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Back during the epidemic, they announced a while ago they were in Ebola and had really good pre-clinical data but weren't pursuing it any further unless they had gov't funding.
I don't believe they ever committed to a piece of the Zika virus vaccine pie, though. Although, they are very well positioned with their technology to respond to epidemics in the future, as evidenced by their Ebola data and making a vaccine in 90 days after sequencing the viral DNA.
I have been in NVAX for three years, as my first purchases were in May and June of 2013. This is my largest holding and the one I follow the most closely.
I am cautiously optimistic that they will achieve statistically significant results in their Ph3 trial for elderly RSV vaccine, "Resolve", especially since the FDA worked with them to design the primary objective of prevention of moderate-severe RSV-associated lower respiratory tract disease, as defined by the presence of multiple lower respiratory tract symptoms. This was in contrast to the Ph2 trial, which had a primary outcome of reducing the incidence of respiratory illness due to RSV.
Getting FDA approval of this vaccine for RSV in the elderly population would be a huge victory for the company. Any follow-on indications, like the maternal and pedi population that they're working on, is icing on the cake. Aside from that, their combo respiratory vaccine (quadrivalent flu + RSV) would be their next game changer. Their prior studies in their flu vaccine alone were impressive enough.
Overall, I'm pretty bullish on their prospects; but I may take a little off (hopefully before trial results if I can guess timing correctly) and a little more off if they have successful Ph3 results. I'm sure there will be a pop on good data followed by a correction until launch and financial results start to be revealed.
Other factors that might happen between Ph3 and launch are, obviously, announcement of an ex-US partner and/or buyout. Stan has stated over and over that they plan to go-it-alone (except for an ex-US partner), but I'm not convinced that they wouldn't sell for the right price.
They seem to have beefed up their manufacturing capabilities and can produce millions of vaccines, but they would have a better chance of robust financial results if they sold out to a large pharma like Pfizer, Novartis, Sanofi, GSK, Merck, or AstraZeneca. This is all stemming on successful Ph3 results, of course. Eventually, they would probably do more for their shareholders in the long-term if they didn't sell out and kept everything in house (except for ex-US), especially if their other trials pan out.
There would probably be hiccups and risk along the way like with a slow roll out, but I think they could meet the demand for the RSV vaccine. If shareholders were willing to hold and the company chose not to sell out, we'd be rewarded much more than selling out to a large pharma this year or early next.
Saw that. Seems like an unnecessary response in share price to the delay. That's a lot of patient data, requiring time to sift through it all. Maybe SRPT took up so much of their time, and now they need to get back to their logjam of work. :)
Quite possibly.
http://www.who.int/csr/research-and-development/zika-rd-pipeline.pdf
The link above shows all the companies with hats in the ring. There are some heavy hitters, but with NVAX's ability to produce a vaccine in 90 days (and subsequent ability to mass produce thereafter), they should stand a very strong chance at funding.
Remember, they produced a very effective Ebola vaccine in 90 days in response to the epidemic, but they were "late" to the game because other companies had already been working on Ebola prior to that huge outbreak in Africa.
I think that they won't move anything along further than the initial stages without funding from gov't because they have their eyes on RSV studies.
Hmmm. That's a lot of volume. I wonder if it has anything to do with triple witching hour. Or perhaps maybe some fund is rebalancing?
Yup, still here. Just waiting till Q3. Latest round of financing seemed weird and unnecessary...didn't like that little surprise, but I'm putting trust in the management. We shall see.
[OT] Yup, my wife said the exact same thing as you when I showed her this article. She actually picked up some at Whole Foods today.
$WFM [WFM mentioned but in a good way ;)]
FDA finds wood fillers in Parmesan cheese, investigates large retailers
(RNN) - The Parmesan cheese you’ve sprinkled as a topping for your pizzas and other foods could contain wood, according to a new report.
The U.S. Food and Drug Administration visited a cheese factory in Pennsylvania in 2012 and found evidence of Castle Cheese Inc. adding fillers, such as wood pulp, in their 100 percent real Parmesan cheese.
This cheese has been distributed to some of the largest grocery chains in the U.S.
The FDA stated that some Parmesan suppliers were mislabeling their products and filling them with cellulose, which is an anti-clumping agent made from wood pulp.
Castle President Michelle Myrter is set to plead guilty to criminal charges this month, according to Bloomberg News. Myrter faces up to a year in prison and a $100,000 fine.
Neal Schuman, the owner of New Jersey-based company Arthur Schuman Inc., is the biggest seller of hard Italian cheeses in the U.S. He estimated that 20 percent of U.S. production, which is about $375 million in sales is mislabeled.
Schuman has insisted that the grated cheese Americans use on their pizza and penne should be real, and if it’s not the label should say that.
The grated cheese bought in stores was tested for wood pulp, and the Center for Dairy Research’s cheese technologist Dean Sommer said cellulose is a safe additive to cheese, as long as it constitutes no more than two to four percent.
The results of cellulose found in cheese labeled 100 percent Parmesan from Walmart Stores' Great Value 100 percent Grated Parmesan Cheese was 7.8 percent, Jewl-Osco’s Essential Everyday 100 percent Grated Parmesan Cheese was 8.8 percent, the Whole Foods 365 brand contained 0.3 percent cellulose and Kraft had 3.8 percent.
Spokespersons for Jewel-Osco, Whole Foods, Walmart and Kraft Heinz said they are investigating these results.
In recent years, the FDA has enforced labeling rules on goods to keep consumers safe.
Copyright 2016 Raycom News Network. All rights reserved.
www.wfsb.com/story/31246197/fda-finds-wood-fillers-in-parmesan-cheese-large-retailers-investigated
I have thought about the fact that they may throw there hat in the arena if that viral genome has been fully decoded. They could finally prove to the big boys that they are legit by showing them how fast they can produce a vaccine. They were "late" to Ebola only because they started years behind the other competitors. But this huge amount of funding would not explain that solely. It's going to be used for RSV, flu, combo respiratory vax, and anything else they need [pandemic flu, ?Ebola (I doubt it), Zika, etc].
Correct. Must meet the exception.
What do you think of this mode of financing and the terms?
$300 million, up from $200 million offer
Novavax Prices $300 Million of Convertible Senior Notes Due 2023Source: GlobeNewswire
GAITHERSBURG, Md., Jan. 25, 2016 (GLOBE NEWSWIRE) -- Novavax, Inc. (Nasdaq:NVAX), a clinical-stage vaccine company focused on the discovery, development and commercialization of recombinant nanoparticle vaccines and adjuvants, today announced the pricing of $300 million aggregate principal amount of convertible senior unsecured notes that will mature on February 1, 2023 (the Notes). The Notes are being offered and sold only to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended. Novavax has also granted the initial purchasers of the Notes an option to purchase up to an additional $30 million aggregate principal amount of the Notes, solely to cover over-allotments. The offering was upsized from the previously announced size of $200 million.
Citigroup and J.P. Morgan are acting as joint book-running managers of the offering. Piper Jaffray and Guggenheim Securities are acting as Co-Lead Managers.
The Notes will bear cash interest at a rate of 3.75%, payable on February 1 and August 1 of each year, beginning on August 1, 2016. The Notes will not be redeemable prior to maturity and will be convertible into shares of Novavax common stock. The initial conversion rate for the Notes is 146.8213 shares of Novavax' common stock per $1,000 principal amount of the Notes, which is equivalent to an initial conversion price of approximately $6.81 per share of Novavax' common stock, representing an approximately 22.5% conversion premium based on the last reported sale price of Novavax' common stock of $5.56 per share on January 25, 2016.
Novavax estimates that the net proceeds of the offering will be approximately $291 million (or approximately $320 million if the initial purchasers' over-allotment option is exercised in full), after deducting the initial purchasers' discounts and commissions, but prior to deducting estimated offering expenses. Novavax intends to use the net proceeds from the offering for the advancement of its clinical-stage vaccine candidates, including its recently initiated pivotal Phase 3 clinical trials of its RSV F Vaccine in older adults and pregnant women, as well as its other clinical and preclinical research programs, and general corporate purposes, which may include working capital, product development, manufacturing and process development expenditures, capital expenditures, acquisitions and other strategic purposes. Novavax also intends to use a portion of the net proceeds from the offering to pay the cost of certain capped call transactions (described below).
In connection with the pricing of the Notes, Novavax also entered into privately negotiated capped call transactions with certain financial institutions (the option counterparties). The capped call transactions are expected generally to reduce the potential dilution upon conversion of the Notes in the event that the market price per share of Novavax' common stock, as measured under the terms of the capped call transactions, is greater than the strike price of the capped call transactions, which initially corresponds to the conversion price of the Notes, and is subject to anti-dilution adjustments generally similar to those applicable to the conversion rate of the Notes. The cap price of the capped call transactions will initially be $9.73 per share, which represents a premium of approximately 75% based on the last reported sale price of Novavax' common stock of $5.56 per share on January 25, 2016, and is subject to certain adjustments under the terms of the capped call transactions. If, however, the market price per share of Novavax' common stock, as measured under the terms of the capped call transactions, exceeds the cap price of the capped call transactions, there would nevertheless be dilution upon conversion of the Notes to the extent that such market price exceeds the cap price of the capped call transactions. If the initial purchasers of the Notes exercise their over-allotment option, Novavax expects to enter into additional capped call transactions with the option counterparties.
Novavax expects that, in connection with the capped call transactions, the option counterparties or their respective affiliates will enter into various hedging transactions, including (without limitation) derivative transactions with respect to Novavax' common stock and/or to purchase Novavax' common stock concurrently with or shortly after the pricing of the Notes. This activity could impact the market price of Novavax' common stock or the Notes at that time, and could result in a higher effective conversion price for the Notes. In addition, the option counterparties and/or their respective affiliates may, from time to time, modify their hedge positions by entering into or unwinding various hedging positions, including (without limitation) derivative transactions with respect to Novavax' common stock and/or by purchasing or selling Novavax' common stock or other securities of Novavax in secondary market transactions. This activity could also impact the market price of Novavax' common stock or the Notes, which could affect the value of the shares that a holder of Notes receives upon conversion of the Notes.
The offer and sale of the Notes are not being registered under the Securities Act, or any state securities laws. The Notes may not be offered or sold in the United States except pursuant to an exemption from the registration requirements of the Securities Act and any applicable state securities laws.
This news release does not constitute an offer to sell or a solicitation of an offer to buy the securities described herein, nor shall there be any sale of these securities, in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the laws of such jurisdiction.
About Novavax
Novavax, Inc. (Nasdaq:NVAX) is a clinical-stage vaccine company committed to delivering novel products to prevent a broad range of infectious diseases. Its recombinant nanoparticles and Matrix-M(TM) adjuvant technology are the foundation for groundbreaking innovation that improves global health through safe and effective vaccines.
Forward-Looking Statements
This press release contains forward-looking statements. Investors are cautioned not to place undue reliance on these forward-looking statements, including, but not limited to, statements regarding the estimated net proceeds of the offering and Novavax' anticipated use of proceeds, Each forward-looking statement is subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statement. Applicable risks and uncertainties include, but are not limited to, those related to whether or not Novavax will be able to consummate the offering and the capped call transactions on the timeline or with the terms anticipated, if at all, the conduct, timing and potential results from Novavax' clinical-trials and other preclinical studies, Novavax' plans for and potential timing of regulatory filings, the expected timing and content of regulatory actions, Novavax' plans regarding partnering activities and business development initiatives, and the timing and success of Novavax' commercialization, if any, of its product candidates. In addition, Novavax' management retains broad discretion with respect to the allocation of the net proceeds of this offering. Applicable risks also include those that are listed under the heading "Risk Factors" and elsewhere in Novavax' Annual Report on Form 10-K for the fiscal year ended December 31, 2014, in addition to the risk factors that are included from time to time in Novavax' subsequent SEC filings. Novavax undertakes no obligation to update these forward-looking statements to reflect events or circumstances occurring after this press release. Except as otherwise noted, these forward-looking statements speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement.
Novavax, Inc.
Barclay A. Phillips
SVP, Chief Financial Officer and Treasurer
Andrea N. Flynn, Ph.D.
Senior Manager, Investor Relations
ir@novavax.com
240-268-2000
Also, only outside the US...
"The offer and sale of the Notes are not being registered under the Securities Act, or any state securities laws. The Notes may not be offered or sold in the United States except pursuant to an exemption from the registration requirements of the Securities Act and any applicable state securities laws."
BioNitrogen Plant FL Taylor, LLC v. Fulcrum Global Solutions, LLC
https://www.pacermonitor.com/public/case/10505360/BioNitrogen_Plant_FL_Taylor,_LLC_v_Fulcrum_Global_Solutions,_LLC
Pure craziness today! I think patient investors will be rewarded in the long run.
Thanks. Admittedly, as I've said before, I haven't followed this story as closely as I used to, but occasionally check in to see ongoing events.
From that article...what does this mean to you?
"The Lender, however, which is controlled by a member of BION’s board of directors, has agreed to fund the..."
Is this referencing the initial lender (Annon Consulting) or a new lender for the $43,981 that BION is seeking?
In either case, do we know who the Board member is that is also the lender?
If this is regarding Annon, I know there was speculation on this forum that the lender was Kornegay hiding behind Annon, but BK is no longer a Board member. The next best logical guess for the mysterious front person would be Contreras, I suppose?
Geez, just when you thought Ebola was gone. Hopefully for Africa's sake this will just be a continued "smoldering."
No new insight. Everything is pretty much as NVAX has been describing on their calls and PRs. They are hitting almost of their of deadlines for trial initiations and completions (except for the pedi RSV vaccine trial, which a while ago they said was going to have delayed enrollment). Ph3 and Ph2 trials are starting, further investigating RSV vaccines in different patient populations. Also awaiting FDA guidance on Ph3 trial design for maternal RSV. So there will be some data to look forward to in Q3/Q4 2016 for which we should have some (hopefully) impressive readouts. Of course, we could always hear some news about NVAX's Ebola vaccine as other companies' Ebola vax candidates may continue to fail. I, however, am not holding my breath on any gov't funding for now given that they already sponsored a couple other companies and the Ebola threat seems to have gone away. While RSV and flu vaccines are NVAX's major pipeline components, they continue to impress with their ability to make an effective vaccine within 90 days after the viral genome is mapped. That's faster than anybody else. The only reason they didn't get funding for their Ebola vaccine was because other companies already had candidates in their pipeline. NVAX was "late" to the game, but one might argue that they were able to very quickly develop a candidate and maybe even the most effective one (with the added characteristic of not needing to be frozen). I was anticipating Q3 2015 for quite some time, but I think Q3/Q4 2016 will be just as exciting.
If BION ultimately fails to come out of the bankruptcy protection, I wouldn't be surprised to see "Annon" (whoever they really are) take the patents and reverse merge into another shell and start the whole pump & dump scam again.
I would recommend you check out the Facebook page of somebody named "Mo Tonya." It's like a community activist page for Perry, FL. This page may have been mentioned before here (maybe even by me), but there is some interesting info there about Applied Gaia. That company seems pretty fishy too. Lot of shady companies between BioNitrogen, Annon, and Applied Gaia. Maybe they're all in bed together...and with some of the city leaders possibly as well.
True. Volume is high compared to normal avg vol but not nearly as high as it could be.
The time gap does seem long, but it could certainly still be those original fraudsters. Maybe they didn't need to strike such a "deal" until recently because BION had been trading just enough volume and at just enough price per share that they could just keep cashing in shares comfortably for profit. When people started sniffing around and not trusting BION and their financials, maybe this whole thing was concocted to ultimately transfer ownership and start the whole pump and dump again. If those people were still involved, then they had probably just kept profiting from the PRs that BION released noting all their progress with city funds, etc.
I admit, they really did get a lot accomplished for this just to be a slimy shell pump-and-dump; but there has always been something sketchy about them, despite all the promise of their technology. I just wonder about the legitimacy of it...wouldn't one of the big urea producers have come in and bought them out if it really was disruptive technology? Also, they were never able to get EPC done. It always seemed related to lack of money, but maybe it also proved not effective? I'm just conjecturing at this point.
The straw that broke the camel's back for me was Brian Kornegay being arrested last Fall. I sold that day because I had enough. I figured all the players involved were crooked insiders looking to get rich. They also pulled the wool over legislators eyes, too. That, or they were all in bed together.
Thanks for chiming in nodummy. I was hoping you would at some point.
Phase 2 Data for Investigational Orally Active HIF-PHI Roxadustat (FG-4592) Show Anemia Correction in Incident Dialysis Chronic Kidney Disease Patients Regardless of Iron Repletion Status, Iron Supplementation Regimen, or Dialysis Modality
October 22, 2015
SAN FRANCISCO, Oct. 22, 2015 (GLOBE NEWSWIRE) -- FibroGen, Inc. (Nasdaq:FGEN) (“FibroGen”), a research-based biopharmaceutical company, along with its partner, AstraZeneca (NYSE:AZN), today announced that the Journal of the American Society of Nephrology has published Phase 2 data showing roxadustat, an investigational therapy for the treatment of anemia in patients with chronic kidney disease (CKD), achieved 96 percent hemoglobin (Hb) response and increased mean Hb regardless of baseline iron repletion status, C-reactive protein level, iron regimen, or dialysis modality within 7 weeks.
The primary endpoint, the mean maximum Hb change from baseline (baseline Hb 8.3+1.0 g/dL), was 3.1 ±0.2 g/dL (SEM) among the efficacy evaluable subjects (n=55). Hb response, defined as Hb increase by ≥ 1.0 g/dL, was achieved in 96 percent of all roxadustat-treated subjects, with a median time to Hb response of 3 weeks in each cohort.
“This trial demonstrated that roxadustat may be able to correct anemia in an incident dialysis population, and to do so with either oral or IV iron supplementation even when the patient’s initial iron status does not meet broadly accepted clinical practice guidelines,” said Anatole Besarab, MD, executive director, clinical research, at FibroGen, and lead author. “The correction of anemia with roxadustat did not require prior iron repletion as is often the case with erythropoiesis-stimulating agents. This independence of hemoglobin response from iron regimen or basal iron status resulted from reduction in the hepcidin levels.”
The rates of increase in mean Hb over the 12-week treatment period and the mean Hb levels during the last four weeks were similar among patients receiving oral or intravenous (IV) iron (mean maximum Hb change of 3.4 to 3.5 g/dL). Roxadustat therapy in the absence of any form of iron supplementation still led to a mean maximum Hb increase of 2.8 g/dL.
“We designed this study to evaluate the ability of roxadustat to correct hemoglobin in what is widely regarded as the highest risk yet least frequently studied population of CKD patients,” said Thomas Neff, chief executive officer of FibroGen. “Our study showed that newly initiated dialysis patients with end stage renal disease had a robust hemoglobin response regardless of whether they received IV or oral iron supplementation. FibroGen and its partners are currently conducting a global Phase 3 clinical program evaluating the efficacy and safety of roxadustat in patients with anemia due to CKD, including incident and stable dialysis patients and patients not on dialysis.”
Current treatment of anemia in CKD requires erythropoiesis-stimulating agents (ESAs) with IV iron supplementation, particularly in end stage renal disease patients (ESRD). In standard clinical practice, ESRD patients who have recently started dialysis are a clinically challenging population. During the first four months of dialysis initiation, life-threatening cardiovascular complications and other adverse events generally occur more frequently than thereafter, leading to a higher mortality rate for incident dialysis patients than for stable dialysis patients.1 It is during this period of initiation that the highest doses of erythropoietin analog and IV iron use are required. In addition, a variety of factors, including the obligate need for IV iron with ESAs, inhibit optimal Hb correction during this initiation period.2
About the Study
This was a randomized, open-label, dose-titration study in incident dialysis subjects not receiving ESA treatment to evaluate the efficacy of roxadustat in the correction of anemia.
This study was conducted in 60 patients who received no iron, oral iron, or IV iron while treated with roxadustat for 12 weeks.
Eligible patients were erythropoietin analog-naïve, had initiated dialysis two weeks to four months before enrollment with baseline Hb values ≤10.0 g/dL, had ferritin levels of 50 to 300 ng/mL, had transferrin saturation levels of 10% to 30%, had normal liver function, and had not received IV iron therapy within four weeks prior to randomization. In this study, 24 hemodialysis (HD) subjects received no exogenous iron supplementation, 12 HD and 12 peritoneal dialysis (PD) subjects received oral iron, and 12 HD subjects were administered IV iron.
Roxadustat was dosed orally three times weekly for 12 weeks. Initial doses (1.0 - 1.7 mg/kg per dose) for the first four weeks were determined using three body weight tiers, followed by dose adjustment evaluations every four weeks based on Hb, to a maximum of 2.5 mg/kg.
Roxadustat was well tolerated in the safety population. Treatment-emergent adverse events were reported in 30 patients, 50 percent of all patients in the safety population. The nature and severity of the adverse events was typical for ESRD patients undergoing HD or PD. Adverse events characterized as severe (n=4), life-threatening (n=0), or fatal (n=2) were reported in six (10 percent) patients.
Detailed results and safety data from the trial were published in Journal of the American Society of Nephrology and can be viewed here: http://jasn.asnjournals.org/content/early/2015/10/22/ASN.2015030241.full.pdf+html.
About Roxadustat (FG-4592)
Roxadustat is an orally administered small molecule inhibitor of hypoxia-inducible factor (HIF) prolyl hydroxylase activity, in development for the treatment of anemia in patients with chronic kidney disease. HIF is a protein transcription factor that induces the natural physiological response to conditions of low oxygen, "turning on" erythropoiesis (the process by which red blood cells are produced) and other protective pathways.
About Chronic Kidney Disease
CKD affects more than 200 million people worldwide and more than 30 million adults in the U.S. Although it can occur at any age, it becomes more common in aging populations and the prevalence is increasing. Currently, no curative treatment or ability to stop kidney deterioration in CKD exists with the exception of kidney transplantation, creating a significant unmet medical need.
About FibroGen
FibroGen is a research-based biopharmaceutical company focused on the discovery, development, and commercialization of novel therapeutics to treat serious unmet medical needs. The company utilizes its extensive experience in fibrosis and hypoxia-inducible factor (HIF) biology to generate development programs in multiple therapeutic areas. Its most advanced product candidate, roxadustat, or FG-4592, is an orally administered small molecule inhibitor of HIF prolyl hydroxylase (HIF-PH) activity in Phase 3 clinical development for the treatment of anemia in CKD. A second product candidate, FG-3019, is a monoclonal antibody in Phase 2 clinical development for the treatment of idiopathic pulmonary fibrosis (IPF), pancreatic cancer and liver fibrosis. For more information please visit:www.fibrogen.com.
Forward Looking Statements
This release contains forward-looking statements, including statements regarding the increasing prevalence of CKD and the potential for roxadustat to be able to correct anemia in an incident dialysis population regardless of baseline iron repletion status or method of iron supplementation. Actual prevalence of CKD and our actual results may differ materially from those indicated in these forward-looking statements due to risks and uncertainties that are described in our Annual Report on Form 10-K and our quarterly reports on Form 10-Q filed with the Securities and Exchange Commission, including the risk factors set forth therein. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release and we undertake no obligation to update any forward-looking statement in this press release, except as required by law.
References
United States Renal Data System. 2013 USRDS annual data report: Epidemiology of kidney disease in the United States, Volume 2, Chapter 5.National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD, 2013.
United States Renal Data System. 2013 USRDS annual data report: Epidemiology of kidney disease in the United States, Volume 2, Chapter 2.National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MDContact Greg Mann FibroGen, Inc. 415-978-1433 gmann@fibrogen.com
FibroGen, Inc.
News Releases
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© 2015 FibroGen Inc.
Have a great trip, TW. Safe travels.
CTRV - ContraVir Reports New Data demonstrating CMX157 to be 60-Fold More Potent Against Hepatitis B Virus than Gilead's Viread(R)
EDISON, N.J., Oct. 5, 2015 /PRNewswire/ -- ContraVir Pharmaceuticals, Inc. (NASDAQ: CTRV), a biopharmaceutical company focused on the development and commercialization of targeted antiviral therapies, today announced preliminary data dramatizing the unique properties of CMX157, the Company's highly potent lipid prodrug of the successful antiviral drug tenofovir (TFV). CMX157 was shown to be 60-fold more active than tenofovir against the hepatitis B virus (HBV) based on in vitro studies. This significant potency difference has considerable potential in increasing the safety profile and reducing the side effects compared to tenofovir DF (Viread(R)).
The Company believes CMX157's lipid-conjugate design clearly differentiates it from tenofovir DF. ContraVir plans to file an investigational new drug (IND) application for CMX157 to treat HBV before year-end 2015. CMX157 benefits from earlier human studies in volunteers under an IND for HIV. ContraVir is focused on a quick evaluation of CMX157 in a Phase 2 clinical study in patients with hepatitis B which it plans to begin in 2016.
CMX157's enhanced absorption technology which utilizes the natural lipid uptake pathway to target the liver has the potential to lower systemic exposure compared to tenofovir, resulting in reduced off-target toxicity. Other studies with CMX157 are examining the efficiency of CMX157 prodrug conversion to the active antiviral, tenofovir diphosphate, within targeted hepatocytes, and further assessing the in vitro safety profile of CMX157, including a comprehensive evaluation of the likelihood of drug-drug interactions.
The United States is expected to see more than a 15% rise in hepatitis B patients through 2033 and there are about 350 million chronic HBV patients worldwide. ContraVir is committed to meeting its timelines so that the Company is positioned to treat these patients and capture this attractive and growing market.
About CMX157
CMX157 is a novel lipid acyclic nucleoside phosphonate that delivers high intracellular concentrations of the active antiviral agent tenofovir diphosphate. Compared to tenofovir, CMX157 is up to 60-fold more active against HBV and more than 200-fold more active against all major HIV subtypes in vitro. CMX157's novel structure results in decreased circulating levels of tenofovir, lowering systemic exposure and thereby reducing the potential for renal and bone side effects. It has completed a Phase 1 clinical trial in healthy volunteers, demonstrating a favorable safety, tolerability and drug distribution profile.
About ContraVir Pharmaceuticals
ContraVir is a biopharmaceutical company focused on the discovery and development of targeted antiviral therapies with two candidates in mid-to-late stage clinical development. ContraVir's lead clinical drug, FV-100, is an orally available nucleoside analogue prodrug that is being developed for the treatment of herpes zoster, or shingles, which is currently in Phase 3 clinical development. In addition to direct antiviral activity, FV-100 has demonstrated the potential to reduce the incidence of debilitating shingles-associated pain known as post-herpetic neuralgia (PHN) in a Phase 2 clinical study. ContraVir is also developing CMX157, a highly potent analog of the successful antiviral drug tenofovir, for the Hepatitis B virus (HBV). CMX157's novel structure results in decreased circulating levels of tenofovir, lowering systemic exposure and thereby reducing the potential for renal side effects.
Forward Looking Statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as "anticipate," "believe," "forecast," "estimated" and "intend," among others. These forward-looking statements are based on ContraVir's current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, substantial competition; our ability to continue as a going concern; our need for additional financing; uncertainties of patent protection and litigation; uncertainties with respect to lengthy and expensive clinical trials, that results of earlier studies and trials may not be predictive of future trial results; uncertainties of government or third party payer reimbursement; limited sales and marketing efforts and dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. As with any drug candidates under development, there are significant risks in the development, regulatory approval, and commercialization of new products. There are no guarantees that future clinical trials discussed in this press release will be completed or successful, or that any product will receive regulatory approval for any indication or prove to be commercially successful. ContraVir does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in ContraVir's Form 10-K for the year ended June 30, 2015, and other periodic reports filed with the Securities and Exchange Commission.
For further information, please contact:
Tiberend Strategic Advisors, Inc.
Tirth Patel (investors)
tpatel@tiberend.com; (212) 375-2681
Claire Sojda (media)
csojda@tiberend.com; (212) 375-2686
To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/contravir-reports-new-data-demonstrating-cmx157-to-be-60-fold-more-potent-against-hepatitis-b-virus-than-gileads-viread-300153886.html
SOURCE ContraVir Pharmaceuticals, Inc.
(END) Dow Jones Newswires
October 05, 2015 06:00 ET (10:00 GMT)
Novavax Announces Grant of Up to $89 Million to Support Development of RSV F Vaccine to Protect Infants Via Maternal Immunization
Bill & Melinda Gates Foundation to Support Development of the RSV F Vaccine Program
GAITHERSBURG, Md., Sept. 29, 2015 (GLOBE NEWSWIRE) -- Novavax, Inc., (Nasdaq:NVAX) a clinical-stage vaccine company focused on the discovery, development and commercialization of recombinant nanoparticle vaccines and adjuvants, today announced it has been awarded a grant of up to $89 million from the Bill & Melinda Gates Foundation to support development of the RSV F Vaccine Phase 3 clinical trial in pregnant women, planned to initiate during the first quarter of 2016. This grant will also support regulatory licensing efforts, providing a path to WHO prequalification. Upon licensure, Novavax has agreed to make the RSV F Vaccine affordable and accessible to people in the developing world.
“Respiratory syncytial virus (RSV) is the leading cause of pneumonia in infants, and currently there are no affordable approaches to protecting children in the developing world from this viral disease,” said Dr. Keith Klugman, Director of the Bill & Melinda Gates Foundation’s Pneumonia Program. “Maternal immunization may provide protective antibodies to infants during the first few months of life, and we hope this vaccine will protect infants from this disease to help them live healthy, productive lives.”
“Along with today’s announcement of top-line data from the Phase 2 clinical trial of our RSV F Vaccine with the goal to protect infants via maternal immunization, we are very gratified to receive the support of the Bill & Melinda Gates Foundation to improve the health of infants throughout the world,” said Stanley C. Erck, President and CEO. “Our groundbreaking Phase 2 results in both maternal and older adult target populations, underscore the promise of our RSV F Vaccine programs. We look forward to carrying our recent momentum into the fourth quarter as we prepare to initiate two pivotal Phase 3 trials of our RSV F Vaccine.”
A fact sheet on maternal immunization is available at the Novavax website, novavax.com/download/files/pipeline/151_Novavax_FactSheet_FIN_D_9x10.pdf
About RSV
Respiratory syncytial virus (RSV) is the most common cause of lower respiratory tract infections and the leading viral cause of severe lower respiratory tract disease in infants and young children worldwide, with estimated annual infection and mortality rates of 64 million and 160,000, respectively1. In the US, RSV is the leading cause of hospitalization of infants2. Despite the induction of post-infection immunity, repeat infection and lifelong susceptibility to RSV is common3,4. Currently, there is no approved RSV 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 vaccine company committed to delivering novel products to prevent a broad range of infectious diseases. Our recombinant nanoparticles and Matrix-M™ adjuvant technology are the foundation for groundbreaking innovation that improves global health through safe and effective vaccines. Additional information about Novavax is available on the company’s website, novavax.com.
References:
Nair, H. et al. Global burden of acute lower respiratory infections due to respiratory syncytial virus in young children: a systematic review and meta-analysis. Lancet, 2010; 375: 1545-1555.
Hall, C.B. et al. Respiratory Syncytial Virus-Associated hospitalizations Among Children Less Than 24 Months of Age. Pediatrics, 2013; 132(2): E341-348.
Glezen, W.P. et al. Risk of primary infection and reinfection with respiratory syncytial virus. Am J Dis Child, 1986; 140:543-546.
Glenn GM, et al. Modeling maternal fetal RSV F vaccine induced antibody transfer in guinea pigs. Vaccine, 2015; In press. http://dx.doi.org/10.1016/j.vaccine.2015.08.039.
Novavax, Inc.
Barclay A. Phillips
SVP, Chief Financial Officer and Treasurer
Andrea N. Flynn, Ph.D.
Senior Manager, Investor Relations
ir@novavax.com
240-268-2000
Russo Partners, LLC
David Schull
Todd Davenport, Ph.D.
david.schull@russopartnersllc.com
todd.davenport@russopartnersllc.com
212-845-4271
Novavax, Inc.
The last piece of news we've been waiting for! Everything went well with their Phase 2 trials. Too bad it all had to occur in a bearish market environment. I'm liking their chances at success in all their Phase 3 trials. I'm very excited to hear about the $89 million grant from the Gates Foundation.
They are well positioned for 2016.
Thanks, TFletcher, for clearly having a good sense of humor and getting a chuckle out of that post. My whole point from my first post regarding fact vs. opinion was that we should be trying to develop a culture of acceptance and friendliness on the message board here. It doesn't matter whether or not the poster is for or against BioNitrogen. Whatever viewpoint (pro or con) each person brings here can be valuable info to everybody. There is no need to chide anybody for his/her standpoint or guess at their age or anything like that. It was my OPINION that some of your posts, particularly with Gatorlady, were snide and condescending, which has no use here. Forgive me for interpreting some of your posts that way, as I understand emotions are not clearly conveyed in the written text.
I'm almost 100% sure that years ago I used to scream and yell on this board when people tried to bash BION, claiming they were just trying to get shares for lower price. My little petty arguments with those other posters meant nothing in the grand scheme of things. Similarly, all these posts about fact vs. opinion will mean nothing in the grand scheme of things. BION will either succeed or fail on their own merits. In the meantime, I think the board should be used to toss around info, ideas, and opinions re BION (pro or con).
I was a staunch BION supporter in the past; however, my faith was shaken and I sold all my shares, as I've previously disclosed. I'm still watching with interest from the sideline, but I have no immediate plans to buy back in. I'll keep watching (and probably not posting much), but I just wanted to post to encourage people to be welcoming to other posters, particularly new posters and people who may express opinions contrary to BION longs. We can probably all learn from each other. Thanks.
This is a stock message board. I don't get the constant effort at trying to legislate opinion out of here and allow only facts. Facts and hard data are obviously important; but if you think people can't come here to express opinion and sound off one way or the other, then I think you're missing the whole point about these message boards. I'm pretty sure that we're all adults and can decide for ourselves, and easily determine, the difference between fact or opinion. I think both should be welcome here. I've been on this board since 2012, and there has been plenty of conjecture with nobody taking offense to it.
Forgot to say that, overall, I'm more bullish on DBVT than AIMT. Long @ $25 and $34.
I think DBVT has a potentially viable treatment option for peanut allergy (and quite possibly milk and egg with their platform). I had hoped DBVT would have a better overall response (higher percentage of responders) and higher dose of peanut protein tolerated, which AIMT appears to have accomplished in their trial. I worry, however, about the dropout rate in AIMT's trial due to GI side effects. Right now, AIMT may have the better clinical data/response, but it may not matter if half can't tolerate the drug.
DBVT reached statistical significance in their child cohort but failed to reach statistical significance with the older cohort (adolescent and/or adult, can't remember full details of the age breakdown off top of my head). I recall that if they tightened their definitions of responders they reached stat sig in that group. It's a mystery to me why the placebo group responded so well to increased peanut protein. Seems pretty fluky.
Besides the above issue, another potential snafu going forward for DBVT could be real-world compliance with a daily patch vs. a daily pill. Sure, trial compliance with the patch was great; but I wonder would it be in the real world, especially in toddlers whose parents may forget to put on the patch...or the kids try to remove them.
As an aside, I was surprised by the robust share price increase since DBVT's recent secondary offering in the US. Share price appreciated more than it did off of the trial data. Might have been the Baker Brother effect (they added to their position significantly), not sure, though.
Anyway, those are my late-night thoughts that I could type from my phone.
Yup. Insider enrichment only.
re ARTH
FWIW, ARTH was a pump-and-dump stock:
promotionstocksecrets.com/arch-therapeutics-inc-arth/
Disclosure: I traded this stock a couple of times for a profit having had access to the above report prior to it being made open to the public. I am no longer a member of the subscription group (it's great, BTW, for traders), as I work full time in healthcare and couldn't be available to make trades as frequently as was needed. Not to mention, I really didn't have the risk tolerance needed for it. I am now basically just a long-term biotech investor in my retirement account.
Yes, the market for RSV is very significant, never mind the potential for NVAX to supplant the leaders in the flu vaccine industry. I can't wait for their combo respiratory vaccine (RSV plus quadrivalent seasonal flu). Plus, they can get vaccine made 90 days after viral genome coded. They can respond to pandemics like none other.
Novavax Announces Positive Top-Line Data from Phase 2 RSV F-Protein Vaccine Clinical Trial in Older Adults
First respiratory syncytial virus (RSV) vaccine to demonstrate efficacy in any population
Statistically significant vaccine efficacy in prevention of symptomatic RSV disease in older adults
Large prospective epidemiological study of RSV; detected a seasonal attack rate of 4.9% for symptomatic RSV disease
PR Newswire, Gaithersburg, MD, August 10, 2015 -- Novavax, Inc. (Nasdaq: NVAX), a clinical-stage vaccine company focused on the discovery, development and commercialization of recombinant nanoparticle vaccines and adjuvants, today announced positive top-line data from a Phase 2 clinical trial of its RSV F-protein recombinant nanoparticle vaccine candidate (RSV F Vaccine) in older adults (60 years of age and older). The RSV F Vaccine was well-tolerated and fulfilled the Company’s expectations of the primary, secondary and exploratory objectives of the trial.
“It’s increasingly appreciated that RSV causes an enormous amount of illness on an annual basis, particularly in the older population. An RSV infection can predispose older adults to developing secondary pneumonia and admission to the hospital,” said Dr. William Schaffner, Professor of Preventive Medicine and Infectious Diseases, Vanderbilt University Medical Center. “Each year in the United States, approximately 14,000 people ages 65 or older die of RSV infections and approximately 900,000 have some sort of medical encounter with a doctor, or emergency room, or are hospitalized. Prevention remains the highest goal of medicine and those of us in preventative medicine and public health would like to prevent as many of these infections as possible.”
The Novavax trial was a randomized, observer-blinded, placebo-controlled Phase 2 trial of 1,600 older adult participants conducted at 10 sites in the United States. The trial was designed to prospectively examine the incidence of all symptomatic respiratory illnesses associated with RSV, in community-living older adults who where treated with placebo. The trial also evaluated safety and immunogenicity of the unadjuvanted, 135 µg dose of the RSV F Vaccine compared to placebo. Finally, the trial estimated the efficacy of the RSV F Vaccine in reducing the incidence of respiratory illness due to RSV.
The trial is the first to demonstrate efficacy of an active RSV immunization in any clinical trial population, and showed statistically significant vaccine efficacy in prevention of all symptomatic RSV disease (44%) and RSV disease with symptoms of lower respiratory tract infection (46%) in older adults. The observed efficacy was similar to or better than multiple recent effectiveness estimates for a number of licensed respiratory vaccines tested in older adults including pneumococcal and standard-dose seasonal influenza.1,2 The trial also established an attack rate for symptomatic RSV disease of 4.9% in older adults, 95% of which included lower respiratory track symptoms, and confirmed the significant burden of RSV disease in this population. In addition, statistically significant efficacy against more severe RSV illness, as defined by the presence of multiple lower respiratory tract symptoms associated with difficulty breathing, was 64% in several ad hoc analyses. Kaplan-Meier curves showed continued divergence of active vaccinees from placebo recipients over the nearly 6 months during which RSV was detected, demonstrating the durability of protection throughout the RSV season.
As expected from the Company’s prior trials, anti-F IgG and palivizumab-competing antibody (PCA) titers peaked rapidly at day 14, plateaued at day 28 and remained at elevated levels through day 56; the last time point currently analyzed. There were greater than four-fold increases in both anti-F IgG and PCA concentrations at trial days 14, 28 and 56, and serologic responses in over 90% of vaccinated subjects, indicating a robust immune response, similar to the findings from the Company’s prior trial in older adults. Finally, the safety profile in vaccine recipients was nearly identical to that of placebo recipients with regard to both local and systemic events.
“These efficacy data represent a historic advance for the field,” said Gregory Glenn, M.D., Senior Vice President, Research and Development. “This is also an important confirmation of the burden of RSV disease in older adults and highlights the high rate of lower respiratory tract symptoms in those infected by RSV in a large, prospective trial. It is clear that our RSV F Vaccine provided statistically significant efficacy in older adults, a population that historically has been difficult to protect. The reduction in symptomatic RSV, RSV with lower respiratory tract illness and RSV associated with difficulty breathing are breakthrough results. We look forward to making details of these data public at an appropriate forum in the future.”
“The development of an RSV vaccine has been a decades-long challenge,” said Stanley C. Erck, President and CEO. “We are thrilled by the groundbreaking efficacy of our RSV F Vaccine in older adults. We are committed to pursuing an aggressive developmental timeline for this program which includes discussions with regulatory authorities and initiation of a pivotal Phase 3 trial as early as the fourth quarter of this year. We also expect to announce safety and immunogenicity data from the RSV F Vaccine Phase 2 trial to protect infants via maternal immunization later this quarter.”
A live webcast link to a presentation that details data from the trial is available under the “Investors/Events” section of the Novavax website at novavax.com.
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 2.4 million adults 65 years of age or older are infected with RSV annually in the U.S. leading to as many as 900,000 medical interventions and 14,000 deaths each year. Currently, there is no approved RSV 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 vaccine company committed to delivering novel products to prevent a broad range of infectious diseases. Our recombinant nanoparticles and Matrix-M™ adjuvant technology are the foundation for groundbreaking innovation that improves global health through safe and effective vaccines. Additional information about Novavax is available on the Company’s website, novavax.com.
References:
http://www.cdc.gov/flu/professionals/vaccination/effectiveness-studies.htm
Bonten, M.J.M. et al. Polysaccharide Conjugate Vaccine against Pneumococcal Pneumonia in Adults. NEJM, 2015; 372:1114-1125.
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, 2014, 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:
Novavax, Inc.
Barclay A. Phillips
SVP, Chief Financial Officer and Treasurer
Andrea N. Flynn, Ph.D.
Senior Manager, Investor Relations
ir@novavax.com
240-268-2000
Russo Partners, LLC
David Schull
Todd Davenport, Ph.D.
david.schull@russopartnersllc.com
todd.davenport@russopartnersllc.com
212-845-4271
Novavax Announces Positive Data From Phase 2 Trial of Quadrivalent Seasonal Influenza VLP
GAITHERSBURG, Md., July 30, 2015 (GLOBE NEWSWIRE) -- Novavax, Inc. (Nasdaq:NVAX), a clinical-stage vaccine company focused on the discovery, development and commercialization of recombinant nanoparticle vaccines and adjuvants, today announced positive top-line data from a Phase 2 clinical trial of its recombinant quadrivalent seasonal influenza virus-like particle (VLP) vaccine candidate (Seasonal Influenza VLP). This project has been funded in whole or in part with Federal funds from the Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority, Department of Health and Human Services under the Company’s contract with HHS-BARDA (HHSO100201100012C). The trial demonstrated that the Seasonal Influenza VLP vaccine candidate was well-tolerated with no vaccine-related serious adverse events. The trial met its immunogenicity targets and demonstrated potential to meet the Center for Biological Evaluation and Research (CBER) criteria for accelerated approval.
Novavax’ technology platform enables the creation of recombinant, strain-specific VLPs. Novavax’ Seasonal Influenza VLP consists of VLPs representing four different strains of influenza virus, each expressing strain-specific hemagglutinin and neuraminidase antigens. This dose-ranging clinical trial was designed to evaluate the safety and immunogenicity of the Seasonal Influenza VLP in 400 healthy adults. The primary outcomes of the trial assessed safety and tolerability of the Seasonal Influenza VLP and quantified immune responses to each of the four influenza strains based on hemagglutination-inhibiting antibody titers. The secondary outcomes evaluated neuraminidase-inhibiting antibody titers for all four influenza strains.
“Titers of antibodies that inhibit hemagglutination by the influenza virus – called hemagglutination-inhibiting or HAI antibodies – remain the best-accepted correlates of the protection provided by influenza vaccines. We were very pleased to see that our Seasonal Influenza vaccine candidate elicited increases in HAI titers for all four viral strains that would allow our vaccine to fulfill CBER’s criteria for accelerated approval,” said Louis F. Fries III, M.D., Chief Medical Officer, Novavax. “Novavax has made a concerted effort to improve the antigens in our Seasonal Influenza vaccine. In particular, for the two viral strains (out of the four) for which we had sought immunogenic improvement, we showed robust HAI titer responses, approximately 50% greater than those in our prior phase 2 trial. Further, we measured neuraminidase-inhibiting (NAI) antibody responses against seasonal influenza viruses for the first time, and were able to detect significant NAI antibody responses to all four influenza strains, including strong responses against the B virus strains.”
Novavax President and CEO, Stanley C. Erck, said, “These positive topline data from the Phase 2 trial of our Seasonal Influenza vaccine candidate represent an important achievement in this program. We look forward to a complete review of these data with our partner BARDA to determine next steps in the development of this product. Our collaboration with BARDA also includes the development of our novel H7N9 Influenza vaccine candidate in combination with Matrix-M™. We expect the next steps in our collaboration will be the initiation of a Phase 2 clinical trial of the H7N9 vaccine candidate in the adult population in the first quarter of 2016.”
About Novavax
Novavax, Inc. (Nasdaq:NVAX) is a clinical-stage vaccine company committed to delivering novel products to prevent a broad range of infectious diseases. Our recombinant nanoparticles and Matrix-M™ adjuvant technology are the foundation for groundbreaking innovation that improves global health through safe and effective vaccines. Additional information about Novavax is available on the Company’s website, novavax.com.
Contact:
Novavax, Inc.
Barclay A. Phillips
SVP, Chief Financial Officer and Treasurer
Andrea N. Flynn, Ph.D.
Senior Manager, Investor Relations
ir@novavax.com
240-268-2000
Russo Partners, LLC
David Schull
Todd Davenport, Ph.D.
david.schull@russopartnersllc.com
todd.davenport@russopartnersllc.com
212-845-4271
Novavax, Inc.
New 52-week intraday high ($13.12) today. EOM.
New 52-week closing high ($12.43) today. EOM.
Does anybody have a running count of how many accountants they have gone through since 2012? Seems like they change more than yearly, which I would think even changing yearly is a bit much. I could go through all their 8Ks (even quarterly and yearly statements, if not all of their accountant changes were PR'd), but I was just wondering if anybody else noticed the accountant change trend and paid it any mind.