NEWARK, NJ / ACCESSWIRE / October 21, 2014 / BioNeutral Group Inc. (OTC Pink: BONU) (BONU), a specialty life science technology based company today addressed the Ebola decontamination issue. Surfaces contaminated with Ebola pose a threat in the spread of this disease. While other disinfectants may be used to decontaminate surfaces containing Ebola, the Company believes that none can offer the level of decontamination efficacy and efficiency offered by YGIENE(TM) 206 Sterilant which eliminates all harmful microorganisms. YGIENE(TM) 206 Sterilant is the fastest ready to use sterilant with a 20 minute kill time, and is chlorine and aldehyde free. YGIENE(TM) 206 Sterilant provides an extra level of confidence in eliminating Ebola in addition to other harmful microorganisms on contaminated surfaces either by wetting surfaces or immersing contaminated articles.
YGIENE(TM)Sterilant/Disinfectant is registered with the US EPA as a sterilant with a 20 minute contact time. As a sterilant, YGIENE(TM) 206 kills all harmful microbial life including Ebola as long as the nonporous surface has contact with YGIENE(TM) for the full 20 minutes.
As indicated on the YGIENE(TM) 206 Sterilant label: "a sterilizer is an antimicrobial pesticide that destroys or eliminates all forms of microbial life in the inanimate environment, including bacterial spores. The term "sporicide" is deemed to be synonymous with "sterilizer". Since sterilization includes eradication of all living microorganisms, such claims are intrinsically related to protection of human health (EPA DIS/TSS-9)."
The Company believes that the ease of application and this high level of broad spectrum efficacy sets the ready to use YGIENE(TM) 206 Sterilant apart from other available disinfectants.
Advanced Sterilant Kills Dangerous Pathogens.
No other product for infection control addresses the range of pathogens killed as does Ygiene 206 Sterilant: an advanced antimicrobial that destroys or eliminates ALL forms of microbial life in the inanimate environment, including bacterial spores. Since sterilization includes eradication of all living microorganisms, such claims are intrinsically related to protection of human health. Ygiene 206 Sterilant saves lives by eradication of the most difficult and dangerous pathogens, including MRSA, C. difficile, and many other hard-to-eradicate microorganisms.
Fastest Times to Kill - Seconds, Not Hours
With the most rapid time-to-kill, Ygiene 206 Sterilant is without question one of the most effective and logistically efficient sterilant / cleaners available anywhere. With Ygiene 206 Sterilant, time-to-kill is measured in seconds and minutes, not hours, enabling fast sterilization and rapid return to service for hospital and healthcare facilities, equipment and personnel.
Ultimate Safety for Facilities, Patients, Equipment and Personnel
BioNeutral's Combinational Chemistry has enabled the creation of this world-class sterilant to break down into harmless substances when its work is done - protecting the environment as well as facilities, equipment, personnel and most importantly patients. Ygiene 206 Sterilant is environmentally friendly, and is available as a pre-mixed, ready-to-use (RTU) formula, maximizing efficiency while providing an unparalled level of safety.
In summation, the data for both Synta and Exelixis are strong. Both deserve a multi-billion dollar market cap but are trading at a significant and short term discount. Pfizer, Gilead, and its competitors will require growth. There is now (sp? no) question about that. The Street is completely discounting these companies and I think before it releases news that send stocks flying, a larger competitor that needs growth should consider stepping in."
The median progression free survival (PFS) for BRAFi-naïve patients was 13.7 months. Results for vemurafenib-progressor patients (n=66) showed a 15 percent confirmed ORR, 42 percent stable disease rate, and median PFS of 2.8 months. The median overall survival (OS) for BRAFi-naïve patients had not been reached, with a 1 year survival estimate of 83 percent. For the vemurafenib-progressor patients the median OS was 8.3 months with an estimated 1 year survival of 32 percent. Thus, the data were extremely favorable.
processes. Part 3
Exelixis also recently presented data for Cobimetinib in combincation with Vemurafenib to treat metastatic melanoma with a specific mutation (BRAF-600.) This is a little data heavy, but I will do my best to walk through the epidemiology. The phase 1b dose escalation study was designed to evaluate the safety and tolerability of cobimetinib in combination with vemurafenib. The dose escalation stage of the trial comprised 10 dosing cohorts of 3-6 patients and evaluated three different dosing schedules of cobimetinib in combination with twice daily administration of vemurafenib.
After the maximum tolerated dose, that is, the dose which patients can most reasonably withstand without severe side effects was defined, two dose cohorts were expanded and additional patients with BRAF-mutated melanoma who were either BRAFi-naïve or vemurafenib-progressing patients were accrued. As of October 1st, 2013, 129 patients had been treated, comprising 66 patients who had previously progressed while receiving vemurafenib and 63 patients who were BRAFi-naïve. Of the 63 BRAFi-naïve patients, 43 (68 percent) were previously untreated and 20 (32 percent) had been treated with agents other than a BRAFi. The majority of the patients had Stage IV, M1c melanoma at the time of enrollment (vemurafenib-progressors 82 percent, BRAFi-naïve 70 percent.) The median duration of follow-up in vemurafenib-progressor and BRAFi-naïve patients was 6.3 and 12.7 months, respectively.
The final results of the exploratory secondary endpoints of BRIM7 showed anti-tumor activity for the combination of cobimetinib and vemurafenib. In BRAFi-naïve patients (n=63), an 87% confirmed overall response rate (ORR) was achieved, including 10 percent complete responses and 78 percent partial responses. An additional 10 percent of patients achieved stable disease. The majority of tumor responses were observed within the first six weeks following initiation of treatment.
Soon we will learn the final results of the COMET-1 trial and I estimate the data will show that Cometriq demonstrates superior death risk reduction relative to the standard prednisone treatment in men with metastatic castration resistant prostate cancer who had progressed while using the combination of docetaxel and either Zytiga or Xtandi. If the drug shows effect and eventually had FDA approval, just how much are we talking about here? Well, Dendreon’s (NASDAQ:DNDN) Provenge could take $400 to $500 million in peak sales, which I believe Cometriq could do alone for metastatic castration-resistant prostate cancer. What else? Don’t forget, unlike many smaller biotechs, Exelixis has FDA approval for treatments. In fact, Cometriq is already approved to treat metastatic medullary thyroid cancer by the FDA and just recently receiving EU clearance to market its therapy in Europe. For this condition, Exelixis should see revenues of $100-$200 million when sales ramp up. This is extremely attractive for a larger company that needs a revenue stream to fund its own research and development.
But there is more. The company has a decent pipeline. Aside from thyroid cancer and prostate cancer, Cometriq is also being studied in two other phase 3 trials. These are the METEOR and CELESTIAL trials to study its effects relative to standard therapies. These trials will assess Comtriqs efficacy in hindering metastatic renal cell carcinoma and hepatocellular carcinoma patients who’ve received treatment with Nexavar. The only trouble is that competition is stiff with other companies. Thus, Exelixis data will have to be strong to gain market share. This may be why investors over reacted to the news that the COMET-1 study was continuing. In the mean time, the company has a bevy of other cooperative agreements with large players like Merck and GlaxoSmithKline that will provide the necessary cash that Exelixis requires to conduct its trials and further its research and development
This article is almost a month old but I thought it would be an interesting read for fellow longs:
Christopher F Davis
July 05, 2014
. . . " There is another company that I also believe is incredibly undervalued and the Street is completely discounting. I have identified Exelixis as a great takeover target for Pfizer or any other of its competitors. I think after a selloff in shares, Exelixis may on its own be one of the best opportunities for a trader to double their money this year. Why should Pfizer or any other company care about Exelixis? Well, Exelixis has been riding high all year. This multibillion dollar market capitalization company was recently just cut in half after the company’s update to its phase 3 results for Cometriq (also known as cabozantinib) as a treatment for late-stage prostate cancer.
In a press release back in March, Exelixis announced that the independent data monitoring committee overseeing its COMET-1 phase 3 trial involving Cometriq in metastatic castration-resistant prostate cancer had recommended the trial proceed to its final analysis. Normally a trial proceeding is considered fantastic news as it would signify the safety, tolerability, and potentially efficacy of an experimental therapy. However, with the metastatic prostate cancer field beginning to get crowded by drugs from rivals, investors absolutely punished the stock sending it from $6.00 to just over $3.00 in a week.
There is a fear that Cometriq doesn’t offer a superior risk of death reduction. But a 50 percent drop on this news? That’s far overblown. Twenty percent would have been understandable. Now, the stock is starting to turn the corner once more. If anyone is going to buy them out, now would be the time. Exelixis stock dipped to $3.02 but has now recovered over to $3.50. But not only is it technically reversing, it has upcoming catalysts and has other things going for it, which in my opinion make it extremely compelling.
I hope you are Shaun Zirnhelt, if so great article and well written, if not - you should have gave him credit for being the author.
• In an interview with TheStreet's Adam Feuerstein, David Miller elaborates on his view that Roche (RHHBY +1.3%) has a strong incentive to acquire Exelixis (EXEL +10.7%) in order to capture the full margin of the combination therapy cobimetinib and currently-approved Zelboraf (vemurafenib). He says that the combo regimen could reach peak sales of $1B and should be priced at a premium to Glaxo's (GSK -0.4%) inferior offering of Tafinlar and Mekinist. He believes it will establish itself as the standard of care as a first-line therapy for BRAF-mutated melanoma.
• Earlier today, Roche announced positive results from a Phase 3 clinical trial where patients lived significantly longer when treated with the combo regimen compared to placebo.
I thought 7001ctc`s comment was worth sharing here - "I'm a 16 year survivor of castrate resistant prostrate cancer, successfully treated to date by the founder of the Prostate Cancer Research Institute, Dr. Mark Scholz. I am also the president of the network serving over 100 worldwide patients of this worst kind of PC.
Several years ago, during the annual PCRI annual conference, attended by over 500 oncologists and patients, Dr. Scholz showed the incredible results of a ,metastatic patient with tumors throughout his body treated with Carbo(sic) for 6 months. Every one of the multiple tumors, except one tiny one, had disappeared. Dr, Scholz said "in all my experience of treating many hundreds of metastatic patients, I've never seen such a positive result".
That is why I'm a believer in the future of Cabo."
oncodoc, wilder - please do not let the naysayers and idiots here keep you from posting. There are several longs here like myself who appreciate your input and knowledge. I do not post that often but I do read intelligent posts that the two of you and some others offer. We will keep giving you thumbs up! Keep up the good work!
search short squeeze for site - can`t post the link
Daily Short Sale Volume view
Short Interest (Shares Short) 47,311,400
Days To Cover (Short Interest Ratio) 15.0
Short Percent of Float 26.29 %
Short Interest - Prior 48,779,000
Short % Increase / Decrease -3.01
Daily Naked Short Selling List view
Short Squeeze Ranking™ view
% From 52-Wk High ($ 8.41 ) -57.07%
% From 52-Wk Low ($ 3.37 ) 7.12%
% From 200-Day MA ($ 5.73 ) -37.00%
% From 50-Day MA ($ 6.35 ) -43.15%
Price % Change (52-Week) -21.86%
My other contention relates to its pipeline which is being largely discounted throughout this process. First, Cometriq is also being studied in two other phase 3 trials METEOR and CELESTIAL to study its effects against a placebo (usually a high-profile branded drug) in metastatic renal cell carcinoma and hepatocellular carcinoma patients who've received treatment with Nexavar. Why aren't investors giving these potentially life-altering studies any credit?
In addition to other ongoing studies with Cometriq, Exelixis has a mountain of ongoing collaborations that range between preclinical and phase 2 in nature (nine studies altogether). The breakdown includes four therapies partnered with Bristol-Myers Squibb, two with Sanofi, and one each with Merck, GlaxoSmithKline, and Daiichi-Sankyo. The result is ample upfront cash from these collaborations and plenty of marketing firepower should these collaborative therapies be approved.
In sum, I believe we've seen a classic overreaction to modestly bad news from the COMET-1 trial and a complete disassociation from investors as to the potential of its remaining pipeline and partnerships. I'm now long Exelixis and hopeful that Cometriq's additional indications may help move the company's total annual revenue to more than $1 billion before the end of the decade."
Written by Sean Williams titled "Why I Bought Exelixis" 4-4-2014
. . . "Despite Exelixis' tumble, which at one point equaled nearly half of the company's value in a four-day span, I decided to purchase the company for my own personal portfolio as I see a bright future for Cometriq and its overall pipeline.
Let's take things step-by-step and I'll show you why I'm so optimistic about Exelixis.
To begin with, we have the ongoing COMET-1 trial which I anticipate will demonstrate superior death risk reduction relative to the placebo (prednisone) in men with bone-dominant mCRPC who had progressed while using the combination of docetaxel and either Zytiga or Xtandi. Although it may not "stand out" per se, the drug itself should still see revenue on par, if not slightly better than Dendreon's Provenge which is also failing to stand out. Dendreon's drug is capable of approximately $400 million in peak sales, which I believe is a fair estimate worldwide if Cometriq is approved in mCRPC.
Second, we have Cometriq already approved to treat metastatic medullary thyroid cancer by the FDA and just recently receiving EU clearance to market its therapy to MTC in Europe. Based on company projections of roughly 500 to 700 patients in the U.S., and my own personal estimate of a similar amount in the EU, peak sales in this indication could total around $200 million at a price of $9,900 per month.
Added together, I already believe there's peak potential of $600 million if Cometriq gains the mCRPC indication inclusive of its U.S. and EU approval for MTC. Based on its current valuation of around $700 million we're looking at a company trading at just over one times peak sales. Given that we're seeing clinical-stage companies valued at three to five times annual peak sales estimates regularly, I have to believe either the entire market is overvalued or Exelixis is being brutally undervalued. Regardless of which one it is, further downside appears minimal in my opinion.
That is true and what bell says is right too but IMO I think we can get a higher price to sell at. I`ve traded PAL once for 100% profit and I feel I can do it again. My cost average is 0.43 this time, lower than last and with the volatility here & palladium`s current situation; 0.86 is certainly achievable in the near term. This is a great stock to trade but risky to invest in. That said, I do wish the investors here success.
Lonmin LMI.LN -2.39% PLC saying Wednesday the positions of the different parties were too far apart for mediation. Workers at the country's largest platinum mines have been on strike since Jan. 23 demanding higher salaries.
Palladium demand remains robust. U.S. auto sales have climbed back to precrisis levels, while China said Wednesday it is again targeting economic growth of 7.5%.
"As the market gets tighter, people who hold the metal are unlikely to sell because prices will move higher, so that just exacerbates tightness," said Mr. Winship.
Walter de Wet, commodity analyst at Standard Bank, said while the market won't run out of either platinum or palladium soon, "the market is increasingly wondering from where supply will come. It is now a question of price, i.e. at what price the holders of aboveground inventory of platinum and palladium would be willing to part with inventory."
Even so, some think Wednesday's price move may run out of steam, at least for now.
"This push might take a breather, but then it will go again I think," said Mr. Winship. "The South African situation to us seems like it could continue for a number of weeks still. It is a market which is tight, industrial demand is strong and quite frankly miners are battling to deliver."
By Laura Clarke (WSJ)
March 5, 2014 1:29 p.m. ET
The price of palladium shot up Wednesday to a level not seen for nearly a year as fears about potential sanctions on Russia, the world's largest producer, put a spotlight on risks to supply of this precious metal.
Palladium traded on the spot market hit $779.50 per ounce, its highest level since early April 2013, as the U.S. government said it is prepared to enact financial sanctions on Russia if Moscow didn't begin pulling troops from Ukraine's Crimea region.
Russia accounts for over 40% of global mined supply of palladium, which is primarily used to make autocatalysts for cars and trucks and is also used by electronics and jewelry makers. Any trade embargo against Russia could hinder access to the metal.
At the same time, strikes have disrupted output in South Africa, which as the next top producer accounts for 30% of mine supply.
Russia's stockpiles of palladium, which it has historically sold onto the market representing another source of supply, are thought to be all but exhausted.
"If you look at everything they've produced and everything they've sold, that number is getting close to zero, so we don't think there is much lying around," said Scott Winship, portfolio manager at Investec Asset Management. The company's commodities and resources team has around $3.6 billion in assets under management. Its gold fund, managed by Mr. Winship, holds around $400 million, with around 10% of that invested in platinum-group metals.
"If sanctions are pursued this [price move] would likely be a sustainable gain and prices are likely to trend toward the $1,000 mark," said Gautam Batra, an investment strategist at Signia Wealth, which has around 2.2 billion pounds ($3.7 billion) in assets under management. Its typical balanced portfolio can have as much as 10% invested in precious metals at any time.
In South Africa, talks between platinum miners and labor unions have been suspended indefinitely with Lonmin
. . . Europe's energy security and indeed economic recovery at risk.
Russia and Ukraine together account for roughly 40% of global grain exports, mainly wheat. Russia is also a large corn exporter and a conflict would likely lead to food and energy price inflation.
Ore deposits of palladium are rare and are mostly located in Russia and South Africa. Russian resource nationalism, as has been seen with natural gas, could lead to supply disruptions and to palladium going higher in the coming months. Some analysts believe palladium may be in deficit for most of the next decade as Russia depletes stockpiles and industrial uses and investment demand for the precious metal increase.