagnostic intended to help clinicians and researchers identify the presence of beta-amyloid plaque in the brain."
Beta-amyloid plaque is widely believed to play an important role in the development and progression of Alzheimer's disease, Lilly notes, a disease that currently affects more than five million Americans alone. Despite advances in understanding Alzheimer's there is still no definitive way to diagnose the disease until after death, making good diagnostic candidates very desirable.
Dr. Daniel M. Skovronsky, founder and CEO of Avid, describes his company's relationship with Lilly as "productive and long-standing" and looks forward to not only moving florbetapir forward but work with Lilly's scientific team to "continue our work to develop new molecular imaging agents capable of changing the medical management of significant chronic human diseases."
Reportedly, Avid will continue to operate from its current Philadelphia location, and it will provide uninterrupted support for ongoing academic clinical trials, including the Alzheimer's Disease Neuroimaging Initiative (ADNI), as well as ongoing clinical trials for other pharmaceutical companies.
Florbetapir is used in conjunction with positron emission tomography (PET) technology and is being assessed for the ability to detect beta-amyloid plaque deposits in living patients. Avid notes that the agent was the first beta-amyloid imaging compound to enter multicenter, IND clinical studies in the United States, and has now been studied in more than a dozen trials in more than 700 subjects ranging from cognitively normal individuals to those with Alzheimer's dementia. In addition to a pivotal Phase III image-to-autopsy study, other clinical studies are also being conducted in the European Union, North America, South America, Australia and Asia.
The acquisition, should it make it through all the customary closing conditions, could be a significant gain for Lilly on the regulatory approval front. The company sustained a setback in Alzheimer's disease research in August when it halted development of semagacestat, a gamma secretase inhibitor, because preliminary results from two ongoing long-term Phase III studies showed it did not slow disease progression and was associated with worsening of clinical measures of cognition and the ability to perform activities of daily living. (However Lilly's solanezumab, another compound in Phase III trials as a potential Alzheimer's treatment, was unaffected by that setback, as its mechanism of action is different.)
The company has also been buffeted in other therapeutic areas recently.
In late October, Moody's Investors Service made rumblings about downgrading Lilly's A-1 rating after the FDA called for a new study on the experimental diabetes drug Bydureon, which Lilly developed with Amylin Pharmaceuticals. FDA wants Lilly to assess cardiac risks the drug may pose, and that will likely push potential approval of the drug into 2012.
Adding to Lilly's recent woes is a looming patent cliff, with Bloomberg noting that by 2013, the company will lose patent protection for drugs that account for half its revenues. One of the most notable of those drugs is Zyprexa, used to treat such conditions as schizophrenia and bipolar disorder, which loses patent protection in April 2011, and was one of Lilly's biggest-selling drug last year, boasting revenue of $4.9 billion.
