Download DRAFT 1 – Ajaz Hussain`s comments

Media Release
Medienmitteilung
Communiqué Aux Médias
Sandoz International
Industriestr. 25
83607 Holzkirchen,Germany
Tel: +49 8024 476 2596
Fax: +49 8024 476 2599
www.sandoz.com
Sandoz launches SurePalTM – Simple and Secure Device
Innovation for Patients Using Human Growth Hormone (hGH)

New device is a Sandoz innovation that will be available exclusively with Omnitrope

SurePal introduces simple and secure features that bring significant benefits to hGH
patients

SurePal represents Sandoz’ latest commitment to hGH patients and the endocrinology
community
®
Holzkirchen, Germany, September 23, 2013 – Sandoz announced today the launch of
SurePal™, a new delivery device to optimize the simplicity and security of administering
Omnitrope® human growth hormone for patients, their physicians and care givers. SurePal has
been CE marked in accordance with European Union (EU) laws on medical devices. The
device is now available for patients in the United Kingdom and will be launched globally.
SurePal is a medical device for Omnitrope with cartridges that require no reconstitution, or
priming, and a sliding injection button that requires minimum force to operate. Its safety
features include non-interchangeable dose-specific cartridges, a dose memory function that
remembers the patient’s daily dose and needle hider to reduce anxiety for patients afraid of
needles. The new device has been specially designed by Sandoz to offer enhanced simplicity
and security during treatment. In a usability study conducted in 106 patients in Germany and
the U.S., 92 percent of respondents found an injection with SurePal very easy or easy to
accomplish.
“SurePal is a Sandoz innovation that demonstrates our unwavering commitment to Growth
Hormone patients," said Mark McCamish, MD, Ph.D. Sandoz’ Head of Global Development for
Biopharmaceuticals & Oncology Injectables. “Sandoz has invested significant time and
resources to ensure that SurePal is a simple and secure solution that will provide major
benefits to patients.”
“Patients treated with growth hormone therapy require an injection of hGH on a daily basis
which requires significant commitment from the individual, parent or primary caregiver,” said
Peter Laing, Paediatric Advanced Nurse Practitioner Endocrinology, Alder Hey Children’s NHS
Foundation Trust. “Therefore ease of use and simplicity of the growth hormone device
combined with features of added patient safety are essential to ensure good treatment
outcomes and this is why I believe SurePal provides a quantum leap for hGH patients.”
1/4
Media Release
Medienmitteilung
Communiqué Aux Médias
Sandoz International
Industriestr. 25
83607 Holzkirchen,Germany
Tel: +49 8024 476 2596
Fax: +49 8024 476 2599
www.sandoz.com
®
About Omnitrope (somatropin)
Omnitrope® (somatropin) is a recombinant human growth hormone indicated for treatment of
short stature in children and growth hormone deficiency in adults.
It is approved for use by the US Food and Drug Administration (FDA) and European Medicines
Agency (EMA) for:

Pediatric: Treatment of children with growth failure due to growth hormone deficiency
(GHD), Prader-Willi Syndrome, Small for Gestational Age, Turner Syndrome, Chronic Renal
Insufficiency (EU only) and Idiopathic Short Stature (US only).

Adult: Treatment of adults with either adult onset or childhood onset GHD.
Omnitrope® is a global brand that has grown significantly since it was first introduced in 2004. It
was the first biopharmaceutical medicine in the world to be approved by health authorities
according to a biosimilar pathway. Omnitrope is produced and manufactured in Europe in
Kundl and Schaftenau, Austria.
About SurePal™
Sandoz filed for approval of the SurePal™ injection pen for use with Omnitrope® with
European Union (EU) and Unites States (US) medicine authorities in 2013. SurePalTM has
been CE marked in accordance with European Union (EU) laws on medical devices and is
awaiting US Food & Drug Administration (FDA) action.
About Sandoz
Sandoz, the generic pharmaceuticals division of Novartis, is a global leader in the rapidly
growing generics industry. Sandoz offers a broad range of about 1,100 high-quality, affordable
products that are no longer protected by patents. With nearly 26,000 employees in
approximately 140 countries, Sandoz holds the #1 position globally in biosimilars, injectables,
ophthalmics and dermatology as well as a strong global #5 position in inhalables. Key product
groups include antibiotics, treatments for central nervous system disorders, gastrointestinal
medicines, cardiovascular treatments, and hormone therapies. Sandoz develops, produces,
and markets these medicines along with pharmaceutical and biotechnological active
substances and anti -infectives. In addition to strong organic growth in recent years, Sandoz
has made a series of acquisitions including Lek (Slovenia), Sabex (Canada), Hexal (Germany),
Eon Labs (US), EBEWE Pharma (Austria), Oriel Therapeutics (US), and Fougera
Pharmaceuticals (US). In 2012, Sandoz posted sales of USD 8.7 billion.
2/4
Media Release
Medienmitteilung
Communiqué Aux Médias
Sandoz International
Industriestr. 25
83607 Holzkirchen,Germany
Tel: +49 8024 476 2596
Fax: +49 8024 476 2599
www.sandoz.com
Sandoz is on Twitter. Sign up to follow @Sandoz_global at http://twitter.com/sandoz.
###
For further information, contact:
Sreejit Mohan
Head of Communications
Biopharmaceuticals & Oncology Injectacles
Sandoz
+49 (0) 80244762550
[email protected]
3/4