Exclusive: CEO says Avid tracer widely used in clinical trials

HONOLULU (Reuters) - Avid Radiopharmaceuticals has taken an unconventional approach in developing its experimental imaging agent to find brain plaques associated with Alzheimer’s disease.

The privately held company is making it available to just about anybody who needs it for research, including the National Institute on Aging’s Alzheimer’s Disease Neuroimaging Initiative, or ADNI, a five-year, $60 million study aimed at identifying early signs of Alzheimer’s disease.

“From the very beginning, it has been our idea to make the compound available to whoever wants it. We never say no,” Dr. Daniel Skovronsky, chief executive of Philadelphia-based Avid Radiopharmaceuticals, said in an interview on Saturday at the Alzheimer’s Imaging Consortium in Honolulu.

The meeting is taking place ahead of the Alzheimer’s Association scientific meeting, where Avid’s late-stage clinical study results will be presented on Sunday.

“The fundamental decision we had to make as a company was do we keep it super secret and not let anyone touch it until it’s approved, or do we try something different?” Skovronsky said.

Skovronsky, a pathologist and former academic researcher, thinks that may be one reason his company is about a year ahead of larger rivals General Electric GE.N and Bayer BAYGn.DE in developing a compound that can image brain plaques associated with Alzheimer's disease.

“That is probably how we were able to leapfrog the big guys,” he said.

Avid and the two established makers of imaging agents are vying for a potential global market estimated at $3 billion to $5 billion.

The company’s radioactive dye called AV-45 is designed to stick to brain plaques and make them light up on PET scans,

If approved by U.S. regulators, Avid’s product will give doctors and drug companies a tool to see brain plaques in people before they develop memory problems.


Even before winning U.S. marketing approval, the compound is already being widely used in clinical trials by both Pfizer PFE.N and Eli Lilly LLY.N -- two of Avid's investors -- as well as Bristol-Myers Squibb BMY.N, and the National Institute on Aging has just started using it in its ADNI study looking early signs of Alzheimer's disease, a mind-robbing form of dementia that affects more than 26 million people globally.

The idea of a radioactive dye that sticks to amyloid plaques in the brain is not new. For several years, academic researchers have been using a dye called Pittsburgh Compound B, or PiB.

But PiB uses carbon 11 as its radioactive tracer, which has a half life of just 20 minutes. That means it has to be made in a facility with a cyclotron, a kind of particle accelerator, then quickly injected into a patient.

That has limited its use as a commercial product.

Skovronsky’s dye uses fluoride 18, which has a two-hour half life, long enough to be made at a different location and transported to imaging centers.

“The real advance of Avid is to take the basic discovery of PiB and make it practical from a business standpoint,” Bill Thies, chief medical officer of the Alzheimer’s Association, said in an interview.

“You go from a molecule that has to be synthesized on site to a molecule that can be synthesized and delivered in a timely way to imaging centers. That now becomes a practical commercial product.”

Dr. Reisa Sperling, who runs clinical trials on Alzheimer’s drugs at Brigham and Women’s Hospital in Boston, said Avid’s decision to make its compound available during drug development may give the company an edge as new drugs become approved that require a diagnosis of Alzheimer’s.

“They made very good strategic decision,” she said.

Editing by Eric Beech