HEALTH

FDA approves Phadia’s allergy diagnosis test

BY Michael Johnsen

PORTAGE, Mich. Phadia on Thursday announced the recent Food and Drug Administration clearance of ImmunoCAP Rapid, the first point-of-care test to assist in the diagnosis of allergy in the practitioner’s office.

“This is another significant step in our mission to make ImmunoCAP testing available to all the clinicians managing patients with allergic disease, including asthma and rhinitis,” stated Michael Land, president of Phadia US. “In an era when the prevalence of allergy and asthma is described by many as ‘an epidemic,’ ImmunoCAP Rapid gives physicians access to additional clinical information that can help them arrive at a definitive diagnosis. They can also inform patients about the presence or absence of allergic disease while they are still in the office.”

The original ImmunoCAP Specific IgE blood test technology measures Immunoglobulin E (IgE) antibodies to indoor, outdoor and food allergens in a small sample of blood.

ImmunoCAP was the first allergy test to be cleared by the FDA as a truly quantitative test for identifying allergen sensitization. Reducing exposure to a specific allergen that is the source of sensitization is recognized by the National Institutes of Health as one of the most important steps in the effective management of allergic asthma.

ImmunoCAP Rapid is designed to be used at the point of care. Needing only a small sample of whole blood taken from the fingertip, the single-use, disposable device provides a first look at the IgE profile for patients based on the 10 most common inhaled allergens in the United States.

The results are available in 20 minutes, allowing the practitioner to quickly make evidence-based decisions. In addition, this timeframe allows the practitioner and patient to discuss appropriate treatments, including targeted exposure reduction, while the patient is still in the office.

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Icy Hot maker Chattem feels the economic slump

BY Michael Johnsen

CHATTANOOGA, Tenn. The economy is taking its toll on consumer-packaged goods manufacturers, as inventory cut-backs and retail and increased promotional spending prove to be a drag on earnings.

“While total revenues in the first quarter were lower than expected, we remain confident about the strength of our brands and our prospects for the balance of fiscal 2009,” stated Zan Guerry, Chattem chairman and CEO, in announcing the company’s first quarter results for the period ended Feb. 28. “Retail sales of our existing brands as measured by A.C. Nielsen and mass merchandiser point-of-sale data, excluding the discontinued Icy Hot Heat Therapy and Icy Hot Pro Therapy, increased by approximately 5% and 6% for the four and thirteen weeks ending March 21, 2009, respectively.”

Chattem reported that total revenues for the first quarter of fiscal 2009 were $116.1 million, representing a 3.9% decrease. The decrease in total revenues was due primarily to a $4.3 million reduction in international revenues, the company reported, but the balance of the decrease was related to lower sales of Icy Hot, Selsun, Bullfrog and Dexatrim, “caused in part by the timing of shipments, reduced retail inventory levels and two fewer shipping days in the first quarter of fiscal 2009,” the company stated.

The recall last year of the air-activated, self-heating Icy Hot Heat Therapy patch product was also a factor, Chattem noted.

Also adversely impacting Chattem total revenues was an increase in promotional programs that are recorded as a reduction of revenue rather than as advertising and promotion expense, the company added.

Advertising and promotion expense in the first quarter of fiscal 2009 decreased by $5.9 million to $28.6 million, or 24.6% as a percentage of total revenues as compared with 28.6% of total revenues in the prior year quarter. A&P expense was lower for the first quarter of fiscal 2009 due in part to an increase in promotion programs utilized by retailers that were recorded as a reduction of revenue rather than A&P expense and price efficiencies realized on certain media purchases.

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OTC product sales increased 2.4% in 2008, new research reveals

BY Michael Johnsen

LITTLE FALLS, N.J. Manufacturers’ sales of over-the-counter drugs grew by 2.4% to $18.3 billion in 2008, according to the latest research in Nonprescription Drugs USA 2008: Market Analysis and Opportunities from worldwide consulting and research firm Kline & Company, released Tuesday.

Private-label OTC medicines were up 8.2% over the same time period, within which antacids and allergy medicines posted the highest growth last year, driven primarily by increases in sales of private-label omeprazole (Procter & Gamble’s Prilosec OTC) and cetirizine (Johnson & Johnson’s Zyrtec).

Allergy, asthma, and sinus medications were up 17.3% as a result of strong sales from Johnson & Johnson’s Zyrtec brand switch from Rx-to-OTC, as well as its equivalent private-label cetirizine; feminine products was another area that grew 7.3% in 2008 as a result of strong sales growth of personal lubricants, as well as the Rx-to-OTC switch brand Plan B by Barr Laboratories.

“By contrasting the overall growth rates for OTCs with the growth rates for private-label products we can easily make the case that more Americans were seeking value and using private-label in 2008,” stated Laura Mahecha, industry manager at Kline’s Healthcare practice.

Not all categories suffer from higher private-label growth, however, as some are able to maintain growth for branded products.

“During tough economic times, consumers are willing to spend more for some brands they are loyal to and that offer good efficacy,” Mahechas said.

If consumers view brands as being a commodity or not offering special advantages, conversely, they may be able to make the trade-off to private-label.

“As the recession continues into 2009, we expect to see increased ‘value messages’ as part of branded advertising to combat the impacts of private-label erosion. Branded OTCs may use advertising messages to stress the brand’s value, efficacy, safety, and possibly longer-lasting doses, which translates into fewer doses and therefore, costs less,” Mahecha said.

According to preliminary research for Kline’s upcoming report Impact of Recessions on the U.S. OTC Market, past declines during recessions have not been particularly steep for the industry. OTC sales declined two years in a row — from 1999 to 2000 — with overall manufacturers’ sales dropping 0.6%, and then it declined again from 2000 to 2001 by 0.5%.

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