PHARMACY

Amgen posts increase for Q4 2007

BY Drew Buono

THOUSAND OAKS, Calif. Amgen has released its fourth quarter and full year earnings. For the fourth quarter, the net income of the company increased 3 percent to $1,088,000 compared to $1,060,000 in the fourth quarter of 2006.

For the full year, the company had an adjusted net income of $4,804,000 versus $4,620,000 in 2006, a 4 percent increase. Although revenue decreased in the fourth quarter by 2 percent, for the full year it increased by 4 percent to $14,771,000.

The company was affected negatively by the new labeling requirements from the Food and Drug Administration for anemia drugs or erythropoiesis-stimulating agents. The FDA changed the labeling information after finding that patients who were taking the drugs due to chemotherapy were actually dieing sooner than patients who had not received the drug.

Amgen’s two big anemia drugs, Aranesp and Epogen decreased in sales in the fourth quarter, which was when the announcement was made by the FDA, combined by 28 percent. Aranesp decreased 25 percent to $827 million and Epogen decreased by 3 percent to $638 million.

“2007 was Amgen’s most challenging year,” said Kevin Sharer, chairman and chief executive officer. “Despite the unexpected reduction in revenues of our erythropoietin products, we delivered earnings per share very close to the low end of our original guidance. I am also encouraged by our recent denosumab trial results and the potential of our pipeline. 2008 presents challenges and opportunities and while we are optimistic, we are ready for whatever might come our way,” concluded Sharer.

Denosumab is Amgen’s new osteoporosis drug, which recently proved in a study to be better at improving bone density than Fosamax.

Even with this information, the company sill expects revenue to decrease in 2008 and be in the range of $14.2 to $14.6 billion.

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Harvard program seeks to discourage doctors from prescribing pediatric antibiotics

BY Drew Buono

CAMBRIDGE, Mass. A program was conducted at the Harvard Medical School in an effort to change doctors’ prescribing habits for antibiotics and to educate parents of small children about the proper use of antibiotics, according to Reuters.

The program was initiated because of the emergence of microbes that are resistant to antibiotics because doctors prescribed the medications when they weren’t really needed.

Harvard Medical School’s Jonathan Finkelstein and colleagues conducted the program in 16 Massachusetts communities between 1988 and 2003. Finkelstein’s team measured changes in antibiotic prescribing rates among three groups of children: 3 to 24 months, 24 to 48 months, and 48 to 72 months.

By the end of the study, the intervention had not changed the rate of antibiotic use in the youngest group, but for children between 24 and 48 months, the rates decreased by 4.2 percent and for the oldest children, the rates decreased by 6.7 percent.

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Patent office rejects Gilead patents for Viread

BY Drew Buono

WASHINGTON The Patent and Trademark Office has tentatively rejected four patents for Gilead Sciences’ HIV drug Viread, according to published reports.

The Public Patent Foundation filed a petition in March seeking to revoke the patents for the drug because they felt the drug should never have been patented in the first place, as the technology used to make the drug had been previously disclosed publicly.

The PTO is now re-examining the patents. Industry experts have said that it is common for the federal agency to tentatively rule patents invalid after having been asked by a third party to re-examine them. What would be unlikely would be the patents being permanently revoked, which has only occurred about 10 percent of the time.

Gilead sells Viread under that name and in combination with other drugs as Truvada and Atripla. Taken together, the three HIV treatments generated $3.1 billion in sales last year, according to the company.

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