Sanofi Pasteur submits supplemental application to FDA for flu vaccine
SWIFTWATER, Pa. Sanofi Pasteur, the vaccines division of the Sanofi-Aventis Group, on Friday announced the company has submitted a supplemental application for licensure of its influenza A(H1N1) 2009 monovalent vaccine to the Food and Drug Administration.
Responding to recent recommendations by the FDA, the company’s supplemental application requests the FDA’s evaluation of the influenza A(H1N1) 2009 strain change, which is expected to expedite the licensure process for the pandemic vaccine.
“Filing this application is consistent with our commitment to work collaboratively with public health officials in producing a vaccine against the influenza A(H1N1) 2009 virus,” stated Wayne Pisano, president and CEO of Sanofi Pasteur. “It is essential that we pursue the vaccine licensure pathway made available to us, while at the same time, continue the important clinical studies of our vaccine.”
The supplemental application follows recent recommendations by the FDA to evaluate the influenza A(H1N1) 2009 monovalent vaccines using the same regulatory process by which it approves new viral strains contained in the annual seasonal influenza vaccines.
While these strain change supplements are not required to be supported by new clinical data, immunogenicity and safety data will be made available through clinical studies. Sanofi Pasteur will test the immunogenicity and safety of its influenza A(H1N1) 2009 monovalent vaccine through clinical trials in the U.S., which began Aug. 6. The planned clinical trials will consist of approximately 2,000 subjects and will also evaluate the safety and potential benefits of adding an adjuvant to the pandemic vaccine.
Military cutting costs via Rx negotiations; NACDS hails finding as pharmacy victory
ALEXANDRIA, Va. Vindicating claims made over the last two years or more by the National Association of Chain Drug Stores and other pharmacy groups, the Department of Defense revealed that allowing the military to negotiate with drug manufacturers for lower prices on retail prescriptions is saving taxpayers big sums of money.
NACDS president and CEO Steven Anderson Thursday hailed the findings as a victory for community pharmacies — and for freedom of choice for military members and their families.
The Defense Department revealed that it will spend an estimated $1.67 billion less on prescription drug medications in the 2010 fiscal year than previously projected. Behind the cost savings: a change in the way the agency obtains drug supplies for prescriptions sold in community pharmacies to beneficiaries enrolled in the TRICARE military health program. That change became effective with the release of new DoD regulations in March that allow the military to obtain pricing discounts for prescriptions sold at retail.
Those discounts, generated through direct negotiations between federal procurement officials and pharmaceutical companies, are clearly lowering the costs for the TRICARE program — and for the military beneficiaries who fill prescriptions in local community pharmacies.
“This is a true victory for military service members and their families,” Anderson said. “A rule implemented earlier this year enabled the Department of Defense to obtain pricing discounts for retail prescription medications,” he added. “Those discounts will result in remarkable savings for the Department, which translates to pharmacy choice for TRICARE beneficiaries. Military families will maintain the option to obtain their prescriptions and other pharmacy services from a retail pharmacy.
Anderson cited “an ongoing, multi-year effort” by NACDS to preserve freedom of choice for military beneficiaries, and to prevent the government from discouraging those beneficiaries — via higher out-of-pocket costs — from obtaining their prescriptions at a retail pharmacy rather than through a mail order pharmacy or military base pharmacy. The pricing discounts had long been sought by the retail pharmacy industry as a way to level the playing field between retail and mail order pharmacies serving the more than 9 million military health beneficiaries enrolled in the federal program. Historically, retail pharmacies have operated at a competitive disadvantage vis-a-vis mail-order and military-base pharmacies, because prescription costs were higher for military members and their families if they chose to fill their scripts in a community pharmacy setting.
“The value of a pharmacist in counseling on adhering to medication regimens, preventing possible drug interactions and improving health outcomes is invaluable to all patients, and should not be limited for the brave men and women and their families who serve and sacrifice,” Anderson asserted.
Home Diagnostics, Inc. reports spike in retail sales
FORT LAUDERDALE, Fla. Home Diagnostics, Inc. on Thursday realized a 45.2% increase in retail channel sales for the second quarter ended June 30, the company announced.
Retail sales were driven by the continued national rollout of the TRUEresult and TRUE2go blood glucose monitoring systems and the expanded product portfolio at Walmart. Though total revenue for the second quarter was $32.7 million, a decrease of 2.1%. International sales decreased 22.3%, reflecting lower sales in Latin America following the company’s decision to limit its exposure in that region due to poor economic conditions.
“We are particularly pleased with our domestic sales which grew during the quarter, outpacing the reported results of the majority of our branded competitors, which reported sales declines for the quarter,” stated Joseph Capper, president and CEO of HDI. “This reflects our position as a leading provider of value-priced, high-quality blood glucose monitoring products. We achieved 45% growth in our retail channel, driven by strong reception of our new products, TRUEresult and TRUE2go, as well as organic growth of existing products with our major retail partners.”