Updated 4:54 p.m.
The Dublin, Ohio, company that distributes drugs including radiopharmaceuticals used in patient imaging studies, is using its industrial know-how to enable researchers to develop new products. In this way, Cardinal can be the company that is the first to make or distribute medicines developed by these collaborations.
Being first to market with new radiopharmaceuticals is all-important as markets for drugs to produce single photon emission computed tomography (SPECT) and positron emission tomography (PET) images mature and new applications for nuclear imaging — like diagnosing Alzheimer’s disease — emerge.
U.S. sales of radiopharmaceuticals used in SPECT and PET imaging was $1.2 billion in 2009 and expected to reach $4.8 billion by 2017, according to the latest Market for SPECT and PET Radiopharmaceuticals report by Bio-Tech Systems Inc. Radiopharmaceuticals are radioactive drugs that are ingested or injected to diagnose diseases like cancer.
Softening prices, a global shortage of a radioisotope and new ways to use nuclear medicine are causing companies to invest in new perfusion agents that boost image resolution while reducing the time of each study. For instance, Fludeoxyglucose — a radiopharmaceutical that contains glucose and is increasingly being used to identify cancer tumors — is a fast-growing technique in nuclear medicine.
That said, radiopharmaceuticals have a huge limitation: they must be used within hours of being produced because the radioisotopes from which they are made have very short lives. That’s where Cardinal Health comes in.
Cardinal operates 155 nuclear pharmacies nationwide, said John Rademacher, the company’s president of Nuclear and Specialty Pharmacy Services. These pharmacies “are close to our customers and deliver high-quality products and services,” Rademacher said.
“There’s a substantial amount of investment in the pharmaceuticals community around novel new agents — biotracers — that will help identify disease-states in their earliest forms,” he said. “There is a tremendous amount of work under way on agents that identify amyloid plaque in the brain, which is a precursor and a strong indication of Alzheimer’s disease.
“There’s also work under way for additional cardiac indications around a PET perfusion agent that helps measure blood flow through the heart and other areas that give richer information and data to cardiologists,” he said. “And there are oncology drugs being developed for prostate cancer, for better detection of breast cancer.”
In light of the emerging radiopharmaceuticals, Cardinal Health has been striking collaborations with universities and drug companies “to assist these innovators in developing their products,” Rademacher said. That means “helping support their clinical trials, and then ultimately providing an access point to commercialize those products when they receive FDA approval.”
A few weeks ago, Cardinal said it would provide manufacturing and distribution support to the American College of Radiology Imaging Network, which is conducting nationwide clinical trials with PET to figure out if long-used imaging agents can be used in new ways to tell whether cancer treatments are having their desired effects.
A day later, Cardinal and the University of Washington announced a public-private collaboration to advance the use of molecular imaging in clinical investigations and trials.Molecular imaging is one of the most promising areas of development in biotechnology, Cardinal and the university said. Radiopharmaceuticals are injected into the body so that a PET scanner can detect and trace abnormal cell functions that could tell of heart or brain diseases, or cancer.
Through the collaboration, the university’s Department of Radiology will relocate some of its molecular tracer laboratories to Cardinal’s PET manufacturing facility in downtown Seattle. The laboratory of John Grierson, who developed the PET agent F-18 fluorothymidine that Cardinal Health now distributes, will make the move. The university radiologists will get to use the cyclotron in the Cardinal facility.
“Cardinal Health’s nuclear pharmacy expertise and its commitment to supporting the growth of molecular imaging through clinical investigations make it an outstanding partner to help us work toward our ultimate, shared goal: to lessen the impact of devastating conditions including cancer, neurological disorders and cardiovascular disease,” said Dr. Norman J. Beauchamp, University of Washington radiology professor and chairman of the university’s Radiology Department.
Cardinal operates 32 cyclotrons nationwide and is investing in more. “It’s part of an integrated strategy to not only be a distributor of the radiopharmaceuticals … but it’s also to build manufacturing capabilities to bring out these products through clinical trial support, but more importantly, to be in the position to assist in the distribution of these products once they receive [Food and Drug Administration] approval,” Rademacher said.
Cardinal also operates a collaboration center in Phoenix, Arizona, at which drug companies, including Avid Radiopharmaceuticals Inc., work with the Ohio company to develop new radiopharmaceuticals. There, Cardinal applies its commercialization, manufacturing and distribution expertise to enable the transfer of technology. The company plans to open a similar center for academic collaborators near Ohio State.
“We’re more of an enabler,” Rademacher said. “The way I like to describe our role is, we’re small ‘r’ on the research side but big ‘d’ on the development side. We look at ourselves as being the commercialization engine for these radiopharmaceuticals as they move through those phases of clinical trial and ultimately into a commercial setting.”
To ensure its continuing role as enabler, Cardinal invests more than $10 million a year in quality management technologies for manufacturing radiopharmaceuticals, as well as in its research collaborations, Rademacher said.
“Ultimately, we believe that what we do in nuclear medicine and in our nuclear pharmacy businesses is help to lower the overall cost of healthcare,” he said.
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