Teva gets FDA okay for hGH needle-free injection

The firm has been marketing Tev-Tropin since 2005, but only with a regular injection.

Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA; TASE: TEVA) and its partner, Antares Pharma, Inc. (NYSE Amex: AIS), have received FDA approval for a "needle-free injection" of Teva's human growth hormone (hGH) product.

Teva has been marketing the hGH since 2005, but until now it has only been available as a regular injection. Annual sales of Teva's Tev-Tropin [somatropin (rDNA) for injection] brand human growth hormone have been several tens of millions of dollars.

Antares currently markets its needle-free injection system in Europe and Asia.

Antares president and CEO Paul K. Wotton said, “This is the first product approval stemming from our portfolio of product collaborations with Teva and is a very exciting milestone for the company. Importantly, it is another example of delivering on our strong focus and commitment to patients, together with our partners, to provide new ways to administer drugs. We look forward to the launch of this product by Teva.”

According to industry estimates, the market for human growth hormone in the United States is approximately $1 billion which is the largest market segment globally.

Also today, Teva rival Mylan signed a collaboration agreement with Indian company Biocon Ltd. to develop and market generic biologic compounds. Leader Capital Markets analyst Yoav Burgan said, "Another player is trying to put itself on the biogenerics map, but with all due respect to Biocon, you can't place it in the first tier of biogenerics firms in the world. This is not worrying news for Teva."

Shares in Teva rose 0.7% by mid-afternoon in New York, reflecting a market cap of $41.73 billion.

Published by Globes [online], Israel business news - - on June 29, 2009

© Copyright of Globes Publisher Itonut (1983) Ltd. 2009

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