Avid Radiopharmaceuticals Inc., an eight-year-old startup, will likely beat General Electric Co. and Bayer AG to the market with the first imaging test to pinpoint Alzheimer’s early on in the disease.
A quick, definitive diagnosis would enable patients to start drug treatments sooner, join trials for experimental medicines, plan for future disability and rule out other reasons for dementia. It also would create a $3 billion market that Avid may be hard-pressed to defend, said Harry Glorikian of Scientia Advisors, an industry consulting firm.
All three companies are developing chemical dyes to identify proteins in the brain, called beta amyloid, that are markers for Alzheimer’s. Avid has completed the final tests needed for U.S. approval, and aims to submit its results this year, the company said. While that may give Avid a year’s head start over GE and Bayer, in testing at earlier stages, it doesn’t assure long-term market dominance, Glorikian said.
“The devil’s in the details of the data,” said Glorikian, the managing partner for Cambridge, Massachusetts-based Scientia. When doctors can finally look at data from all three, the winner will be the company that is “superior,” he said.
Marketing prowess will also count in determining which company dominates, said Glorikian and analysts who follow Alzheimer’s treatments. GE, based in Fairfield, Connecticut, is the world’s largest maker of medical imaging equipment, and Bayer, based in Leverkusen, is Germany’s largest drugmaker.
All three of the tests are designed to cause beta amyloid clumps to light up when the patients’ brains are scanned using PET, or positron emission tomography. The scanners read radiation from the dyes, which bind to beta amyloid.
Each of the companies in the diagnostics race will present its data at the International Conference on Alzheimer’s Disease starting July 10 in Honolulu. Avid, founded in 2002, is the first to finish the third and final stage of testing.
GE rose 21 cents, or 1.4 percent, to $14.83 in New York Stock Exchange composite trading yesterday. Bayer rose 45 cents to 46.05 euros in Frankfurt trading.
The new dyes would be a big improvement over existing diagnostic methods, said Michael Weiner, director of the Center for Imaging and Neurodegenerative Disease at the University of California, San Francisco. “Up until now it’s been very, very difficult to identify this pathological process before people become demented,” he said in a telephone interview.
Alzheimer’s disease was first described in 1906 by German doctor Alois Alzheimer, for whom the illness was named. In the decades before brain imaging technology was developed, doctors diagnosed the ailment by its symptoms and by examining brain tissue after a patient died.
5.1 million Americans
Even today, with the advent of PET and other imaging methods, doctors continue to rely on memory tests, family histories, and interviews with relatives, and autopsies are still required to verify the presence of amyloid plaques. As many as 5.1 million Americans may have Alzheimer’s, the most common form of dementia in older people, according to the U.S. National Institutes of Health.
While there is no cure, drugs such as Aricept, from New York-based Pfizer Inc. and Eisai Co. of Tokyo, can ease the symptoms, and may be especially helpful if administered at an early stage, doctors and analysts said. The global market for such drugs was about $7.5 billion last year, according to consultants IMS Health Inc. in Norwalk, Connecticut. Once the new imaging agents are available, the market for Alzheimer’s drugs and dyes may swell to $10 billion, said Glorikian.
Software and ‘Wetware’
GE and Bayer bring strengths to the diagnostics race. Jonathan Allis, global head of imaging for GE Healthcare, said that amyloid imaging alone “is not enough.” Diagnosis and treatment involve behavioral assessments, use of blood markers, “and the need for powerful software analysis to help clinicians make sense of it all,” he said in an e-mailed statement.
Only GE has the hardware, software, and “wetware,” or biology, he said.
Bayer, whose health-care group had sales of 16 billion euros in 2009, has no presence in the market for medical imaging equipment. The company has had a stake in diagnostics since the 1930s and imaging agents fit with that historical interest, said Barbara Putz, the company’s head of clinical development for molecular imaging.
Bayer’s compound was initially developed by Avid; Bayer licensed it in 2007. In addition to starting phase 3 testing for that drug, the company said in June that it is working with TauRx Pharmaceuticals Ltd., a closely held Singaporean drugmaker, to develop an Alzheimer’s test based on a different biomarker, tangled molecules in the brain called tau proteins.
If family members can obtain reliable information from tests like these, they may be more attentive and caring toward a relative who is slowly progressing, Putz said in a phone interview. “With patients it is important to have an accurate diagnosis as early as possible,”
Hank Kung, Avid’s chief scientific adviser, acknowledges his competitors’ resources and marketing clout.
“GE is a much bigger company,” Kung said in an interview. It is “hard to predict” which imaging agent will dominate commercially. At the same time, Avid’s drug has the advantage of a very fast scanning time, meaning “the patient doesn’t have to wait long” in the imaging machine, he said.
Avid Chief Executive Officer Daniel Skovronsky said interim results from the clinical trials showed that the amyloid plaques in PET scans of living patients were identical to the plaques doctors later found in autopsies of their brains. This proves the test’s accuracy, Skovronsky said in a telephone interview.
While Avid plans to sell its agent in the U.S. and Europe, the company has ties to the medical unit of Siemens AG of Munich, Germany. In addition to making the dye for Avid, Siemens sells a range of medical systems similar to GE’s product line, and it is going head-to-head with its American rival in PET. Siemens and Avid declined to comment on how their partnership will evolve in the future, although Skovronsky said Avid will continue to rely on strong partners and backers.
“As a growing biotech company, there’s always need for financing,” Skovronsky said. “We are always thinking about where our next dollar is going to come from.”
Important as early diagnosis is for patients, one of the biggest contributions of the new tests may be in drug development, said Murali Doraiswamy, head of the biological psychiatry division at Duke University Medical School in Durham, North Carolina, who has been involved in Avid’s drug trials. Using the dyes with PET scans, “you can pick out patients who have higher levels of amyloid, expose them to treatments and see if the treatment is clearing out the amyloid in the brain or not,” he said in an interview.