• Latest NICE cost-benefit guidance includes Sandoz’s Omnitrope^®as one of seven recommended somatropin products to treat growth failure in children¹
• Guidance recommends that, where more than one product is suitable, the least costly option should be chosen¹
• Omnitrope^®has seven years’ worth of quality, safety and efficacy data

The NICE guidance recommends the use of Sandoz’s Omnitrope^® (liquid somatropin for injection) as one of seven recommended somatropin products – the first time that NICE has recommended the use of a biosimilar.

The guidance issued by the NICE Appraisal Committee noted that Omnitrope had undertaken head-to-head trials with the reference product as part of its regulatory submission to the European Medicines Agency (EMA) and found that there were no differences in terms of safety or efficacy between the products^1,2. Biosimilars are approved by the EMA on the basis that they have demonstrated comparable quality, safety and efficacy to their reference product³.  They are generally priced lower than the reference product, partly reflecting the fact that EMA does not require complete duplication of the reference product’s clinical trial program.

NICE says that, when more than one product is suitable, the least costly option should be chosen¹.  NICE recommended that a discussion should be held between a clinician and patient to choose the somatropin treatment received, based on therapeutic need and the likelihood of adherence to treatment.

“This is an important decision, the ramifications of which go far beyond the UK,” said Ameet Mallik, Global Head Sandoz Biopharmaceuticals. “Biosimilars, pioneered by Sandoz, are recognized around the world as having comparable safety, efficacy and quality to existing biopharmaceuticals following loss of patent protection. This latest guidance further reinforces the confidence that leading authorities have in our products.”

Dr Richard Stanhope, Consultant Pediatric Endocrinologist, said: “I have 10 years of clinical experience using Omnitrope^® with my pediatric patients and I believe it is both effective and well tolerated.  I welcome the decision by NICE to recommend the option of a biosimilar; it will benefit patients by providing an alternative, equally effective treatment option as well as offering much needed cost savings to the NHS.”

Omnitrope^® was the first product to be approved in the EU as a biosimilar, in 2006.  It now has seven years’ worth of comparable efficacy and safety data² including clinical trial phase data.

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Disclaimer

The foregoing release contains forward-looking statements that can be identified by terminology such as “should,” “potential,” “likelihood,” “will,” or similar expressions, or by express or implied discussions regarding potential future revenues from Omnitrope or any of Sandoz’s other biosimilar products. You should not place undue reliance on these statements. Such forward-looking statements reflect the current views of the Company regarding future events, and involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that Omnitrope or any of Sandoz’s other biosimilar products will achieve any levels of revenue in the future. In particular, management’s expectations regarding such products could be affected by, among other things, unexpected regulatory actions or delays or government regulation generally; competition in general; unexpected clinical trial results, including unexpected new clinical data and unexpected additional analysis of existing clinical data; government, industry and general public pricing pressures; the impact that the foregoing factors could have on the values attributed to the Group's assets and liabilities as recorded in the Group's consolidated balance sheet, and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the US Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those anticipated, believed, estimated or expected. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

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About Sandoz

Sandoz, a Division of the Novartis group, is a global leader in the field of generic pharmaceuticals, offering a wide array of high-quality, affordable products that are no longer protected by patents.  Sandoz has a portfolio of approximately 1000 compounds and sells its products in more than 130 countries.  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) and Eon Labs (US), and EBEWE Pharma (Austria).  In 2009, Sandoz employed around 23,000 people worldwide and posted sales of USD 7.5 billion.

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For further information

Eric Althoff, Novartis Global Media Relations, +41 61 32 47999, eric.althoff@novartis.com
 
Chris Lewis, Sandoz Global Communications, +49 8024 476 2550, chris.lewis@sandoz.com

Novartis Investor Relations

International:
Susanne Schaffert

Pierre-Michel Bringer

Thomas Hungerbuehler

Isabella Zinck

Central phone no: +41 61 324 7944

E-mail: investor.relations@novartis.com
 
North America:
Richard Jarvis +1 212 830 2433

Jill Pozarek +1 212 830 2445

Edwin Valeriano +1 212 830 2456

E-mail: investor.relations@novartis.com

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References:

1.  Human growth hormone (somatropin) for the treatment of growth failure in children (review of NICE technology appraisal guidance 42). Final guidance, published May 26, 2010. 

2.  Romer T et al.  Clinical paper on ‘Seven Years of Safety and Efficacy of the Recombinant Human Growth Hormone Omnitrope in the Treatment of Growth Hormone Deficient Children: Results of a Phase III Study’. Hormone Research 2009; 72: 359–369.

3.  European Public Assessment Report (EPAR) Omnitrope – http://www.ema.europa.eu/humandocs/PDFs/EPAR/Omnitrope/060706en1.pdf