HEALTH

H1N1 incidence rate climbs, CDC notes peak as ‘extremely unusual’

BY Michael Johnsen

ATLANTA The H1N1 influenza pandemic of 2009 continued to surge last week, as the number of states reporting widespread activity climbed to 46, barely a few weeks into the official 2009-2010 cold-and-flu season, according to a Centers for Disease Control and Prevention briefing held Friday.

The CDC update was soon followed by a national emergency declaration from the White House.

Tom Frieden, CDC director, suggested that in a typical season, 46 states reporting widespread activity would represent the peak of illness in the season. That’s not necessarily the case this year.

“To be basically in the peak of flu season in October is extremely unusual,” Frieden said. ”It is though a very different pattern and the fact that we’re having a young person’s flu now doesn’t mean we’re not going to have an older person’s flu later in the year.”

And while more people are suffering from flu-like symptoms, fewer people have been able to get the flu shot be it either seasonal or H1N1. The H1N1 vaccine has been trickling out to states even as most flu clinics have exhausted their supplies of seasonal vaccine because of record demand. Already, many companies that provide flu clinic services, including Maxim Health, have had to cancel clinic offerings due to lack of seasonal vaccine.

To date, more than 85 million doses of seasonal vaccine have been distributed, with an additional 30 million on its way. “[News of seasonal vaccine shortages] were surprising to us until we got back, this week, new data about the uptake of seasonal flu vaccination— which has been unprecedented,” Frieden said. “By our estimates, over 60 million people have been vaccinated already for seasonal influenza,” he added, noting that this many inoculations delivered this early in a season is unprecedented.

“At the government [level] we are doing everything we can to get [the H1N1] vaccine out as soon as it becomes available,” Frieden said. “Shipping is overnight. We’re distributing to literally tens of thousands of doctors, hospitals, health centers throughout the country,” he said, suggesting there now is a significant amount of H1N1 vaccine available. As of Friday, there were 16.1 million doses available for shipping.

But that “significant amount” is proving to be not enough, Frieden conceded.

“What we have learned more in the last couple of weeks is that not only is the virus unpredictable, but vaccine production is much less predictable than we wish. We are nowhere near where we thought we’d be by now. We are not near where the vaccine manufacturers predicted we would be,” he said. ”The technology we are using, although it’s tried and true, is not well suited for pandemics.”

The number of H1N1 cases to date already number in the millions, Frieden said, and is disproportionately impacting younger people as compared to the seasonal flu. “This remains largely a young person’s disease, but we are seeing it increasingly affect young adults as well as children,” he said. “We are still not seeing significant numbers of cases in the elderly, and that is a characteristic of this virus which has not changed since spring.”

The pandemic influenza  is currently in its second wave, Frieden added, with the first occurring in the spring.

So far, the mortality rate associated with H1N1 remains relatively mild, and the H1N1 virus remains susceptible to such antiviral medicines as Tamiflu.

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Pfizer reports 3Q profit rise, revenue drop

BY Alaric DeArment

NEW YORK Job cuts helped raise Pfizer’s third-quarter 2009 profits by 26% over third-quarter 2008, even though the company had lower overall sales, according to an earnings report released Tuesday.

The world’s largest drug maker reported profits of $2.9 billion, compared with $2.3 billion a year ago, though revenues were $11.6 billion, a 3% decrease from $12 billion in third-quarter 2008. The company said the decrease in revenues and the rise in the value of the dollar kept profits from increasing further.

Pfizer’s $68 billion acquisition of Wyeth, while giving the company a leg up in vaccines, biologics and OTC drugs, helped offset profits by requiring it to pay higher interest rates on its bonds, according to the report. The company incurred $22.5 billion in debt through the acquisition, prompting Standard & Poor’s to lower its bond rating from AAA to AA.

Such drugs as the pain drug Lyrica (pregabalin) and the cholesterol-lowering drug Lipitor (atorvastatin calcium) had strong sales overseas, but primary-care drugs in general had a mediocre performance thanks to lower sales of Lipitor in the United States. Cancer drugs, likewise, had lackluster performance, despite growth in recent years in the cancer drug market in general.

Though the drug Sutent (sunitinib malate) sold well, the company lost market exclusivity in Europe for the drug Camptosar (irinotecan), and had lower sales overseas due to the strengthening of the dollar, helping to drive sales down from $389 million in third-quarter 2008 to $371 million this quarter.

Meanwhile, sales of specialty drugs — drugs prescribed by specialist doctors rather than primary-care physicians — were $1.6 billion, a 3% increase over third-quarter 2008, thanks largely to strong sales of such drugs as the multiple sclerosis treatment Rebif (interferon beta-1a) and the pulmonary arterial hypertension drug Revatio (sildenafil citrate).

“The completion of the Wyeth acquisition represents a significant milestone in the transformation of Pfizer,” Pfizer CEO Jeffrey Kindler stated. “We are beginning to implement our integration plan in order to quickly maximize the value of our expanded and more diversified global product portfolio in key high-growth areas. With customer-centric businesses, supported by research organizations, Pfizer is now well positioned to deliver greater value to patients and shareholders.”

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Pfizer returns to consumer care with Wyeth buy

BY Michael Johnsen

NEW YORK The approval last week of the Wyeth acquisition by Pfizer marks the return of a consumer-care division to Pfizer, and a considerable one at that.

Pfizer in 2006 sold its then OTC division to Johnson & Johnson as part of an initiative to capitalize on its pharmaceutical pipeline. Then the recession hit, and the need for a significant cash-flow generator like an OTC division again became paramount to pharma companies. So in addition to the pharmaceutical symmetries inherent in the deal — biologics and vaccines — the return of an OTC division to Pfizer is consequential.

There will be a degree of continuity as Wyeth Consumer Healthare is exchanged for Pfizer Consumer Healthcare on all OTC packaging — former president of Wyeth Consumer Healthcare, Cavan Redmond, remains in charge of the division as group president, diversified businesses at the new Pfizer. In addition to OTCs, animal health and nutrition, Cavan also picks up responsibility for capsule manufacturer Capsugel.

Pfizer’s new OTC division is strongest in internal analgesics behind its venerable Advil brand — comprising 16.8% dollar share of the category, the pain reliever generated $340.8 million in sales across food, drug and mass (minus Walmart) outlets for the 52 weeks ended Oct. 4, according to Information Resources Inc., down slightly by 2.5% in an economy that continues to skew toward private label.

Other areas of significance include dietary supplements, with $189.7 million in Centrum sales (down 1%) and $53.4 million in Caltrate sales (up 3.8%); cold and allergy, where in addition to Advil Cold, Wyeth fields Alavert and Robitussin. Indeed, almost $1-out-of-every-$3 spent on cough syrups is used to buy a Robitussin product, which generated $91.5 million for the 52 weeks ended Oct. 4, up 27.2%. Across the digestives aisle is Preparation H, with more than $75 million in annual sales, and Fibercon, which generates more than $10 million annually. And in lip care, the new Pfizer division will field Chapstick, a brand with more than $80 million in annual sales.

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