Sandoz receives FDA approval for Omnitrope<sup>&reg;</sup> Pen 10 with liquid cartridge

3. 9. 2008

Sandoz has received US Food and Drug Administration approval for its Omnitrope® Pen 10 with liquid cartridge. Omnitrope, a somatropin, is approved for long-term treatment of ediatric patients who have growth failure and long-term replacement therapy in adults with growth hormone deficiency.

There are approximately 50,000 pediatric patients and 25,000 adult patients who use a somatropin in the US.1 The Omnitrope Pen 10 with liquid cartridge provides increased treatment flexibility for physicians and a more convenient dosage form for patients. It will also offer significant cost savings compared to the reference product, Genotropin®, and other leading recombinant growth hormones.

“The FDA approval of the 10 mg strength of Omnitrope will allow physicians to treat a broader spectrum of patients with a high quality, lower cost treatment option,” said Bernhard Hampl, chief executive officer of Sandoz Inc., the US subsidiary of Sandoz. “Follow-on biologics are a key part of the Sandoz strategy and we are committed to increasing patient access through follow-on biologics once patents have expired.”

The 10 mg version has been marketed by Sandoz in key European countries since earlier this year. A 5 mg strength version, Omnitrope Pen 5 with liquid cartridge, has been available in the US since March.

Omnitrope is highly similar to Genotropin in its safety and efficacy profiles.

Sandoz pioneered the field of follow-on biologics with the approvals and subsequent launches of a lyophilized powder form of Omnitrope in the US and Europe. Omnitrope was the first follow-on biologic to receive approval and be made available to patients in both regions. It was the first ever medicine to be approved in the EU as a biosimilar, the European regulatory term for such products.

Follow-on biologics are a key part of the Sandoz strategy to focus on difficult-to-make generics that provide added patient benefits. Due to the rising costs 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 building a strong global pipeline of follow-on biologics, with 25 projects currently under development.

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Lek, a Sandoz company, is one of the pillars of leading world generics company Sandoz. It operates as a global development center for products and technologies, as a global manufacturing center for active pharmaceutical ingredients and medicines, as a competence center for the development of vertically integrated products, as a Sandoz competence center in the field of development and manufacturing of biopharmaceutical products and as a supply center for the markets of CEE, SEE and CIS, sales Slovenia and sales services for Sandoz’s global markets. Lek d.d. employs about 2,820 people and achieved total sales of USD 904 million in 2006. For further information please consult

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 more than 840 active substances in over 5 000 forms worldwide. Key product groups include antibiotics, treatments for central nervous system disorders, gastrointestinal medicines, cardiovascular treatments and hormone therapies. Sandoz develops, produces and markets these drugs along with pharmaceutical and biotechnological active substances and anti-infectives. In addition to the strong organic growth in recent years, Sandoz has made a series of acquisitions including Lek (Slovenia), Sabex (Canada), Hexal (Germany) and EonLabs (U.S.) and sells its products in more than 110 countries. In 2006, Sandoz employed around 21,000 people worldwide and posted sales of USD 6 billion.

Novartis AG (NYSE: NVS) is a world leader in offering medicines to protect health, cure disease and improve well-being. Our goal is to discover, develop and successfully market innovative products to treat patients, ease suffering and enhance the quality of life. Novartis is the only company with leadership positions in both patented and generic pharmaceuticals. We are strengthening our medicine-based portfolio, which is focused on strategic growth platforms in innovation-driven pharmaceuticals, high-quality and low-cost generics and leading self-medication OTC brands. In 2006, the Group’s businesses achieved net sales of USD 37.0 billion and net income of USD 7.2 billion. Approximately USD 5.4 billion was invested in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ approximately 101,000 people and operate in over 140 countries around the world. For more information, please visit

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This press release contains statements and conclusions based on projections of Lek’s future business operations. These estimates are derived from the best information currently available. In case these forecasts prove unreliable, the actual results could prove different from those projected.

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For further information contact:

Katarina Klemenc Dinjaški

Corporate Communications

Lek Pharmaceuticals d.d.

Phone: + 386 1 580 22 43

Fax: + 386 1 580 24 32