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Siga Technology: Health Agency Plans Summit on U.S. Biological Threat Preparations Friday, Feb. 5, 2010 WASHINGTON
-- The U.S. Health and Human Services Department next week plans to conduct a summit with other government entities as it works to reassess the nation's strategy for producing treatments for biological weapons materials and other public health threats (see GSN, Feb. 3). (Feb. 5) - The Obama administration has planned a conference next week to review the development and procurement of biological threat countermeasure as part of an initiative launched last year by U.S. Health and Human Services Secretary Kathleen Sebelius, shown in December (Chip Somodevilla/Getty Images).
The two-day conference will examine federal policies and activities from initial research all the way through government approval of the sale of vaccines and other agents and suggest what improvements, if any, should be made to the system. The workshop is the latest step in an ongoing review of the country's medical countermeasure development and procurement effort launched by HHS Secretary Kathleen Sebelius last year (see GSN, Dec. 2, 2009).
Countermeasures are usually defined as drugs and vaccines that ward against chemical, biological, radiological, and nuclear agents and emerging infectious diseases. "We want to have more promising discoveries, more advanced development, more robust manufacturing, better stockpiling and more effective distribution practices," Sebelius said of the effort Monday during the department's fiscal 2011 budget rollout. "Our ultimate goal is to have the kind of biodefense system that is so dependable and robust that potential terrorist give up and say, 'It's not worth the effort,' and when Mother Nature strikes we are ready to respond."
The evaluation is being led by Nicole Lurie, assistant secretary for preparedness and response, and will be completed "by the end of the first quarter of 2010," Sebelius said. It was ordered in the wake of the government's response to the H1N1 influenza outbreaks last summer -- when development of a vaccine progressed slower than originally expected. The spread of H1N1 drew attention to the government's reliance on outdated technology, such as using chicken eggs to grow vaccines, "an unpredictable process we've used for the last 50 years," the HHS secretary said Monday.
The review was also spurred by the fact the government has failed to successfully develop a second-generation anthrax vaccine nearly nine years after the 2001 anthrax mailings despite spending tens of millions of dollars on the effort, according to Eric Toner, a senior associate with the University of Pittsburgh's Center for Biosecurity. "A new anthrax vaccine has been on top of everybody's list of the countermeasures we need the most," Toner said in an interview last week. "After all this time we still don't have that and they've had to cancel the contract. Now's the time to go back and relook at this, relook at the process." In 2006, the government canceled an $877.5 million program for production of an anthrax vaccine that was being run through Project Bioshield (see GSN, Dec. 20, 2006).
President Barack Obama acknowledged the HHS examination in his first State of the Union address last week. "We are launching a new initiative that will give us the capacity to respond faster and more effectively to bioterrorism or an infectious disease -- a plan that will counter threats at home, and strengthen public health abroad," the president told lawmakers. The day before Obama's speech the U.S. government received a failing grade from the Commission on the Prevention of Weapons of Mass Destruction Proliferation and Terrorism for failing to move aggressively with a plan to "rapidly recognize, respond and recover" in the event of a biological attack. A White House official said last week the timing of the announcement was purely a coincidence. Toner countered that there was "no doubt it was directly in response" to the report card issued by the WMD panel. "The initiative he referred to was announced in December. That's ongoing, but I can't imagine that we would have put the sentence in the speech had not the report card been all over the news for the last two days," he said. Other experts in the biodefense field disagree with that assessment. The administration is "so upset they're not upset. They don't even take [the report card] seriously," said Barry Kellman, president of the International Security and Biopolicy Institute. "Frankly, a lot of people are reacting that way."
"The government has 60 programs, is spending billion of dollars and has hundreds of people working on this issue," he said in an interview last week. "To say this effort is an F is ridiculous." The Pipeline The existing countermeasure development pipeline, as established in 2004, begins with the National Institutes of Health or a research entity within the Defense Department conducting basic research on a drug or vaccine before transferring the materials to the Biomedical Advanced Research and Development Authority at Health and Human Services. The authority then provides financial and managerial support for companies to develop the treatments. The licensed end product would be purchased through Project Bioshield, which was intended to receive about $5.6 billion over 10 years to purchase medicines designed to protect U.S. citizens from the effects of a WMD attack. To date, the effort has purchased about $2 billion worth of countermeasures for the Strategic National Stockpile, which stores medical supplies in the event of a bioterrorism incident or other public health emergency. The administration and Congress shifted roughly $609 million in fiscal 2010 from Project Bioshield's Special Reserve Fund, including a $305 million transfusion to the advanced development authority (see GSN, Jan. 8). The fiscal 2011 spending plan unveiled Monday transfers $476 million from the Special Reserve Fund to the same office so that it might take research to the preproduction stage for drugs and therapies for medical emergencies. White House spokesman Nick Shapiro said there are four goals the initiative hopes to produce: a concerted approach to medical countermeasure development; a focus on multiuse products; an emphasis on innovation and disruptive technologies; and the establishment of new and more effective public-private partnerships. "Prior government efforts have been mostly unable to counter market forces driving private industry toward more profitable products outside of key public health needs," Shapiro told Global Security Newswire in an e-mail message last week. "Our new approach will turn this around. We will pursue a business model that leverages market forces and reduces risk to attract pharmaceutical and biotechnology industry collaboration with the U.S. government." A successful model, according to Shapiro, can be applied "more broadly to the urgent need for novel medical countermeasures in global health, provide a pathway toward more affordable and effective pharmaceuticals here at home, and ensure that the United States remains at the forefront of global biotechnology." The Obama administration's approach "says all the right things" but it is "unclear how they're going to overcome the impediments that have plagued the program in the past," according to Jonathan Tucker a senior fellow with the James Martin Center for Nonproliferation Studies.
"The Bush administration made a major effort on medical countermeasure development but it didn't get very far." Still, he called the current examination the "first step toward a solution." Toner said the review is "absolutely needed" because "the system hasn't been effective.
Before the 2006 passage of the Pandemic and All-Hazards Preparedness Act, companies interested in medical countermeasures had to bear most of the costs of advanced development, including expensive clinical trials, despite the risk that the product might fail to achieve licensure. The lack of federal funding for advanced development created a financial desert known as the "valley of death" between government-supported basic research and funding under Project Bioshield, according to Tucker.
Successful countermeasure development also has proven difficult because there are few economic incentives for the major pharmaceutical companies to develop biodefense medicines and vaccines for the government, he said. "These are public companies that want to maximize profits," Tucker said. "They're happier selling Viagra than smallpox vaccine." The market for biodefense countermeasures is very small -- essentially limited to government agencies -- and there are major legal liability risks involved if the products have unexpected side-effects.
"You can't infect someone with smallpox to test if an antiviral drug is effective," Tucker told GSN. "So the licensing process has to rely on efficacy studies in animal models. Yet the Food and Drug Administration hat yet to map out a clear path to licensure based on animal studies alone." The Summit There are a half-dozen objectives for the Feb. 11-12 session at the National Academy of Sciences building, according to an Institute of Medicine announcement. They include identifying strategies to "optimize" the federal medical countermeasures enterprise; examining ways to enhance the conversion of early investments in basic science toward potential finished products; and evaluating possible changes to the regulatory oversight process for medical countermeasures. At this time, Health and Human Services does not anticipate the cost of the evaluation will exceed $1 million, with funding being allocated from the advanced development authority, according to an department spokeswoman. Those funds will cover the costs associated with "the development of white papers in three topic areas, several workshops, and associated costs for consolidating and analyzing information from all of the sources to generate a final report for the HHS Secretary," Gretchen Michael, communications director for the assistant secretary for preparedness and response, said in an e-mail message today. In addition to next week's conference, a working group of the National Biodefense Science Board will hold a workshop at the end of February, Michael told GSN. That meeting will examine the emergency medical countermeasure enterprise and strategy through "consideration of a series of case studies," she said. The board will send a report to Secretary Sebelius by March 31 and the assistant secretary will make policy recommendations a few weeks after that, according to Michael. Representatives from the Homeland Security and Defense departments are likely to attend next week's conference, along with officials from various departments within Health and Human Services, such as the Centers for Disease Control and Prevention and the advanced development authority, according to Toner. Michael confirmed that "multiple" agencies with Health and Human will attend the summit, as will members of the Pentagon. Representatives from academia, and the pharmaceutical and biotechnology communities will also attend the workshop, she added. Toner said he could not predict what conclusions workshop participants would reach, adding that Health and Human Services "is trying to be fairly open-minded and look at a whole new approach to developing and acquiring countermeasures. Who know what will come out of it." "I hope the outcome of the review is an increased understanding that the review, while necessary and appropriate, falls short of what is needed to improve global biopreparedness for intentional attacks and will spur, therefore, more far-reaching policy initiatives," Kellman said in an e-mail message this week. He did not elaborate. There will be some "major reform" of the countermeasure development and procurement process but "it's not yet clear how they're going to go about it," according to Tucker.
Fazit: Siga selbst wird bei dem Gipfel bzw. Meetings zugegen sein, da mit mit ST-246 den Smallpox Markt bedient und mit ST-193 einen Wirkstoff für Anthrax. Werden die Ziele so wie ausgegeben, in der nahen Zukunft umgesetzt, wird Siga möglicherweise bereits nächste Woche im Mittelpunkt des Interesses stehen, sei es durch die Vergabe des Auftrages von Barda aus 2009, sei es das weitere Förderprogramme für die Entwicklung der beiden Wirkstoffe aufgelegt werden. Es könnte der Beginn eines neuen Zwischenspurtes für die Siga- Aktie sein. Es bleibt spannend!
ich hoffe, dass wir von den ereignissen nicht überrascht werden, so dass man noch zeit zum reagieren hat.
allen jedenfalls viel erfolg!!
Das Kurse an den Börsen auf und ab gehen, sollte allen hier klar sein. Ist übrigens nicht böse gemeint.
cultom
SIGA was at $4 in March and through Sept, kept in the $8 range before a dip to $6 and then a surge to $10 in late Nov. SIGA then it lost 50% of its value, falling to $5 in Dec before establishing a floor at $6 in the last 6 weeks. SIGA has 25+ million shares in the float and over 12% are short-sellers. I believe SIGA is on the Up-Trend and those shorters will begin to ‘buy’ as the stock returns to its high. In its current price range, ACHN is a near-term (3 Mo) ‘Buy on the Dips’ consideration for me. Today, RBC Capital Markets initiated coverage of SIGA with an ‘Outperform’.
SIGA specializes in the development of pharmaceutical agents to fight bio-warfare pathogens and on Jan 19, announced it had staged a full-scale, ‘real’ smallpox bio-attack simulation with the government of Israel. It was the largest bio-defense drill in Israeli history. While no drug was deployed in the maneuvers, hundreds of experts from over 70 countries observed the two-day exercise that took place in and around Tel Aviv.
On Dec 14, SIGA announced the closing of its offering of 2,725,339 shares of common stock to a select group of institutional investors at a price of $7.35 per common share. SIGA plans to use the net proceeds from the sale of the shares for general corporate purposes, including development of the Company's product candidates, the acquisition or in-license of technologies, products or businesses, working capital and capital expenditures.
Additional Public Smallpox Stockpile Initiatives in the Pipeline - After Israel now GB want to buy?
Contingency planning for a deliberate release of smallpox in Great Britain - the role of geographical scale and contact structure
Thomas House , Ian Hall , Leon Danon and Matt J Keeling
BMC Infectious Diseases 2010, 10:25doi:10.1186/1471-2334-10-25
Published: 14 February 2010
Abstract (provisional)
Background
In the event of a release of a pathogen such as smallpox, which is human-to-human transmissible and has high associated mortality, a key question is how best to deploy containment and control strategies. Given the general uncertainty surrounding this issue, mathematical modelling has played an important role in informing the likely optimal response, in particular defining the conditions under which mass-vaccination would be appropriate. In this paper, we consider two key questions currently unanswered in the literature: firstly, what is the optimal spatial scale for intervention; and secondly, how sensitive are results to the modelling assumptions made about the pattern of human contacts?
Methods
Here we develop a novel mathematical model for smallpox that incorporates both information on individual contact structure (which is important if the effects of contact tracing are to be captured accurately) and large-scale patterns of movement across a range of spatial scales in Great Britain.
Results
Analysis of this model confirms previous work suggesting that a locally targeted 'ring' vaccination strategy is optimal, and that this conclusion is actually quite robust for different socio-demographic and epidemiological assumptions.
Conclusions
Our method allows for intuitive understanding of the reasons why national mass vaccination is typically predicted to be suboptimal. As such, we present a general framework for fast calculation of expected outcomes during the attempted control of diverse emerging infections; this is particularly important given that parameters would need to be interactively estimated and modelled in any release scenario.
Background of RFP Amendment:
Senior Obama Official Steers Sole-Source Contracts to Former Business Associates
by Capitol Confidential
It has been reported, a company by the name of PharmAthene, which is closely tied to the late Congressman John Murtha and Tara O’Toole, an Under Secretary at the Department of Homeland Security (DHS) has received preferential treatment by our good friends in the federal governmenat the expense of Joe Taxpayer.
BIG GOVERNMENT has learned that a little known entity named the Biomedical Advanced Research and Development Authority (BARDA) at the Department of Health and Human Services (HHS) is adding millions of dollars to a contract awarded way back in 2003 that PharmAthene inherited, rather than conducting a fair and open competition. In government speak, that means PharmAthene is about to get huge sums of additional cash without ever having competed for it. Coverage of this sole-source award has already received significant news coverage and attention from numerous outlets, including Citizens for Responsibility and Ethics in Washington (CREW).
But it’s not as if PharmAthene is hiding it. They’re actually promoting the fact that they’re getting sole-source contracts that do away with any competition and fatten their bottom line.
According to a recent PharmAthene press release:
“David P. Wright, President and Chief Executive Officer of PharmAthene, commented, ‘In consultation with BARDA, today PharmAthene submitted a White Paper for advanced development of SparVax(TM) in response to the BAA. If BARDA finds our submission acceptable, a formal proposal will be requested. We believe that, if awarded, funding provided under this BAA, along with potential additional funding under our existing contract with BARDA, will be sufficient to advance SparVax(TM) to a stage where it will be eligible for consideration for a Project BioShield procurement contract.’”
In spite of the fact that Candidate Obama ran and was elected on a pledge to eliminate just these kinds of sole-source contracts, his administration appears to be taking it to a whole new level, particularly when one considers this has do with national security.
The BIG GOVERNMENT question is, why?
BARDA and the Obama Administration (i.e. Tara O’Toole) are propping up PharmAthene all in an effort to position the company to become the national vaccine maker despite having less than 50 employees and a questionable balance sheet .
A little background will be useful here…
Prior to entering the administration, Tara O’Toole ran the Center for Biosecurity at the University of Pittsburgh Medical Center (UPMC) and advised the Alliance for Biosecurity. As has been reported, PharmAthene basically controlled the Alliance and has been working feverishly to get the Center for Biosecurity to become the nation’s government-owned vaccine maker, meaning literally billions for O’Toole’s friends at PharmAthene, who have already enjoyed both earmarks and government contracts at the American people’s expense.
But the timeline here is very interesting. Apparently, the Center for Biosecurity left the Alliance in October of last year, right before O’Toole’s nomination cleared numerous hurdles and she got the job at DHS. Furthermore, in December, with no fanfare whatsoever, PharmAthene got their sole-source contact from BARDA.
http://biggovernment.com/capitolconfiden...
Siga: And the clock goes: Tick-Tock - Tick - Tock!
Just a reminder for those who are thinking ONLY of this therapeutic smallpox RFP that SIGA is bidding on now.....there should be additional US purchases to follow. While the international market is huge, there are probably prophylaxis, geriatric/IV, and adolescent/suspension formulations of 246 still to come in new RFPs from the US Government. While the geriatric/IV formula might be small...but expensive potatoes, a new prophylaxis RFP could easily be as big, if not bigger than, the therapeutic... RFP... particularly if the dosage is different. Dr. Rose has mentioned on several occasions that 25% of the US population base is under 10 years old or younger so there is an appreciable market there with another RFP too. One of the initial RFP questions asked if the 12M additional courses included any of the other types of courses....the answer was may or may not on prophylaxis....but there would be additional contracts to address other formulations. (question 21) IMO, this definitely means some portion of the 12M additional courses should be bought at a minimum. Lots more growth over the the next couple of years in the basic contract to fund further pipeline development.
Gruß
Nette News in der letzten Woche und guter Ausblick. Im Moment bin ich sehr zufrieden mit SIGA.
For the full year 2009, total revenues were $13.8 million as compared to $8.1 million in 2008, and net operating loss was $11.9 million as compared to $8.7 million in 2008. Net loss per common share was $0.47 as compared to $0.25 in 2008. SIGA's performance in 2009 was mainly driven by the continued development of ST-246(R), including completion of a Phase II human safety clinical trial and the initiation of the commercial manufacturing validation campaign.
For the fourth quarter of 2009, total revenues were $4.0 million as compared to $2.5 million in 2008, and operating loss was $3.7 million as compared to $2.5 million in 2008.
Total assets as of December 31, 2009 were $25.9 million as compared to $8.8 million on December 31, 2008.
Ayelet Dugary, Chief Financial Officer of SIGA Technologies, stated, "We ended the year with a stronger balance sheet, greater liquidity and significant institutional investor support. During 2009, we raised approximately $20 million, which has positioned us to meet our commitments and invest in our programs."
2009 Key Financial Results
Revenues
For 2009, revenues from research and development contracts and grants were $13.8 million, an increase of $5.7 million, or 71.2%, from $8.1 million in 2008. This increase is due mainly to an increase in revenues recognized from our existing program to establish large-scale manufacturing and packaging of ST-246 and revenue recognized from our contract for additional formulations and indications of ST-246.
Research and Development
For 2009, research and development expenses were $17.4 million, an increase of $5.8 million, or 50%, from $11.6 million in 2008. Expenditures related to the manufacturing, packaging, and stability testing of ST-246 increased $3.3 million. Other costs related to ST-246 and the development of our other lead drug candidates increased $1.2 million from the prior year. Employee compensation expenses increased $978,000, mainly due to the hiring of additional expert R&D and support personnel.
Selling, General and Administrative Expenses
For 2009, selling, general and administrative expenses were $7.5 million, an increase of $2.9 million, or 64%, from $4.6 million in 2008. This increase is due mainly to higher stock-based compensation charges, higher general corporate and litigation legal support, and an increase in accounting fees.
Financial Condition and Liquidity
Cash, cash equivalents and short-term investments at December 31, 2009 were $14.5 million and $5.0 million, respectively, as compared to a cash and cash equivalents balance of $2.3 million at December 31, 2008. In 2009, we strengthened our balance sheet with the sale of 2.7 million shares of our common stock for net proceeds after offering expenses of $18.6 million, in addition to receipt of $7.4 million of proceeds from exercises of warrants and options to acquire shares of our common stock.
Annual Report on Form 10-K
SIGA is filing today with the Securities and Exchange Commission its Annual Report on Form 10-K for its fiscal year ending December 31, 2009. SIGA urges its investors to read this Annual Report on Form 10-K for further details concerning the Company. The Annual Report on Form 10-K is also available on the Company's website, at http://www.siga.com.
Analyst Raises SIGA Estimates to $11 per Share
SIGA Technologies, Inc. (SIGA, Free Analysis), a drug development company in the biodefense industry, has moved significantly off of its $4.73 52-week lows, but remains undervalued according to at least one analyst. Noble Financial raised its price target from $7 to $11 per share, and maintained its Buy rating on the company.
Earlier this month, RBC also released positive comments on the company after a conference panel. The analyst saw significant near-term potential upside in the stock due to an expected contract with the U.S. Government and maintained its own Outperform rating on the stock. On April 1st, the company is also meeting with RBC Capital in Boston.
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