PHARMACY

NIH announces government-sponsored clinical trial of H1N1 vaccine

BY Michael Johnsen

WASHINGTON The National Institutes of Health on Friday announced that it is preparing to launch the first government-sponsored clinical trial to determine what dose of the 2009 H1N1 influenza vaccine is needed to induce a protective immune response in people with asthma, especially those with severe disease.

The Centers for Disease Control and Prevention has recommended that certain at-risk populations receive the new H1N1 vaccine as a priority before the general population. These target populations include pregnant women, healthcare providers and individuals with underlying chronic medical conditions, including asthma.

“People with severe asthma often take high doses of glucocorticoids that can suppress their immune system, placing them at greater risk for infection and possibly serious disease caused by 2009 H1N1 influenza virus,” stated Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases. “We need to determine the optimal dose of 2009 H1N1 influenza vaccine that can be safely administered to this at-risk population and whether one or two doses are needed to produce an immune response that is predictive of protection.”

People who have severe asthma may be particularly at risk for infection with the 2009 H1N1 influenza virus. A report published in 2004 suggested that some people who took high doses of glucocorticoids to treat their asthma may receive less protection from influenza vaccines against some strains of influenza. Early in the 2009 H1N1 flu outbreak a CDC review of hospital records found that people with asthma have a four-fold increased risk of being hospitalized with infection compared to the general population.

Early results from other clinical trials of 2009 H1N1 influenza vaccines in healthy adults have shown that a single 15-microgram dose of 2009 H1N1 influenza vaccine without adjuvant is well-tolerated and induces a strong immune response in most participants. The same vaccine also generates an immune response that is expected to be protective in healthy children ages 10 to 17 years. Ongoing trials are comparing the immune response to one and two doses of 15- or 30-micrograms of vaccine given three weeks apart in various populations.

The study is being cosponsored by the NIAID and the National Heart, Lung, and Blood Institute, both part of NIH.

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PHARMACY

IMS Health forecasts growth in U.S., global pharmaceutical markets

BY Alaric DeArment

NORWALK, Conn. Strong near-term growth in the U.S. pharmaceutical market will drive growth in the global pharmaceutical market, according to a forecast by market research firm IMS Health.

In its IMS Market Prognosis report, the firm forecasted market growth of 4% to 6% on a constant dollar basis next year, exceeding $825 billion, with an expansion of up to 7% through 2013, when the total market value will expand to at least $975 billion. Growth in the United States, likely to be 3% to 5% in 2010, is expected to drive global growth.

“Overall, market growth is expected to remain at historically low levels, but stronger-than-expected demand in the U.S. is living both our short- and longer-term forecasts,” IMS SVP healthcare insight Murray Aitken said in a statement. “The economic climate will continue to be a dampening influence in most mature markets, particularly in those countries with rising budget deficits and publicly funded healthcare systems.”

Blockbuster drugs that generate $137 billion in sales a year – particularly Pfizer’s Lipitor (atorvastatin calcium), GlaxoSmithKline’s Seretide (fluticosone propionate and salmeterol xinafoate) and Plavix (clopidogrel bisulfate), by Sanofi-Aventis and Bristol-Myers Squibb – will lose patent protection over the next five years and face generic competition. At the same time, new drugs that treat diseases such as cancer, osteoporosis and multiple sclerosis are unlikely to generate the same sales as the blockbuster drugs. These two factors will combine to dampen growth prospects, according to IMS.

Still, growth prospects in the United States have improved, the report said. Pharmacy chains have more tightly managed their inventory levels based on expectations of patient demand, which has increased purchasing volatility but also created higher-than-expected sales growth in first quarter 2009. Meanwhile, papers have sought to limit price increases and boost the use of generic drugs.

“In the U.S., pricing flexibility and inventory management actions are contributing to much higher growth than anticipated earlier this year and are the main reasons for the upward adjustment to our five-year forecast,” Aitken said.

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Sanofi Pasteur: H1N1 shot boosts immune response

BY Michael Johnsen

LYON, France Sanofi Pasteur, the vaccines division of the Sanofi-Aventis Group, on Thursday announced that a single dose of influenza A (H1N1) 2009 monovalent vaccines, Panenza (15 mcg dose, non-adjuvanted) or Humenza (3.8 mcg dose, adjuvanted), administered to children (3 years of age and older) and adults just one time induces a robust immune response that is considered protective in 93% or more of adults 18 to 59 years old and in 83% or more of adults 60 years of age and older, according to results from clinical trials conducted in Europe.

In children 3 years of age through 17 years of age, 94% or more of study participants achieved seroprotective antibody response.

“These significant clinical data concerning Sanofi Pasteur’s pandemic influenza vaccines will help build public confidence in the vaccine and will support efforts by health authorities to face the challenge posed by pandemic influenza,” stated Wayne Pisano, president and CEO of Sanofi Pasteur.

The results are based on interim analysis following the first vaccination dose from clinical trials conducted in France and Finland. No serious adverse events have been observed to date in these clinical trials. Local injection site (redness, swelling and pain) and systemic complaints of mild fever, headache and fatigue were reported.

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