Tecovirimat must be getting close to FDA approval and a big milestone payment? Siga is going to see another huge payday upon reaching this milestone. This path was well known after the primate trial in 2006, that's why Siga went with the "bad faith" attempt
* DoD-affiliated personnel (including US civilian employees, contractors and other US personnel and dependents, as well as allied military forces and local nationals) of any age, not breastfeeding
* Has been exposed to or infected with orthodox viruses (i.e., variola (smallpox), vaccinia, monkeypox, or cowpox) OR Has developed serious complications from vaccinia vaccination (eg, eczema vaccinatum, progressive vaccinia, generalized vaccinia that is severe or persistent, and select cases of inadvertent inoculation due to severe pain related to mucosal involvement, ocular involvement) resulting from vaccination, secondary transmission, or other exposure
* Is available for clinical follow-up for duration of the treatment and follow-up period
* Must be able to swallow capsules
found under clinical trials:
Expanded access is currently available for this treatment.
((First received: March 4, 2014))
The purpose of this clinical protocol is to treat individuals with Tecovirimat after exposure to orthodox viruses. Monkey Pox or Smallpox
alpha, I have to agree when the DSC used the word furtive along with ill will.
furtive, I had to look it up:
attempting to avoid notice or attention, typically because of guilt or a belief that discovery would lead to trouble; secretive.
BARDA did the first deal with Siga because of the extraordinary potency with lack of side effects shown in the antiviral trials for Tecovirimat. BARDA would likely have confirmed more than the $450 million if not for the furtive taste Siga comes with. The ONLY competition is CMX-001 failed to prevent death in a primate trial against (monkey pox), I think it is a stretch to think they will even be allowed an actual smallpox/primate trial. All the above makes me think BARDA will add to the Tecovirimat order somewhere near the original 14 million courses as planned and canceled.
"Siga's" ill will precedes it and is very well known, no doubt it hampers BARDA dealing with them. Maybe it would be smart to try for a discounted lump sum and handover of Tecovirimat rights to Pharmathene? More wild guessing on my part. More likely, thinking Tecovirimat has millions of more doses coming from BARDA and Siga will not part with it.
Another $60 to $70 million in the pipeline to be delivered by first quarter '15. I think the actual total was mentioned in the yearly or last quarterly.
Siga should have no problem with a $250 to $300 million lump sum payment. More "bad faith" negotiations would be a disaster for them. Siga & PIP shareholders would have done much better but for the "bad faith" fiasco."The contract award is worth $433 million and includes options that would raise the contract's total value to approximately $2.8 billion, if exercised"
DAMAGES: The Delaware Supreme Court announces new law in this opinion: When the parties have a Type II agreement to negotiate in good faith, and the record supports the trial court’s finding that the parties would have reached an agreement but for the defendant’s bad faith negotiations, the plaintiff is “entitled to recover contract expectation damages.” Slip op. at 37. Expectation damages presuppose that “the plaintiff can prove damages with reasonable certainty.” See footnote 99. Because this is the first time the Delaware Supreme Court clarified this issue of damages, it reversed and remanded for Chancery to reconsider the award of damages in light of this opinion.
* This is where the lump payment becomes an acceptable solution? Siga really needs to settle out of court and avoid looking worse than they are. There are more BARDA orders coming for a smallpox antiviral and Siga doesn't need a guilty verdict on their record. Siga and PIP are likely having some serious discussions after Parson's last verdict laid out the process for calculating an award. Getting past this stage ASAP and not looking like a shady company should be Siga's goal. And, to do it ASAP as BARDA has been refunded and there is a limited time to fund the next round of orders.
In 2004, Congress passed the Project BioShield Act—a ten-year, $5.6 billion fund .Bioshield would address each of the 4 threat agents, including Bacillus anthraces (anthrax), smallpox virus, botulinum toxins, and radiological/nuclear agents
2 category A threats, anthrax and smallpox
There were very high hopes after it was announced ST-246 (an antiviral) in Sept 2006 had stellar results. That was the moment Siga got sellers remorse and ....
* ...the court affirmed the trial court’s finding that SIGA acted in bad faith, noting that bad faith “contemplates a state of mind affirmatively operating with furtive design or ill will.”
* the aggrieved party is entitled to “expectation” or “benefit of the bargain” damages (e.g., lost profits)
" Shouldn't be long folks"? Could be 2 weeks or 6 months is my guess with it being an out of court settlement. The interest cost on $100 million or $500 million....
Looking for an analyst that follows Siga? Haven't seen any, nor any upgrades despite all the cash flowing into their coffers. Strange for Wall Street to miss pumping Siga
I'm impressed with Andrew Fein, H.C. Wainright
Has a conservative target of $4
Lays out his argument for valuation and concludes:
"The Court also noted that PIP is entitled to “pre and post-judgement interest at the legal rate, compounded quarterly.” We understand this presumed interest rate to be equal to approximately 11.25%. When all of these assumptions are taken in totality, we believe the lump sum payment to PIP has the potential to near $350M, or in excess of $6/share.”
*not sure about his 11.25% interest rate, I am sure the interest rate is going to be painful and Siga shareholders (including Perelman) want the bad faith penalty they are paying to cease. Shouldn't be long folks.
(pay prejudgment interest)
Parson's telling Siga to think hard about appealing on the bad faith the Supreme Court and he agree upon.
June 30, 2014
Cash and cash equivalents $99,029,327
Total current assets.............$129,734,471
The Company received approximately $15.3 million for the delivery and acceptance in July of 115,000 courses.
By Jen Christensen, CNN
updated 3:07 PM EDT, Fri July 11, 2014
(CNN) -- At least two of the vials employees at the National Institutes of Health found in an unused storage room earlier this month contain viable samples of the deadly smallpox virus, the Centers for Disease Control and Prevention said Friday.
Employees found six forgotten vials when they were preparing to move a lab from the Food and Drug Administration's Bethesda, Maryland, campus to a different location. The laboratory had been used by the NIH but was transferred to the FDA in 1972.
(and from CDC -)
CDC Media Statement on Newly Discovered Smallpox Specimens
On July 1, 2014, the National Institutes of Health (NIH) notified the appropriate regulatory agency, the Division of Select Agents and Toxins (DSAT) of the Centers for Disease Control and Prevention (CDC), that employees discovered vials labeled ”variola,” commonly known as smallpox, in an unused portion of a storage room in a Food and Drug Administration (FDA) laboratory located on the NIH Bethesda campus.
...The vials appear to date from the 1950s. Upon discovery, the vials were immediately secured in a CDC-registered select agent containment laboratory in Bethesda.
(((1950's))) - Looks like keeping the Tecovirimat, which is a cure not a vaccine, in stock for a few more decades does make sense. I suspect the security of the old USSR smallpox vials are in doubt also.
Thanks for sharing the news on Prescott. They did a lot of the hard work in preventing PIP management from screwing shareholders.
"Prescott Group Urges All PharmAthene Shareholders to Vote AGAINST Proposed Theraclone Merger
Special Meeting Scheduled to Take Place December 3rd, 2013"
They also had a keen insight on how PharmAthene may be heading for a payoff and possibly dissolving the company if the Siga has enough cash:
"The management of PharmAthene is also voting…with their feet: Although the transaction purports to be a “merger of equals,” in reality Theraclone will run the show after PharmAthene’s management team receives a multi-million dollar payment to abruptly exit."
Good to have Prescott on board in a bigger way. Siga, Perelman and MacAndrews & Forbes should be able to come up with the lump sum and hang onto Arestvyr.
Actual smallpox trials after recent CDC safety problems were exposed in press seem doubtful when you already have a smallpox antiviral pill. The Ebola hysteria being the last nail in the coffin to prevent any more testing with the smallpox virus stored at the CDC in Atlanta.
So, Siga please quit the never ending warning that you may not get future contracts BARDA intends to award.
November 15, 2006
...SIGA Technologies, Inc., [SIGA] says its smallpox drug, SIGA-246, has successfully completed two independent primate trials, one sponsored by the National Institute of Allergy and Infectious Diseases and the other conducted at the Army Medical Research Institute of Infectious Diseases. Last month the company said the drug provides complete protection against human smallpox virus in nonhuman primates. In the two independent trials involved infection with high doses of monkeypox virus, which may be lethal in primates if left untreated. "Taken together with the recent breakthrough results from the smallpox virus study, the data continue to support the use of SIGA-246 as the first drug available to prevent and treat disease caused by pathogenic poxviruses without significant side effects,"
(CMX001 has failed a monkeypox trial and will probably never be tested with an actual smallpox trial, so future contracts look assured to stay with Tecovirimat (formerly known as ST-246 and Arestvyr)
Emergent BioSolutions’ (EBS) and BARDA
Emergent has signed a total of six multi-year contracts since 2004 for $2.6bn worth of BioThrax. The standing contract was signed in September of 2011 and extends through September of 2016 for a total of $1.25bn and up to 44.8 million doses of the drug.
Google it folks and you will see the numbers are real. The contract happens to be for the vaccine for pre-exposure prophylaxis of anthrax disease. Biothrax is an old drug FDA approved with a known history in humans. Something Sparvax will never be able to do because phase III testing in humans will never be allowed, maybe a big part of why Sparvax was put on the back burner by BARDA.
Anyhow, my main point is that Tecovirimat was a possible billion dollar drug in 2006. Looking forward to a last minute deal. Siga's team is fully aware of their "bad faith" and have heard from Judge Parsons and the Delaware Supreme Court that justice will be served with interest.
If Pharmathene gains possession through BK or whatever I suspect them to offer the government a much better price. Maybe close to the $100 the government thought possible. It will still be a lot of profit. Good for shareholders and taxpayers.
$1.2 billion, Maybe the bad faith boyz will come with the full amount Parsons awards Pharmathene and continue to "deal" with BARDA as they have in the past. Trying to get every last penny from anyone they deal with. Mr Perelman is a billionaire and then you have his McAndrews and assorted crew with plenty of cash and "bad faith" know how to get ever richer off this one deal.
GLTA the good people
For smallpox if you can't do human phase III studies (it's far too lethal so you can't) that the CMV monkey should be the second animal test to best prove a drugs potency and safety in humans.
The competition is CMX001 from Chimerix. I company I have owned for years and recently sold most of as I think it has reached a fair valuation. CMX001 is an effective drug to be used against in pox diseases in general, just not in CMV monkeys. You can google it and see all the problems and the workarounds they are attempting for smallpox.
Arestvyr (Tecovirimat) was injected up to 2 days following lethal injections of smallpox and the monkeys never had side effects from drug or disease. All lived healthy until they were put down for security concerns over having monkeys alive and around that were injected with a lethal dose of smallpox.
BARDA will not have that much trouble making a choice on which smallpox