Novartis wins key vaccine contract
WASHINGTON The Department of Health and Human Services on Thursday announced a $487 million multiple-year contract with Novartis Vaccines and Diagnostics to build the first U.S. facility to manufacture cell-based vaccine for seasonal and pandemic flu.
“Today we are taking an important step in our ongoing commitment to pandemic preparedness,” said Robin Robinson, director of the HHS Biomedical Advanced Research and Development Authority, which will oversee the contract. “In a pandemic we would need vaccine ready within six months. That’s why the National Strategy for Pandemic Influenza set domestic surge capacity as a goal in preparing the nation for a pandemic. That goal could not be accomplished using the traditional egg-based method of producing flu vaccine.”
Because cell-based influenza vaccine can be made faster and in greater quantities than traditional vaccine, the new facility is expected to increase the U.S. capacity to make pandemic influenza vaccine by at least 25%.
Cell-based vaccine production could more easily meet surge capacity needs because cells could be frozen and stored in advance of an epidemic or developed rapidly in response to an epidemic. Cell-based vaccine production also dramatically reduces the possibility for contamination and promises to be more reliable, flexible, and expandable than egg-based methods.
Currently, influenza vaccines licensed by the Food and Drug Administration are made in specialized chicken eggs using a process that has changed little in more than 50 years. In place of eggs, cell-based vaccine production uses laboratory-grown cells that are capable of hosting a growing virus. The virus is injected into the cells where it multiplies. The cells’ outer walls are removed, harvested, purified, and inactivated. Using this technology, a vaccine can be produced in a matter of weeks.
New cell-based influenza vaccines provides an option for people who are allergic to eggs and, therefore, unable to receive current flu vaccines. Cell-based production avoids other problems that egg-based production has, such as a potential shortage of eggs due to poultry-based diseases.
The cell-based vaccine technology can also be used to make vaccines for seasonal influenza and other major emerging infectious diseases.
Under the contract, Novartis and HHS share the cost of the new cell-based influenza vaccine manufacturing facility in Holly Springs, N.C., with the HHS contract covering 40% of the cost and Novartis bearing 60%.
Also under the contract, Novartis will provide two new flu vaccines for seasonal flu or for pre-pandemic use. The contract builds on progress made through a previous HHS contract award to Novartis to accelerate the development of cell-based influenza vaccine.
The new contract also will fund scientific studies, called clinical bridging studies, to compare existing Novartis vaccines to new ones, including those developed in the new facility, to show that these new ones are also safe and effective. By comparing new and existing vaccines, the company can provide information quickly to the FDA to request licenses for the new vaccines.
If licensed by the FDA, the new cell-based vaccines made in the United States could be purchased for by the federal government for vaccine stockpiles.
MTI launches Rite Aid Radio
MIAMI BEACH, Fla. Music Technologies International on Tuesday announced that it’s “Rite Aid Radio,” a music and messaging program designed exclusively for Rite Aid, is now available chainwide.
“We relished the opportunity to start from scratch with Rite Aid in creating a music environment that is much more ‘tune’ with their customers,” said Bradley Golden, president of MTI. “We feel that we have helped to create an even more inviting audio ambiance in the stores.”
MTI built the music library song by song to appeal to Rite Aid’s customers, the company stated, and also allows Rite Aid to broadcast messages to speak directly to its customers.
This partnership is actually the resumption of a relationship from the 1990’s when MTI provided a similar program to Rite Aid.
“Our number one priority is keeping our customers happy,” said Jerry Cardinale, Rite Aid senior vice president of indirect procurement. “We feel that MTI’s music and messaging program helps us achieve this goal. MTI shares our philosophy of absolute dedication to customer service.”
Duane Reade announces $3.5 million settlement for Q4 2008
NEW YORK Duane Reade, without admitting liability, has announced a $3.5 million litigation settlement that will result in a $3.5 million one-time, pre-tax charge for the fourth quarter.
The two class action cases concern the retailer’s alleged past payment practices for certain overtime and employee non-exempt classifications.
The settlement is subject to the approval of the U.S. District Court for the Southern District of New York. The company stated that while it believes it can “strongly defend against the matters involved in this litigation” it has decided to settle to avoid additional defense costs and uncertainty surrounding the litigation.
The retailer, which operates 251 stores, is expected to announce its fourth quarter and fiscal year 2008 results in March.