Company Overview of GE Medical Systems, Inc.

GE Medical Systems, Inc. announced that it has filed a supplemental new drug application (sNDA) that will allow the company to manufacture Optison (Perflutren Protein-Type A Microspheres Injectable Suspension, USP), within its own facility. Optison is a contrast agent that may improve the visualization of the left ventricular border - an area of the heart that is critical to see in order to assess and diagnose certain heart diseases. Upon approval, the company will provide supply of Optison to the U.S. market from its manufacturing facility in Oslo, becoming the only contrast media manufacturer to supply its own stock for the US. Optison is indicated for use in patients with suboptimal echocardiograms to opacify the left ventricle and to improve delineation of the left ventricular endocardial borders. Optison is not for use in patients with known or suspected: Right-to-left, bi-directional, or transient right-to-left cardiac shunts, or hypersensitivity to perflutren, blood, blood products or albumin. It should not be administered by intra-arterial injection. As for all ultrasound contrast agents, Optison has a boxed warning indicating that serious cardiopulmonary reactions, including fatalities, have occurred uncommonly during or following perflutren-containing microsphere administration. Most serious reactions occur within 30 minutes of administration. Healthcare professionals should assess all patients for the presence of any condition that precludes Optison administration and always have resuscitation equipment and trained personnel readily available. Optison remains an important diagnostic option for patients with suboptimal echocardiograms. Additionally, Optison offers a unique, convenient value to clinicians and patients: It is stable at room temperature for up to 24 hours and takes less than 60 seconds to prepare, allowing for quick access to contrast in hospital settings like the cardiac lab or emergency room.

Merck & Co. Inc. and GE Medical Systems, Inc. announced a clinical study collaboration, license and supply agreement for use of [(18) F]Flutemetamol, an investigational positron emission tomography (PET) imaging agent, to support Merck's development of MK-8931, a novel oral beta amyloid precursor protein site cleaving enzyme (BACE) inhibitor and Merck's lead investigational candidate for Alzheimer's disease (AD). Accumulation of beta amyloid in the brain is a pathological characteristic related to Alzheimer's disease. Currently, AD is diagnosed by clinical examination (i.e., medical history, physical, neurological, psychiatric and neuropsychological exams, laboratory tests and Magnetic Resonance Imaging [MRI] or Computed Tomography [CT] scan). An AD diagnosis can only be confirmed through histopathological identification of characteristic features, including beta amyloid plaques, in post-mortem brain samples. Under the agreement, GE Healthcare will supply [(18) F]Flutemetamol to help select patients for clinical trials and evaluate this investigational agent as a companion diagnostic tool. A joint Merck and GE Healthcare Imaging Advisory Committee will oversee the planned imaging studies.

GE Medical Systems, Inc. announced that it is cutting 2% of its jobs in Wisconsin, where it has 6, 500 employees, and 10% of its workforce in Vermont, where it employs about 500 people. This will reduce complexity, speed up decision making and help to become more accessible to company's customers, the company said. Based on the 2% estimate, about 130 people could lose their jobs in Wisconsin - including employees in the Milwaukee area where GE has its U.S. headquarters and product lines including computed tomography, nuclear medicine and magnetic resonance imaging.