GE Press Release:

GE Healthcare Presents Parkinsonian Syndromes and Alzheimer’s Disease Research Data and Introduces New Products at Society of Nuclear Medicine and Molecular Imaging Annual Meeting

Downloads

May 30, 2013

Computed Tomography

Life Sciences

Medical Diagnostics

Molecular Imaging

Company Showcases Innovative Hardware, Software and Radiopharmaceutical Solutions

30 May 2013 — VANCOUVER — GE Healthcare today announced that results from three company studies utilizing DaTscan™ (Ioflupane I 123 Injection) in Parkinsonian Syndromes or the investigational imaging agent [¹⁸F]flutemetamol, will be presented at the 2013 Annual Meeting of the Society of Nuclear Medicine and Molecular Imaging (SNMMI 2013) taking place in Vancouver from June 8-11.

GE Healthcare will also be exhibiting its newest patient-focused solutions including its new hybrid imaging scanner that balances low dose radiation capabilities with high image quality.

“We are committed to bringing some of the world’s fastest and most effective imaging solutions to market and are proud to exhibit some of these technologies at this year’s SNMMI meeting,” said Steve Gray, president and CEO, MICT & AW, GE Healthcare.“

GE Healthcare-sponsored research study presentations include:

DaTscan Presentations

• Publication 191 - Accuracy of DaTscan™ (Ioflupane I 123 Injection) in diagnosis of early parkinsonian syndromes (PS) – presented Monday, June 10, 12:30 – 2:00pm, West Building, Room 215-216
• Publication 1781 - Safety profile of DaTscan™ (Ioflupane I 123 Injection), a radiopharmaceutical indicated for visualization of the striatal dopamine transporter using SPECT – presented Tuesday, June 11, 2:45 – 4:15pm, West Building, Exhibit Hall A

DaTscan is a radiopharmaceutical indicated for striatal dopamine transporter visualization using single photon emission computed tomography (SPECT) brain imaging to assist in the evaluation of adult patients with suspected Parkinsonian syndromes (PS). DaTscan may be used to help differentiate essential tremor from tremor due to PS (idiopathic Parkinson’s disease, multiple system atrophy and progressive supranuclear palsy). DaTscan is an adjunct to other diagnostic evaluations. DaTscan/DaTSCAN has not been approved by Health Canada for use or distribution in Canada.

[¹⁸F]flutemetamol Presentation

• Publication 302 - Automated quantification of [18F]flutemetamol data - Comparison with standard of truth based on histopathology – presented Tuesday, June 11
  8:00 AM - 9:30 AM, West Building, Room 215-216

[¹⁸F]Flutemetamol has not been approved by regulatory authorities, and is not available for sale in any market, including Canada.

Visitors to the GE Healthcare booth (#307) will be able to explore a Technology Pavilion and get a glimpse into the possible future of nuclear medicine and molecular imaging technologies. GE’s current transformational technologies will also be on display, including:

• Optima* NM/CT 640, a new performance SPECT/CT system that helps physicians balance low patient radiation dose and performance efficiency with high image quality
• Discovery* PET/CT 610, the first double-digit and highest sensitivity found on any PET/CT scanner†commercially available.
• Software applications that are helping to provide exam results easier and quicker than prior generation GE solutions.

GE Healthcare experts will be offering two “user sessions” for healthcare professionals and media to learn more information about imaging techniques and technology. These include:

• Advances in Molecular Imaging: Current Concepts and Future Potential in Quantification – Sunday, June 9, 6:30pm, Renaissance Vancouver Harborside
• Radiopharmacy User Group Forum – Thursday, June 6 and Friday, June 7, Fairmont Waterfront, Vancouver

A Commitment to Understanding Neurodegenerative Disease

GE Healthcare takes a comprehensive approach to understanding a variety of neurological disorders such as Alzheimer’s disease, Parkinson’s disease, post-traumatic stress disorder, concussion, traumatic brain injury and Multiple Sclerosis through its ongoing research to uncover the causes, risks, and physical effects of these conditions. By collaborating with the pharmaceutical industry to assist in their development of the next generation of therapies to treat these disorders and working with potential partners in the industry, GE Healthcare can provide imaging support for clinical trials of therapeutic agents.

* Trademark of General Electric Company.

† With an absolute sensitivity of 10cps/kBq. Source: ITN Online PET/CT Comparison Charts. May 2012 - Represents typical system performance, measured according to NEMA Standards Publication NU2-2007. Sensitivity is defined as the number of counts per unit time detected by the device for each unit of activity present in a source, based on the average of measurements at 0 and 10 cm.

DaTscan / DaTSCAN has not been approved by Health Canada for use or distribution in Canada.

DaTscan has been approved by FDA and under the name DaTSCAN by EMA as well as various other global regulatory authorities.

Important Risk and Safety Information about DaTscan (I 123 Ioflupane Injection)

INDICATIONS AND USAGE - DaTscan is a radiopharmaceutical indicated for striatal dopamine transporter visualization using single photon emission computed tomography (SPECT) brain imaging to assist in the evaluation of adult patients with suspected Parkinsonian syndromes (PS). DaTscan may be used to help differentiate essential tremor from tremor due to PS (idiopathic Parkinson’s disease, multiple system atrophy and progressive supranuclear palsy). DaTscan is an adjunct to other diagnostic evaluations. DaTscan was not designed to distinguish among PD, MSA, and PSP. The effectiveness of DaTscan as a screening or confirmatory test and for monitoring disease progression or response to therapy has not been established.CONTRAINDICATIONS - DaTscan is contraindicated in patients with known hypersensitivity to the active substance, any of the excipients, or iodine. WARNINGS AND PRECAUTIONS - Hypersensitivity Reactions -Hypersensitivity reactions, generally consisting of skin erythema and pruritis, have been reported following DaTscan administration. Thyroid Accumulation - The DaTscan injection may contain up to 6% of free iodide (iodine 123 or I-123). To decrease thyroid accumulation of I-123, block the thyroid gland at least 1 hour before administration of DaTscan; failure to do so may increase the long-term risk for thyroid neoplasia. ADVERSE REACTIONS - In clinical trials, headache, nausea, vertigo, dry mouth or dizziness of mild to moderate severity were reported. In postmarketing experience, hypersensitivity reactions and injection site pain have been reported. DRUG INTERACTIONS - Drugs that bind to the dopamine transporter with high affinity may interfere with the DaTscan image. The impact of dopamine agonists and antagonists upon DaTscan imaging results has not been established. SPECIFIC POPULATIONS – Pregnancy - It is unknown whether DaTscan can cause fetal harm or increase risk of pregnancy loss in pregnant women. DaTscan should be given to pregnant women only if clearly needed. Like all radiopharmaceuticals, DaTscan may cause fetal harm depending on the stage of fetal development, and the magnitude of the radionuclide dose. Radioactive iodine products cross the placenta and can permanently impair fetal thyroid function. Nursing Mothers - It is not known whether DaTscan is excreted into human milk, however, I-123 is excreted into human milk. Because many drugs are excreted into human milk and because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to interrupt nursing after administration of DaTscan or not to administer DaTscan. Nursing women may consider interrupting nursing and pump and discard breast milk for 6 days after DaTscan administration to minimize risks to a nursing infant. Pediatric Use - The safety and efficacy of DaTscan have not been established in pediatric patients. Geriatric Use - There were no differences in responses between the elderly and younger patients that would require a dose adjustment. Renal and Hepatic Impairment - The effect of renal or hepatic impairment upon DaTscan imaging has not been established. The kidney excretes DaTscan; patients with severe renal impairment may have increased radiation exposure and altered DaTscan images.DRUG ABUSE AND DEPENDENCE - Ioflupane I 123 Injection is a DEA Schedule II controlled substance. A DEA license is required for handling or administering this controlled substance. OVERDOSAGE - It is unknown whether or not ioflupane is dialyzable. The major risks of overdose relate to increased radiation exposure and long-term risk for neoplasia. In case of radioactivity overdosage, frequent urination and defecation should be encouraged to minimize radiation exposure to the patient. PROCEDURE - Radiation Safety - DaTscan emits radiation and must be handled with safety measures to minimize radiation exposure to clinical personnel and patients.

Prior to DaTscan (Ioflupane I 123 Injection) administration, please read the Full Prescribing Information.