Omnitrope Pen 10 to hit market

Chain Drug Review, Sept 29, 2008

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

There are about 50,000 pediatric patients and 25,000 adult patients who use a somatropin in the United States. The Omnitrope Pen 10 with liquid cartridge is said to provide increased treatment flexibility for physicians and a more convenient dosage form for patients. It has also been designed to offer significant cost savings compared to the reference product, Genotropin, and other leading recombinant growth hormones.

"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," says Bernhard Hampl, chief executive officer of Sandoz Inc., the U.S. 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 company has marketed the 10 mg version in key European countries since earlier this year. A 5 rag-strength version, Omnitrope Pen 5 with liquid cartridge, has been available in the U.S. since March.