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The DoD pulled funding for SRPT's Ebola program and ended up only continuing to provide it to TKMR's Ebola program. SRPT still gets funding for it's Marburg program, though. The DoD's decision to support TKMR and not SRPT was based on the clinical data, as well as a necessary budget cut it had to make.
Meant to post this a couple of days ago when I read it initially. But the point is that Medimmune's Synagis may be losing market share. This opens the door even more for NVAX. Or maybe it makes AZN/Medimmune think more about proposing a buyout of NVAX down the road when more Ph2 data comes out (as well as Ph3).
Antiviral-drug maker fights pediatricians' new advice
www.modernhealthcare.com/article/20140728/INFO/307289975#
By Associated Press
Posted: July 28, 2014 - 12:30 pm ET
Tags: Associated Press (AP), Associations, AstraZeneca, Centers for Disease Control and Prevention (CDC), Infection Control, Physicians
A costly drug given mostly to premature babies is at the center of a clash between the manufacturer and the nation's leading pediatrician's group, which recommends scaling back use of the medicine.
The dispute involves new guidelines from the American Academy of Pediatrics, which say medical evidence shows the drug benefits few children other than very young preemies. The medicine guards against a common but usually mild virus that can cause serious lung problems.
It's the second time in two years that the influential group has recommended narrowing use of the drug, sold by MedImmune under the brand name Synagis. MedImmune is fighting back with full-page newspaper ads that say the updated policy threatens "our most vulnerable babies."
Synagis protects against RSV, or respiratory syncytial virus, which infects nearly all U.S. children by the age of 2. For most, it causes only mild, cold-like symptoms. But it is also the most common cause of pneumonia in U.S. infants, and as many as 125,000 young children are hospitalized with RSV each year, according to the federal Centers for Disease Control and Prevention.
It was approved in 1998 for use in certain "high-risk" children, based on research showing benefits for certain children including premature infants born at 35 weeks or earlier. The pediatricians' group says it has sought to provide more specific guidance because the government's definition of high risk is vague.
The medicine is given in a series of seasonal injections costing thousands of dollars, and a recent lag in Synagis sales may explain MedImmune's tactics, which include recruiting parents to help tout the drug.
Sales for the first quarter of 2014 totaled $328 million, down 19% from $414 million in the same period last year, according to an earnings report from parent company AstraZeneca.
Company spokeswoman Alisha Martin said it placed full-page ads in The New York Times and several other newspapers because "we felt it important to inform parents — including the half-a-million women who give birth prematurely each year — of the decisions being made that could impact the lives of their children."
Studies show the drug can slightly reduce risks for being hospitalized but doesn't shorten hospital stays or lessen chances for long-term complications or death, said Dr. H. Cody Meissner, a member of an academy committee involved in drafting the new guidance and an infectious disease expert at Tufts Medical Center.
Advances in treatment for preemies in recent years make Synagis, also known as palivizumab, unnecessary for many, the academy says. Its new guidance recommends it only for: infants born before 29 weeks; older preemies with chronic lung disease and those with certain heart problems; and certain other at-risk children younger than age 2.
Healthy older preemies should not get the drug, the academy says in guidelines published online Monday. Its 2012 advice included use in some older, healthy preemies.
Melony Sorbero, a senior Rand Corp. researcher, has studied RSV and said the academy's narrowed recommendations make sense based on scientific evidence of limited benefits.
MedImmune's newspaper ads say the new guidelines will leave about 140,000 infants born between 29 and 35 weeks "unprotected." The ads say: "Why put these babies at risk?" They include a photo of a tiny preemie hooked up to medical machinery.
A Washington, D.C.-area mother, Deb Discenza, has helped the drugmaker locate parents to participate in a MedImmune RSV awareness program and says she was paid for sharing information about her daughter's experience. Her daughter was born at 30 weeks, or about two months early, in 2003. The baby may not have qualified for the medicine under the academy's new guidance but her mother believes Synagis treatment that first year "is what saved us."
The little girl's doctor declined to offer the drug after she turned 1, and she developed asthma. Discenza believes Synagis might have prevented it.
She said her health insurance covered the shots, but she's among parents who worry coverage will be denied based on the new recommendations.
Susan Pisano, spokeswoman for the industry group America's Health Insurance Plans, says insurers consider medical groups' recommendations but that it's too soon to determine if the pediatricians' new advice will affect coverage decisions.
The $0.22 share price you mentioned is reflective of CELG's forward stock splits. They IPO'd in 1987. They have since split their stock in 2000, 2004, 2006, and 2014. So looking back at the chart over the years, the share prices have been adjusted for the forward splits.
Having said that, though, this is an interesting website showing what one's investments would have looked like over time in CELG:
www.1stock1.com/1stock1_1844.htm
Thanks for posting this update from the site.
I found this particularly interesting:
A groundbreaking for both projects is planned for
summer 2014, with completion scheduled for early 2016.
I will be ecstatic if they break ground this summer. I'm not holding my breath, though.
Also, this:
BioNitrogen plans to build five plants in the United States
and Canada within the next five years, many of which
are located in low-income rural communities in the
southeastern United States, and an additional 10 plants
overseas in the next 10 years
We've also heard these types of projections but have yet to see any come to fruition. I must admit, though...Hendry County seems to be moving very nicely...and faster than Hardee County, which seemed to have so much potential initially.
If this site can get going, other sites should definitely be easier.
Price coming down into a better entry range...albeit prior to the release of the updated 6MWT results.
I agree that the decline was expected, and I'm waiting to get back in. This stock is always so up and down, and it never seems to hold the euphoria after good PR.
What did you think about the price action today, specifically, though? I saw it was getting knocked down but there were some decent-sized purchases at the ask throughout the day after it kept getting knocked down on smaller lots.
TIA
I initially thought something was up the last two days; but based on some other messages boards, people were predicting this run up to an even $5.00 closing price days ago due to the options expiration on Friday.
Nevertheless, I'd love to see the price keep climbing rather than fall back next week if the market makers or big buyers are done with the manipulation.
All good points, Big Bake. Also, it should be noted that the offer price was lower than what some of the insiders just bought at recently on the open market.
Novavax Announces Proposed Public Offering of Common Stock
Novavax Announces Proposed Public Offering of Common Stock
GAITHERSBURG, Md., June 4, 2014 (GLOBE NEWSWIRE) -- Novavax, Inc. (Nasdaq:NVAX), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of recombinant nanoparticle vaccines and adjuvants, today announced that it intends to offer to sell, subject to market and other conditions, $100 million of its common stock in an underwritten public offering. As part of this offering Novavax, Inc. intends to grant the underwriters a 30-day option to purchase up to an additional $15 million of its common stock. The success, the size and the terms of this offering cannot be guaranteed.
Citigroup and JP Morgan are acting as joint book-running managers of the offering.
All shares being offered are to be sold by Novavax, Inc., with the net proceeds from the offering to be used for general corporate purposes, the advancement of its clinical-stage vaccine candidates and its preclinical research programs, manufacturing and process development activities, capital expenditures and other strategic purposes.
The securities described above are being offered by Novavax pursuant to its registration statement on Form S-3 previously filed and declared effective by the Securities and Exchange Commission (SEC). This press release does not constitute an offer to sell or a solicitation of an offer to buy the securities in the offering, nor shall there be any sale of these securities in any jurisdiction in which an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such jurisdiction. The offering may be made only by means of the preliminary prospectus supplement and the prospectus relating to the proposed offering, copies of which may be obtained, when available, from Citigroup and JP Morgan, Attention: Citigroup, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, by telephone at (800) 831-9146; or J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717 or by telephone: (866) 803-9204.
About Novavax
Novavax, Inc. (Nasdaq:NVAX) is a clinical-stage biopharmaceutical company creating vaccines and vaccine adjuvants to address a broad range of infectious diseases worldwide. Using innovative proprietary recombinant nanoparticle vaccine technology, the company produces vaccine candidates to efficiently and effectively respond to both known and newly emergent diseases.
Forward-Looking Statements
Statements contained in this release, including those relating to the sale of common stock, and those statements using words such as "expects" and "intends" are forward-looking statements that involve a number of risks and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. These risks and uncertainties include, but are not limited to: our ability to successfully complete the offering on terms and conditions satisfactory to us; the possible adverse impact on the market price of our shares of common stock due to the dilutive effect of the securities to be sold in the offering; capital market risks; our ability to raise additional capital when needed; and other risk factors identified from time to time in the reports we file with Securities and Exchange Commission (SEC), including our Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K, which are available at www.sec.gov. We caution investors not to place considerable reliance on the forward-looking statements contained in this press release. 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.
CONTACT: Barclay Phillips
SVP, Chief Financial Officer and Treasurer
Novavax, Inc.
240-268-2000
(MORE TO FOLLOW) Dow Jones Newswires
June 04, 2014 16:01 ET (20:01 GMT)
179,400 tons of urea annually. EOM.
Thanks for that info. I wish they had that info on the new website like they used to on the old website.
What did you mean by your statement that Bionitrogen doesn't need the $5 million from Taylor County to pay for the EPC? Did they get funding elsewhere? Did the cost for EPC come down?
That's exactly what I was referring to when I said there was selling pressure. All that volume but no significant increase in price. That could mean more shares entering market. Scary thought. It is a pink sheet stock, after all. Unless they actually get EPC and then bonds get sold. That will make this thing move. That's about it. Or maybe another pump and dump like when this thing started. Hoping this gets going. This is either a very well ran fraud by convincing politicians in Florida and Louisiana, businesses like Casale and AMEC, and all us shareholders that their business is legit (or maybe they're all complicit)...or this is truly a legit company about to see some nice progress.
There's definitely selling pressure. The ask is almost always at the current market price, if not lower. Only recently had I noticed the ask higher than the current market price. There's no incentive for the price to go higher when people keep selling to unload shares.
Hi, TW.
Glad to see you back and posting a bit. I have been pretty low key for the most part as well but definitely reading and keeping up like you. I actually just finished watching the video of the ribbon cutting ceremony about an hour or so ago. It was much more important of an event than I was initially thinking it was going to be. To see all the major players and stakeholders involved at that meeting was amazing and very reassuring, esp. the project manager from AMEC. Now if we could just get that EPC paid for and completed!! I was also very impressed to hear the names Deutsche Bank and Stifel Nicolaus.
To answer your question about how many facilities they are hoping to build in the near term, based on their investor fact sheet:
Near-term: Establish 5 facilities in the US from Texas to Florida over the next 5 years
Long-term: Add 10 international facilities, resulting in total capacity of ~3mm tons of
urea, or approximately 2.6% of current global demand.
BION initially thought that they could produce their plant at $62 million (www.marketwired.com/press-release/bionitrogen-reports-on-financial-advantages-building-smaller-modular-urea-fertilizer-pinksheets-bion-1621519.htm), but the cost has risen to around $150-250 million (sseassociation.org/Presentations/2013/Kornegay/2013-Kornegay.PDF). And, who knows, maybe it could be even more now.
As far as the timeline, last I remember was that it would take 1.5 yrs to construct vs. 5-7 for traditional fertilizer plants (www.reuters.com/article/2012/04/04/idUS209993+04-Apr-2012+MW20120404). BioNitrogen's old website used to have a nice side-by-side comparison of their plant vs. a traditional carbon-based/fossil fuel fertilizer plant, but they don't have that on the new site anymore. Their plants would be less expensive and quicker to build than the traditional plants.
Kudos to all BION's staff for all the crazy behind-the-scenes work they have been doing over the past year or two. We had no idea this was in the works for so long but were so focused on Hardee County.
Anyway, that's it for now. Have a good night, all. Hope to see the steps keep progressing here. It has been a long ride.
As an aside, I still am attached to their old logo, but their new one is growing on me.
Original Logo:
New Logo:
One Year Follow-Up From RSV F-Protein Vaccine Candidate Phase 1 Elderly Trial Demonstrates Sustained Levels of Immune Response
Sustained levels of RSV F antibody and palivizumab-competing antibody responses demonstrated over a 4 to 6 month period
Results support accelerating development plans for "seasonal" elderly RSV vaccine
Phase 2 clinical trial in elderly anticipated to start in late-2014/early-2015
GAITHERSBURG, Md., May 12, 2014 (GLOBE NEWSWIRE) -- Novavax, Inc. (Nasdaq:NVAX) today announced follow-up data from its dose-ranging Phase 1 clinical trial of its respiratory syncytial virus (RSV) F-protein vaccine in 220 elderly adults (60 years of age and older, with a mean age of 68) that was initiated in October 2012. In the placebo-controlled trial, subjects received a single injection of either 60µg or 90µg of the RSV F-protein vaccine candidate, with or without aluminum phosphate as an adjuvant.
Positive top-line interim safety and immunogenicity data released by Novavax in July 2013 described antibody responses 28 and 56 days post-immunization. Overall immune responses were greater in groups receiving the 90µg dose compared to the groups dosed with 60µg. Also, robust anti-F IgG responses and palivizumab competing antibody (PCA) responses were observed in all vaccine recipients. Notably, by day 56, subjects receiving the 90µg dose without adjuvant achieved PCA responses at a geometric mean of 142µg/ml, which approximate the peak levels seen in pharmacokinetics trials of palivizumab in infants receiving repeat palivizumab injections (~150µg/ml) and exceeded trough levels seen (~70µg/ml) in those same studies, indicating that the vaccine induced antibody levels that are likely to be protective.
In the one-year follow up data released by Novavax today, the company reported that the group receiving the 90µg dose without adjuvant, anti-F levels and PCA were significantly elevated over baseline at day 118, with a geometric mean of 130µg/ml, and at day 180, with a geometric mean of 114µg/ml. For the same group, at day 180, anti RSV A neutralizing antibodies were log2 8.8 and RSV B neutralizing antibodies were log2 9.0, both considered protective levels in seroepidemiology studies.
"Typically, RSV season lasts four to five months, so it was important to see follow-up data which support that our vaccine could be protective across a full RSV season, similar to seasonal influenza vaccination. Our data suggest that, since protective levels are diminished at day 365, annual boosts of our vaccine may be warranted," said Dr. Gregory Glenn, Senior Vice President of Research and Development at Novavax. "The monoclonal antibody palivizumab has been shown to protect infants against severe RSV disease but has only a 21-day half-life and is therefore given in multiple injections to sustain protective levels. A single dose of our RSV F vaccine candidate appears to sustain immunity in the elderly at levels that exceed what was protective in infants, and does so over a long-enough period of time to cover an entire RSV season."
Stan Erck, President and CEO of Novavax, stated, "We were pleased to see that a 90µg dose of our RSV F vaccine candidate was immunogenic and sustained levels that appear to be protective over an entire RSV season. These results encourage us to accelerate our development plans to include an annual seasonal RSV vaccine for the elderly where there is a burden of disease and incidence rate similar to that of an influenza virus, and clearly support initiation of a Phase 2 clinical trial as early as later this year or early-2015.
About RSV
RSV is a major respiratory pathogen in infants, children, and adults. RSV infections in adults represent re-infections and are generally mild to moderate in severity, except in persons with high-risk conditions including the elderly and adults with underlying chronic cardiac or pulmonary disease. It is estimated that between 11-17,000 adults die of RSV infection annually in the U.S., with and up to 180,000 admitted to hospital with respiratory symptoms. Currently, there is no approved RSV prophylactic vaccine available. Palivizumab is a monoclonal antibody, licensed and sold by Medimmune as Synagis®, that targets the RSV F protein and is used for prophylaxis against RSV disease in high risk infants.
About Novavax
Novavax, Inc. (Nasdaq:NVAX) is a clinical-stage biopharmaceutical company creating novel vaccines and vaccine adjuvants to address a broad range of infectious diseases worldwide. Using innovative proprietary recombinant protein nanoparticle vaccine technology, the company produces vaccine candidates to efficiently and effectively respond to both known and newly emergent diseases. Additional information about Novavax is available on the company's website, novavax.com.
Forward-Looking Statements
Statements herein relating to the future of Novavax and the ongoing development of its vaccine and adjuvant products 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, 2013, and filed with the Securities and Exchange Commission (SEC). Investors are cautioned not to place considerable reliance on the forward-looking statements contained in this press release. You are encouraged to read company filings with the SEC, available at 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 the company undertakes no obligation to update or revise any of the statements. The company's 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.
CONTACT: Barclay A. Phillips
SVP, Chief Financial Officer and Treasurer
Novavax, Inc.
240-268-2000
Source: Novavax, Inc.
This stock is so volatile. Even on a day-to-day basis or intraday basis. I'm sure a lot of swing traders have made a lot of $$ here. I'm not a swing trader but have been in and out of this a couple of times with gains. I was hoping it might test $23 again but we'll have to see where it goes. Good luck to you as well :)
What price are you looking to get back in? I am on sidelines waiting to get back in myself. TIA.
Wonder who bought all those shares today: 949,335 shares at 03:39:00.
Oh, ok. I have previously looked at that PDF when the new site went live but somehow glossed over that. I'll check it out again.
Thanks.
I haven't seen that. Are you subscribed to the RSS thing to get notifications when the website it updated? I have not had experience doing that but might look into it.
can you provide the link to where you saw info about Haldor Topsoe?
Thanks
pSivida Presents Preclinical Data Demonstrating Sustained Release of Avastin Using Tethadur at ARVO Annual Meeting
Today: Monday 5 May 2014
pSivida Corp. (NASDAQ: PSDV) (ASX: PVA), a leader in the development of sustained release products for treating eye diseases, today announced that the Company presented the first peer-reviewed preclinical data demonstrating the use of pSivida’s Tethadur™ technology to provide sustained release of Avastin at the 14th Annual Meeting of ARVO (Association for Research in Vision and Ophthalmology).
pSivida’s Dinesh K. Nadarassan presented a poster entitled “Sustained Release of Bevacizumab (Avastin) from BioSilicon”. The data from preclinical studies conducted by pSivida concluded that long-term sustained release of antibodies such as Avastin is achievable with Tethadur, a form of pSivida’s BioSilicon™ technology, and that the release of the antibodies is controllable over a wide range by adjusting the pore size and surface area of Tethadur.
“The implications of the ability to control the duration of sustained delivery of antibodies through pore size are significant,” said Dr. Paul Ashton, president and chief executive officer of pSivida. “By varying pore size, we believe the release rate of antibodies loaded into Tethadur can be controlled, which could permit sustained delivery of antibodies that currently must be delivered by frequent injections. For example, Avastin and the two of the top-selling Veg-F ophthalmic drugs today are injected as frequently as once a month.”
pSivida’s Tethadur, an application of BioSilicon technology, is designed to provide sustained delivery of large biologic molecules, including peptides, proteins and antibodies. BioSilicon technology utilizes a fully-erodible, honeycomb structure of nano-porous, elemental silicon to provide sustained delivery of therapeutics. The study evaluated the effect of pore size in Tethadur on Avastin release over a period of three weeks.
About pSivida Corp.
pSivida Corp., headquartered in Watertown, MA, develops tiny, sustained release, drug delivery products designed to deliver drugs at a controlled and steady rate for months or years. pSivida is currently focused on treatment of chronic diseases of the back of the eye utilizing its core technologies, Durasert™ and Tethadur™. The injectable, sustained release micro-insert ILUVIEN® for the treatment of chronic DME considered insufficiently responsive to available therapies, licensed to Alimera Sciences, Inc., is marketed in the U.K. and Germany and has also received marketing authorization in Austria, France, Portugal, and Spain and is awaiting authorization in Italy. Alimera has filed for ten additional EU country approvals through the Mutual Recognition Procedure. Alimera is seeking FDA approval for ILUVIEN for DME in the US. pSivida has commenced a Phase III clinical trial of Medidur™ for the treatment of posterior uveitis, a chronic back-of-the-eye disease, which uses the same micro-insert as ILUVIEN. An investigator-sponsored clinical trial is ongoing for an injectable, bioerodible micro-insert to treat glaucoma and ocular hypertension, a product candidate on which Pfizer Inc. has an option. pSivida's FDA-approved Retisert®, licensed to Bausch & Lomb Incorporated, provides long-term, sustained drug delivery to treat posterior uveitis.
SAFE HARBOR STATEMENTS UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995: Various statements made in this release are forward-looking, and are inherently subject to risks, uncertainties and potentially inaccurate assumptions. All statements that address activities, events or developments that we intend, expect or believe may occur in the future are forward-looking statements. The following are some of the factors that could cause actual results to differ materially from the anticipated results or other expectations expressed, anticipated or implied in our forward-looking statements: uncertainties with respect to: ability of BioSilicon and Tethadur to successfully deliver proteins, peptides and other large biologic molecules on a sustained basis; Alimera's ability to obtain regulatory approval for, and if approved, to finance, successfully commercialize and achieve market acceptance of, and generate revenues to pSivida from, ILUVIEN for DME in the U.S.; Alimera's ability to finance, achieve additional marketing approvals, obtain adequate pricing and reimbursement for, successfully commercialize and achieve market acceptance of, and generate revenues to pSivida from, ILUVIEN for DME in the EU; the ability to finance, complete and achieve a successful outcome for Phase III trials for, and file and achieve marketing approvals for, Medidur for posterior uveitis, including achieving acceptable risk-to-benefit and safety profiles in light of the CRL for ILUVIEN; initiation, financing and success of Latanoprost Product Phase II trials and any exercise by Pfizer of its option; ability to develop product candidates and products and potential related collaborations; initiation and completion of clinical trials and obtaining regulatory approval of product candidates; continued sales of Retisert; adverse side effects; ability to attain profitability; ability to obtain additional capital; further impairment of intangible assets; fluctuations in operating results; decline in royalty income; ability to, and to find partners to, develop and market products; termination of license agreements; competition and other developments affecting sales of products; market acceptance; protection of intellectual property and avoiding intellectual property infringement; retention of key personnel; product liability; consolidation in the pharmaceutical and biotechnology industries; compliance with environmental laws; manufacturing risks; risks and costs of international business operations; credit and financial market conditions; legislative or regulatory changes; volatility of stock price; possible dilution; absence of dividends; and other factors described in our filings with the SEC. Given these uncertainties, readers are cautioned not to place undue reliance on such forward-looking statements. Should known or unknown risks materialize, or should underlying assumptions prove inaccurate, actual results could differ materially from past results and those anticipated, estimated or projected in the forward-looking statements. Our forward-looking statements speak only as of the dates on which they are made. We do not undertake any obligation to publicly update or revise our forward-looking statements even if experience or future changes makes it clear that any projected results expressed or implied in such statements will not be realized.
Follow pSivida on social media:
Twitter: https://twitter.com/pSividaCorp
Facebook: https://www.facebook.com/pages/PSivida-Corp/544893792199562
LinkedIn: http://www.linkedin.com/company/psivida
Google+: https://plus.google.com/u/0/b/113754643626984244726/113754643626984244726/posts
The President's Blog: http://www.thechairmansblog.com/paul-ashton
For more information on pSivida, visit www.psivida.com.
Martin E. Janis & Company, Inc.
Beverly Jedynak, President
+1 312.943.1123
M: +1 773.350.5793
bjedynak@janispr.com
New Experimental Vaccine Produces Immune Response Against Middle East Respiratory Syndrome Coronavirus (MERS-CoV)
University of Maryland School of Medicine Study Published in Vaccine Highlights First Potential Effective Means for Preventing MERS Coronavirus Outbreak
BALTIMORE and GAITHERSBURG, Md., April 30, 2014 (GLOBE NEWSWIRE) -- The University of Maryland School of Medicine (UM SOM) and Novavax, Inc. (Nasdaq:NVAX) today announced that an investigational vaccine candidate developed by Novavax against the recently emerged Middle East Respiratory Syndrome Coronavirus (MERS-CoV) blocked infection in laboratory studies. UM SOM and Novavax also reported that a vaccine candidate against Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV) developed by Novavax on a similar platform also inhibited virus infection. Researchers reported these findings in an article published in the April 13, 2014 issue of Vaccine1.
Historically, vaccine strategies for emerging pathogens have been limited due to the sudden nature in which the virus first appears and delayed by the protracted traditional vaccine development process. This peer-reviewed manuscript describes a novel method to rapidly develop vaccines against previously unknown viruses, such as MERS-CoV, which appear suddenly and cause severe illnesses in humans. The experimental vaccines, which were tested in conjunction with Novavax' proprietary adjuvant Matrix-M™, induced neutralizing antibodies, or immune responses, that prevent viruses from infecting cells.
"Our protein nanoparticle vaccine technology is proving to have the potential to respond rapidly to emerging viruses such as MERS-CoV and certain potential pandemic influenza strains, addressing what are clearly urgent public health needs," said Gale Smith, Ph.D., Vice President of Vaccine Development at Novavax. "Novavax will continue to evaluate this technology to produce highly immunogenic nanoparticles for coronavirus, influenza, and other human disease pathogens with the potential for pandemic and sustained human to human transmission."
"The emergence of SARS-CoV and MERS-CoV demonstrates how coronaviruses can spillover from animals into humans at any time, causing lethal disease," said Matthew B. Frieman, Ph.D., Assistant Professor of Microbiology and Immunology at the University of Maryland School of Medicine and corresponding author on the publication. "Despite efforts to create a vaccine against SARS-CoV, no vaccine candidate has, to date, been successfully licensed for use. We have demonstrated that this novel method rapidly creates SARS-CoV and MERS-CoV vaccines that induce neutralizing antibodies in mice."
"The University of Maryland School of Medicine investigators are continually working toward a better understanding of the interactions between the human immune system and a variety of known and novel harmful microbes," said E. Albert Reece, Vice President of Medical Affairs, the University of Maryland and the John Z. and Akiko Bowers Distinguished Professor and Dean, University of Maryland School of Medicine. "This makes our faculty poised to respond to emerging infectious diseases, such as MERS-CoV, which threaten the health and wellbeing of the global population."
The vaccine candidates were made using Novavax' recombinant nanoparticle vaccine technology and based on the major surface spike (S) protein, a SARS-CoV and MERS-CoV surface protein responsible for attaching the virus to cells. Novavax previously demonstrated that spike protein nanoparticles could protect animals against lethal live challenge using the SARS-CoV virus2.
About MERS-CoV
MERS-CoV, first identified in 2012, is one of a family of viruses with the potential to rapidly spread from a benign infection of animals to cause severe disease in humans. In 2003, a previously unknown coronavirus called SARS-CoV caused an outbreak that raised health alarms by infecting over 8,000 individuals and killing 775. According to the World Health Organization, the novel MERS-CoV thus far has resulted in 107 deaths out of 345 infections, the majority of which are characterized by severe illness and hospitalizations. Both diseases were marked by a jump from animals to people and while SARS-CoV spread more quickly in humans, MERS-CoV is proving to be more deadly.
About University of Maryland School of Medicine
Established in 1807, the University of Maryland School of Medicine was the first public medical school in the United States, and the first to institute a residency-training program. The School of Medicine was the founding school of the University of Maryland and today is an integral part of the 11-campus University System of Maryland. On the University of Maryland's Baltimore campus, the School of Medicine serves as the anchor for a large academic health center which aims to provide the best medical education, conduct the most innovative biomedical research and provide the best patient care and community service to Maryland and beyond. www.medschool.umaryland.edu.
About Novavax
Novavax, Inc. (Nasdaq:NVAX) is a clinical-stage biopharmaceutical company creating novel vaccines and vaccine adjuvants to address a broad range of infectious diseases worldwide. Using innovative proprietary recombinant protein nanoparticle vaccine technology, the company produces vaccine candidates to efficiently and effectively respond to both known and newly emergent diseases. Novavax is involved in several international partnerships, including collaborations with Cadila Pharmaceuticals of India, LG Life Sciences of Korea, PATH and recently acquired Isconova AB, a leading vaccine adjuvant company located in Sweden. Together, Novavax' network supports its global commercialization strategy to create real and lasting change in the biopharmaceutical and vaccinology fields. Additional information about Novavax is available on the company's website, novavax.com.
About Vaccine
Vaccine is the pre-eminent journal for those interested in vaccines and vaccination. It is the official journal of The Edward Jenner Society, The International Society for Vaccines and The Japanese Society for Vaccinology. www.elsevier.com/locate/vaccine
References:
1. C. M. Coleman et al. Purified coronavirus Spike protein nanoparticles induce coronavirus neutralizing antibodies in mice. Vaccine. In press, April 13, 2014.
2. Y. Liu et al. Chimeric severe acute respiratory syndrome coronavirus (SARS-CoV) S glycoprotein and influenza matrix 1 efficiently form virus-like particles (VLPs) that protect mice against challenge with SARS-CoV, 2011; 29(38): 6606-6613.
Copies of the paper are available to credentialed journalists upon request; please contact Elsevier's Newsroom at newsroom@elsevier.com or +31-20-4853564.
Novavax Inc., Forward-Looking Statements
Statements herein relating to the future of Novavax and the ongoing development of its vaccine and adjuvant products 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, 2013, filed with the Securities and Exchange Commission (SEC). 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 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.
CONTACT: Media Contacts:
Christopher Hardwick
(chardwick@som.umaryland.edu)
University of Maryland School of Medicine
410-706-5260
Barclay A. Phillips
SVP, Chief Financial Officer and Treasurer
Novavax, Inc.
240-268-2000
David Schull or Andrea Flynn, Ph.D.
david.schull@russopartnersllc.com
andrea.flynn@russopartnersllc.com
Russo Partners
212-845-4271
Source: Novavax, Inc.
New BioNitrogen website has been launched.
www.bionitrogen.com
An entertaining read. Thanks for sharing.
Can't wait for him to be wrong about this prediction, re NVAX:
http://www.thestreet.mobi/story/12677838/1/mad-money-lightning-round-i-like-mt-bank.html
*"Agree" that it would be a blow...not "after" that it would be a blow
After that it would be a blow to Hardee County if it never comes to fruition, given all the time and effort put forth so far (i.e. the money set aside for rail spur, the land purchase, the fact that Bionitrogen has ties to Hardee County via Brian Samuels, and the proximity of the proposed plant to Florida Light and Power and the other fertilizer company that was providing them with trees for biomass). At this point, though, I'd like to see the first plant get going no matter where the heck it starts.
Notice how the Perry News Herald says "serving the tree capital since...". Looks like biomass clearly won't be issue there, which I'm sure Bionitrogen already knew before going this far.
Excellent. Our boy, Brian Samuels, knocking it out of the park! Great find, Codaras. Thanks for posting.
Hardee County Development Authority doesn't believe BioNitrogen is real?
An official welcome to the IHub BION board, Swikey.
Your screen name looks familiar. Do you also post on the BION Yahoo message board using the username Swikeey? I used to check that board myself, but I gave up on Yahoo for this particular ticker b/c it is useless, as you undoubtedly know if that was you who used to post over there. This MB is much better, although still probably under-utilized. Glad you have been following along for a year and a half over here, though.
BTW, do you know if the scandal at the Hardee County Development Authority has anything to do with BION or is it totally unrelated?
I have seen that happen once before where they were downgraded to Limited Info but came back to their typical Pink listing after becoming current with filings.
I like how this is another person on the Novavax team who has previously worked at Medimmune's and had experience with Synagis.
Press Release: Novavax Appoints Dr. Cindy Oliver as Senior Vice President, Process Development Operations
6 minutes ago - DJNF
Novavax Appoints Dr. Cindy Oliver as Senior Vice President, Process Development Operations
GAITHERSBURG, Md., April 7, 2014 (GLOBE NEWSWIRE) -- Novavax, Inc. (Nasdaq:NVAX), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of recombinant nanoparticle vaccines and adjuvants, today announced the appointment of Cynthia N. Oliver, Ph.D. to the position of Senior Vice President, Process Development Operations, effective April 8, 2014. Dr. Oliver will be responsible for all process development activities, with a specific focus on the company's RSV F-protein nanoparticle, seasonal influenza and pandemic influenza vaccine candidates.
Dr. Oliver has been a consultant of Novavax since 2011 where her significant expertise and experiences have helped the Company formulate and execute on critical process development strategies. From 1993 until 2010, Dr. Oliver held a variety of positions, including Vice President, Process Biochemistry and Formulation Sciences at Medimmune, Inc., with responsibilities that included vaccines, proteins, monoclonal antibodies and small molecules, including the commercial products Synagis(R) and FluMist(R). Prior to MedImmune, she had similar responsibilities at Merck Research Laboratories, and spent a number of years working at the National Institutes of Health in the National Heart, Lung and Blood Institute. She earned her doctorate from Johns Hopkins, her masters from University of Massachusetts, and her bachelor's degree from Connecticut College.
"At Novavax, successful process development is critical to the ongoing development of our novel vaccines and it serves as the foundation upon which a consistent, GMP commercial manufacturing process is built. Cindy's extensive experience, industry knowledge and managerial aptitude complement our ongoing efforts to bring our RSV, seasonal influenza and pandemic influenza vaccine candidates to licensure," said Stan Erck, President and CEO of Novavax, Inc. "After working with us as a consultant for three years, I am delighted that Cindy has agreed to join Novavax to lead our process development efforts."
Dr. Oliver remarked, "Novavax' progress and success in Phase 2 clinical trials evidences its commitment to bringing important, and in the case of RSV, industry-leading vaccines to the market. I have been delighted to consult with Novavax to this stage, and am equally delighted to head up our efforts to develop safe, high quality vaccines and state-of-the-art vaccine production. Novavax' approach to developing these and other, earlier-stage preclinical vaccine candidates, has tremendous commercial potential, and I am honored to lead the process development function that supports this exciting technology."
About Novavax
Novavax, Inc. (Nasdaq:NVAX) is a clinical-stage biopharmaceutical company creating novel vaccines and vaccine adjuvants to address a broad range of infectious diseases worldwide. Using innovative proprietary recombinant protein nanoparticle vaccine technology, the company produces vaccine candidates to efficiently and effectively respond to both known and newly emergent diseases. Additional information about Novavax is available on the company's website, novavax.com.
Forward-Looking Statements
Statements herein relating to the future of Novavax and the ongoing development of its vaccine and adjuvant products 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, 2013, and filed with the Securities and Exchange Commission (SEC). Investors are cautioned not to place considerable reliance on the forward-looking statements contained in this press release. You are encouraged to read company filings with the SEC, available at 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 the company undertakes no obligation to update or revise any of the statements. The company's 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.
CONTACT: Barclay A. Phillips
SVP, Chief Financial Officer and Treasurer
Novavax, Inc.
240-268-2000
(END) Dow Jones Newswires
April 07, 2014 12:33 ET (16:33 GMT)
Agree. Over the past week or so, I have started to get a little nervous about the price action. I worry now about the interim results which have already been collected by NVAX in their RSV study in women of childbearing age. I hope there is not this huge selling pressure due to some negative inside information. That always makes me nervous b/c retail investors are always the last to know. Otherwise, maybe this is manipulation by market makers to obtain cheaper shares for somebody by taking out stops so that if good news is released, then somebody got a lot of shares at a discount from the 52-week high.
I am still hopeful for excellent results from the RSV study b/c of the data hitherto and the fact that NVAX is making the same palivizumab antibody that Synagis is, but it's through an active rather than passive process. I think, therefore, that the efficacy of the tested vaccine should be robust. If there is a potential for downfall, it'd likely be in an adverse reaction, likely from the adjuvant. That's what we would probably have to worry about if the Ph2 results aren't as expected.
The thing that gets me is the conference call we just had where they kept talking about their excitement to get going on further RSV studies. You would think that they wouldn't have been so gung ho on this if they knew their interim results were poor. Of course, maybe they can hide behind their Safe Harbor statement? I don't know. Either way, it'd be disingenuous for them to tout their excitement going forward for RSV if they knew their interim results were poor.
I'm not sure if it's really so much related to the fiscal losses because everyone expects that in these early-stage small-cap biotechs. I think the MAJOR issue is the fact that there are only 3 patients enrolled out of 388. They have a loooong way to go, and it's not happening very quickly. I think there is concern that their timeline to complete enrollment by end of 2015 is not likely to happen, unless enrollment picks up as all these centers start screening patients. There was a bearish article on Seeking Alpha that was good at elucidating a new possible timeline for enrollment.
I'm still long on this stock but realize it's going to be a long-term play!
Novavax, Inc. beats by $0.01, beats on revenue • 4:20 PM
Novavax, Inc. (NVAX): Q4 EPS of -$0.07 beats by $0.01.
Revenue of $8.74M (+91.2% Y/Y) beats by $2.52M.
Enanta Pharmaceuticals (ENTA) PT Raises to $45 at Leerink Swann
www.streetinsider.com/Analyst+PT+Change/Enanta+Pharmaceuticals+%28ENTA%29+PT+Raises+to+$45+at+Leerink+Swann/9263249.html