FDA approves Barr’s generic Yasmin
MONTVALE, N.J. Barr Laboratories has received approval from the Food and Drug Administration for its application to manufacture and market a generic version of Yasmin, drospirenone and ethinyl estradiol, an oral contraceptive product manufactured and marketed by Bayer Schering Pharma.
On March 3, Barr announced that the District Court for the District of New Jersey had ruled in favor of its subsidiary, Barr Laboratories in the challenge of the patent listed by Bayer Schering Pharma, AG for Yasmin. In his ruling, Judge Peter G. Sheridan found that the patent at issue was invalid, because it was obvious. On April 1, Bayer Schering appealed this ruling to the U.S. Court of Appeals for the Federal Circuit.
The product had annual sales of approximately $575 million for the twelve months ended February 2008, based on IMS sales data.
AmerisourceBergen reorganizes management
VALLEY FORGE, Pa. Drug distribution and health services giant AmerisourceBergen Corp. today announced a major restructuring of its operations.
The result, said company spokesman Michael Kilpatric, will be a “more streamlined organizational structure designed to drive increased efficiency and effectiveness.”
In line with the changes, Terry Haas, ABC executive vice president and chief integration officer, has left the company “to pursue other interests,” according to the company. ABC president and chief executive officer R. David Yost praised Haas for his “extraordinary contribution to AmerisourceBergen,” as well as the major role he played in the integration of Amerisource and Bergen Brunswig following their merger.
Yost explained the restructuring as follows: “To continue meeting the challenges of an ever changing pharmaceutical environment, AmerisourceBergen needs the infrastructure and cost structure that allows the Company to compete as the most efficient and effective operating company in our industry. It is with that singular focus that we are further integrating our organization.”
The organizational changes are effective immediately. Among the management shifts underway:
- Michael DiCandilo, ABC executive vice president and chief financial officer, expands his duties with the added position of chief operating officer for AmerisourceBergen Drug Corp. (ABDC) and continues to report directly to Yost. The ABDC functions reporting to DiCandilo in his new role include Supply Chain Management; Operations—including the distribution network—and Financial Operations, which previously reported to him. Yost continues to lead ABDC and continues to have the executives leading sales and marketing reporting to him.
- Steven Collis, executive vice president of AmerisourceBergen and president of the ABC Specialty Group, also has an expanded role that now encompasses supervision of PMSI, the company’s workers’ compensation business. “Steve continues his responsibilities for helping shape the policy and strategy of ABC and for more closely integrating [the specialty group] across AmerisourceBergen,” the company noted. He continues to report directly to Yost.
- Thomas Murphy, senior vice president and chief information officer, will also take on additional duties by assuming leadership of Business Transformation, the company’s multi-year process improvement project, which includes design of an ERP (Enterprise Resource Planning) system for ABDC and the corporation. Yost continues his executive leadership of the overall improvement effort, while Murphy continues to report directly to DiCandilo.
FDA sees growing number of counterfeit drugs
NEW YORK According to The Lancet, the Food and Drug Administration saw an eight-fold increase in the number of new counterfeit prescription medications from 2000 until 2006.
What’s worse is that worldwide sales of counterfeit drugs are forecasted to reach $75 billion by 2010. This is, in part, due to weak regulatory systems in developing countries, where around 10 to 30 percent of drugs might be fake, according to the journal.
Counterfeiting may have caused the deaths of at least 81 patients in the U.S. after they were treated with a contaminated batch of heparin, a blood-thinning drug.
Last week the FDA told a congressional hearing it believed a dangerous contaminant found in batches of the heparin may have been deliberately added. The contaminant, traced back to a Chinese supplier, was structurally similar to heparin but 100 times cheaper.
The counterfeit drug trade was becoming more difficult to combat even before the tainted heparin was discovered, as criminals were using more sophisticated techniques to bypass standard laboratory tests. For instance, by adding cheaper substances that mimicked genuine drugs.
Substances used to taint medicines varied from chalk to antibiotics to highly lethal substances, said the editorial.