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Health Canada Approves New Indications for PrOmnitrope(R) (Somatropin), Canada's First Subsequent Entry Biologic (Biosimilar)

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BOUCHERVILLE, Quebec, Sept. 2, 2015 (GLOBE NEWSWIRE) -- Sandoz Canada Inc., a Novartis company, has received approval from Health Canada for a number of additional indications for PrOmnitrope® (somatropin), a recombinant human growth hormone used to treat growth problems in both pediatric and adult patients. PrOmnitrope® is Canada's first subsequent entry biologic (biosimilar), which are follow-on versions of original biological molecules and, unlike most generic copies of chemical medicines, undergo their own safety and efficacy clinical studies.

"Health Canada's approval of additional indications for PrOmnitrope® confirms that we continue to be a pioneer in differentiated products," says Michel Robidoux, President of Sandoz Canada. "We are committed to making this high-quality biosimilar available to more patients in Canada, as well as to making the initiation of PrOmnitrope® therapy easier. For example, PrOmnitrope®'s liquid formulation (PrOmnitrope® Solution) eliminates the need for reconstitution, and the SurePal™ pen is designed to make the injection process simple."
The additional indications for PrOmnitrope® (somatropin) approved by Health Canada include:

For children:

  • SGA Indication : The treatment of growth failure (current height standard deviation score [SDS] less than - 2) in short children born SGA (birth weight and/or length below -2 SD) and who fail to achieve catch-up growth (height velocity SDS less than 0 during the last year) by 2 to 4 years or later.
  • TS Indication : The treatment of short stature associated with Turner syndrome in patients whose epiphyses are not closed.
  • ISS Indication : The long-term treatment of idiopathic short stature (ISS), also called non-growth hormone-deficient short stature. This is defined by a height standard deviation score (SDS) less than -2.25 and is associated with growth rates unlikely to permit attainment of adult height in the normal range. In pediatric patients for whom diagnostic evaluation excludes other causes associated with short stature that should be observed or treated by other means. PrOmnitrope® treatment for ISS should be prescribed only for those patients whose epiphyses are not closed.

For adults:

PrOmnitrope® (somatropin [rDNA origin] for injection) is indicated for replacement of endogenous growth hormone in adults with growth hormone deficiency who meet either of the following two criteria:

  • Adult Onset (AO): Patients who have growth hormone deficiency, either alone or associated with multiple hormone deficiencies (hypopituitarism), as a result of pituitary disease, hypothalamic disease, surgery, radiation therapy, or trauma.
  • Childhood Onset (CO): Patients who were growth hormone deficient during childhood as a result of congenital, genetic, acquired, or idiopathic causes.

The above are in addition to PrOmnitrope®'s two initial indications:

  • Growth Hormone Deficiency (GHD) in Children: Long-term treatment of children who have growth failure due to an inadequate secretion of endogenous growth hormone. Other causes of short stature should be excluded.
  • Adult Growth Hormone Deficiency (GHD): Long-term replacement therapy in adults with growth hormone deficiency due to underlying hypothalamic or pituitary disease or who were growth hormone deficient during childhood. Growth hormone deficiency should be confirmed by an appropriate growth hormone stimulation test. Patients who were diagnosed as growth hormone deficient during childhood must be retested before treatment starts.

Sandoz is the global market leader with over 50 percent volume share of biosimilars approved in North America, Europe, Japan and Australia. Sandoz currently markets three biosimilars (somatropin, filgrastim and epoetin alfa) outside the United States, each of which occupies the #1 biosimilar position in its respective category. The Sandoz pipeline has several biosimilars across the various stages of development, including five programs in Phase III clinical trials/filing preparation. This is more than any other company in the industry.

To obtain additional information on this product visit www.omnitrope.ca.

Disclaimer

The foregoing release may contain forward-looking statements that can be identified by terminology such as "new", "the first" and "pioneer", or similar expressions, or by express or implied discussions regarding future sales of the above-mentioned products. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results with the above-mentioned products to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that the above-mentioned products will receive any additional marketing approvals in any other countries, or that it will reach any particular sales levels. In particular, management's expectations regarding commercialization of the above-mentioned products could be affected by, among other things, additional analysis of clinical data in respect of the above-mentioned products, new clinical data, unexpected clinical trial results, unexpected regulatory actions or delays or government regulation generally, the company's ability to obtain or maintain patent or other proprietary intellectual property protection, competition in general, increased government, industry, and general public pricing pressures, and other risks and factors referred to in the Form 20-F filed by Novartis 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. Sandoz 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.

About Sandoz Canada

Established in Boucherville, Quebec, Sandoz Canada is part of Sandoz International GmbH, the world's second largest producer of generic drugs and a company of the Swiss multinational corporation, Novartis. A leader in its field, Sandoz Canada develops, produces, markets and distributes a wide range of generic products used, among others, in anesthesia, infectious diseases, oncology, dermatology, cardiology, and pain management. The Boucherville manufacturing plant specializes in the production of key injectable products.

About Sandoz

Sandoz, a division of Novartis, is a global leader in generic pharmaceuticals, driving sustainable access to high-quality healthcare. Sandoz employs more than 26,000 people worldwide and supplies a broad range of affordable, primarily off-patent products to patients and customers around the globe.

The Sandoz global portfolio comprises approximately 1,100 molecules, which accounted for 2014 sales of USD 9.6 billion. Sandoz holds the global #1 position in biosimilars as well as in generic anti-infectives, ophthalmics and transplantation medicines.

Nearly half of Sandoz's portfolio is in differentiated products – products that are scientifically more difficult to develop and manufacture than standard generics.
In addition to strong organic growth since consolidating its generics businesses under the Sandoz brand name in 2003, Sandoz has consistently driven growth in selected geographies and differentiated product areas through a series of targeted acquisitions.

Sandoz is on Twitter. Sign up to follow @Sandoz_global at http://twitter.com/Sandoz_Global.

CONTACT: Sandoz Canada Annick Lambert +1 450 641 4903 ext. 2964 annick.lambert@sandoz.com Sandoz Global Communication Neil Moorhouse +49 8024 476 2597 neil.moorhouse@sandoz.com

Source: Sandoz Canada