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Farmas USA

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#76139

Re: Farmas USA

Vamos a ver qué nos depara la tarde. Suerte para todos y que el cierre de sesión lo podamos celebrar con un Soberano.

NVAX

#76141

Re: Farmas USA

Novavax Announces Grant of Up to $89 Million to Support Development of RSV F Vaccine to Protect Infants Via Maternal Immunization
Bill & Melinda Gates Foundation to Support Development of the RSV F Vaccine Program
GAITHERSBURG, Md., Sept. 29, 2015 (GLOBE NEWSWIRE) -- Novavax, Inc., (Nasdaq:NVAX) a clinical-stage vaccine company focused on the discovery, development and commercialization of recombinant nanoparticle vaccines and adjuvants, today announced it has been awarded a grant of up to $89 million from the Bill & Melinda Gates Foundation to support development of the RSV F Vaccine Phase 3 clinical trial in pregnant women, planned to initiate during the first quarter of 2016. This grant will also support regulatory licensing efforts, providing a path to WHO prequalification. Upon licensure, Novavax has agreed to make the RSV F Vaccine affordable and accessible to people in the developing world.

“Respiratory syncytial virus (RSV) is the leading cause of pneumonia in infants, and currently there are no affordable approaches to protecting children in the developing world from this viral disease,” said Dr. Keith Klugman, Director of the Bill & Melinda Gates Foundation’s Pneumonia Program. “Maternal immunization may provide protective antibodies to infants during the first few months of life, and we hope this vaccine will protect infants from this disease to help them live healthy, productive lives.”

“Along with today’s announcement of top-line data from the Phase 2 clinical trial of our RSV F Vaccine with the goal to protect infants via maternal immunization, we are very gratified to receive the support of the Bill & Melinda Gates Foundation to improve the health of infants throughout the world,” said Stanley C. Erck, President and CEO. “Our groundbreaking Phase 2 results in both maternal and older adult target populations, underscore the promise of our RSV F Vaccine programs. We look forward to carrying our recent momentum into the fourth quarter as we prepare to initiate two pivotal Phase 3 trials of our RSV F Vaccine.”

A fact sheet on maternal immunization is available at the Novavax website, http://novavax.com/download/files/pipeline/151_Novavax_FactSheet_FIN_D_9x10.pdf

#76142

Re: Farmas USA

Novavax Announces Positive Top-Line Data from Phase 2 Clinical Trial of RSV F Vaccine to Protect Infants via Maternal Immunization
-RSV F Vaccine was safe and well-tolerated
-Significant anti-F, PCA and microneutralizing antibody responses elicited in mothers
-Efficient antibody transfer from mothers to infants observed
-Results suggest potential to protect infants when they are most at risk
GAITHERSBURG, Md., Sept. 29, 2015 /PRNewswire/ -- Novavax, Inc., (Nasdaq: NVAX) a clinical-stage vaccine company focused on the discovery, development and commercialization of recombinant nanoparticle vaccines and adjuvants, today announced positive top-line data from a Phase 2 clinical trial of its RSV F-protein recombinant nanoparticle vaccine candidate (RSV F Vaccine) to protect infants via maternal immunization. Novavax also announced today that it has been awarded a grant of up to $89 million by the Bill & Melinda Gates Foundation to support development of the RSV F Vaccine Phase 3 clinical trial in pregnant women, planned to initiate during the first quarter of 2016.

Fact sheet on maternal immunization is available at http://novavax.com/download/files/pipeline/151_Novavax_FactSheet_FIN_D_9x10.pdf
The purpose of the Phase 2 trial was to evaluate the safety and immunogenicity of the RSV F Vaccine in healthy pregnant women. The trial also assessed the transplacental transfer of maternal antibodies induced by the vaccine, the impact of maternal immunization on infant safety during the first year of life and RSV-specific antibody levels through the infants' first six months of life.

The trial was a randomized, blinded, placebo-controlled Phase 2 trial which enrolled 50 healthy pregnant women in their third trimester. Women were randomized to receive either placebo or 120 micrograms of RSV F Vaccine adjuvanted with 0.4 mg of aluminum phosphate. They were followed through the remainder of their pregnancies, delivery and for an additional 180 days postpartum to assess safety and immunogenicity as measured by serum RSV anti-F IgG, microneutralizing, and palivizumab-competing antibody (PCA) titers. Upon delivery, umbilical cord blood samples were obtained to determine the titers of RSV PCA, anti-F IgG, and microneutralizing titers in their infants. Additional serum samples from the infant participants were obtained over the following six month period to provide a preliminary estimate of the half-life of vaccine-induced maternal antibodies.

Women in the vaccinated group demonstrated a geometric mean 14-fold rise in anti-F IgG, 29-fold rise in PCA, and 2-fold rise in microneutralization titers. In contrast, women who received placebo demonstrated no significant change in their antibody levels. At delivery, the geometric mean anti-F IgG antibody titer in immunized women was 7,244 Elisa Units (EU) and on average, the infants' antibody titer equaled 100% of the mothers' anti-F IgG antibody titer. The geometric mean PCA antibody titer was 212 micrograms/mL in immunized mothers and the average PCA antibody transfer within the mother-infant pairs was 90%. Finally, geometric mean microneutralizing antibody titers in immunized mothers were 759 and 481 micrograms/mL for RSV/A and RSV/B respectively, and the average microneutralizing antibody transfer within the mother-infant pairs was 90% for RSV/A and 100% for RSV/B. The estimated half-lives of infant PCA, anti-F IgG, RSV/A and RSV/B microneutralizing antibodies, based on data through day 60, were 41, 30, 36 and 34 days, respectively.

"Maternal immunization is an elegant and accepted approach to protect infants in the first few months of life, the time period when they are most vulnerable to RSV," said Gregory Glenn, M.D., Senior Vice President, Research and Development. "These data are consistent with immune responses observed in our earlier trials of women of child-bearing age. As anticipated, infants received a significant bolus of all anti-RSV antibodies via transplacental transfer. Half of all hospitalizations due to RSV occur within the first three months of life and, based on these data, the RSV F Vaccine demonstrates the potential to protect infants when they are most at risk of infection."

"These data illustrate the promise of our RSV F Vaccine to protect infants via maternal immunization, demonstrating robust immune responses in women with antibody transfer to infants. We look forward to advancing our maternal immunization program to a Phase 3 clinical trial with the support of the Bill & Melinda Gates Foundation," said Stanley C. Erck, President and CEO. "We have now delivered positive top-line data from multiple clinical trials this quarter, including two from our RSV F Vaccine program. These announcements are not only significant achievements for our company, but important contributions to the field. We look forward to sustaining this momentum in the coming months, as we intend to initiate two pivotal Phase 3 trials."

#76143

Re: Farmas USA

NVAX

Esa es una muy buena suma de pasta para seguir con el estudio! Gran noticia sin acabar de leerla! jaja
Un plus a la noticia de verdad. Pero buen plus!

#76144

Re: Farmas USA

NVAX
Vamonos para arriba...ahora solo falta fondos BARDA para el ébola y completamos el día.

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