Teva And Antares Announce FDA Approval Of Needle-Free Injector Product For Administration Of Tev-Tropin(R) (Human Growth Hormone)

Main Category: Pediatrics / Children's Health
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 01 Jul 2009 - 3:00 PST

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Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) and its partner, Antares Pharma, Inc. (NYSE Amex: AIS) announced the approval of a Supplemental New Drug Application (sNDA), which added "needle-free injection" to its Tev-Tropin® [somatropin (rDNA) for injection] brand human growth hormone (hGH) drug label. Teva will market the Antares needle-free device as the Tev-Tropin Tjet Injector system.

"We are pleased to add this new technology to our growing portfolio through our successful partnership with Antares, and to offer patients a less invasive delivery system," stated Larry Downey, head of Teva's North America Brand Pharmaceuticals division. "This significant achievement demonstrates our ability to leverage our leadership in the pharmaceutical industry, and our ongoing commitment to utilize our global strengths in innovative activities."

"This is the first product approval stemming from our portfolio of product collaborations with Teva and is a very exciting milestone for the Company" said Paul K. Wotton, President and Chief Executive Officer of Antares Pharma. "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."

Human growth hormone is a protein given by injection that is commonly used to treat children with growth hormone deficiency. Pediatric patients benefit both from the avoidance of using needles as well as the rapid injection speed associated with giving needle-free injections. 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. Antares currently markets its needle-free injection system for use in the treatment of growth hormone deficient children through its partners in Europe, Japan and Asia.

Source
Tev-Tropin®