FDA grants AstraZeneca patent extension for Arimidex
WASHINGTON AstraZeneca said the Food and Drug Administration has granted it another six months of patent protection for its breast cancer drug Arimidex.
The patent extension through June 2010 was granted under pediatric exclusivity rules because the company conducted trials to investigate the drug’s potential for pediatric conditions with symptoms due to increased estrogen production. The company received the extension even though the drug did not pan out for these conditions, and the company will not be seeking a new licensed indication for them.
Arimidex (anastrozole) has been approved for use for three different medical conditions. In 1995, it was approved for the treatment of advanced breast cancer in postmenopausal women with disease progression following tamoxifen therapy. The drug was later approved, according to the FDA, for use in the “first-line treatment of postmenopausal women with hormone receptor positive or hormone receptor unknown locally advanced or metastatic breast cancer,” and the “adjuvant treatment of postmenopausal women with hormone receptor positive early breast cancer” (in 2000 and 2002, respectively).
In the U.S., Arimidex sales reached $507 million for the first nine months of 2007. Arimidex has a market-leading 38.3 percent share of total prescriptions for hormonal treatments for breast cancer. Sales for the nine months were up 15 percent, with total prescriptions 6 percent higher than last year.
NACDS Foundation dinner raises $2.2 million
ALEXANDRIA, Va. The National Association of Chain Drug Stores this week held its Ninth Annual Foundation Dinner in New York City. This year’s fundraising event far surpassed previous records, increasing for the third consecutive year, raising $2.2 million for the NACDS Foundation.
The mission of the NACDS Foundation, the organization reported, is “to enhance support of pharmacy education, student scholarships, research and training that advance community pharmacy’s public service, and charitable organizations.”
Emmy award winner Tim Russert addressed the attendees, sharing his thoughts gained from a remarkable career, from being managing editor and moderator of Meet the Press as well as, political analyst for NBC Nightly News to serving as as senior vice president and Washington bureau chief of NBC News.
Donations raised from the dinner help advance the role of community pharmacy in numerous ways, including major research projects, pharmacy student scholarships, and charity work. Over the years, the NACDS Foundation has provided nearly $2 million in support to pharmacy education to help ensure the future of a strong and vibrant industry. And in the last year alone, it provided nearly $1 million in grants to charitable organizations that positively impact the lives of patients and the communities the chain drug industry serves.
“We could not be more thrilled or more grateful at the extensive generosity set forth by our benefactors,” said Phil Schneider, NACDS Foundation president. ”The contributions raised will enable the NACDS Foundation to continue, and even increase its work to advance community pharmacy.”
Kentucky pharmacists call on Sen. McConnell to fast-track Medicaid bill before holiday
FRANKFORT, Ky. Kentucky community pharmacy owners held a press conference today at Capital Pharmacy and Medical Equipment urging Senate Minority Leader Mitch McConnell, R-Ky., to help ensure S.1951, the Fair Medicaid Drug Payment Act of 2007, is brought to the Senate floor for a vote before it adjourns this year.
The bill is intended to fix the Medicaid generic prescription drug pharmacy reimbursement cuts called for by the Centers for Medicare & Medicaid Services that are scheduled to take effect early next year. Pharmacy advocates claim that the CMS cuts threaten the economic viability of community pharmacy, as well as patient access to pharmacy services.
“Community pharmacy owners like myself are being put in a terrible bind because of the coming cuts to Medicaid reimbursement,” said Mac Bray, owner of Capital Pharmacy and Medical Equipment. “My options will be to either turn my back on my Medicaid patients by limiting or dropping my services, or suffer huge financial losses by continuing to participate in the Medicaid program. Senate Minority Leader Mitch McConnell can spare myself and other pharmacists from making that Hobson’s Choice by pushing for the Senate to pass S. 1951 before they go home for the Holidays.”
“Who can stay in business at 36 percent below cost?” said Brad Hall, executive director of the Kentucky Pharmacists Association. “The federal government’s AMP [average manufacturers price] formula does not properly measure retail acquisition costs for community pharmacies like Capital Pharmacy and Medical Equipment here in Frankfort. The real world consequences of this disastrous federal policy will be felt most profoundly by patients, who will see their access to prescription drugs and the valued expertise of their trusted local pharmacists undermined. When that happens these patients will be forced to more expensive options such as visiting emergency rooms. This can all be avoided if Congress acts before the rule is fully implemented on Jan. 30, 2008.”