Farmas USA

8.9\22

NVAX

Menudos ludópatas estamos hechos...

Yo digo 7'25/18'50, eso mismo.

NVAX
Finales de junio 7,35
Fase 3 17,50

6.27 / 10.12

NVAX

Bioinvest . MTSL #829

http://www.bioinvest.com/wp-content/uploads/2016/06/MTSL-Issue-829.pdf

ACAD, ALKS, FPRX, INCY, IONS, XON, MDCO, NVAX, SGMO, ZIOP

NVAX – Further Differentiated Seasonal Combination Respiratory Vaccine Program; TidBits From The MTSL NVAX Access-To-Management Call

NVAX announced that their influenza vaccine technology will switch from the virus-like particles (VLPs) to the same core technology as the RSV vaccine – which is based on nanoparticles. The nanoparticle design builds on advances achieved with the RSV F Vaccine (and the Company’s Ebola and MERS vaccines), which has delivered the first-ever positive RSV immunity and broad protection against multiple strains. The decision to switch is based on internal proprietary research that resulted in an even-more differentiated flu vaccine. Supportive data was presented last week at a New Approaches to Vaccines for Human and Veterinary Tropical Diseases Keystone Symposia in Cape Town, South Africa. Data included in the presentation demonstrate Novavax’ progress in developing seasonal influenza nanoparticles that are protective in a ferret influenza challenge model when combined with their proprietary adjuvant, Matrix-M™. The vaccine candidate is based on a hemagglutinin (HA) nanoparticle and elicited broadly neutralizing antibodies to all three types of influenza viruses: A(H3N2), A(H1N1), and B, with specificity to both contemporary and historical influenza strains.

NVAX has identified several advantages, representing an evolution in vaccinology that have guided their strategic approach:

• Influenza nanoparticles are engineered to display conserved antigenic regions, which elicit broadly neutralizing antibodies (see Exhibit 1)
• Improved manufacturing yields
• Use of Matrix M adjuvant, which has been shown to be well-tolerated and highly effective at stimulating enhanced immunity

As with the RSV vaccine that has changed the landscape to identify conserved epitopes, the NVAX HA nanoparticle has shown broad neutralizing antibodies across different strains of flu. The result is a better flu vaccine. Furthermore, the newversion has more synergy with the NP RSV vaccine (e.g., equal pH etc) – which results in an ideal combination for a flu/RSV vaccine. Phase I trials of the combo are expected to begin in Q1:17. In our view, this further differentiates the flu vaccine alone and even more so with the RSV/vaccine combo. Potential partners are now aware of the NP influenza program. Also, the BARDA contract will end on time in September; it was very narrowly focused on VLPs for flu – and NVAX’s move to NP from VLPs is outside of the current contract – they may seek a new contract but it is too early to say. The Company has a strong relationship with the agency, but most importantly, NVAX can move aggressively on their own.

Update FromOur Webcast – On June 3, we held a webcast with MTSL subscribers and the senior management of NVAX. A replay is available on our website at http://www.bioinvest.com/access-to-management-conference-call-with-novavax-nvax-6-3-16/. The key near-termevent is the unblinding of the Phase III RESOLVE trial of the RSV vaccine in the elderly due in Q3:16 ( https://clinicaltrials.gov/ct2/show/NCT02608502?term=Novavax+RSV&rank=3  ). The 11,850 subject study mirrors the same endpoints as in the successful Phase II 1,600 patient trial. The database has been locked. The incidence of the recent RSV season is in line with the previous ~5 seasons and that is what the trial size/design is based upon. In fact, NVAX added an extra ~2,000 last year for increased power, but still enrolled the study well ahead of schedule.

While we are not going over the entire webcast, we suggest subscribers listen to the replay. Our takeaway message is that Novavax management is very experienced in launching both vaccines and RSV drugs (e.g., Synagis) and has applied this experience – supported by a Big Pharma/Bio-type budget – to the RSV vaccine. Very few companies have executed at such a high level as Novavax has on the RSV vaccine. In our view, investors are just becoming aware of how large the vaccine candidate can be. Discussions with partners are underway for an ex-US collaboration. (However, we know that once companies begin regional/ex-US talks of a near-term blockbuster, discussions often veer to a worldwide deal and/or possibly a takeover. In our view, this is the market we are now in.) For quite some time, we believed that with the right execution and an ACIP recommendation, a multi-billion vaccine opportunity is close by. The call continued to confirm that belief.

Commercial SVP John Trezzino reviewed the global market size and the dynamics of launching a new vaccine with payors, government agencies and insurance companies. The most cost-effect health care in the world is #1 – clean water and #2 – vaccines, so we believe the Company will face little opposition to gaining global recommendations to prevent the major cause of all lower respiratory infections (ALRI) in older adults and children worldwide . The Company expects to price the RSV vaccine somewhere between the price of a highdose flu vaccine ($38 Fluzone) and Prevnar ($178 per). (Think about this compared to a price of a new cancer drug.)

Management is currently guiding the launch of the vaccine for the 2018/2019 RSV season. However, with the recent FDA Fast Track designation and the fact that ACIP meets three times a year including February, in our view, there is a chance that approval/launch can occur by next Fall. While we are not factoring that into our price target, our history with the NVAX management team since 2013 is one of underpromise and overdeliver. We remain optimistic on the outcome.

Como casi siempre me pasa me identifico con el modo de trabajar y valorar de esta gente.
(Bueno os confieso que esos informes se los escribo yo desde hace meses. Jiijijiji😂😂😂😂

Aquí la traducción de cosas importantes.

NVAX
In our view, investors are just becoming aware of how large the vaccine candidate can be. Discussions with partners are underway for an ex-US collaboration. (However, we know that once companies begin regional/ex-US talks of a near-term blockbuster, discussions often veer to a worldwide deal and/or possibly a takeover. In our view, this is the market we are now in.) For quite some time, we believed that with the right execution and an ACIP recommendation, a multi-billion vaccine opportunity is close by. The call continued to confirm that belief.

Desde nuestro punto de vista los inversores están empezando a darse cuenta de lo grande (potencial económico) que puede ser la vacuna candidata del RSV F.

Las negociaciones con posibles Partners están en marcha para buscar un socio para fuera de USA. (Sin embargo ya sabemos que estas negociaciones para acuerdos regionales para un Blockbuster suelen conducir a acuerdos globales e incluso Opas)

Desde hace tiempo hemos creído que la correcta ejecución (por parte de Novavax) y la recomendación de ACIP convierten a la vacuna RSV en una oportunidad única con un potencial billonario y la conferencia con la directiva de Novavax confirma esa creencia.

Commercial SVP John Trezzino reviewed the global market size and the dynamics of launching a new vaccine with payors, government agencies and insurance companies. The most cost-effect health care in the world is #1 – clean water and #2 – vaccines, so we believe the Company will face little opposition to gaining global recommendations to prevent the major cause of all lower respiratory infections (ALRI) in older adults and children worldwide . The Company expects to price the RSV vaccine somewhere between the price of a high- dose flu vaccine ($38 Fluzone) and Prevnar ($178 per). (Think about this compared to a price of a new cancer drug.)

El Vicepresidente Senior de Operaciones Comerciales, John Trizzino revisó el tamaño del mercado global y la dinámica de lanzamiento de una nueva vacuna por los pagadores, las agencias gubernamentales y las compañías aseguradoras. El mejor sistema de protección de la salud en base al costo/efecto es:
1 El agua limpia
2 Las Vacunas
Así que creemos que la compañía tendrá poca oposición a la hora de obtener recomendaciones globales para la prevención de la mayor causa de infecciones respiratorias de las vías bajas en personas mayores y niños en el mundo.
La compañía espera que el precio para su vacuna este entre el precio de una dosis alta de vacuna de la Gripe, los 38$ del Fluzone (de la que hablamos hace unas semanas) y los 178$ del Prevnar. Hay que pensar en este precio en comparación al precio de un nuevo fármaco contra el Cancer.

Con cosas así, es difícil no creer que lo mejor está por llegar. No creéis??
Feliz domingo!!!

7,13/14,92 es mi apuesta. Saludos

Triskis, cambio mi porra

7$ / 20,82$ 

NVAX