PHARMACY

Progen, Avexa agree to merger

BY Alaric DeArment

MELBOURNE, Australia Two Australian biotech companies have announced that they will merge, in a deal worth $13.6 million.

Progen Pharmaceuticals announced Monday that it would purchase Avexa in a deal that will come to a vote among shareholders of both companies in the first three months of 2009. The merger, unanimously recommended by the boards of both companies, will create one of Australia’s largest biotechnology companies; at the closing of the transaction, the combined company will have more than $40.8 million in cash.

The companies said the merger would create a “balanced portfolio” of infectious disease and cancer drug assets, including apricitabine, a drug in phase 3 testing as a treatment for HIV.

“This transaction provides a unique opportunity for Progen shareholders to invest in an integrated portfolio with near-term milestones that include Avexa’s exciting phase 3 program,” Progen CEO Justus Homburg 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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