Seen this size of blocks on a lot of stocks when triple witching day.
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.
Novavax announced new plans to develop a nanoparticle influenza + RSV combo vaccine to begin Phase I/II studies in 2017. We view this revamp of an antiquated VLP flu vaccine program as a positive that will be easier to co-formulate and offer product line extension of the company's leading RSV vaccine as competition comes to market. Novavax remains our Top Pick ahead of Phase III RSV vaccine data in 3Q:16 with a BLA filing next year. The RSV vaccine recently received Fast Track designation from the FDA and Novavax will likely seek priority review with first projected sales in 2018. We reiterate our Overweight rating and $14 target.
New Flu+RSV Combo Vaccine Plans. Novavax is now developing a nanoparticle influenza + RSV vaccine. Novavax presented preclinical data from the new program at the Keystone Symposium on Vaccines last week in South Africa. Both the RSVF vaccine and the new quadrivalent flu nanoparticle vaccine induce robust antibody production. Importantly, combining the vaccines produced similarly high levels of antibody across antigens, demonstrating that broad based, multi-pathogen protection could be achieved with a single vaccine. The multi-valent nanoparticle combo vaccine will be easier to co-formulate and offer product line extension of the company's leading RSV vaccine as competition comes to market. Novavax expects to begin Phase I/ II studies in 2017. The new flu+RSV combo vaccine will no longer fall under the current BARDA contract, so we are reducing near-term revenues, which will primarily be derived from the Gates Foundation grant to support the Phase III PREPARE maternal immunization trial.
Phase III RSV Data in 3Q:16. Novavax immunized 11,850 elderly subjects in the Phase III RESOLVE trial and expects to report top-line data in 3Q:16. We expect Novavax to file a BLA in 2017. The RSV vaccine has received Fast Track designation for both elderly and maternal immunization and Novavax will likely seek elderly priority review.
Sentiment: Strong Buy
Following the recent announcement that the company is shifting to a nanoparticle approach for seasonal flu, we are updating our model. Specifically, we are pushing out the potential approval for a seasonal flu vaccine to 2023 from 2020 and lowering our probability of success to 25% from 50%. That said, we see limited impact to near-ter m expenses as we believe the advancement of the nanoparticle based vaccine was already planned. Bigger picture, we see minimal value reflected for flu in the current stock price. RSV remains the key value driver and in our view near-ter m stock performance hinges on the success of the phase III Resolve study for the RSV vaccine in elder ly subjects where we see a good probability of success.
Investment Thesis, Valuation and Risks -
Novavax (Overweight; Price Target: $11.00)
We rate NVAX shares Overweight based on what we see as a good probability of success for the respiratory syncytial virus (RSV) vaccine program in elderly patients. This view is based on the recently reported phase II data. We expect top-line results from this study in 3Q/16 which represent the key catalyst for the company.
Maintaining our Dec 2016 price target of $11. Our valuation is based on a DCF using our explicit forecasts through 2031 and assumes a probability of success of 70% in elderly RSV, 60% in material immunization, and 55% in pediatric RSV and 25% (previously 50%) in US influenza sales. We use a 9% WACC and 1% terminal growth rate.
Risks to Rating and Price Target
NVAX is susceptible to the standard risks that apply to the entire biotech industry, including development, regulatory, commercial, manufacturing, financing, and IP pitfalls. More specific risks to the downside include clinical setbacks (particularly for the RSV program) and competition from other companies looking to develop an RSV vaccine.
Sentiment: Strong Buy
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Respiratory Syncytial Virus Infections- Market Insights, Epidemiology and Market Forecast-2020
Report Code : dimfr2016004 | Publisher : Delveinsight
Published Date : 01 May, 2016 | No of Pages: 70
Report DescriptionTable of ContentsCompanies MentionedRelated Reports
The Respiratory Syncytial Virus Infections- Market Insights, Epidemiology and Market Forecast-2020 report provides an overview of the disease, epidemiology and global market trends for the seven major markets ie: United States, EU5 (France, Germany, Italy, Spain, UK) and middle east countries (Jordan, Saudi Arabia, Kuwait, Oman, UAE, Tunisia, Turkey, Egypt, Lebanon and Qatar). According to DelveInsight, the market for preventive therapies to treat RSV Infections will experience modest annual growth over the 2010-2020 forecast period, as market size increase from $148.9 million to 777.49 million in European five countries.
Respiratory syncytial virus (RSV) is a virus that causes infections of the lungs and respiratory tract. It's so common that most children have been infected with the virus by age 2.RSV can cause upper respiratory infections (such as cold, fever and otitis media) and lower respiratory tract infections (such as pneumonia, bronchiolitis, tracheobronchitis). RSV also affects adults and can also become serious in older adult with heart and lung diseases, or anyone with a very weak immune system (immune compromised).
Key Coverage and Benefits:
• The report will help in developing business strategies by understanding the trends shaping and driving the global Respiratory Syncytial Virus Infections
• Identifying patient populations in the global Respiratory Syncytial Virus Infections market to improve product design, pricing, and launch plans.
• Organize sales and marketing efforts by identifying the best opportunities for Respiratory Syncytial Virus Infections therapeutics in each of the markets covered.
• To understand the future market competition in the global Respiratory Syncytial Virus Infections therapeutics market and Insightful review of the key market drivers and barriers.
Scope of the Report:
• Report covers the disease overview including etiology, pathophysiology, symptoms, diagnosis, disease management, and current treatment options.
• Marketed information including available prescription drugs, its patent and exclusivity details followed by drug sales till 2018.
• The Report also covers the detailed global historical and forecasted epidemiological data covering United States, EU5, Middle Eastern Countries and rest of the word from 2010-2020.
• It also provides Market size of Respiratory syncytial virus (RSV) for United States, EU5, Middle Eastern Countries from 2010 and forecasted Market size to 2020
Sentiment: Strong Buy
Novavax, Inc. (NASDAQ:NVAX) has announced plans to develop a nanoparticle influenza and Respiratory syncytial virus (RSV) combo, for which it will start the Phase I/II studies in calendar year 2017 (CY17). Piper Jaffray believes that the company’s Virus-Like-Particles (VLP) flu vaccine program will prove to be beneficial, as it will be easy to co-formulate and offer a product line extension to the RSV vaccine in the competitive space.
While the Food and Drug Administration (FDA) has recently granted a Fast Track designation to the company’s RSV vaccine, Novavax looks to receive a priority review in time with the first projected sales in CY18. It submitted pre-clinical data from the new program at the keystone Symposium on Vaccines, held in South Africa last week.
The RSVF vaccine and the new quadrivalent flu nanoparticle vaccine encourage strong antibody production. More importantly, the vaccines’ combination produced high levels of antibody antigens, which displayed that multi-pathogen production could be attainable with a single vaccine.
The firm believes that the RSV vaccine for elderly patients is set to enter the market in CY18, priced at $50, while the combo is likely to replace the vaccine in CY22, at an estimated price of $75. FY22 sales are forecasted to be $2.76 billion, based on an assumption of 50% and 15% penetration in the elderly & pediatric and maternal vaccination markets, respectively. Piper Jaffray values the combined RSV/flu program at $4.04 billion, through the application of 5x multiple to these revenues, discounted back at 25%.
As per the sell-side firms, the vaccines may fail to gain approval from the regulatory authorities. Moreover, the Biomedical Advanced Research and Development Authority (BARDA) agreement may weaken, and the company may need additional funds. The firm maintained its Overweight rating on NVAX stock, along with a $14 price objective
Sentiment: Strong Buy
Shorts and bashers are very busy here lately, don't you think?
They are increasing the frequency of their messages.
Always the same messages, the same phrases repeated over and over again.
But at this point, everyone here knows what is true and what is not true, what can happen and what can not happen ...
... and what is happening is some guys are running out of time.
Look at the volume on the rise. Q3 is coming ...
Sentiment: Strong Buy
Very simple. They will release interim data this June.
1.- If data is awesome, trial will be stopped and company will receive an approval recommendation.
2.- if data is ok, trial continues until the end, 2018.
3.- if data is bad, trial canceled. Game over.
More likely, option 2.
Well, bballgm, many will take it as negative because it is a negative scenario, like starting from scratch. One step back in order to continue the program, yes, but one big step back at first sight.
Novavax's RSV F Vaccine has received Fast Track designation from the FDA in the elderly. This could accelerate review of the BLA next year and set up approval for the 2017/'18 RSV season. We expect Phase III RESOLVE data in 3Q:16. Novavax remains our top pick for 2016 for elderly RSV data. We reiterate our Overweight rating and $14 target.
• RSV F Gets Fast Track in Elderly. This morning, Novavax announced Fast Track designation for RSV F Vaccine in the elderly. This designation is a clear positive as it could accelerate review of the BLA next year, gaining approval for the 2017/'18 RSV season. The RSV vaccine also has Fast Track designation for protection of infants via maternal immunization.
• NVAX Phase III Data in 3Q:16. Novavax immunized 11,850 elderly subjects in the Phase III RESOLVE trial. The company believes this RSV season is comparable to last year and remains on track to report pivotal data by the end of 3Q:16 with a BLA filing in 2017. Importantly, Novavax also expects to report repeat vaccination data from the Phase II rollover study in elderly subjects, which could facilitate ACIP vaccine recommendation and support reimbursement on launch. Novavax intends to sell the RSV-F vaccine in the U.S. and has received significant overseas partnering interest. We currently forecast peak RSV vaccine sales of $1.2B by 2022.
Sentiment: Strong Buy
I think BARDA contract expires by September so I hope we get some news before that. I wouldn't like to wait until Sep with news pending about Ph3 Elderly and BARDA. Too much in just one month, to much stress for my hearth. LOL
Sentiment: Strong Buy
hello, I think this was not posted before. This time I couldn't get the full doc, I just got three pages of the report.
I hope you can see these 3 links
Sentiment: Strong Buy