AnGes website announces trial start date and estimates a $ 5 billion annual market if approved.
This is a question for the thinkers that used to gather here in mass as opposed to the current crop of yaks who have nothing to discuss.
Which would move the stock and validate Vical the best, news that Bristol Meyer Squib is using Vaxfectin in the next generation of their cancer immunotherapies or the news that a major pharma has licensed CyMVectin to go after the universal vaccine against birth defects?
Insider buying dipped last week as we recorded records for executive team members and directors for 62 companies. Perhaps, the early week volatility scared them back to the boardroom?
Anyway, today we highlight a company that meets a number of our favorite criteria.
Insiders switched from selling to buying
Cluster buying from multiple executives
Unusually large tickets
Previous history of "getting it right"
Last week, four insiders at Vical Incorporated (NASDAQ:VICL) purchased 580,000 shares for a total investment of $823,600.
[Related -Vical (VICL) Licenses Vaxfectin Adjuvant For Use In Malaria Vaccines To Cyvax]
Vical researches and develops biopharmaceutical products based on its deoxyribonucleic acid (DNA) delivery technologies for the prevention and treatment of serious or life-threatening diseases.
The Company has three active independent clinical and preclinical development programs in the areas of infectious disease and cancer, including a fully enrolled Phase III clinical trial using its Allovectin immunotherapeutic in patients with metastatic melanoma; a completed preclinical program, with an allowed investigational new drug application, using its CyMVectin prophylactic vaccine formulated with its Vaxfectin adjuvant to prevent cytomegalovirus, infection before and during pregnancy, and a preclinical program with therapeutic and prophylactic vaccines for herpes simplex virus type II formulated with its Vaxfectin adjuvant.
[Related -Stocks Jump As Fed Acts To Spur Growth; Equinix (EQIX) Surges]
All four have a remarkably similar Vical history of selling or buying for $0.01 per share. Last week's activity was the first time that any of the quartet – or any other team members for that matter – purchased VICL shares. All the other activity was selling or acquiring shares for a penny.
Although there were four buyers, we are going to focus on the biggest. Chief Executive Officer, President, Acting Chief Financial Officer and Director, Mr. Vijay B. Samant stepped up and bought 330,000 shares at $1.42 for a total sales price of $468,600. That's close to half of his annual pay of $921,000. Would you put half your pre-tax income into any stock idea without having intimate knowledge of the inner workings and prospects?
Prior to last week, we counted 12 Samant Vical sales and one non-open market purchase of 84,600 shares at a penny (the rich getting richer). That's why his January purchase stands out. Depositing some cash into VICL is in direct contrast to the ATM, cash withdrawal role the stock has played for the CEO.
At the end of 2013, the company was at various phase 1 and 2 studies with the FDA. Based on insider transaction rules, we would not expect to hear much in the way of news until the late spring/early summer at the earliest. However, that doesn't mean that our quarter of buyers isn't privy to results and data on the trials to date.
With the quartet's history of cashing out, the recent cluster of buying is a matter of connecting the dots. The change of heart has to be taken seriously.
The big disappointment is the inept management team and Board of Directors that isn't focused on wealth creation for shareholders. Vical needs to make a CyMVectin deal or a Vaxfectin deal that produces some value. They should also open up about where the Herpes tests will be conducted so as to build credibility for their future programs. A-7 shredded Vijay and Vical credibility. EVERYTHING they do should be devoted to restoration of credibility as that is what will cause the stock to be valued based on potential. We are punished by bad management that hasn't faced any consequence.
AnGes has also announced a cancer treatment that shuts down blood vessel formation to cancerous tumors. They don't talk about the delivery platform in their news release but I would expect them to use Vical just as they do for Collategene.
On the Collategene front, the Japanese program you quote PM Abe on is just like the Breakthrough Drug Program in the U.S. It would not be a shock to see Collategene get breakthrough designation in both countries. It would be good for each nation to show this level of cooperation to speed a product attacking diabetes to market.
It should be no longer than 3 weeks that we get an earnings report and update. A milestone payment from Astellas for the launch of Solid Organ Transplant CMV vaccine test would be great news that could drive more upside to the stock as it would almost surely cause the quarter to be cash flow positive. The earnings update will also serve shareholders well if the sites of the Herpes trial are disclosed so the market can assume the trial is going to happen ASAP. The biggest game changing surprise would be a deal on a universal CMV vaccine. Second big possible upside surprise would be a good deal on the VaxFectin adjuvant. Third good upside surprise would be a BOD deal with investment bankers to sell the company. Fourth would be Vijay deciding to spend more time with his family and turning over the reigns at Vical to a new CEO.
BS) – Nearly two dozen cases of the potentially deadly H1N1 flu virus have been confirmed in the Chicago area, CBS 2 has learned.
Finding the flu virus among patients at Loyola University Medical Center in Maywood is keeping special machines working overtime right now. Seven patients at Loyola tested positive for Influenza A on Christmas Eve. Five of them had the H1N1 strain known as swine flu.
They’ve detected a sudden burst of the 2009 swine flu spreading right here in the Chicago area. Microbiologist Paul Schreckenberger says last week alone, 21 patients tested positive for Influenza A. All but one of those cases were the 2009 H1N1 swine flu.
“We don’t know why it’s emerging,” Schreckenberger says.
He says people may have gotten a false sense of security over the last couple of flu seasons, which were comparatively mild.
In Texas, the rush is on for flu shots. The very flu shots that Texans Dustin Wright, and his wife, Ashley, never received.
Dustin was hit with H1N1 flu strain, or swine flu, and he died Dec. 5.
“You don’t think it will happen to you,” Ashley says.
H1N1 is causing 80 percent of the flu infections this year. It’s the same strain that triggered a nationwide pandemic in 2009. But at that time, it was new. Now, it’s not, and the current flu vaccine offers protection.
“That really is, in terms of prevention and protection, the best method, in terms of reducing transmission or spread of influenza,” Rush University Medical Center physician Alexander Tomich says.
But remember, it takes two weeks after you get the shot to build up the anti-bodies that provide protection from the flu. So, the earlier you get it the better.
According to the Centers for Disease Control, less than half of all Americans get a flu shot each
In an award that nobody ever competes for, Vijay Samant of San Diego’s Vical Inc. (Nasdaq: VICL) was named on Tuesday as the worst biotech CEO of 2013 by the stock market website The Street.
The annual award, partly based on a poll of The Street’s readers, was based on delays surrounding the release of the phase 3 results of Vical’s drug allovectin, meant to treat skin cancer.
Adam Feuerstein, senior columnist at The Street, writes that analysis of the study was delayed for years until the company finally announced in August that the results were negative. The day the announcement was made, the company lost more than half its stock value, dropping from $3.58 to $1.53 per share, prompting a string of lawsuits.
But worse was to follow. The company waited three months -- until mid-November -- to announce details of the test showing that melanoma patients treated with allovectin fared worse than patients treated with conventional chemotherapy. Only 4.6 percent of patients treated with allovectin reported that their tumors shrank, compared to 12.3 percent of chemotherapy patients.
“Prolonging this study by delaying the analysis caused undue harm to patients,” Feuerstein wrote. “That's disgusting, inexcusable behavior.”
But Vical continues to try to develop new drugs. With its stock currently valued at $1.02, the company on Tuesday announced initial tests of a proposed treatment for genital herpes and last week began phase 2 testing on a proposed vaccine for organ transplant patients, in partnership with Tokyo’s Astellas Pharma Global Development.
"We are very pleased with the collaborative nature of our relationship with Astellas and with the progress being made," Samant said at the time.
Feuerstein’s other four nominees for worst CEO were Joe Zakrzewski of Amarin (Nasdaq: AMRN), Harvey Berger of Ariad Pharmaceuticals (Nasdaq: ARIA), John Johnson of Dendreon (Nasdaq: DNDN) and Tuan Ha Ngoc of Aveo Pharmaceuticals (Nasdaq: AVEO). Samant won with 71 percent of the 14,140 votes cast by Feuerstein's readers.
Vijay Samant, Vical
Biotech CEOs don't land on the Worst list just because of failed clinical trials. Drug blowups are common and can strike even the best company, so there's no shame in it. I make exceptions to this rule, of course, like if a CEO purposefully hides or delays negative trial results. And worse, if after an improperly delayed clinical trial is finally analyzed, the results show the experimental drug put patients in harm's way.
Samant delayed the results of Vical's allovectin phase III study in melanoma. I lost track of how many times the analysis of the study was pushed back, but it was years. Samant and Vical finally announced the failure of the allovectin study in August. Few were surprised.
However, three months later, Vical disclosed that allovectin caused tumors to shrink in 4.6% of patients compared to a tumor response of 12.3% in patients treated with the chemotherapy used as a control in the study. The difference was actually statistically significant against allovectin.
In a secondary analysis, the median overall survival of patients treated with allovectin was 18.6 months compared to 24.1 months for patients treated with chemotherapy.
Allovectin caused more harm to melanoma patients than chemotherapy. Prolonging this study by delaying the analysis caused undue harm to patients. That's disgusting, inexcusable behavior and ample reason for Samant's nomination as the Worst Biotech CEO of 2013.
What we NEED to know is does starting this trial constitute a milestone, if so how much revenue does it bring to Vical, if the Solid Organ Transplant market is added to the Vical-Astellas CMV product how much bigger is the addressable market. There is still $95 million in milestone revenue for Vical on the Astellas deal so this is important to a company that has many doubters about viability as a going concern.
December 3, 2013
Anges MG Co., Ltd.
About us Press Conference held in Japan
Domestic early realization is expected by the Pharmaceutical Affairs Law - " Koratejen
Received the revised Pharmaceutical Affairs Law and was established during the current Diet session , the Company
Possibility of drugs of " regenerative medicine on the day
I held a press briefing entitled Perspectives " of future events by Law .
First, Ryuichi Morishita , Osaka is a lecturer at a briefing
( Cabinet Office Regulatory Reform conference committee , our menu Professor
From Di Cal Advisor) , growth strategy around the axis of the regenerative medicine promoted by the government , and in the
In there was a lecture about the role of the Pharmaceutical Affairs Law plays . In particular , real early in the regenerative medicine product
Gene therapeutic agent is included in the target of this system also benefits , conditional approval system that leads to iodide
Point has been emphasized .
Then , Yamada British president of the Company , was for severe limb ischemia due to the revision of the Pharmaceutical Affairs Law
Child treatment " Koratejen
We will explain once again that to resume the development of the country of " .
The Pharmaceutical Affairs Law , early conditional approval system that can shorten the time-to- approval , but was included ,
Koratejen of the Company will aim to early commercialization by leveraging the system .
This system if it is effective, the device Ichihaya in Japan
Commercialization of regenerative medicine , including a clause gene therapy
Access is enabled.
Video of Press Conference is viewable from the following link .
Why the post-antibiotic world is the real-life version of the zombie apocalypse
The perverse economics of the antibiotics industry means the human race could be in trouble
By John Aziz | 1:20pm ET
Bacteria are outsmarting our drugs.
Bacteria are outsmarting our drugs. (Joe Raedle/Getty Images)
ight now, humanity is engaged in an epic battle against fast-adapting and merciless predators. No, zombies are not beating down doors to tear chunks of flesh out of the living. Rather, humanity is being hunted by deadly pathogenic bacteria that have gained resistance to antibiotics.
And thanks to the peculiar incentives that drive the pharmaceutical industry, it looks like the cavalry may be a long time in coming.
To understand the current state of the antibiotics market, we have to go back millennia. Humans have co-existed with bacteria throughout our history. They live in our bodies from birth to death. It’s estimated that up to three percent of a typical human's body mass is made up of symbiotic bacteria, which assist us with bodily functions like digesting food.
Most bacteria in the human body are kept in check by the body’s immune system. But bacteria are constantly evolving to survive and reproduce. Either the immune system successfully adapts to new threats, or the body risks being overrun. Sometimes the immune system will fail to respond to a novel bacterial threat, allowing the bacteria to kill the host.
Before antibiotics were widely available, any accident, injury, or medical procedure that allowed pathogenic bacteria into the body was potentially deadly. One in nine skin infections was fatal. One in three cases of pneumonia led to death. Invasive surgeries including caesarean sections left the patient open to killer infections. Insect bites, burns, and blood transfusions frequently became a source of infection.
So the discovery of the first antibiotic, penicillin, by Alexander Fleming in 1928 remains one of the high points in medical history. Antibiotics kill bacteria, which meant wounds were no longer death sentences. Yet when Fleming won the Nobel Prize for medicine in 1945, he warned of the dangers of antibiotic resistance:
It is not difficult to make microbes resistant to penicillin in the laboratory by exposing them to concentrations not sufficient to kill them… There is the danger that the ignorant man may easily underdose himself and by exposing his microbes to non-lethal quantities of the drug make them resistant. [NobelPrize.org]
Fleming’s prediction was right. Penicillin-resistant bacteria arrived while the drug was still being given to only a few patients. Each new class of antibiotics since then has soon been greeted by resistant bacteria.
One breeding ground for antibiotic-resistant bacteria is in farm animals. Low doses of antibiotics have been used since the 1950s to enhance growth. In the U.S., over 80 percent of all antibiotics are now used on farm animals. But low doses encourage resistance, just as Fleming warned. Recent studies show that antibiotic-resistant bacteria have been found widely in farm animals raised for meat, as well as wild animals, including crows, foxes, and sharks.
Scientists are fighting a running evolutionary battle with the bugs. A patient in New Zealand died this year after contracting an infection resistant to all known antibiotics. Doctors declared him the first patient of the "post-antibiotic era." The Centers for Disease Control and Prevention recently warned that drug-resistant bacteria kill at least 23,000 people annually in the U.S, and cost the health care system $20 billion per year.
Unfortunately for the human race, research into antibiotics remains costly. One estimate suggests that the cost of bringing a new antibiotic to market is over $1 billion, and that new antibiotics lose $50 million on average. There are far more profitable drugs for pharmaceutical companies to throw money at, since antibiotics are usually single-serve drugs for humans, not long-term treatments.
Drugs for chronic conditions tend to be more profitable. And with drug resistance quickly evolving, rendering older antibiotics ineffective, pharmaceutical companies have even less incentive to invest in the drugs.
The economics are perverse. Taking preventative action today would not be very profitable because there are fewer potential customers. The incentives to produce more and better antibiotics only kick in under the worst circumstances, when millions of people are dying from antibiotic-resistant infections.
With investment, there would be plenty of reasons to be optimistic about the future. New antibiotics today are typically discovered by culturing bacteria in a laboratory, and scientists so far have cultured less than one percent of the bacterial species on the planet, meaning there is still a huge pool of possibilities out there that remains untested.
There are also a large variety of organic compounds — for example, from insects — that may hold promise as antibacterials. Some scientists are even looking into the possibility of using nanotechnology to fight bacteria — tiny machines that can hunt down pathogenic bacteria and destroy them. Sooner or later, one of these approaches may yield an innovation that pathogenic bacteria cannot develop resistance to.
In July 2012, President Obama signed the GAIN (Generating Antibiotic Incentives Now) Act, a bipartisan bill to fast-track the creation of new antibiotics. Twelve new antibiotics in development have so far received fast-track status, which should speed up the approval of new drugs for difficult-to-treat conditions.
But whether the law will be sufficient to create enough new antibiotics to win the evolutionary arms race remains to be seen. Developing antibiotics is still expensive, and the antibiotics that we do have are still being over-prescribed for humans and doled out in sub-clinical doses to farm animals — both of which gives bacteria opportunities to develop resistance.
If the problem continues to grow, the U.S. and other countries will have to invest a whole lot more in antimicrobial technologies, or create incentives for Big Pharma to do so. Like the zombie apocalypse, the post-antibiotic world would not be a pretty place to live in.
There are now 36 days for Vijay to make his herpes time table. He is such a failure as CEO you have to bet he will blow this too and diminish the teacup of credibility he still has. Vical just needs to sell itself and end the misery since the BOD isn't going to do anything to help like blowing out the CEO.
The long survival time for the few responders is something that Vical needs to account for and extract value from. I just pray that the company sells itself to someone with competence to get something produced and sold for a profit. Vijay has given away the products that are approved and can't get anything else approved.
The trial failure was announced August 12th not in May so what do you know. AnGes has a big news release on the reverse split on their Japanese website today.
When you think about how much money Vical was able to get others like AnGes, who had to announce a 100 for 1 reverse split today, to invest in Allovectin #$%$ just unbelievable. I can't see Vical doing anything without some milestone payments coming in for doing something besides surviving. Speaking of surviving, why is Vijay still heading the company? No body listens to him any more and no one believes him about anything. The A-7 debacle will keep anyone from jumping on Herpes until there is a revenue stream. Vical should probably license it to a partner the street will give credibility as it doesn't get it done on science or business.
They're investors who are waiting for this POS to become profitable for them then they can sell and die happy.
There was an interesting news release on the AnGes Japanese language site following the A-7 news indicating the company would not need to go out of business. AnGes had to tell investors the revenue stream they were projecting from the Vical investment was not going to happen. It causes one to wonder how AnGes was confident enough of the revenue to include it in projections.
Vijay made many misleading statements. One of the biggest revolves around the safety profile of Allovectin 7 and the size of the market that cannot tolerate chemo. Vijay said 10% of those diagnosed with melanoma cannot take chemo. Given a $35 billion annual chemo market, that 10% alone is enough to take A-7 to market, but Vijay decided that market forces required better survival stats than Chemo....really, what about the 10% who can't take it? If A-7 is as good as chemo, but has no ill effects, and can be improved with adjuvants, how did they throw in the towel so easily, with a 10% marketshare begging to be taken? Vijay is toxic, I hope the suits get a dollar and his resignation.