PHARMACY

Sangamo enters $3 million licensing agreement with Pfizer

BY Alaric DeArment

RICHMOND, Calif. A biotech that develops zinc finger DNA-binding proteins announced a licensing agreement with Pfizer Monday worth $3 million.

Sangamo BioSciences will provide Pfizer with a worldwide, non-exclusive license for the use of certain ZFP nuclease reagents to eliminate the glutamine synthetase gene in Chinese hamster ovary cell lines and for the use of the modified cells for clinical and commercial production of therapeutic proteins. Under the agreement, Pfizer will give Sangamo an upfront payment of $3 million for a fully paid license.

“Our colleagues at Pfizer have made fundamental contributions to establish the breadth and utility of [ZFP nucleases] in cell line engineering,” Sangamo president and CEO Edward Lanphier said.

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AstraZeneca seeks approval for use of Nexium in infants

BY Alaric DeArment

NEW YORK AstraZeneca has submitted a supplemental application to the Food and Drug Administration for the use of the drug Nexium as a short-term treatment of gastroesophageal reflux disease in infants.

GERD, which is closely related to acid-reflux disease, affects about 7 million children in the United States.

The FDA has already approved Nexium (esomeprazole magnesium) for use in children between 1 and 17 years of age, though AstraZeneca hopes to have it approved in infants less than a year old.

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Amgen applies for FDA approval of denosumab osteoporosis, cancer treatment

BY Alaric DeArment

THOUSAND OAKS, Calif. Amgen has submitted an approval application to the Food and Drug Administration for denosumab, a treatment for women with postmenopausal osteoporosis and patients undergoing hormone ablation for prostate and breast cancer, the biotech company announced Friday.

The approval application contains data from six phase 3 trials involving more than 11,000 patients, the company said. Amgen also plans to submit applications in Canada, Australia, the European Union and Switzerland.

“Today’s submission marks a significant step toward realizing our goal of making this important therapeutic available to patients at risk for fractures, for whom there is a significant need for new therapies,” Amgen EVP for research and development Roger Perlmutter said.

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