Sandoz: Making a World of Difference in Generics

Frank Della Fera, VicePresident, Sales andMarketing, Sandoz US

As one of the largest manufacturers of generic pharmaceutical products in the United States, Sandoz is committed to making a world of difference in generics.

With more than 300 active projects, 95 Abbreviated New Drug Applications (ANDAs) pending, and approximately 40 ANDAs filed in 2007, the global network of Sandoz R&D centers works to ensure that the company continually brings opportunities to customers and patients. Its 8 development centers throughout the world?including the United States,Canada, Austria, and Germany?each are pursuing work not only in tablets and capsules, but injectables, creams, ointments, and other dosage forms as well.

The launch of Omnitrope (somatropin [rDNA original]) for injection in 2007 has clearly positioned Sandoz as a leader in the emerging field of biogenerics, and Sandoz is committed to bringing other biologics to market pending patent expiry.

Marketed by Sandoz

Omnitrope Pen 5 with Liquid Cartridge

Omnitrope (somatropin [rDNA origin]) for injection recombinant is approved for long-term treatment of pediatric patients who have growth failure and as long-term replacement therapy in adults with growth hormone deficiency. The Omnitrope Pen 5 with liquid cartridge is available in 5-mg strength in a convenient patient delivery system; the liquid is already dissolved in a ready-to-use cartridge and can be loaded into the pen for injection. According to the FDA, Omnitrope is highly similar to Genotropin in its pharmacokinetic/ pharmacodynamic, safety, and efficacy profiles, which is a very high regulatory standard and the same comparability standard currently applied to brand products when they make manufacturing changes.

The company is uniquely positioned to develop, manufacture, and bring to market difficult-to-make pharmaceuticals. Recent examples demonstrating this core capability include metoprolol ER, which uses the first and only generic multiple-unit pellet system tablet for extended release, and Omnitrope, which leverages the company?s competence in manufacturing biopharmaceuticals. In fact, for more than 25 years, Sandoz has been manufacturing more than a dozen different biopharmaceutical products for clinical and commercial use.

Sandoz, the third largest generic supplier in the United States, offers a product portfolio featuring approximately800 products. Sandoz is also a leader in the anti-infective market with more than 30 products.

The company is well on its way to achieving its mission to be the main provider of high-quality, affordable medicines, helping to secure long-term access to health care for people around the world.

To learn more about the company and view its online product catalog, visit www.us.sandoz.com.