Sandoz Canada

Sandoz Canada

April 22, 2009 10:22 ET

Sandoz Canada Receives Approval for Recombinant Human-Growth Hormone Omnitrope™, the First Subsequent Entry Biologic in Canada

MONTREAL, QUEBEC--(Marketwire - April 22, 2009) -

- Approval further reinforces Sandoz positioning as pioneer of this new regulatory class of medicines, following launch of biosimilars / follow-on proteins in Europe, US and Australia

- Approval of Omnitrope as first Subsequent Entry Biologic increases access to high-quality medicines and offers patients safety and efficacy combined with greater cost effectiveness

Sandoz Canada announced today that it has received market authorization for Omnitrope™ in Canada. Omnitrope™ is the first version of a previously approved recombinant biotechnology drug to be approved by Health Canada under the regulatory term Subsequent Entry Biologic (SEB).

Omnitrope™, a somatropin (rDNA origin) for injection, is approved for the long-term treatment of children with growth failure due to an inadequate secretion of endogenous growth hormone, and long-term replacement therapy in adults with growth hormone deficiency due to an underlying hypothalamic or pituitary disease or who were growth deficient during childhood.

The Omnitrope™ Pen 5 and 10, with liquid cartridges, have been approved by the Biologics and Genetic Therapies Directorate of Health Canada in 5 mg/1.5 mL and 10 mg/1.5 mL strengths. This new delivery system is more convenient for patients because the liquid is already dissolved in a ready-to-use cartridge and can be loaded into the pen for injection.

"Subsequent Entry Biologics, known as biosimilars in Europe and follow-on proteins in the US, are a key part of the Sandoz strategy to focus on difficult-to-make products that provide added patient benefits," said Pierre Frechette, President and CEO of Sandoz Canada. "Due to the rising cost of health care and the growing need for more complex treatments, they will play an increasingly important role in ensuring access to medicines."

Sandoz is the pioneer in this new field, with three biosimilar medicines already approved and marketed in Europe: Omnitrope™ (somatropin), Binocrit® / Epoetin alfa Hexal® (erythropoetin) and Filgrastim Hexal® (GCSF) - also approved as Zarzio®. Omnitrope™ was the first ever medicine to be approved under the regulatory term "biosimilar" in Europe and is also approved and marketed as a "follow on protein" in the US. Sandoz continues to develop a comprehensive biopharmaceuticals pipeline, with numerous projects at various stages of development.

This pioneer position is based on decades of experience in biotechnology manufacturing for both internal and external customers as well as significant cross-divisional synergies within the Novartis Group including a joint global Technical Development and production network.

Sandoz strongly supports a balanced position on SEBs, which advocates that the same standards of high quality and science consistently be applied to all medicines, and recognizes the role that generic drugs and Subsequent Entry Biologics can play in the healthcare system.

About Sandoz Canada

With more than 209 molecules, Sandoz offers one of the broadest portfolios of products in Canada. Sandoz continues to showcase its leadership by adding to its portfolio each year through product development and innovation in oral, injectable and difficult-to-make products, such as modified release and Subsequent Entry Biologics.

Sandoz Canada employs about 680 people, most of whom are based at the Boucherville facilities (South-Shore of Montreal).

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. 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). In 2008, Sandoz employed around 23,000 people worldwide and posted sales of USD 7.6 billion.

Forward-Looking Statement

The foregoing release contains 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 Omnitrope™. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results with Omnitrope™ to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that Omnitrope™ 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 Omnitrope™ could be affected by, among other things, additional analysis of Omnitrope™ clinical data, 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.

Contact Information

  • Sandoz Canada
    Monika Sniec
    Communications Manager
    450-641-4903 ext. 2518
    450-641-3170 (FAX)
    www.sandoz.ca
    or
    Sandoz Global Communications
    Chris Lewis
    +49 8024 476 2550
    +49 8024 476 2599 (FAX)