GE Healthcare Files Supplemental New Drug Application for Its Own Manufacturing of Optison™ (Perflutren Protein-Type A

  GE Healthcare Files Supplemental New Drug Application for Its Own
  Manufacturing of Optison™ (Perflutren Protein-Type A Microspheres Injectable
  Suspension, USP)

  Upon Approval, GE Healthcare’s Oslo Facility Will Provide Stock to the US
 Becoming Only Contrast Media Manufacturer to Supply Its Own Stock to the US
                                    Market

Business Wire

PRINCETON, N.J. -- January 15, 2013

GE Healthcare (NYSE:GE) today 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, GE Healthcare will provide supply of Optison to the US 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: (1) Right-to-left, bi-directional, or transient right-to-left
cardiac shunts, or (2) 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.

“GE Healthcare is committed to providing safe, innovative, and effective
medical products that aid in the detection of cardiovascular diseases, and
today’s filing is further evidence of that commitment,” said Stephen
Lightfoot, General Manager, Core Imaging, GE Healthcare Medical
Diagnostics.“While we cannot predict a timeline for regulatory authority
approval, we look forward to servicing the US cardiology community directly in
2013.”

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.

Optison vials do not contain preservative and are for single patient use only.
Healthcare professionals should follow labeled instructions for product
handling and use and discard unused product properly.

The most frequently reported adverse reactions following clinical trial use of
Optison were headache, nausea and/or vomiting, warm sensation or flushing, and
dizziness. Cardiac arrests and other serious but non-fatal adverse reactions
were uncommonly reported post-marketing. Most of these uncommon reactions
included cardiopulmonary symptoms and signs such as cardiac or respiratory
arrest, hypotension, supraventricular and ventricular arrhythmias, respiratory
distress, or decreased oxygenation. Reports also identified neurologic
reactions (loss of consciousness or convulsions) as well as anaphylactoid
reactions.

Important Risk and Safety Information About Optison^TM (Perflutren
Protein-Type A Microspheres Injectable Suspension, USP)

BOXED WARNING: SERIOUS CARDIOPULMONARY REACTIONS: Serious cardiopulmonary
reactions, including fatalities, have occurred uncommonly during or following
perflutren-containing microsphere administration. Most serious reactions occur
within 30 minutes of administration. Assess all patients for the presence of
any condition that precludes Optison administration. Always have resuscitation
equipment and trained personnel readily available.

INDICATIONS: Optison is indicated for use in patients with suboptimal
echocardiograms to opacify the left ventricle and to improve the delineation
of the left ventricular endocardial borders. CONTRAINDICATIONS: Do not
administer Optison to patients with known or suspected: (1) Right-to-left,
bi-directional, or transient right-to-left cardiac shunts, or (2)
Hypersensitivity to perflutren, blood, blood products, or albumin. Do not
administer Optison by intra-arterial injection. WARNINGS: Anaphylactoid
Reactions: In postmarketing use, uncommon but serious anaphylactoid reactions
were observed during or shortly following perflutren-containing microsphere
administration, including in patients with no prior exposure to
perflutren-containing microsphere products. High Ultrasound Mechanical Index:
High ultrasound mechanical index values may cause microsphere cavitation or
rupture and lead to ventricular arrhythmias. Additionally, end-systolic
triggering with high mechanical indices has been reported to cause ventricular
arrhythmias. The safety of Optison at mechanical indices greater than 0.8 and
the safety of Optison with the use of end-systolic triggering have not been
evaluated. PRECAUTIONS: General: Optison contains albumin, a derivative of
human blood. Based on effective donor screening and product manufacturing
processes, it carries an extremely remote risk for transmission of viral
disease and Creutzfeldt-Jakob disease (CJD), no cases of which have ever been
identified for albumin. Pregnancy: Adequate or well-controlled studies were
not conducted in pregnant women. Optison should be used during pregnancy only
if the potential benefit justifies the potential risk to the fetus. Nursing
Mothers: It is not known whether this drug is excreted in human milk. Because
many drugs are excreted in human milk, caution should be exercised when
Optison is administered to a nursing woman. Pediatric Use: Safety and efficacy
have not been established in pediatric patients, or in patients with
congenital heart disease. ADVERSE REACTIONS: The most frequently reported
adverse reactions following clinical trial use of Optison were headache,
nausea and/or vomiting, warm sensation or flushing, and dizziness.
Postmarketing Experience: Cardiac arrests, and other serious, but non-fatal
adverse reactions, were uncommonly reported. Most of these uncommon reactions
included cardiopulmonary symptoms and signs such as cardiac or respiratory
arrest, hypotension, supraventricular and ventricular arrhythmias, respiratory
distress, or decreased oxygenation. Reports also identified neurologic
reactions (loss of consciousness or convulsions) as well as anaphylactoid
reactions.

Prior to Optison administration, please read the Full Prescribing Information.

About GE Healthcare

GE Healthcare provides transformational medical technologies and services that
are shaping a new age of patient care. Our broad expertise in medical imaging
and information technologies, medical diagnostics, patient monitoring systems,
drug discovery, biopharmaceutical manufacturing technologies, performance
improvement and performance solutions services help our customers to deliver
better care to more people around the world at a lower cost. In addition, we
partner with healthcare leaders, striving to leverage the global policy change
necessary to implement a successful shift to sustainable healthcare systems.

Our "healthymagination" vision for the future invites the world to join us on
our journey as we continuously develop innovations focused on reducing costs,
increasing access and improving quality and efficiency around the world.
Headquartered in the United Kingdom, GE Healthcare is a $17 billion unit of
General Electric Company (NYSE: GE). Worldwide, GE Healthcare employs more
than 46,000 people committed to serving healthcare professionals and their
patients in more than 100 countries. For more information about GE Healthcare,
visit our web site at www.gehealthcare.com.

Contact:

GE Healthcare
Scott Lerman
609-514-6346 (office)
609-937-9352 (mobile)
Scott.lerman@ge.com