Novartis's Experimental Meningitis Vaccine Meets Goals in Late-Stage Study

Novartis AG said an experimental meningitis B vaccine met the goals of a late-stage clinical study.

The vaccine, called 4CMenB, achieved a “robust immune response” in the study of more than 3,600 infants, the Basel, Switzerland-based company said today in an e-mailed statement. The drug also had “an acceptable” side-effect profile, the company said.

Novartis expects the results of additional clinical trials over the next few months and plans to seek European regulatory approval for the vaccine by the end of 2010. The compound may be used in different age groups and alongside other vaccines, the Swiss drugmaker said. Infants are particularly vulnerable to the meningitis B virus which can kill within 48 hours of the first symptoms appearing, according to Novartis.

“Meningitis B can be devastating for affected families and is a major concern for pediatricians who care for children with this serious illness,” said Andrew Pollard, Professor of Pediatric Infection and Immunity at the University of Oxford. “Many cases of meningitis are prevented today by the vaccines we give to our children, but the more complex meningitis B remains as a major threat.”

Novartis pioneered the technology known as “reverse vaccinology’’ to develop the shot after decoding the genetic makeup of a pathogenic meningitis strain.

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Dendreon’s Provenge Approval Sparks New Era for Cancer Vaccines

Dendreon Corp. won approval for its only product, the prostate cancer vaccine Provenge, concluding a three-year battle with U.S. regulators to introduce the first therapy to train the body’s immune system to destroy tumors.

Provenge may reap annual sales of $4.3 billion by 2020, said George Farmer, a Canaccord Adams Inc. analyst in New York. Its clearance will also benefit more than a dozen other companies developing drugs in the emerging field of cancer immunotherapy, said Joseph Pantginis, an analyst with Roth Capital Partners in New York.

“This approval represents the first cancer immunotherapy product approved in the U.S. and is truly a landmark event,” Pantginis said in a research report yesterday.

Provenge, cleared yesterday for use against advanced prostate tumors, will initially be available at about 50 sites used for clinical trials, and more widely distributed after four plants are cleared for use by mid-2011, Seattle-based Dendreon said in a statement. It will cost $93,000 for a typical three- dose course of treatment, the company said.

Food and Drug Administration approval of Provenge “will definitely inform the clinical development programs of other companies” working on vaccine treatments for cancer, said Janice Reichert, a senior research fellow at the Tufts Center for the Study of Drug Development in Boston, in a telephone interview before the decision was announced.

The most advanced of these vaccines include Seattle-based Oncothyreon Inc. and German drugmaker Merck KGaA’s Stimuvax for breast and lung malignancies; ipilimumab from Bristol-Myers Squibb Co. of New York, for melanoma; and British drugmaker Oxford BioMedica Plc’s TroVax for prostate and kidney cancer.

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FDA Approves New Vaccine to Prevent Japanese Encephalitis

The U.S. Food and Drug Administration today approved IXIARO, a vaccine to prevent Japanese encephalitis (JE) which is caused by a mosquito-transmitted virus found mainly in Asia. IXIARO will be the only vaccine for JE available in the United States.

"This vaccine offers protection for individuals who travel to or live in areas where outbreaks are known to occur," said Karen Midthun, M.D., acting director of the FDA's Center for Biologics Evaluation and Research.

In Asia, JE affects about 30,000 to 50,000 people each year, resulting in 10,000 to 15,000 deaths. JE is rarely seen in the United States, with very few cases reported among civilians and military traveling from the United States to Asia.

The virus that causes JE affects membranes around the brain and mild infections can occur without apparent symptoms other than fever and headache. In people who develop severe disease, JE usually starts as a flu-like illness but can worsen, causing high fever, neck stiffness, brain damage, coma, or even death. The disease is transmitted via infected mosquitoes; it is not spread from human to human.

IXIARO is a second-generation JE vaccine,in that itis manufactured using cell culture technology leading to improved manufacturing efficiency as well as more reliable control of the vaccine manufacturing process. This technology utilizes an established bank of cells that can be drawn from at any time contributing to the assurance of consistent vaccine quality.It also enhances the ability to rapidly manufacture a vaccine on a large scale if needed, without compromise to the vaccine's safety or effectiveness.

Clinical studies were conducted in more than 800 healthy men and women in the United States and Europe. Participants received either IXIARO or JE-VAX, another U.S.-licensed vaccine that is no longer being manufactured. The studies found that IXIARO produced sufficient levels of antibodies in the blood to protect against JE. IXIARO requires two doses instead of JE-VAX's three.

The vaccine was well tolerated and the most commonly reported adverse events were headache, muscle pain and pain, swelling, and tenderness at the injection site. Overall, it was more tolerable and had fewer side effects than the comparator, JE-VAX.

IXIARO is manufactured by Intercell Biomedical, Livingston, U.K.

Source : www.fda.gov

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