Sandoz launches SurePalTM – Simple and Secure Device Innovation for Patients Using Human Growth Hormone (hGH)

Holzkirchen, 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.

  • 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

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.”

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.

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SOURCE: Sandoz