PHARMACY

CDC announces distribution of record number of flu vaccines

BY Michael Johnsen

ATLANTA The Centers for Disease Control and Prevention on Friday announced that the nation’s influenza vaccine manufacturers have reported more than 103 million doses of influenza vaccine have been distributed as of Nov. 2—an amount that represents more doses than had ever previously been distributed at this date.

“This is good news. Influenza vaccine appears to be more widely available than ever before, and we want people who should be receiving an annual flu vaccination to be sure that they do,” stated Jeanne Santoli, deputy director of CDC’s Immunization Services Division. “Thanks to the increased production of flu vaccine, more people than ever can get protection from a potentially very serious disease. We are hopeful that this year a record number of people will get vaccinated.”

CDC officials believe that most influenza vaccine providers currently have supplies sufficient for meeting demand. As many as 132 million total doses of vaccine could be produced by the end of the 2007-2008 flu seasons, according to manufacturers. This record amount would be about 12 million more doses than were produced during the 2006-2007 season. During the 2006-2007 season, manufacturers distributed 102.5 million doses to providers. CDC officials have worked closely with flu vaccine manufacturers, distributors and the Food and Drug Administration to ensure improved flu vaccine availability.

Santoli noted that some health care providers may not have received their complete order of vaccine yet, as CDC has encouraged vaccine manufacturers and major distributors to use partial vaccine shipments to get doses to as many providers as possible at the earliest opportunity. Flu vaccine distribution typically continues through December and early January.

The 2007-2008 influenza season is just beginning, and nationwide, influenza activity is currently very low. So far, only two states are reporting local influenza activity—Florida and Hawaii.

Santoli noted that almost 75 percent of Americans are recommended to be vaccinated, and that health care providers and people at higher risk for influenza-related medical complications should especially make getting a flu vaccination a high priority. While anyone can get influenza, the flu can be particularly dangerous for certain groups of people who are at greater risk of developing serious flu-related complications, such as pneumonia. Groups at higher risk of flu-related complications include infants and young children, pregnant women, children and adults with chronic medical conditions like asthma, diabetes, or heart disease, and people 65 years old and older.

In addition, close contacts of high risk persons, such as other household members, caregivers and health care personnel should also get vaccinated in order to protect their loved ones or those they care for. Vaccination of those who live with or care for infants is particularly important because children less than six months of age should not get a flu vaccine. Vaccination is also encouraged for anyone who wants to decrease his or her risk of getting the flu.

Since the onset, duration and severity of flu season is unpredictable, and different types and strains of influenza circulate throughout the flu season, CDC’s Advisory Committee on Immunization Practices recommends that influenza vaccine be offered as long as influenza viruses are continuing to circulate in the community.

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FDA approves KarmelSonix’s home asthma assessment device

BY Allison Cerra

KarmelSonix, a developer and marketer of asthmatic and pulmonary devices, has received Food and Drug Administration approval for its device, the WIM-PC.

KarmelSonix specializes in the analysis of sounds emitted from the body (specifically, wheezing) heard in asthmatic patients. The device consists of a sensor attached to the patient’s neck and chest near the windpipe, and a computerized system that analyzes the sounds and determines whether the sounds indicate a life threatening situation requiring the sufferer to be admitted to hospital, or whether the condition can treated at home or at a clinic.

The Australian-traded company is a merger of Karmel Medical and PulmaSonix. Founded in 1996 under the name Karmel Medical, the company has raised $8 million and it even received FDA approval for its device (a previous generation of the WIM-PC), but the company’s inability to market the product proved more difficult than anticipated. Karmel Medical eventually merged the company with an Australian shell called PulmaSonix, and a third company.

KarmelSonix recently raised $6 million (US$5.3 million) on the Australian Stock Exchange at around 17 cents per share in U.S. dollars.

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Prestige announces revenue decline for Q2

BY Michael Johnsen

IRVINGTON, N.Y. Second-quarter results for Prestige Brands were negatively affected by both the voluntary removal of two kids’ cough-cold products under the Little Remedies banner as well as diversion, the company stated during a conference call Thursday.

“During Q2, we uncovered diversion behavior by a small number of our international customers,” reported Mark Pettie, Prestige chairman and chief executive officer. “We immediately stopped sales to these customers and took other steps that make us confident that we have eradicated this behavior. However, the short-term result of this necessary action was an 18 percent decline in Q2 in international revenues versus year-ago.”

Prestige also reviewed its pricing lists to help prevent the cost differentials between markets that entice diverters. “We reviewed our price list across our entire customer base to make sure that there were no longer opportunities out there for this situation to present itself in other parts of the geography. It was isolated primarily to the Caribbean.”

Pettie said that despite this setback, the company would still focus on international growth opportunities.

Prestige’s net revenues for the second fiscal quarter ended Sept. 30 were $87.3 million, 3 percent higher than net revenues in the prior year comparable period. Net revenues for the quarter would have been 4 percent higher, and organic sales for the quarter would have been 2 percent higher than the prior year quarter were it not for the industry-wide voluntary withdrawal of infant cough/cold products in which the company participated. Accordingly, Prestige increased its allowance for estimated returns by $1.1 million and its allowance for obsolescence by $800,000 to reflect the two withdrawn items.

However, the recall of cough/cold products for toddlers under the age of two has not impacted the overall kids cough/cold market, Pettie said. “No. Absolutely not. Consumption of [other Little Remedies] products is staying exactly where we projected it at this point,” he said. “We will continue to monitor that as this unfolds. You can expect that media coverage of this will ebb and flow as FDA goes through its longer-term deliberations,” Pettie said.

The discussion for FDA now will focus on what happens with medicines marketed to children between the ages of two and six, Pettie said. “If [FDA] continues to allow [the industry] to market products to that segment, [Prestige] is ramped up and ready to go with our re-entry strategy. But it is probably going to be beyond this year’s cough/cold season before that ruling comes down.”

Prestige also reported that retailers have been slow to build inventory entering the 2007/2008 cough/cold season. “After two consecutive soft cough/cold seasons, many of our retailers appear to be shifting toward a more consumption-based ordering pattern,” Pettie said. “We welcome that in some regards, because it helps our supply chain as well.”

Looking forward, Prestige plans to grow its Chloraseptic brand beyond sore throat indications. “There is ample consumer evidence that we can push out beyond those [indications] so we are focusing on [new] items that would move Chloraseptic beyond its core heritage and at the same time build scale behind that very important brand.”

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