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Current Swine Flu News Concentrator July 30, 2011 To June 13, 2012. 164 comments
Explanation:
I will post Swine-Flu and related articles under this heading. The top of the instablog will contain my current months key links preceded with a one or two liner that explains the link. A more complete summary of the link will be in the comments area. At the bottom of the Instablog we have definition of terms, a summary of Swine Flu / vaccine investment plays, the 2009 H1N1 Flu Outbreak Map, Red Cross Tips For Dealing With The Flu, and Memory Alpha which contains links to previous news concentrators and authors articles on the subject.
_____________________
Update History:
Added definition of Reassortment
Added definiton of R0 (R Naught)
Added Overview of H1N1 / Categories of Vaccine Investment Plays Added Memory Alpha
Added Link to Google's Swine Flu Infection Map
Added Red Cross Tips for Dealing With The Flu
Added definition of EUA and PREP act
Broke Swine Flu Concentrator into two parts for October
Broke Swine Flu Concentrator into three parts for October
Added Swine Flu Concentrator November Part 1
Bolded References to Older Swine Flu Concentrators in Memory Alpha
Expanded the list of stocks discussed in the tags
Alphabetized stocks in the tags
Updated the play by stock list
Added a table that contains the web site addresses for the companies discussed
Moved links over one month old to the new Memory Alpha Reference Library
Added definitions of Clinical Trials and Protocol.
Corrected Roche stock symbol in the web site table
_____________________
Last Swine Flu News Concentrator Links:
Swine Flu News Concentrator May 12, 2011 to July 29, 2011 tinyurl.com/3m7hcfp
Swine Flu News Concentrator March 22, 2011 to May 12, 2011
tinyurl.com/3hgogm4
Swine Flu News Concentrator February 20, 2011 to March 22, 2011
tinyurl.com/4unv2hy
Swine Flu News Concentrator January 28, 2011 to February 20, 2011
tinyurl.com/4u9nlrz
Swine Flu News Concentrator January 11, 2011 to January 28, 2011
tinyurl.com/4maxxdv
Swine Flu News Concentrator December 18 (2010) to January 11, 2011
tinyurl.com/4gs9xzl
Swine Flu News Concentrator November 11 (2010) to December 18, 2010
tinyurl.com/22pykd8
Swine Flu News Concentrator September 23 to November 11 (2010)
tinyurl.com/29eflnpJ
Swine Flu News Concentrator June 14 to September 23 (2010)
http://tinyurl.com/294bzc6
Swine Flu News Concentrator April 8 to June 14
tinyurl.com/25lqvfx
Swine Flu News Concentrator (March 13 - April 8)
tinyurl.com/y8w7mgy
Swine Flu News Concentrator (February 12 - March 13)
tinyurl.com/ykba7dl
Swine Flu News Concentrator January 25 to February 12
http://preview.tinyurl.com/yjccho4
___________________
Some Definitions:
What is Reassortment
When two different virus strains infect the same host, they often exchange genes, a process known as reassortment.
A significant number of experts are concerned that as H5N1 (Avian Flu) spreads more widely and infects more people, it will come across more hosts who are also carrying human flu viruses. This increases the likelihood of a new strain emerging that has the severity of the bird flu virus and the infection rate of the swine flu virus, leading to a new global pandemic with much deadlier consequences than the one we are experiencing at the moment.
What is R naught (R 0)
How many people the average infected person infects is called the basic reproductive number, or R0 (pronounced "R naught").
Measles, which is probably mankind's most contagious infection, has an R0 of about 18. Polio's number is about 6; severe acute respiratory syndrome (SARS) about 5. For seasonal flu strains, the R0 is about 1.2, and for pandemic strains it is rarely higher than 2. For the novel H1N1 strain, it's about 1.6. What this low R0 means is that flu outbreaks are always teetering on the verge of having their myriad chains of transmission broken by people who get infected but don't pass the virus to anyone else.
Swine Flu - Novel H1N1 flu, popularly known as swine flu, is a respiratory infection caused by an influenza virus first recognized in spring 2009. The new virus, which is officially called swine influenza A (H1N1), contains genetic material from human, swine and avian flu viruses. (By Mayo Clinic staff)
Pandemic - The word "pandemic" comes from the Greek "pan-", "all" + "demos", "people or population" = "pandemos" = "all the people." A pandemic affects all (nearly all) of the people.
A World Health Organization phase 6 pandemic indicates that influenza due to the novel H1N1 swine flu is occurring in multiple countries around the world and that human infection is widespread. The classification does not reflect the severity of individual infections.
Cytokine Storm -
When our body detects foreign micro-organisms indicating an infection, our body might respond by over-protecting the site of infection. The body may race so many antibodies to the infection site that they collect in what is known as a cytokine storm.
A cytokine storm, or "Hypercytokinemia" is a potentially fatal immune reaction consisting of a positive feedback loop between cytokines and immune cells.
www.wisegeek.com/what-is-the-cytokine-st...
A positive feedback loop means that as something increases, that increase stimulates further growth.
What makes younger people more susceptible to H1N1 is that their "vigorous immune systems pour out antibodies to attack the new virus. That can inflame lung cells until they leak fluid, which can overwhelm the lungs.
This vulnerability in the young is reminiscent of the Spanish flu of 1918. That strain of flu also struck mostly healthy young adults.
Pulmonary Embolism - Occurs when a blood clot forms in an arm or leg breaks free and enters the lungs where it is too large to pass through the small vessels of the lungs and forms a blockage. This stops blood from flowing into an area of the lung, and the part of the lung dies because it does not receive oxygen.
medicalnewstoday.com/articles/153796.php
What is an Emergency Use Authorization (EUA)?
An EUA may be issued by the Food and Drug Administration (FDA) to allow either the use of an unapproved medical product or an unapproved use of an approved medical product during certain types of emergencies with specified agents.
What is the PREP Act?
The PREP Act authorizes the Secretary of the Department of Health and Human Services ("Secretary") to issue a declaration ("PREP Act declaration") that provides immunity from tort liability (except for willfull misconduct) for claims of loss caused, arising out of, relating to, or resulting from administration or use of countermeasures to diseases, threats and conditions determined by the Secretary to constitute a present, or credible risk of a future public health emergency to entities and individuals involved in the development, manufacture, testing, distribution, administration, and use of such countermeasures.
The PREP Act also authorizes an emergency fund in the United States Treasury to provide compensation for injuries directly caused by administration or use of a countermeasure covered by the Secretary's declaration. While no funds have been appropriated for this purpose, if funds are appropriated, compensation may then be available for medical benefits, lost wages and death benefits to individuals for specified injuries.
cdc.gov/h1n1flu/eua/qa.htm
What are Clinical Trials:
Clinical trials, also known as clinical studies, are research studies in which scientists and doctors test new drugs and treatments to see if they will improve health. Many of today's treatments for cancer are based on the results of past clinical trials. Because of progress made through clinical trials, many people treated for cancer are now living longer.
Clinical trials are divided into four phases.
Phase 1 trials: These trials are the first time a new drug or treatment is given to humans. They are normally carried out in a small number of volunteers (typically 6-20 people) who may include healthy volunteers or patients with the disease for which the product is intended as a treatment in order to find out how safe the treatment is. They also look at how a new drug should be given (by mouth, injected into muscle or the bloodstream, etc.), how often and at what dose. Phase 1 trials can also involve patients for whom standard therapies have failed and for whom no other therapies are available.
Phase 2 trials: These trials involve larger numbers of people (typically 12 - 50). Phase 2 trials continue to look at safety of the therapy but also test how well the new drug or treatment works in patients with different disease types.
Phase 3 trials: These are large studies (100+ people) that look at how well a new drug or treatment works in comparison to current therapies to see which treatment is better. Those taking part are usually divided into two treatment groups: standard treatment versus new treatment.
Phase 4 trials: These trials are usually carried out after the drug or treatment has been approved by the FDA and is readily available for use in the general patient population. The purpose of Phase 4 trials is to continue to study the effects of the drug or treatment on different populations and to look for side effects associated with long-term use.
Back to Top
What is a Protocol:
Clinical trials use written guidelines called protocols. The protocol explains what the trial hopes to accomplish, how the trial will be carried out, and why each part of the trial is necessary. For example, the protocol includes:
* The reason for doing the trial
* How many people will be in the trial
* Who is eligible to take part in the trial
* What study drugs participants will need to take
* What medical tests participants will have and how often
* What information will be gathered
Every doctor or research center that takes part in the trial uses the same protocol. This makes sure that patients are treated identically no matter where they are receiving treatment, and that information from all the centers taking part can be combined and compared.
Why Slow Production for Traditionally Produced (chicken eggs) Swine Flu Vaccine:
One dose of swine flu vaccine for every two eggs, compared with two doses of
seasonal flu vaccine per egg
Sorry if the link does not work... it appears the Boston Globe newspaper appears to be playing games with link addresses... Just copy the link, and Google it.
http://www.boston.com/business/healthcare/articles/2009/10/22/quest_for_swine_flu_vaccine_giving_some_firms_a_boost/
_____________________
Brief Overview of Categories of H1N1/ Vaccine Investment Plays:
I - Vaccines / Prevention
1) Production Method / Capacity plays (NVAX) (VICL) (NVS) (INO)
2) Nationalistic / Population Size Play (SVA - China) (NVAX - India)
3) Injection / Vaccine support services (syringes etc.) (BAX) (BDX)
4) Outsourced production plays
5) Bio -Defence (MDCGF - France)
6) Anti-Mutation / Pan-Influenza Play (CVM) (NNVC) (INO)
7) Universal Flu Vaccine Play (INO)
II - Treatment After Infection Occurs:
1) Dealing with severe lung infections (Fludase® (DAS181)) (CBM) (AEMD)
2) ICU treatments (BCRX) (GSK) (ROG)
III - Population Avoidance:
1) masks/ disinfectants… Surgical masks are good enough (APT) (MMM) (CLX) (ECL) (PURE)
IV - Testing do you have it? (GPRO)
1) Test kits - (DGX)
V - Merger / Acquisitions / Licensing (VICL) (NVAX)
_____________________
Sorry this is still a graphic instead of a table. I played with the table tool, but its a
PITA to work with.
Swine Flu Companies Discussed and Their Web Sites
_____________________
Swine Flu Hits Stuffed Animal World:
2011 H1N1 US Flu Outbreak Map:
Here is a link that gives information by US states. The Link is from DoubleGuns
tinyurl.com/6khyjq
___________________
Red Cross Tips For Dealing With The Flu:
IF YOU ARE ILL -
* Stay in a room separate from common areas of the home and avoid contact with others as much as possible.
* Stay at home for at least 24 hours after their fever is gone without using medicine to reduce the fever.
* Get lots of rest and drink plenty of fluids.
* Consider wearing a facemask, if available and tolerable, when sharing common spaces with household members. (ed - surgical masks ok).
* Check with your healthcare provider about whether to take antiviral medication, or if fever persists, whether antibiotics are needed.
WHEN CARING FOR SOMEONE WHO HAS THE FLU -
*Disinfect door knobs, switches, handles, toys and other surfaces that everyone touches.
* Use detergent and very hot water to do dishes and wash clothes. It's okay to wash everyone's dishes and clothes together. Wash your hands after handling dirty laundry.
* Designate only one adult as the caregiver. People at increased risk of severe illness from the flu should not be caregivers.
* Although not mentioned by the Red Cross, the caregiver should probably ware a surgical mask as well when entering the sick room.
* Deal with crisis situations calmly and confidently to give the best support to the person being cared for.
_____________________
MayoClinic.com Provides Credible, Up-to-Date Information And Decision-Support Tools For Flu Season
Click here to link to the Mayo tool:
www.mayoclinic.com/health/flu-symptoms/F...
_____________________
Suggeted Protocol For Schools To Decide When Flu Should Trigger A Shutdown
www.medicalnewstoday.com/articles/169984.php
After comparing more than two dozen possible scenarios for closing a school, the analysis suggested three optimal scenarios:
1. A single-day influenza-related absentee rate of 5 percent
2. Absenteeism of 4 percent or more on two consecutive days
3. Absenteeism of 3 percent or more on three consecutive days
Disclosure: (sometimes trading, sometimes holding)
Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.
Instablogs are blogs which are instantly set up and networked within the Seeking Alpha community. Instablog posts are not selected, edited or screened by Seeking Alpha editors, in contrast to contributors' articles.
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This post has 164 comments:
Novavax to Report Second Quarter 2011 Financial Results on August 5, 2011
"... Friday, August 5, 2011, before the U.S. financial markets open".
"webcast and conference call hosted ... at 10:00 a.m. Eastern time".
"...available at www.novavax.com under Investors/Events. The dial-in number for the conference call is 1-877-212-6076 (domestic) or 1-707-287-9331 (international)".
This gets you to the IR events page.
www.novavax.com/go.cfm...
PR here.
globenewswire.com/news...
HardToLove
7/25 position opened and closed today. Cost basis even lower now - maybe I should re-calculate over the life of my holding and see what it really is?
HardToLove
"... antibody responses to the vaccine fulfilled the immunogenicity criteria that are required to be considered for accelerated approval of seasonal and pandemic influenza vaccines by the US FDA Center for Biologics Evaluation and Research. These criteria were met at all dose levels after a single injection, including the lowest dose of 5 micrograms. Single administrations of the VLP vaccine induced high levels of HAI titers in subjects without pre-existing detectable immunity to the pandemic strain. Overall, the data indicated that Novavax's H1N1 VLP vaccine was well-tolerated and immunogenic".
More details and commentary:
globenewswire.com/news...
HardToLove
HardToLove
and earnings, -$0.04 vs. estimates of -$0.08.
PR for the release globenewswire.com/news...
HardToLove
They have a whole new administration in place.
They are working with Cadilla on a rabies vaccine.
They are working on flu and adjuvants ( I think he said adjuvants, I got a little distracted because I was placing orders on other stocks and my multi-tasking is severely diminished).
It wasn't a very exciting conference call. Maybe now that they have a new team in place things will come together. Did anyone else listen to it?
The things you mention are all nothing new.
The BARDA paymets were going to be their major revenue maker near-term. Supposedly the official release of the Mexico results are supposed to make progress with FDA licensing go more quickly now.
Don't forget they have the RSV thing going as well - no current vaccine for that. That would be a game changer.
The chatter when the management change took place was all about their experience in selling companies. If there's a major gain in any of the areas that provides a potential revenue stream a sale might seem attractive to some buyer.
I'll check back when I've listened to the CC later today.
HardToLove
The company also has to fight the fact that urgency for product is sporadic, occurring only when the sky is falling during flu seasons, and so the administrative bodies see no need to "fast track", as they did in Mexico when the swine flu pandemic first appeared, once the "crises" is over.
Then it's back to plodding governmental procedures and response times. Look how long it took Mexico to publish results obtained over a year ago.
This is exactly why I have consistently shorted call options ever since owning Novavax. Ignoring the *paper* capital gains losses caused by market-only factors (well, company-induced dilution too) and collecting premiums while I await the rewards I expect will come has kept me feeling quite comfortable. I've not checked recently but I suspect my cost-basis is now somewhere under $1.50. After fees, I picked up another 12 cents/share in two weeks on this last round.
Of course, if pps keeps dropping, that will have to end.
Items for the conference call that I thought worth noting follow. They are substantially as you cited, with the exception of adding the RSV stuff. I've added a little detail.
There is *nothing* exciting because *everything* takes a long time *and* we already knew all of it. If one of the items was getting licensed in a month everybody would be all excited. But it doesn't work that way.
Back when the swine flu appeared and Mexico was "fast tracking" stuff, excitement was everywhere. But that stuff passes and it's *investors* with patience that eventually get rewarded.
------ CC NOTES --------
BARDA base period includes 3 year contract; budget is $97M which covers all expenses for programs plus fixed fee profits; NVAX plans to develop large seasonal flu phase III trial and H1N5 pandemic phase I and II trials, with and without adjuvant during this phase.
Monthly billing and receipts are occurring regularly and with a lag of billed work to receipt of monies of only 30-60 days due to a very good working relationship with BARDA.
The option period (the possible second part of the BARDA contract award) covers 2 years. Budgeted at ~$82M. Covers seasonal and pandemic flu through to filing with FDA for licensure.
[HTL] To *me*, this is a big deal. It says that the costs of these programs are paid for to the point of having FDA approval, at which time we will see the product marketed around the world as needed.[HTL]
The above contract provided a financial pathway that allowed building the team now in place, which includes late-stage clinical development and commercialization experience.
[HTL] This financial pathway did not exist before and was cause of a lot of dilution as the company had to raise funds to continue its efforts. We should see little or none of this now, especially since COH is sufficient for at least 12 months at projected burn rate.[HTL]
RSV vaccine: one of most important vaccines being developed. 75K-125K infant hospitalizations/year in this country. There is no vaccine currently. Entered clinical trials at beginning of year. During 2nd quarter (late May) completed dosing of last subject of dose-escalating trials in 150 subjects in 6 groups.
Rabies early-stage development w/CPLB demonstrated good performance on mouse trials (already known). Current vaccines require 4-5 doses, hard to make, often are in shortage. Needed is vaccine that's easy to make and needs only 2-3 doses, which is what is being developed by Novavax.
Upcoming: series of data points from the three programs coming over the next twelve months:
- By October interim top-line data on phase I RSV clinical trials which leads to design of future clinical studies;
- Later in Q4 initiate 1st new seasonal flu trial under BARDA contract, data from trial available late in H1 2012;
- H1 2012 pandemic trial begins and data available H2.
Financials generally exhibit improving cost management. $22.3M cash & equiv, vs. $31.7M YoY. [HTL]If management doesn't give themselves big bonuses and tons of stock options, we should be good.[HTL]
Good relationship with BARDA exhibited in prompt payments.
Q: R&D recognition - costs + profit fee reimbursable after money is spent. Gone very well so far. Lag of receipt is only 30-60 days.
Q: R&D expense this year - programs starting will increase R&D expense. As expense goes up, so does revenue (costs + profit fee) via the BARDA program.
Q: Cash burn - the $22.3M is good for at least 12 months.
Q: RSV phase II in time for next season? Not ready at that time.
HardToLove
www.cidrap.umn.edu/cid...
Press the link inside the link to read a fab article called
"Antibody Recognizes Many Strains of Flu Virus".
Since the 600 point plunge, I can understand your new picture of a sinking ship, but not one without the rats swimming away.
LOL! Rattie, tell me you are not going down with the ship!
CEO ERCK buys 50K, 8/8-8/10 $1.24.
VP Trizzion buys 20K, 8/9/11, $1.19.
CFO Driscoll buys 20K $1.18 8/9.
Dir. Douglas buys 50K 8/9 $1.20.
HardToLove
"... August 17, 2011 at 2:25pm at Le Parker Meridien, New York City. A live audio-only webcast link for the presentation can be accessed via the Company website at novavax.com under Investors/Events".
globenewswire.com/news...
HardToLove
Check the volume and price action starting yesterday!
Just 1 more penny and it closes the recent gap down and looks like it could go to at least $1.50.
Right now, $1.44 +10.77%.
If it does run, I can do some more options instead of selling!
HardToLove
Blew right through a resistance of $1.50 from 8/12 and the Fibonacci 38.2% re-trace of $1.52. Will exceed the 25-day moving average of 664,429 from last Friday.
Nice to see some enthusiasm.
Might be due to the expected early RSV results expected in October?
HardToLove
Some of the commenters don't like the stock, but the author, Theodore Cohen, does. Today, so does the market - $3.73 ATM, +15.79%. Volume already above the 25-day average.
From last Friday.
seekingalpha.com/artic...
HardToLove
Let's see if the normal "reversion to the mean" lets me rake some more premium this cycle or I miss a bunch of upside.
Regardless, I'll end up net-profit since I've sold calls so many times now.
HardToLove
Hard: You've "Stradivarius-ed'" this stock. Way better than I have.
NVAX is gold plated dudu.
Which is which?
www.nasdaq.com/asp/hol...
Shorts getting squeezed.
"NOVAVAX to Present at Stifel Nicolaus Healthcare Conference"
"... September 8, 2011 at 10:20am at the Four Seasons Hotel in Boston, Massachusetts. A live audio-only webcast link for the presentation can be accessed via the company website at novavax.com under Investors/Events".
globenewswire.com/news...
HardToLove
"NOVAVAX Announces Publication of Results From H5N1 Influenza Virus-Like Particle Vaccine Phase I/IIa Clinical Trial"
"... study of the company's H5N1 influenza virus-like particle (VLP) vaccine candidate that was conducted in 2008".
As we already know, it was safe, well-tolerated, produced good responses, etc.
globenewswire.com/news...
HardToLove
Novavax to Report Top-Line Results From Phase I Respiratory Syncytial Virus Vaccine Clinical Trial on October 3rd at 5th Vaccine and ISV Annual Global Conference
http://bit.ly/r8k1vy
HardToLove
- Well-tolerated with no systemic side-effect trends
- Highly immunogenic with an increase in anti-RSV antibodies in 100% of subjects in the highest-dose group
- Oral and poster presentations to be made at 5th Vaccine and ISV Annual Global Conference in Seattle
ROCKVILLE, Md., Oct. 3, 2011 (GLOBE NEWSWIRE) -- Novavax, Inc. (Nasdaq:NVAX) today announced positive top-line results from a Phase I clinical study of its respiratory syncytial virus (RSV) fusion (F) recombinant nanoparticle vaccine candidate. In a paper titled "Recombinant RSV F nanoparticle vaccine for respiratory disease: antigen characterization, preclinical efficacy and clinical evaluation," Gregory M. Glenn, M.D., Senior Vice President and Chief Medical Officer of Novavax, is presenting safety, immunogenicity and tolerability findings from this study in a poster and oral presentation today and tomorrow, respectively, at the 5th Vaccine and ISV Annual Global Conference in Seattle. In the United States, RSV is the most common cause of bronchiolitis and pneumonia in children under 1 year of age resulting in 90,000 to 147,000 hospitalizations in this age group. Additionally, 900,000 adult and elderly patients are hospitalized annually due to RSV infection in the United States and Europe.
Novavax initiated the blinded, placebo-controlled, dose-escalating Phase I trial in December 2010 to assess the safety and tolerability of aluminum phosphate-adjuvanted (adjuvant) and unadjuvanted formulations of its RSV vaccine candidate. A secondary objective of the study was to evaluate total and neutralizing anti-RSV antibody responses and assess the impact of the adjuvant. The study enrolled 150 healthy adults 18 to 49 years old who were allocated to six cohorts that included 4 dose levels of vaccine. The two highest dose levels were formulated with and without the adjuvant. Subjects were randomized to receive injections of vaccine or saline placebo in a 4:1 ratio on days 0 and 30. Immune responses were evaluated in blood samples taken on days 0, 30, and 60.
"The results from our first RSV in-human study are very encouraging and support expanded testing of this vaccine candidate to those most affected by RSV infection, infants and children, and adults age 65 and older," Dr. Glenn said. "Our findings from this Phase I trial are consistent with our preclinical results in relevant animal models, which indicated that our vaccine candidate was generally well-tolerated, highly immunogenic and produced functional antibodies that neutralized RSV. In the same preclinical studies, the vaccine was fully protective against live-virus challenge, indicating that such measures of immunity are associated with protection. RSV disease is a major unmet medical need and a priority target for vaccine developers, and the results from this trial represent an important step towards reaching the ultimate goal of a safe and effective vaccine."
In his presentations, Dr. Glenn is reporting that Novavax's RSV vaccine candidate was well-tolerated and highly immunogenic, inducing levels of functional immunity that could potentially correlate with protective immunity in future trials. The fusion (F) antigen used in the Novavax RSV vaccine candidate is common to all RSV strains. Antibodies against the F antigen are known to prevent RSV disease in premature infants using the injected monoclonal antibody Synagis® (palivizumab), the current standard of care for RSV prophylaxis in premature infants. The data seen in this trial indicate that the Novavax RSV vaccine candidate induces immunity similar to natural protective immunity, as well as induces responses against the specific molecular target of Synagis on the F protein. Together, these data suggest that the vaccine may hold promise for prevention of RSV illness.
The primary safety findings were local pain and tenderness at the site of injection, the majority of which were mild in nature with no dose-related increase observed. There were no observed vaccine-related serious adverse events or trends for related systemic side effects. The antibody response to the RSV F protein was significantly increased compared to placebo (p<0.001) in all groups and increased by 19 fold in the highest-dose group at day 60. A significant dose-response pattern was observed. High rates of seroconversion were seen at all doses including a rate of 100% at the highest-dose-adjuvant group. Plaque reduction neutralizing titers (PRNT) were also measured and were significantly higher (p<0.01) in all the vaccine groups containing adjuvant. Exploratory measures of the vaccine-generated immunity specific to the Synagis epitope on the RSV F protein indicated that the vaccine induced significant increases (p<0.0001) compared to placebo in all groups.
Stanley C. Erck, President and Chief Executive Officer of Novavax, stated: "I congratulate my colleagues and our clinical investigators on these impressive results which will allow us to continue to pursue the development of a vaccine to prevent RSV infection. There remains an urgent public health need for such a vaccine, as none exist today and current treatments for RSV are expensive, difficult to administer and of limited benefit. We believe our vaccine candidate shows great promise as a potential prophylactic against RSV lower respiratory tract illness. The clinical data from this trial now provides a pathway for us to aggressively move forward in studying this vaccine candidate in infants, young children and older adults who represent the populations most affected by RSV."
About Respiratory Syncytial Virus
RSV is the most important viral cause of lower respiratory tract infection in infants and children worldwide. The global disease burden is estimated at 64 million cases and 160,000 deaths every year. RSV is the most common cause of bronchiolitis (inflammation of the small airways in the lung) and pneumonia in children under 1 year of age in the United States. Each year, 90,000 to 147,000 children in this age group are hospitalized due to RSV infection. Almost all children will have had an RSV infection by their second birthday. When infants and children are exposed to RSV for the first time, 25% to 40% of them have signs or symptoms of bronchiolitis or pneumonia, and 0.5% to 2% will require hospitalization. Most children hospitalized for RSV infection are under 6 months of age. Additionally, wheezing illnesses caused by RSV, particularly those severe enough to lead to hospitalization, are associated with an increased risk of asthma at school age.
It is also estimated that more than 8.5 million adults, including the elderly over age 65 years, are infected and 900,000 patients are hospitalized annually due to RSV infection in the United States and major European countries. In the United States alone there are 177,500 hospitalizations among high-risk adults resulting in annual medical costs exceeding $1 billion. There is currently no approved vaccine for the prevention of RSV.
About Novavax
Novavax, Inc. (Nasdaq:NVAX) is a clinical-stage biopharmaceutical company creating novel vaccines to address a broad range of infectious diseases worldwide. Using innovative virus-like particle (VLP) and recombinant nanoparticle technology, as well as new and efficient manufacturing approaches, the company produces potent vaccine candidates to combat diseases, with the goal of allowing countries to better prepare for and more effectively respond to rapidly spreading infections. Novavax is committed to using its technology platforms to create geographic-specific vaccine solutions and is therefore involved in several international partnerships, including collaborations with Cadila Pharmaceuticals of India and LG Life Sciences of Korea. Together, these companies have worldwide commercialization capacity and the global reach to create real and lasting change in the biopharmaceutical field. Additional information about Novavax is available on the company's website: http://www.novavax.com.
Forward Looking Statements
Statements herein relating to the future of Novavax and its ongoing development of its vaccine candidates, including statements related to clinical results, are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include those identified under the heading "Risk Factors" in the Novavax Annual Report on Form 10-K for the year ended December 31, 2010, and filed with the Securities and Exchange Commission. We caution investors not to place considerable reliance on the forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at http://www.sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.
Synagis® is a registered trademark of MedImmune, LLC.
CONTACT: Frederick W. Driscoll
VP, Chief Financial Officer and Treasurer
Novavax, Inc.
240-268-2000
... $1.3 million ...
... will use these funds over the next two and a half years to develop a Novavax recombinant VLP-based vaccine ...
http://bit.ly/ndxGYO
HardToLove
How that would relate to a grant for vaccine ...
LoL! I just got it! A good one!
I better go get some coffee - only had one cup so far, normally I'm around 5 by now!
You had me really snookered there!
HardToLove
"NOVAVAX Announces Conference Call to Discuss Results From Phase I Trial of Respiratory Syncytial Virus Vaccine Candidate"
"... conference call for invited analysts and institutional investors on October 13, 2011 at 10:30 am ET to review the recent top-line results from a Phase I clinical trial of its respiratory syncytial virus (RSV) fusion (F) recombinant nanoparticle vaccine candidate".
"... The conference call will be accessible on Novavax's website at http://www.novavax.com under the "Investor Info/Events" tab or by telephone at 1 (877) 212-6076 (domestic) or 1 (707) 287-9331 (international). A replay of the webcast will be available".
http://bit.ly/p9hcpW
HardToLove
It's just the way of biopharma, AFAICT, to start with, and then we change management to a team that supposedly has all this great background and still no great news many months later.
If I hadn't been taking options profits, I probably wouldn't have lasted this long.
But I still believe the technology will pay off and management and events will eventually reward me.
I just have to outlast the headwinds until things start to fall in place. As long as I can make some premium it's not "dead money", so I'm OK with that part of it.
Sometime late this week or early next, it's probably time to short some more calls. If I'd known that RSV news was going to be ignored, I would've held the prior round and saved the trading fees.
Oh well, can't get 'em all right all (most of?) the time.
HardToLove
The world market for pharma is dead. Only the American market remains a free market where researchers can hope to regain the outrageous costs of original reserach and development. Note the rising tide of desperate drug marketers soaking up more and more of the available minutes of prime time advertising...
They know their days are numbered, as the last free market steadily slouches toward universal health care and managed care...
Some will manage to morph into that which comes next, huge pill factories producing generic pablum for the proletariate (many are far advanced along this path)...
The small guys still wildly searching for new solutions lack the deep resources to meet the challenge, but CAN (for the brief and shining moment before the final curtain call) jockey for position at the government trough, sipping just enough to stay alive in hopes that one of the fading big's will buy them out and make them rich...
Really, that's the only long term play left. Betting on the legions of littles in hopes that one will win the lottery before the game changes to 100% government control, from about 80% now, and they turn out the lights in free pharma.
Already the United States is discovering that even the most outrageously wealthy nation in all of history CANNOT afford our hideous mixture of inept government welfare and crony corporate malcare... The options are narrowing down to one, the final commitment to medical socialism. I decided this was an inevitable development over a decade past, and so far nothing I have seen sways me from that prediction.
Best case we make the switch soon, while we yet have some national capital to preserve, before we can begin the thrash with costs that may well catapult us back into the third world.
HardToLove
O.G. posted a reminder a couple days back in a QC.
I'm not expecting anything earth-shattering. A surprise could appear in the form of (confirmation of) anticipated dates for reporting next milestones for RSV, Rabies vaccine (Cadilla, but I'm not expecting much here) and/or on-going Swine flu trials.
Investors that believed Erck was the savior because he had experience developing and selling start-ups will soon be singing the same songs they did with the prior management as there's really nothing Erck can do that wasn't being done because of the laborious and time-consuming steps towards approval of a product.
Once there's a product approved, there's potential for rapid developments, but not before IMO.
http://bit.ly/rBFiwn
HardToLove
"... Appoints Erica S. Shane, Ph.D., Vice President, Process Development"
"... was Senior Director of BioProcess Engineering at MedImmune. In this position, she was responsible for technology transfer to clinical and commercial sites as well as scale-up of cell culture and purification processes. Dr. Shane joined the purification department in 1994 and spent 12 years developing clinical and commercial purification processes. Her contributions were critical to the successful launch of Synagis®, a monoclonal antibody medication to help protect high-risk babies from severe RSV disease ...".
There's more to her c.v.
http://bit.ly/s5iKQz
HardToLove
Two stocks folks here have followed mentioned.
(NVAX) Wedbush has a target @ $6 and outperform.
(ZLCS) Oppenheimer has set a $3 price target and buy rating
The article includes links to the ratings PR from the firms.
http://seekingalpha.co...
HardToLove
Zalicus was listed as a top ten pick for this year by several analysts. What a dud!
Novavax I still own, and would love to see the $6.00 target. What a dud, part two.
Beats by $0.03 on EPS (-$0.03 vs expected -$0.06) but misses on revenues, $5.01M vs. expected of $5.36M,
http://bit.ly/rIaxea
hardToLoveH
expect more of the same. .
If this was a concert, I would have walked out a looooong time ago.
One of the bright spots (ignoring the time line) is that they will be testing tri and quad valence concurrently in the same trials. So they might have a small edge there.
I wish trials and other regulatory matters didn't take so darn long.
But the analysts seemed to think that results were good and seemed upbeat, for the most part.
HardToLove
They have not even entered the ramp-up period for their innovation. The longer the delay, the higher the probability someone else that has been closely watching will jump in and steal the chickens. Anyone else have the impression that getting government money is like a kiss of death....
Hmmmm Anyone remember that movie :) One of the great scenes of all time.
"... Appoints Russell "Rip" Wilson Senior Vice President of Business Development".
http://bit.ly/tglkoW
HardToLove
A live audio-only webcast link for the presentation can be accessed via the Company website at http://www.novavax.com under Investors/Events.
http://bit.ly/tuhaQ9
HardToLove
http://ind.pn/sHxpn4
ROCKVILLE, Md., Nov. 21, 2011 (GLOBE NEWSWIRE) -- Novavax, Inc. (Nasdaq:NVAX) today announced that it has entered a long-term lease arrangement for 74,000-square-feet of manufacturing, lab and office space in two facilities in Gaithersburg, MD. The main facility, located at 20 Firstfield Road in Gaithersburg, MD, will become the primary commercial-scale plant for production of the company's vaccines after minor modifications that are expected to be completed by mid-2012. The company's corporate headquarter offices will be relocated to the same campus at 22 Firstfield Road. Novavax operates a pilot-scale vaccine production facility at its current headquarters in Rockville, MD, four miles from the new facilities.
"This state-of-the-art facility ideally meets our process requirements and will provide twice the cGMP production capacity of our current facility," said Stanley C. Erck, President and CEO of Novavax. "We anticipate that it will enable us to supply our vaccines, most immediately our seasonal and pandemic VLP influenza vaccines, to meet our projected clinical- and commercial-supply requirements for the foreseeable future. In addition to cGMP facilities, these buildings will accommodate current and future clinical, R&D and administrative requirements. The company is assessing its long-term needs for the pilot-scale facility, however, I am delighted to report that the very favorable terms of this new lease would allow us to operate both this new facility and our pilot-scale facility at no additional expense over the next several years."
The high-quality laboratory, office, and manufacturing space is owned and operated by Alexandria Real Estate Equities, Inc. ("Alexandria"), Landlord of Choice to the Life Science Industry®. Robert Scheer, President of Scheer Partners, led Novavax through the site-selection process to the facility and represented the biopharmaceutical company in lease negotiations. "With Robert's hard work completed, we look forward to a long and mutually beneficial relationship with Alexandria for many years to come," continued Mr. Erck.
HardToLove
http://yhoo.it/tNKyUX
However, the idea of the ease that NVAX will be able to set up production where and as needed is one of the reasons I am still hopeful.
Keep in mind that only the delivery mechanism is changed, not the characteristics of the surface proteins which get the job done.
If the oral vaccine uses a partially-killed live virus, it has all the drawbacks (slow to production, a certain percentage of adverse reactions risk, ...) of the current vaccines.
MHO, since I'm no expert,
HardToLove
Has NVAX caused delays by not meeting the requirements of the various Phase trials? Slow to build manufacturing capacity? Etc.
When the big scare was in play, they did what was requested in the needed (and possible) time-frame(s). Then, as could be expected, the scare passed and the supposed "fast track" in Mexico and elsewhere got removed.
Yahoo folks were all agog when the new management team came on board. "They're experienced", "They have a good record", "They know how to cut deals and form JVs", yadda, yadda, yadda,
They ignored the fact that NVAX would be stuck working within the same constraints the prior management team worked within,
Result? The same time-frames, the same products progressing at the same rate and everyone knew that no major commercial progress could be made until a commercial approval is in hand.
Personally, when management was changed, I expected nothing to improve (well, we've got a larger building in MD now at lower cost ... YIPPEE! Even so, the economy, rather than management is responsible for that) and my response was "Ho-hum".
The technology is still just as solid, the management is (so far) no better or worse (measured on short-term results) and the time-lines haven't altered (except as required by the regulatory process).
The Rabies, RSV, H1N1, H5N1, ... that were started by the prior team are progressing as the previous management expected.
The "new, improved management team" was nothing more (from an outsider's perspective) panacea for impatient shareholders, IMO.
It was the previous management team that got the HHS/BARDA funding in place from which the current team benefits.
But when things come to fruition, guess who'll get the credit.
I'm no apologist for NVAX. But I'm very cognizant of the environment they must operate within.
The only major complaint I can find, that I buy, is they paid themselves too much. That hasn't changed either. But I could be wrong. The education required to do this sort of work might require these pay scales to get and keep qualified people.
There may be some benefit, down the road, to having additional expertise on-board that is experienced in bringing in the manufacturing process when commercialization finally gets underway. But the cost of having that person on-board now, before any additional revenues are flowing in, just makes it harder to keep the financials improving. Bad move? I don't know.
When I invested with NVAX, I recognized this and that is why you saw me shorting covered calls.
But everyone has different investing time-frames and certainly NVAX has/will disappoint many.
If I've overlooked any major missteps by NVAX (other than the unnecessary and likely more expensive change in management), I'd be glad to be enlightened.
MHO,
HardToLove
------
Novartis (NVS) opens doors to $1B vaccine plant. From: FierceVaccines.
Federal officials have cleared Novartis' North Carolina-based vaccine plant for production of flu vaccines in the event of an influenza outbreak. The $1 billion plant is the first in the U.S. to manufacture vaccines using cultured animal cells rather than the traditional, less flexible egg-based method.
Cell-based vaccine manufacturing is better suited to respond to the demand surge in an influenza outbreak than traditional vaccine production methods. The influenza virus is injected into lab-grown cell lines, where it multiplies until it is removed and inactivated for use in a vaccine. The process takes weeks, rather than months, and cell-based vaccines can be frozen for storage prior to the flu season. Additionally, cell-based vaccines are less susceptible to contamination than perishable egg-based vaccines.
In the event of a pandemic, the new facility could produce up to a quarter of the country's vaccines, according to the HHS press release. The technology can also be applied to known and emerging infectious diseases.
"Today we're marking the first change in influenza vaccine manufacturing in the United States in 50 years," said Robin Robinson, Ph.D., director of the Biomedical Advanced Research and Development Authority in HHS' Office of the Assistant Secretary for Preparedness and Response
http://tinyurl.com/6se...
With NVAX tri-valent, and quad-valent development, in the pipeline, we'll have some defense in place in the next couple years.
And if it's *really* severe, the "disposable manufacturing" process that requires little space can be ramped very quickly.
That will benefit us all.
MHO,
HardToLove
Hopefully the NVAX set-up will be really successful in India.
Keepin' that smile on...
http://on.msnbc.com/tB...
And the same for all that share with others here!
HardToLove
Thanks for continuing to run this and all of your fabulous Concentrators (and for letting me steal the word "Concentrator" for the Axion thread).
####
Okay Novavax, is this going to be the year you're going to climb out of my sock drawer? :-D
NOVAVAX Reports Progress Under Joint Venture in India With Cadila Pharmaceuticals
<snark> This is really speeding along, isn't it?
"... preparing to initiate clinical studies of vaccine candidates to prevent influenza and rabies in 2012 and 2013, respectively".
If I read that correctly, studies will be start this and next year. So two years(?) before any possible approval? Or does India move faster on approvals than the U.S? I suspect *everybody* does. With India's population, they probably need to move faster.
More positive is "CPLB completed positive preclinical immunogenicity studies of a rabies G‑protein nanoparticle vaccine and has recently received approval from the Review Committee on Genetic Manipulation (RCGM) to begin toxicology studies of this vaccine prior to initiating human clinical trials".
And "... state-of-the-art manufacturing facility in Dholka, India, which is now operational and capable of producing a significant volume of novel vaccine doses every year".
Last, "CPLB is also now pursuing early development of undisclosed new vaccine candidates to prevent other diseases".
For the rest of the usual blather ...
http://bit.ly/vJ4oQ5
HardToLove
VICL closed yesterday [Jan 9] at 3.64. This is just below its 200 day MA. However, the stock went into a golden cross in mid January 2011, and its 50 day MA is still well above the 200 day MA.
It took a big dive on the 5th. The purchase was made on the 6th. The reason for the big dive was a stock offering of 13.3M shares offered at 3.75 [the investment bankers purchase price].
Prior to the offering the stock was cruising between $4.5 and $4.25.
This looks like a good opportunity to get in VICL on the cheap or a trading opportunity.
Good post and thanks!
HardToLove
http://bit.ly/wclHqp
I noticed that and options: 1294 options contracts in the $1/$2/$3 strikes traded across all months.
Share volume jumped from 444.34K Friday to 2.8M today.
Since options would account for only 129.4K, the rest must be folks jumping on the band wagon.
Needless to say, implied volatility in the options is getting attractive - 85%-107%, depending on month and strike.
Frankly, I can't see this action being rational at this time. Getting approval is still a long way off even if some contry fast-tracks it again (remember Mexico did that last time and then when flu season ended, snail-track it ensued).
But if volume and price action will hold another couple of days, I'll short covered calls again.
I've been waiting for *something* to bring options back into an attractive scenario.
MHO,
HardToLove
HardToLove
Freya asked for a list of the old stocks we looked at the first time round. So, I decided to post it here,too.
http://bit.ly/AsPpsO
am on Plavix, after 2 hrs of nonstop bleeding through many self doc attempts I went in, the stitches came out today.
mostly on emails, but do post occasionally when i c an interesting Headline.
Am in MWA/CPST/RNF/ATPG Pref. as New, almost ready to rebuy NVAX and totally out of all things REE except Pele Mountain though TAS is on my radar.
I believe we are in the late stage of an H&S bottom in the DJIA with the Right shoulder forming now.
Just scuttle a few of your own supertankers, no muss no fuss.
The last time around, in 2008, Iran unveiled a 200 mph point and shoot torpedo, just an armed motor, no jammable electronics.
I wonder how many they have by now?
http://bit.ly/zLkCiI
A vaccine for norovirus, which is highly infectious and is difficult to kill by cleaning, could be availabe within five years.
To develop the vaccine, scientists working with Arntzen [co-director of the Centre for Infectious Diseases and Vaccinology at Arizona State University] took a gene from norovirus that codes for its protective protein coat and added it to a common tobacco virus. When the virus infected tobacco plants and multiplied inside their cells, it produced thousands of copies of the norovirus protein, which coalesced into virus-like particles. The particles are harmless, but can be used in a vaccine to trigger an immune attack on the virus. The results were presented at the annual meeting of the American Association for the Advancement of Science in Vancouver.
The final version of the vaccine is likely to carry virus-like particles from both major strains of norovirus, and possibly some common sub-strains, to ensure it provides broad protection against the bug. A single shot of nasal spray could be effective for six months to two years, Arntzen said.
The vaccine, which could be available in four to five years, may prove popular in children's day care centres and among cruise ship workers, hospital staff, carers in old people's homes, and the military, all of which face regular outbreaks of norovirus. http://tinyurl.com/847...
It sounds like they do, through replication in the tobacco plant, what NVAX does in their manufacturing environment.
I would *guess* this validates the VLP concept and we get down to competition in speed and price of production.
That assumes that the results are available to others.
HardToLove
"... begun enrollment in a Phase II clinical trial of its quadrivalent seasonal influenza virus-like particle (VLP) vaccine candidate".
"... We believe that most seasonal vaccines in the future will contain a second B strain and thus consist of a quadrivalent, or four-strain, composition. This trial allows us to transition from a trivalent to a quadrivalent seasonal vaccine candidate".
"... being conducted in Australia so that we can evaluate our VLP vaccine candidate prior to the start of the influenza season in the southern hemisphere, and without waiting for the end of influenza transmission in the northern hemisphere".
"Novavax expects to evaluate the top-line data from this Phase II trial in the third quarter of 2012".
http://bit.ly/woNEVf
HardToLove
"NOVAVAX Reports Fourth Quarter and 2011 Year-End Financial Results"
http://bit.ly/yZZowC
Novavax's management will host its quarterly conference call today at 10:00 a.m. EST today. The live conference call will be accessible on Novavax's website at http://www.novavax.com under "Investor Info/Events" or by telephone at 1 (877) 212-6076 (Domestic) or 1 (707) 287-9331 (International). A replay of the webcast will be available on the Novavax website for 90 days after the call and a replay of the conference call will be available beginning today at 1:00 pm through May 09, 2012. To access the replay of the conference call, dial 1 (855) 859-2056 (Domestic) or 1 (404) 537-3406 (International) and enter passcode 55983197.
HardToLove
"8 Reasons To Buy This $1.30 Lottery Ticket" by Bret Jensen.
And he does offer his supporting reasons. Several are grounded in financial fact.
Short, to the point and, AFAICT, correct in his assessment.
What gives me the most confidence is that his time-lines are not unrealistic. Even if I discount the ever-present "buy out" possibility, the positive cash flow in 12-18 months seems doable if the rate of improvement stays anywhere in the vicinity of what it has been for revenue increase and cash burn rates.
He cites the strong insider buying demonstrating management's confidence: "... net buyers of over 350,000 shares over the past six months".
This has been one of Freya's favorite indicators, IIRC.
Unmentioned are the clinical trial phases underway. Various milestones on that path will be achieved this year, with more to go of course. But there are a couple of those trials that *may* be near achieving final stages and approval over the 12-18 months he mentions.
Approval of a product, or even being in the final stages with no potential "fast-track" rugs to be yanked out from under, would be what really breaks the stock to the upside, IMO. 18 months might be a wee bit on the optimistic side, since we are dealing with multiple government bodies on several of the products. But visibility of end-points should be well apparent in that time-frame.
For me, it might be time to add some low-cost trading blocks so I can sell $1 calls on them and make a little $. Or maybe better, sort some $1 puts? I'll have to check and see if it's worth the effort over the time the contracts might have to remain open.
http://seekingalpha.co...
HardToLove
Management stated that they believe their quadra-valent seasonal flu vaccine has some advantage over the egg-based competitors (which recently received some kind of approval for one company), including that Novavax's product should be first-to-market, competitive on COGS basis.
I think if this works out, it's quite an advantage.
HardToLove
Much of that expense is against the BARDA contract though, so the effects on cash position should be muted, IMO. But it will effect the perception of future quarterly results, likely keeping stock prices depressed.
HardToLove
Bird flu kills, chickens quarantined, Mexico's dead and (my Fav.) Olympians are to avoid close contact, handshaking targeted.
These have been reported already but not picked up here.
The absense of followups in the USA is what scares me a tad.
HardToLove
Seems almost comical to ask... but was the gag order on publications published?
What the heck don't they want people to know?
With around 10 wks to go, he has been hospitalized 3 times, in the ICU 2 times both via ambulance, once while unconscious.
Almost lost his legs, almost died twice
And, Yours truly has been credited with saving his life both times.
Talk about "owing me".
When he gets better, I'm gonna collect:)
He says he's looking forward to it and Hi to all.
He will be in my thoughts, as you have been.
I hope he just gets better and better.
HardToLove
Hopes for all the best as well.
"... March 24 and 26, 2012 at the XIV International Symposium on Respiratory Viral Infections in Istanbul, Turkey".
"Later this year, Novavax expects to initiate two separate dose-ranging Phase II trials of its RSV vaccine candidate in the elderly and in women of child-bearing age. These separate trials will be conducted with, and without, an adjuvant and will provide both safety and immunogenicity results in these different age populations".
http://bit.ly/GQHH6O
HardToLove
http://seekingalpha.co...
HardToLove
http://bit.ly/tb0kz2
See the H1N1 chart well below the interactive "Inccident" map.
HardToLove
No revenues contributed yet, AFAIK. Of course, they will be able to manufacture and sell when approvals are finally received.
Like so many things, takes way too long though.
HardToLove
http://bit.ly/HcTpYD
"A live webcast link for the presentation can be accessed via the company website at http://www.novavax.com under Investor Info/Events."
HardToLove
And these are "direct".
http://yhoo.it/HCeRLp
HardToLove
(NVAX): analysts consensus rated a "buy", 5 analysts, EPS ($0.04) estimated for the current quarter.
I don't know how good their record is.
HardToLove
NOVAVAX Launches Phase I Clinical Trial of A/H5N1 Influenza Vaccine Candidate GlobeNewswire
Novavax, Inc. (Nasdaq:NVAX) announced today that it has begun enrollment in a Phase I clinical trial of its monovalent virus-like particle (VLP) vaccine candidate to prevent a potential pandemic disease due to A/H5N1 avian influenza viruses ("bird flu"). This randomized, observer-blind, dose-ranging, placebo-controlled trial is being conducted under the company's contract with the U.S. Department of Health and Human Services' Biomedical Advanced Research and Development Authority (HHS BARDA). The goal of the trial is to evaluate the safety of the VLP A/H5N1 avian influenza vaccine candidate Novavax is developing under the HHS BARDA contract and determine the vaccine's immunogenicity with and without the use of an undisclosed adjuvant ("Adjuvant 1").
The Phase I trial will enroll healthy adult subjects, each of whom will be randomized into one of six treatment groups including varying doses of A/H5N1 VLP vaccine, with or without Adjuvant 1, or placebo. The trial is being conducted in a stepwise manner, enrolling increasing number of subjects, until a target of approximately 333 subjects is reached. All subjects will be evaluated for safety and immunogenicity. Trial participants will receive two identical intramuscular injections at a 21-day interval (Day 0 and Day 21) with study follow-up approximately 13 months from the first dose.
Gregory Glenn, M.D., Novavax's Senior Vice President and Chief Medical Officer, stated: "This is an important trial because it will help determine the most appropriate dose for future studies of our avian influenza vaccine candidate, as indicated by the safety of the vaccine, and how closely the vaccine meets the immunogenicity criteria for an accelerated approval of a potential pandemic influenza vaccine set by the FDA's Center for Biologics Evaluation and Research. We remain grateful for HHS BARDA's support for this trial and look forward to completing enrollment and presenting top-line data in the fourth quarter of this year."
http://bit.ly/Inulyk
HardToLove
"Is The Novavax 'New Paradigm' Worth A Second Look?"
http://seekingalpha.co...
HardToLove
Misses analyst estimates by $0.02 (est. loss of $0.04 vs. realized loss of $0.06) due to starting trials early in Australia, thereby recording a cost of revenue that will not be offset until results are given to BARDA/HHS after trial completion.
http://bit.ly/KzAZB8
CC 10:00, available under investor information tab at Novavax.
Tried to post link to webcast, but something is too busy - times out.
Here's the investor's page though.
http://bit.ly/L5xkzI
HardToLove
EDIT: Site freed up. Here's the link.
http://bit.ly/IJ60YC
"NOVAVAX Launches Additional Phase I Clinical Trial of A/H5N1 Influenza Vaccine Candidate".
"... begun enrollment in a second Phase I clinical trial of its monovalent virus-like particle (VLP) vaccine candidate to prevent potential pandemic disease due to A/H5N1 avian influenza viruses ("bird flu")".
"The goal of this trial is to evaluate the safety of the VLP A/H5N1 avian influenza vaccine candidate ...".
"... trial is identical in design to the Phase I study launched on May 1, 2012".
"Like the first A/H5N1 trial we initiated on May 1, we believe this trial will provide the data to determine whether our vaccine will fulfill the criteria for an accelerated approval of a potential pandemic influenza vaccine ..."
http://bit.ly/IIkcLM
HardToLove
http://yhoo.it/HCeRLp
HardToLove
Last July, share price was $2.92; now @ 86 cents.
Last year, Zalicus was on many 2011 prediction lists as a top 2011 stock to own, and not just biotech stocks; all stocks.
Might have to do a little poking around with this one.
All my pharma stocks have slowly migrated to the back pages of my list, or off the list completely... Perhaps the long term trend I was expecting to set in around 2015-2020 (very dire future for this sector is what I see as big pharma becomes commoditized and government suppresses opportunity worldwide) is eating into these small guys' chances earlier than I thought.
"NOVAVAX, Inc. Announces $12 Million Equity Offering".
What really happened is it did a placement Friday was it placed the shares above the Friday closing price, "... 10,000,000 shares ... common ... to RA Capital Healthcare Fund, LP at a price of $1.22 per share".
http://bit.ly/Ksp5Ie
HardToLove
Vical (VICL) announced the online publication of a new article in The Journal of General Virology detailing results from the co's completed mouse studies with the co's Vaxfectin-formulated plasmid DNA vaccines against herpes simplex virus type 2. These results support the co's decision in early 2012 to advance toward clinical testing, which is expected to begin in 2013.
The FDA's Advisory Committee meets on June 20th to decide on Sanofi's (SNY) semuloparin sodium injection which treats venous thromboembolism [VTE] in cancer patients undergoing chemotherapy.
Things are looking good for Sanofi because in their phase three studies, Semuloparin decreased the death rate of cancer patients due to symptomatic-deep vein thromboembolism, non-fatal pulmonary embolism, or VTE by 64%. That's a remarkable decrease in death rate. In addition, Sanofi and Semuloparin were selected for Best of ASCO in 2011.
There was a slightly higher rate of bleeding (2.8% vs. 2.0%) compared to placebo, but one of the keys is that Semuloparin did not cause lower platelet counts.
If the Advisory Committee gives a positive recommendation on June 20th, the share price should experience a significant pop. Given what's going on with the market, I would watch the stock and see how its doing, than if you want to take a chance, swoop in before June 18 or so. As a bonus, (SNY) has a 5.1% dividend.
I picked up this info from SA's Spencer Knight article:
http://tinyurl.com/729...
I am looking at that June 28th (BMY) play on on Eliquis as well.
Sanofi was one of the stocks I sold two "Marches" ago to raise money for my home. I recall it going higher, but it's about $2 lower now than when I sold it (IIRC).
OT: I'm not buying anything right now, but my broker recommended adding to my Buckeye Pipeline postion, yielding over 8%. I told him, too, that I'm not buying anything until at least mid-summer.
Thanks again!
I'd go for the July options since the June ones expire on the 16th. It looks like $165 plus fees will control 100 shares for the $33 strike. A typical pop of +5% or more would push SNY to $34.41, putting your calls in the money with a month to decide to either take profit or exercise them. With delta already at 59.5%, profit should be noticeable if there is a rise.
Be aware that implied volatility pushes the premium above the $1.08 theoretical value, so catching in intra-day during a down swing should be attempted.
Go long a few more contracts than you actually might want to exercise and the profits from those can cover the cost of the ones you might want to exercise. This could mean that your actual exercise price would net to the strike price.
Alternately, selling a few puts at the $32 strike for the same month would cover ~50% of the cost of the call options, but leave you exposed to the risk of having to buy at $32 if the pop doesn't happen. If the pop does happen, you can exit the short puts position with a small profit.
HardToLove
Got one only, at the low of the day for SNY, at $1.65.
I'll take what the market gives me. I was too cheap to raise my bid to $1.70 and the market-maker was too greedy to drop a nickle. I presume my 1 contract came from another retail investor.
Se la vie!
I'm up a potential $0.15 on it now.
With just one contract in hand, no point in trying to build around that. Maybe if I see another attractive point ...
HardToLove
(June 6, 2012) Insight: Dengue vaccine in sight, after 70 years.
From: Reuters, by Ben Hirschler
Sanofi (SNY), the Paris-based firm hopes for positive results in September from a key trial among children in Thailand that would set it on course to market a Dengue vaccin shot in 2015 which would prevent an estimated 100 million cases of dengue infection each year. Of 20,000 annual deaths, many are of children.
For Sanofi, which has invested 350 million euros ($440 million) in a new French factory to make the three-dose vaccine, it could mean a billion euros in yearly sales as half the world is exposed to the disease, notably in fast-expanding tropical cities from Rio and Mexico to Manila and Mumbai.
In the past 50 years there has been a thirty-fold jump in Dengue cases. The World Health Organisation officially puts infections at 50 to 100 million a year, though many experts think this assessment from the 1990s badly under-estimates the disease. Most patients survive but it is estimated to kill about 20,000 every year, many of these children less able to fight it off.
Sanofi seems closest to offering a viable treatment. And, it promises to be the commercial blockbuster the French firm needs to refresh a portfolio weakened by expiring patents. Its estimate of over 1 billion euros in annual sales - Sanofi's 2011 turnover was 33.4 billion euros - assumes that it is added to routine immunization schedules in Latin America and Asia and is also adopted by travelers from farther afield and by military medics in the United States and Europe.
Meeting that sales potential, while getting the vaccine to hundreds of millions who need it across the tropics, will require a careful balancing act on pricing and supply of a product that has yet to be given a commercial brand name.
Orin Levine, executive director of the International Vaccine Access Center (IVAC) at the Johns Hopkins Bloomberg School of Public Health, says the new vaccine is a potential breakthrough but warned its roll-out may not be straightforward.
First up, the vaccine needs to be given in three installments over the course of a year in order to counter the threat from four different types of dengue virus, none of which confers immunity for the others.
"There are going to be some challenges," says Levine. "There's really good economic potential from this vaccine but I think it may take a ramp-up of three to five years."
SANOFI'S BET
In an ideal world, healthcare experts would like a single-dose or, at most, a two-dose vaccine for mass immunization. A simpler regimen would also be better for travelers, although Pascal Barollier of Sanofi Pasteur, Sanofi's vaccine arm, says many users will be people making regular trips to see families in Latin America or Asia with time to plan ahead. The military, too, often has lead time for troop movements.
Sanofi's Gamble:
In any case, Sanofi is putting its money where its mouth is by spending 350 million euros on a new dengue vaccine factory near Lyon, which is already in test production. It is a substantial gamble, since Sanofi will only learn whether the vaccine really works when it analyses data from a first study of its efficacy on 4,000 Thai children. Results from that clinical study, in what is known as the Phase IIb of the international standard three-stage process of assessment, are expected in the third quarter - most likely September. They will also be presented for scientific scrutiny at the annual meeting of the American Society of Tropical Medicine and Hygiene in Atlanta in November.
If the data is good, Sanofi will file for market approval in countries where dengue is endemic like Australia, Malaysia, Singapore, Thailand and Mexico in 2013, suggesting a regulatory green light in 2014 and commercial launch in early 2015.
Submissions in other countries and for the travelers market would follow in 2014 and 2015.
LOOKING GOOD
Early tests have shown a balanced immune response against all four dengue types and Duane Gubler of the Duke-N.U.S. Graduate Medical School, who has researched dengue for four decades, is optimistic. "Everything they've done so far looks very good," he says. "I think it will be a much better vaccine than malaria."
He expects Sanofi's vaccine will show an efficacy rate of at least 75 to 80 percent, well above the 50 percent or so seen with GSK's malaria shot, which faces the added technical problem of fighting a complex parasite rather than a virus.
The efficacy rate refers to the reduction in the prevalence of subsequent infection among those vaccinated.
Globalization has also brought cases of dengue into southern Europe and the United States, particularly Texas and Florida, although Gubler believes higher living standards mean it is not likely to take off in these regions.
Sanofi is not ready to set a price before it sees the full clinical trial results and has a clearer sense of vaccine yields at its factory. But the drugmaker will embrace "tiered pricing" to make the product affordable, Barollier at the company said.
That has not stopped the guessing. "I would expect, for middle-income countries, they would be looking at prices similar to those of other new vaccines - for example HPV (human papillomavirus), pneumococcal and rotavirus vaccines - which sell for $15 to $70 per course in countries like Brazil, South Africa, Venezuela and Thailand," said IVAC's Levine.
Setting the price will be a test for Sanofi Chief Executive Chris Viehbacher. He reckons his vaccine is about five years ahead of any others and he knows he has a major opportunity to boost his company's reputation by getting the roll-out right.
http://tinyurl.com/dxa...
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We need to watch these results from Thailand in September. As previously mentioned, (SNY) has a potential pop or drop coming on June 20th. with their semuloparin sodium injection - see above Potential Play on Sanof. I think it's unusual for a company to set up manufacturing facilities before a drug is approved. That is sending a buy signal to me.
For more on Dengue see the Dengue News Concentrator http://tinyurl.com/6px...
If you go up a few comments, you can read how to identify the mosquito that carries dengue.
I have spent seven or eight months of my life in Latin America, and amazingly have only ever been bitten once. I have also seen people who stay in sleeze bucket hotels who were bitten all over the place.
Udo's mops the decks three or four times a day; all good hotels down there do the same. If a geko decides to reside in your room, keep it as a working pet!
Definitely bring "new" Deet.
Them bugs down there don't like us smokers. No wonder the ancient Maya "invented" tobacco to make "sikars." <---actual Chorti Maya word!
Noticed Europe still very active with quakes.
http://bit.ly/tb0kz2
"Genzyme Reports Positive Top-Line Results of TOWER, a Pivotal Phase III Trial for AUBAGIOTM* (teriflunomide) in Relapsing Multiple Sclerosis"
http://bit.ly/Ky6I7q
and
"Genzyme Submits Applications to FDA and EMA for Approval of LEMTRADA™ (alemtuzumab) for Multiple Sclerosis"
http://bit.ly/LGbpQ8
I had already made some small $ on a long call position and recently, based on charts, taken a long put position at $34 strike for July expiration.
Now we'll find out how much influence GS has and whether I'm lucky, rather than good! :-))
I assume GS wants to accumulate at low price for later sale at a high price.
I guess I could enter a straddle by going long the calls as well, profiting if there's movement of any amplitude in either direction.
Nah! "In GS We Trust"!
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Good potential for a market whipsaw given the high for the cliff vote combined with unknowns of thePMI and ISM scheduled for this morning.
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Quadruple Witching occurs on Friday Dec 21.
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