PHARMACY

GSK moves forward in plan to acquire Bristol-Myers Squibb Pakistan Ltd.

BY Alaric DeArment

LONDON GlaxoSmithKline will buy Bristol-Myers Squibb’s division in Pakistan, along with several associated trademarks, the British drug maker announced Monday.

GSK plans to spend about $36.5 million to acquire Bristol-Myers Squibb Pakistan Ltd., including a portfolio of more than 30 pharmaceutical brands, some of which occupy leading market positions in key therapeutic disease areas. The drugs include antibiotics, vitamins and dermatology drugs, with sales totaling $19 million last year.

The companies expect to complete the acquisition in early 2009.

“We are continuing to make investments in emerging markets to grow and diversity GSK’s business,” GSK president for emerging markets Abbas Hussain said. “This acquisition reinforces our commitment to Pakistan, broadening our product portfolio and helping us to meet the needs of patients.”

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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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