Showing posts with label Antares Pharma. Show all posts
Showing posts with label Antares Pharma. Show all posts

Teva, Antares get FDA OK for hormone in new device

NEW YORK — Teva Pharmaceutical Industries Ltd. and Antares Pharma Inc. said Monday the companies received Food and Drug Administration approval for use of the human growth hormone Tev-Tropin in a needle-free injection system.

The drug is already approved as an injection.

The approval gives the company's authorization to use the already approved drug in Antares' system, which does not involve a syringe injection. The companies will market the device as the Tev-Tropin Tjet Injector system.

Shares of Ewing, N.J.-based Antares skyrocketed 34 cents, or 47 percent, to reach $1.06 in afternoon trading. The stock earlier hit $1.21, its highest point in more than a year.
Shares or Israel-based Teva rose 55 cents to $49.15.

Antares Pharma (AIS) and BioSante Pharmaceuticals (BPAX) Announce Committee Recommends Continuation of the LibiGel Phase III Clinical Program

Antares Pharma, Inc. (NYSE Amex: AIS) partner BioSante Pharmaceuticals (Nasdaq: BPAX) announced that based upon a review of study conduct and blinded data from the LibiGel Phase III Cardiovascular and Breast Cancer Safety Study, the LibiGel Safety Study External Executive Committee has recommended continuation of the LibiGel Phase III clinical program. A very low cardiovascular event rate has occurred thus far in the LibiGel Phase III clinical studies.

Under the terms of the agreement, BioSante is responsible for all development activities for LibiGel and Antares has retained international commercialization rights to LibiGel in significant territories including the European Union and Japan.

Antares President and Chief Executive Officer, Paul K. Wotton, Ph.D. said, "We are very pleased to see further and encouraging progress made with LibiGel, which uses the Antares Pharma ATD system, an FDA approved technology. A transdermal gel offers an ideal means to deliver drugs like testosterone in a controlled and reproducible way with a convenient to use dosage form. We have an advanced and deep pipeline of ATD based products, including LibiGel, where we have significant intellectual property and commercialization rights. We expect to earn additional milestone and royalty payments in the future from our multi-product agreement with BioSante."

Biosante Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on developing products for female sexual health, menopause, contraception and male hypogonadism

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