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Atara Bio Receives FDA Orphan Drug Designation for STM 434, Atara Bio's Activin Inhibitor for Ovarian Cancer

SOUTH SAN FRANCISCO, Calif., Oct. 20, 2015 (GLOBE NEWSWIRE) -- Atara Biotherapeutics, Inc. (Nasdaq:ATRA), a biopharmaceutical company with a focus on developing meaningful therapies for patients with unmet medical needs in diseases that have seen limited therapeutic innovation, today announced that the U.S. Food and Drug Administration (FDA) Office of Orphan Products Development (OOPD) granted orphan drug designation for the Company's activin inhibitor, STM 434, for ovarian cancer.

"Ovarian cancer is an aggressive tumor type with a significant unmet need for patients,” said Isaac Ciechanover, M.D., President and Chief Executive Officer of Atara Bio. “The receipt of an orphan drug designation for STM 434 is another important milestone for Atara Bio and the progress of our molecularly targeted programs.”

Orphan drug designation is granted by the FDA OOPD to novel drugs and biologics which are defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases/disorders that affect fewer than 200,000 people in the U.S. The OOPD provides incentives for sponsors to develop products for rare diseases, which may include tax credits towards the cost of clinical trials and prescription drug user fee waivers. The orphan drug designation also would entitle Atara Bio to a seven-year period of marketing exclusivity in the United States for STM 434 if it receives FDA approval for the treatment of ovarian cancer.

Ovarian cancer is the fifth leading cause of cancer death in women in the United States. According to the National Cancer Institute, there were an estimated 22,240 new cases of ovarian cancer and 14,030 ovarian cancer deaths...