Novavax (NVAX): Un Nuevo Comienzo

Y..un clasico.. . El numero de cortos ha subido

Tutamen sabes algo de lo que decian que se publicaba en Julio?gracias.

Novavax Confirms Accelerated Approval Pathway Available for Licensure of NanoFlu™

• Pivotal Phase 3 clinical trial expected to initiate in the fall of 2019
• Top-line clinical data expected in the first quarter of 2020

GAITHERSBURG, Md., June 27, 2019 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced it will utilize the accelerated approval pathway for licensure for NanoFlu™, its nanoparticle seasonal influenza vaccine candidate. The U.S. Food and Drug Administration (FDA) acknowledged in a recent letter that the accelerated approval pathway is available to Novavax for its NanoFlu vaccine. Novavax expects to initiate its pivotal Phase 3 clinical trial by the fall of 2019 with top-line clinical data expected in the first quarter of 2020. These immunogenicity data are expected to support a U.S. biologics license application (BLA).

Novavax will conduct an End-of-Phase 2 meeting with the FDA in the third quarter of 2019 to discuss the proposed Phase 3 clinical trial design and other topics that will support the future BLA. The accelerated approval pathway enables Novavax to conduct a non-inferiority immunogenicity clinical trial against a licensed quadrivalent comparator, with a commitment to confirm efficacy post-licensure.

“NanoFlu’s encouraging results observed in prior clinical trials, which demonstrated improved immune responses against licensed comparators, provide us confidence in the future success of the Phase 3 clinical trial,” said Gregory M. Glenn, M.D., President of Research and Development of Novavax. “The accelerated approval pathway allows us to potentially obtain U.S. licensure more expeditiously, and ideally, deliver a greatly needed improved flu vaccine, which could reduce the tremendous medical and economic burden of influenza.”

“The accelerated approval pathway, combined with the strategic partnership we announced today with Catalent Biologics, allow us to efficiently and cost effectively complete the clinical development of NanoFlu through BLA and licensure,” said Stanley C. Erck, President and Chief Executive Officer of Novavax. “The Catalent deal provides an $18 million cash infusion and flexible manufacturing capacity, supported by the experienced professionals transferred from Novavax to Catalent.”

Novavax and Catalent Biologics Enter Strategic Partnership: Allowing Catalent Biologics to Expand Gene Therapy Footprint with Acquisition of Novavax’ Manufacturing Assets and Capabilities

• Manufacturing equipment and related assets to be sold to Catalent’s Paragon Gene Therapy for $18 million in cash
• Over 100 manufacturing and quality employees to join Catalent
• Paragon Gene Therapy to take over two clinical development and manufacturing sites in Gaithersburg, MD
• Long-term agreement for Paragon to support Novavax with product development and manufacturing

GAITHERSBURG, Md., June 27, 2019 (GLOBE NEWSWIRE) -- Novavax, Inc. (NASDAQ: NVAX), a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, and Catalent Biologics’ Paragon Gene Therapy unit, the leading viral vector development and manufacturing partner for gene therapies, today announced an arrangement under which Paragon Gene Therapy will assume the leases to two Novavax product development and manufacturing facilities, giving it immediate access to state-of-the-art manufacturing equipment, people and space to accelerate the growth of its gene therapy development and manufacturing business.

This arrangement significantly reduces Novavax’ operating costs and provides a cash payment at closing of approximately $18 million. This cost savings and cash infusion allow Novavax to focus on advancing NanoFlu™ and ResVax™ through the next phases of clinical development and regulatory review.

Under the terms of the agreement, Paragon Gene Therapy will purchase from Novavax all of the related manufacturing equipment and facility assets; in addition, over 100 of Novavax’ highly qualified manufacturing and quality employees will transfer to Paragon. Concurrently, Novavax will be entering into a long-term arrangement with Paragon to provide process development and manufacturing services for specified Novavax programs. The transactions are expected to close in July 2019.

“This alliance is a true win-win-win for Paragon, Novavax and our employees,” said Stanley C. Erck, President and Chief Executive Officer of Novavax. “This mutually beneficial transaction allows Paragon to quickly support the growth of its gene therapy development and manufacturing business and simultaneously offers Novavax a strategic and cost-effective approach to addressing its manufacturing needs into the future.”

Most Novavax employees at the two sites will transfer to Paragon and will continue to provide process and analytical development and, potentially, manufacture GMP materials for Novavax’ clinical trial supplies for NanoFlu and ResVax, among other new projects. These employees will also provide continuity and support of Novavax’ biologics license applications and post-licensure activities. Over the longer term, Paragon will be available to manufacture commercial quantities of the vaccines for Novavax.

“Novavax’ advanced GMP development and manufacturing capabilities and, even more importantly, its very strong team of experts, will help accelerate our gene therapy manufacturing strategy and rapid growth,” said Pete Buzy, President of Paragon’s gene therapy business. “We welcome the new Novavax employees to the Paragon family and look forward to working closely together in this strategic collaboration to advance Novavax’ innovative recombinant vaccines platform and expand our ability to serve the burgeoning gene and cell therapy market.”

“This transaction allows Novavax to focus on discovery, clinical work, regulatory licensure and commercialization of innovative vaccines that may improve on existing approaches to prevent serious infectious diseases. We are happy to have found a great home for our valued team members transferring to Paragon where they can make a real difference in developing new gene therapies and we thank them for their important contributions to Novavax’ progress” Mr. Erck said.

He reentrado con los 250 cromos que me salí a más o menos el mismo precio.

Creo que son buenas noticias, el AA es muy buena noticia. Y lo otro indica que no van a tener otro partner pero podrán alargar la pasta.

No estoy seguro de cómo le va a sentar al mercado pero el AA da esperanzas.

NVAX

primer nivel de resistencia por los 7,1x ...

Ya hay movimientos en el pre- market, al fin vamos a tener un día sonriente.

Interesante movimiento el de Novavax con este acuerdo. Recibe algo de Cash y va a tener un enorme ahorro de costes al traspasar tanto las instalaciones y el equipamiento como a 100 trabajadores cualificados. Además las instalaciones y los trabajadores seguirán colaborando con Novavax para dar soporte con la aprobación de sus vacunas y su posible comercialización y a largo plazo Paragon podría manufacturar vacunas para Novavax.
No es un partnership que suponga una pérdida sustancial de las futuras ventas de las vacunas y da bastante oxígeno a Novavax en estos momentos.
Eso unido a la confirmación oficial de que se puede hacer la fase 3 del NanoFlu usando la AA son extraordinarias noticias en un momento tan difícil.
El enfermo sigue en la UCI pero sus posibilidades de supervivencia aumentan bastante.

La lectura negativa es que no parece que vayan a tener un partner en los estudios y que más diluciones son el único camino.

Alargan la existencia y la directiva se asegura seguir cobrando sus millonarios sueldos. Al menos el match ball lo han salvado de manera (si el acuerdo es bueno) satisfactoria.

Bueno, tampoco creo que esto descarte un partnership potente en el futuro. Al menos así lo veo yo.
Y que va a hacer más diluciones es algo que tengo claro desde el anuncio de la Fase 3 del RSV.
Creo que, ahora mismo, alejar la posibilidad de declarar la bancarrota o de una OPA a precio de saldo es en si mismo una extraordinaria noticia para quienes estamos comprados.

Quiero decir que es de lo mejor que pueden conseguir ahora dada su posición de debilidad. Un partnership para el RSV supondría casi regalarlo en estos momentos.

No, en el futuro no. Pero lo aleja bastante en el corto plazo. Yo esperaba quizás para la gripe, pero tener el AA les baja mucho los costes.

Necesitan a Gates y distribuir la vacuna del rsv en algún país a poco más de precio de coste para que les dé 1 año de margen.

Parece que las cosas van según plan. Como comenté desde hace tiempo, la AA, es lo único que confiaba, el rsv, lo desechaba. Es un gran paso, para la superviviencia de la empresa.   Esto va según plan. 

para sobrevivir, tienen que diluir y mucho. Según los calculos que subí hace tiempo, tienen que diluir casi 10 millones de acciones. Y ahora tenían 23.3millones. Casi nada....

Sin partner sí. Aunque ahora los gastos se reducirán mucho.

Desde luego si quieren hacer otro estudio de RSV solos la dilución tiene que ser muy muy grande.

Hacer otra fase 3 de RSV en USA puede durar varios años.

Confiaran en q con los resultados de los países donde se apruebe la vacuna (esperemos q con Europa incluida) la FDA admita la aprobación con su fase IV propia, pero hacer otra fase 3 en USA es una locura