Bavarian Nordic A/S : Receives Health Canada Approval of IMVAMUNE Smallpox Vaccine
11/22/2013 | 01:35am US/EasternRecommend:
KVISTGAARD, Denmark, November 22, 2013 - Bavarian Nordic A/S (OMX: BAVA, OTC: BVNRY) announced today that Health Canada has granted a Notice of Compliance approving IMVAMUNE® for active immunization against smallpox in a public health emergency. IMVAMUNE is indicated for persons 18 years of age and older who are contraindicated to replicating smallpox vaccines. This includes individuals with immune deficiencies and skin disorders.
Health Canada is the second regulatory body to approve the company's smallpox vaccine which earlier this year was approved by the European Commission for use in the general adult population in all 28 EU countries and Iceland, Liechtenstein and Norway, where it is marketed under the trade name IMVANEX®.
Since 2008, Bavarian Nordic has collaborated with the Canadian Government to address their biological preparedness requirements. The company was initially awarded a contract to supply 20,000 doses of IMVAMUNE to the Canadian armed forces, followed by a replacement order in 2012. The original contract also provided funding for filing a New Drug Substance application for IMVAMUNE.
"The approval of IMVAMUNE in Canada continues our track record of successfully working with governments to address their biological preparedness requirements. We have partnered with the U.S. government for more than a decade on the development of our smallpox vaccine and we are delighted that Canada now leverages on this successful partnership," said Anders Hedegaard, President and CEO of Bavarian Nordic. "This approval provides further validation of our MVA-BN vaccine technology platform which we have successfully developed and commercialized."
KVISTGAARD, Denmark, November 15, 2013 /PRNewswire/ --
Bavarian Nordic A/S (OMX: BAVA) announced today that it completed the delivery of 20 million doses of IMVAMUNE® smallpox vaccine to the U.S. Strategic National Stockpile (SNS) for use in the event of a smallpox emergency in the U.S.
This order completion is the result of a decade-long research and development partnership between Bavarian Nordic and the U.S. government and fulfills the original contract awarded in 2007, valued at USD 549 million.
"Bavarian Nordic is proud to be a part of fulfilling a US government requirement for bioterrorism preparedness by delivering 20 million doses of IMVAMUNE," said Anders Hedegaard, President and CEO of Bavarian Nordic. "This accomplishment shows that when resources and commitment are applied, industry and government can successfully work together to achieve great things."
Since 2010, Bavarian Nordic has been delivering the vaccine to the SNS. It is being stockpiled for emergency use in individuals with compromised immune systems, such as people with HIV or atopic dermatitis, including children and pregnant and nursing women, who are not recommended to take the previous generation vaccine due to increased risk for severe side effects.
In April, the U.S. government awarded Bavarian Nordic a new contract valued at up to USD 228 million to supply 8 million additional doses of IMVAMUNE needed to maintain the 20 million dose stockpile over time.
About Bavarian Nordic's Partnership with the U.S. Government
Bavarian Nordic initiated the development of IMVAMUNE in 1999. After the U.S. terrorist attacks of 2001, the government expanded its investment in medicines and vaccines to protect against potential bioterrorism agents, by establishing the Project BioShield initiative.
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Sentiment: Strong Buy
For decades, the government has contracted with outside companies for nearly all the medicines intended to protect the public and military personnel against infectious diseases. But the Defense Department has long sought to create its own medical manufacturing arm.
After the 1991 Persian Gulf War, the Pentagon spent hundreds of millions of dollars trying to develop vaccines against more than a dozen exotic pathogens, such as plague and the Ebola virus. The efforts ultimately fell short or were abandoned because of the costs and steep scientific challenges.
"This is a really, really hard thing to do," said David L. Danley, a biologist and retired Army colonel who supervised the Pentagon's vaccine-acquisition program. "The numbers — the costs — just didn't make sense."
The Defense Department has protected its battlefield personnel against the highest-profile biological threats — anthrax and smallpox — by securing access to Health and Human Services' stockpile of vaccines purchased from private pharmaceutical companies.
After the Sept. 11 terrorist attacks and the mailings of anthrax-laced letters that fall, the idea that the military needed defenses against a broader range of threats gained renewed momentum.
The Pentagon contracted with DynPort Vaccine Co. to develop biodefense vaccines, and by 2006 had paid the firm about $700 million. The work has not resulted in a product approved for use by the U.S. Food and Drug Administration.
In 2008, a report by researchers at the University of Pittsburgh Medical Center recommended that the Pentagon oversee the construction and operation of at least two plants for making biodefense medicines, saying that existing arrangements with private vaccine makers had yielded "limited success."
Army Maj. Gen. Stephen V. Reeves, then in charge of the military's defenses against biological and chemical warfare, publicly disagreed.
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By David Willman
November 23, 2013, 7:24 p.m.
WASHINGTON — Despite intense pressure to hold down federal spending, the Defense Department is launching a high-priced effort to create its own production pipeline for vaccines and biodefense drugs — an initiative that defies the advice of government-hired experts and duplicates what another agency is doing.
Construction began in late October on a plant in north Florida that will produce flu vaccine and specialized medicines for the Pentagon to protect military personnel against germ warfare agents.
To begin paying for the initiative, the Obama administration has quietly shifted millions of dollars that had been budgeted for better masks, boots, early-warning sensors and other equipment for troops at risk of exposure to chemical or biological weapons, according to government documents and defense specialists.
The Department of Health and Human Services, meanwhile, is on track to spend billions of dollars to produce the same types of medicines in collaboration with private drug companies and university researchers.
The overlapping efforts are precisely what some policymakers have warned against. The Defense Department program also flies in the face of an analysis, commissioned by the White House, that examined ways the government could bolster production of vaccines and biodefense drugs.
The 2009 analysis recommended against establishing a government-controlled facility, akin to what the Pentagon is doing, saying that contracting with private manufacturers would produce new drugs more quickly and at a lower cost.
The 112-page report has not been shared with Congress or previously publicized. A copy of the document was obtained by the Los Angeles Times.
The Pentagon initiative has been championed by Assistant Secretary of Defense Andrew C. Weber, a presidential appointee. The Times' request for comment from Weber was referred to a top aide, James B. Petro.
In an interview, Petro said the Florida facility was needed to make medicines that the military could not rely on Health and Human Services or others to provide. The goal, he said, was to do "a more efficient and effective job" of acquiring the products.
"It's about making sure that our men and women in uniform have the protection that they need against these threats," said Petro, adding that Weber was aware of the 2009 analysis and that it had informed his staff's "strategic thinking."
Shifting funds from protective gear to help pay for the manufacturing effort was a "portfolio management decision" intended to "achieve balance in yielding both medical and physical defense equipment," Petro said.
Sentiment: Strong Buy
November 15, 2013
On behalf of the Board of Directors, I am delighted to welcome you to the 2013 Annual General Meeting of Mesoblast Limited.
To say that it has been a highly productive year for Mesoblast almost undervalues the breadth and pace of achievements that have been the hallmark of 2013.
A year of intense clinical and commercial activity has affirmed Mesoblast as the world's leading regenerative medicine company with late-stage and approved products across a wide range of diseases with well-defined and unmet medical needs.
Our existing cash reserves, which stood at $292 million at 30 September 2013 and follows a successful financing event earlier this year, are sufficient to meet our current and new product development plans, manufacturing requirements, and personnel needs.
As you all understand, our Company at this stage does not have operational revenues. We continue to incur expenditure on our clinical trials, manufacturing processes and our people. This expenditure is our investment in the future. The Board's role is to ensure that the bulk of our expenditure is on these priorities and that the Company manages this expenditure appropriately to create long-term shareholder value.
Our Chief Executive will discuss with you in detail our current activities and future opportunities.
During 2013, we continued to forge ahead with clinical programs in our four key therapeutic areas of focus - cardiovascular diseases, inflammatory and immunemediated diseases, orthopedic diseases of the spine, and oncology conditions associated with bone marrow transplantation.
The Board was very pleased to see the successful outcome of significant efforts put in by our management team, working closely with their counterparts at Teva Pharmaceuticals Inc., when the FDA recently gave the go ahead to commence a Phase 3 clinical trial in patients with chronic congestive heart failure, a tremendous unmet medical need. We are looking forward to first patient recruitment soon.
The recent acquisition of Osiris Therapeutics' culture-expanded mesenchymal stem cell business has broadened the number of late-phase clinical programs in our strategic areas of focus, and we anticipate cost savings and other synergies across personnel, capital expenditure, and manufacturing. The Board believes this is a farsighted move for Mesoblast for many strategic and commercial reasons.
Our new relationship with JCR Pharmaceuticals has facilitated access to Japan, the world's second largest healthcare market. JCR has exclusive rights to our mesenchymal stem cells for hematological malignancies in Japan, and we look forward to the first registration filing in Japan for approval of an allogeneic stem cell product.
In line with the fast pace of growth of our business, the Board composition and skill sets are constantly being reviewed, and will be strengthened as necessary on par with the increase in strategic oversight provided by the Board.
Mesoblast's Board was enhanced this year with the appointment of eminent cardiac surgeon Dr Eric A. Rose, a world leader in translational research and cardiovascular medicine. His top tier skills are internationally acclaimed in the medical and scientific realms, as is his highly relevant corporate experience gained in his commercial roles at companies such as SIGA Technologies and MacAndrew & Forbes Inc., the holding company of Ronald O. Perelman.
The Board has further leveraged off Eric Rose's experience with his appointment as the chairman of the newly-created Science and Technology Committee. This Board committee, which includes Board members Ben-Zi Weiner and Silviu Itescu, was established to provide oversight of strategic direction and investment in R & D and new technologies, as well as further assist with identifying additional opportunities for our current technologies.
2013 also saw the publication of clinical and preclinical results in prestigious medical and scientific journals, including the New England Journal of Medicine, Circulation Research, and Blood and Bone Marrow Transplantation. Our lumbar spinal fusion results were delivered to the North American Spine Society 28th Annual Meeting and our preclinical results in stroke were presented at Neuroscience 2013.
We continue to recruit knowledgeable and capable staff across all disciplines. Our staff shares a passion to bring our biotherapeutics to market and the Board would like to note their constant diligence, enthusiasm and dedication to our evolving business.
On behalf of the Board, I would also like to thank you, our shareholders, for your support throughout the year. We hope to reward your patience and loyalty by increasing the Company's value proposition as we advance to the next stage of growth.
I would now like to pass the baton to Professor Silviu Itescu, the recipient of the inaugural Pontifical Key Innovation Award presented at the Vatican earlier this year. The award acknowledged his global leadership and ingenuity in translational science and clinical medicine within the field of adult stem cell therapy. Additionally, Silviu was recently appointed to the Australian Academy of Technological Sciences and Engineering, an independent body of eminent Australian scientists and engineers who advance Australia's prosperity through technological innovation. We are proud of this further validation of his valued contributions to society.
Sentiment: Strong Buy
Development and Characterization of an Intranasal Mousepox Model
Southern Research Institute has been awarded a task order from the U.S. Department of Health and Human Services, Biomedical Advanced Research and Development Authority (BARDA), to complete development and characterization of an intranasal mousepox model.
Mousepox (which is caused by the Ectromelia virus) is one of three animal models useful for development of medical countermeasures for smallpox. Southern Research Institute has already validated the non-human primate and the rabbit models for human smallpox for compliance with the FDA Animal Rule. Addition of the murine ectromelia virus model completes Southern Research’s portfolio of animal models used to develop medical countermeasures for smallpox, to study basic questions in disease pathogenesis and to develop countermeasures to orthopoxviruses engineered for enhanced virulence, transmissibility, or the ability to break through vaccine immunity.
Briefly the scope of work for this contract is as follows:
Generate virus stocks - master and working seed banks following a qualified quality control plan
Determine the natural history of the disease to define onset and progression following infection
Characterize the model for use in assessing anti-viral therapeutics designed to identify treatment triggers
Create a Technology Transfer Package such that BARDA may use the model in many laboratories to support its Medical Countermeasures (MCM) program
Model development work has already started and is expected to be completed in 2014.
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Sentiment: Strong Buy
Well, yes, to, in your words, to be generally specific, it's -- we're interested in growth opportunities that are going to create near-term value creation, whether that's through cash inflows or just a -- the point of which the value is transparent to all. So those are the types of things that we are interested in.
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Sentiment: Strong Buy
SEOUL, Oct. 20 (Yonhap) -- South Korea and the United States have agreed to build a government-level integrated response system to better prepare for biological outbreaks and bioterrorism threats, a Seoul's defense ministry official said Sunday.
The surveillance system will allow the two countries to monitor and counter some 10 biological threats such as anthrax and smallpox, and potential biological weapons, the ministry official said.
"There was a joint awareness between the two nations to build a system to better counter various biochemical accidents and terror attacks amid frequent domestic and international threats," said the official.
Lee Nam-woo, who is in charge of the South Korean defense ministry's welfare department, signed the agreement with Joint Program Executive Officer for Chemical and Biological Defense Carmen Spencer in Washington, D.C. on Friday, the official said.
The system will greatly enhance Seoul's defense technology against chemical and biological weapons, the official said, adding that the system will enable the two nations to share various information on vaccines and diseases as well.
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Sentiment: Strong Buy
“I share Gen. Russell’s concern about the known threats,” he said. “As a critical care physician, I’ve treated both SED and tularemia and the thought of having hundreds or thousands of such patients can not even be comprehended by the medical community.”
Russell said he took part in a two-year study of U.S. offensive biological weapons programs that were ended in 1969. It determined that in certain attacks, bio weapons could kill up to 100,000 people.
“The U.S. offensive biowarfare program was very large, very well- funded and very successful,” he said. “By 1969, when the program was terminated, it had achieved the ability to deliver lethal and incapacitating agents in a dry powdered aerosol over very large areas—up to hundreds of square miles.
The agents studied included tularemia and staphylococcal enterotoxin B, known as SEB.
“Tularemia is one of the most infectious agents known, and when delivered by aerosol in high doses, causes a severe respiratory disease that can be fatal,” Russell said. “Tularemia is widely disseminated in nature and easily obtained. SEB causes rapid incapacitation and is also lethal in high concentrations.”
Both agents and the means to deliver them were manufactured by the U.S. military and stockpiled, he said. The arms would be used in combination: one for rapid effect and the other for lethality.
“Both of these agents are readily available to anybody who can isolate a bacteria,” he said.
Russia, China, and Iran—not mentioned by the experts during the hearing—also are suspected of having large-scale biological weapons programs.
The State Department annual report to Congress on arms compliance made public recently stated that China, North Korea, and Russia engaged in activities with biological weapons applications. On Russia the report was categorical in stating, “Russian entities remained engaged … in BW-relevant activities.”
Russell said tularemia is 10,000 times more infectious than anthrax, an agent used in the 2001 attacks in the United States that the FBI linked to Fort Detrick bioweapons specialist Bruce Ivins, who committed suicide in 2008. Anthrax however lingers longer and is a “very, very dangerous” bioweapon, he said.
Bruce Bennett, senior defense analysts with the RAND Corp., said North Korea has a major biological weapons program that included anthrax, cholera, smallpox, and plague, the latter two being infectious diseases.
“North Korean special forces are a likely means of delivering biological weapons,” Bennett said. “The North has some 200,000 special forces, some of whom could deliver devastating biological attacks against South Korea, Japan, and even the United States.”
Depending on wind, weather, and population density, “these forces could infect perhaps 50,000 people per kilogram of anthrax used,” he said.
“North Korean biological weapons pose potentially serious though uncertain threats to South Korea and to the United States,” Bennett said. “This threat should press the United States and South Korea to pursue more complete protections.”
Giroir said genetically modified biological weapons—those that can be designed to attack people with specific genetic markers—are also a threat.
However, Giroir warned that the U.S. government and military need to be prepared for a completely unexpected “unknown unknown” bioweapon—some new type of agent that could emerge.
Such preparations would include frequent testing and exercises against biological weapons attacks, stockpiling vaccines and antidotes and readying facilities and laboratories for rapid production and distribution of anti-biological weapons materials.
Amy Smithson, with the Monterey Institute of International Studies, said Iraq under Saddam Hussein developed biological weapons capable of causing liver cancer and gangrene.
Subcommittee Chairman Rep. Mac Thornberry (R., Texas) said biological weapons threats should be at the top of the list of emerging threats to U.S. security.
“Today’s hearing is a reminder that the national security threats to our nation do not go away or wait patiently while we try to straighten out our budget woes,” he said.
“There are very real and very significant dangers in the world, and the foremost target is America and Americans.
Russell said one of the problems for government is a lack of coordination between agencies and inefficient and uncoordinated efforts.
The Department of Homeland Security is in charge of civilian biological warfare defenses and the Pentagon deals with military biowarfare defense. The Department of Health and Human Services also is responsible for countering the effects of bio weapons.
“The fundamental answer is senior leadership and direction,” Russell said. “If there’s strong central senior leadership, the agencies will respond and work together. If there is not, they will not. They will go their own way. And there’s a lot of history to support that view.”
October 11, 2013 6:12 pm
U.S. Vulnerable to Bio Warfare Attack
The United States remains vulnerable to deadly biological warfare attacks that could kill tens of thousands of people, several weapons specialists told Congress on Friday.
Four bioweapons experts told the House Armed Services subcommittee on emerging threats that terrorists could easily manufacture bacterial weapons like tularemia, an infectious disease that U.S. bioweapons tests in the 1960s revealed capable of producing deaths in the tens of thousands through weaponized infectious diseases.
Rogue states like North Korea and Syria also are suspected of having germ weapons and stockpiles, the experts said.
“Unfortunately, some of the best potential bioweapons exist in nature and are readily available,” retired Army Maj. Gen. Phillip Russell told the hearing.
“This information is widely available on the Internet,” he said. “The equipment is for sale on the Internet. We have seen a tremendous shift of advantage to the adversaries, in this regard, because of the ability of a very small group of people with the expertise to manufacture these weapons. And the weapons are very, very dangerous.”
Russell warned that the Pentagon is unprepared for an attack using biological weapons and has no preventive medical countermeasures for two of the most deadly agents.
“I believe that a significant national vulnerability exists that will persist unless action is taken to improve our countermeasures development efforts,” he said.
Brett Giroir, vice chancellor for strategic initiatives at Texas A&M University said he also worries about biological weapons attacks.
News Brief 10/7/2013, Cheshvan 3, 5774
Concern: Syrian Biological Weapons will Reach Hezbollah
Israel and the United States are concerned that while the Syrian chemical arsenal is being dismantled, its biological weapons may spill over to jihadist groups among anti-government rebels or Damascus ally Hezbollah in Lebanon, according to a Monday-morning report in the Ma'ariv daily.
Confirming the American concerns, a senior U.S. source told the newspaper that the concern was raised in recent talks between American and Israeli representatives. Intelligence bodies of the two countries share the assessment that the government of President Bashar Al-Assad has not used biological agents in his country's civil war.
Long and Strong
Sentiment: Strong Buy