Human Genome Sciences (Anthrax antibiotica) gennemgår en proces der svarer til den BN (MVA koppevaccine) gennemgår og de et pænt skridt foran - nogen der kender selskabets historie angående samarbejdet med USA (evt. Trolmanden) ?
http://www.reuters.com/article/rbssHealthcareNews/idUSN0840878920090708?pageNumber=1&virtualBrandChannel=0
Mvh
Sukkeralf
http://www.reuters.com/article/rbssHealthcareNews/idUSN0840878920090708?pageNumber=1&virtualBrandChannel=0
Mvh
Sukkeralf
9/7 2009 13:18 troldmanden 0
14981 Hej Sukkeralf
Har hørt lidt om dem men det er ikke meget. Der hvor bava står stærkt er at deres anthrax vaccine jo er en kombination af smallpox og anthrax i én og samme vaccine. Og så det at myndighederne allerede kender MVA vektoren særdeles godt og dermed også Bavarian nordic. Og det skulle jo i følge Bavarian nordic selv også være de amerikanske myndigheder der har spurgt bava om de har mulighed for at lave en anthrax vaccine
Men hele anthrax programmet er langt bag smallpox. For mig bekendt har de ikke engang sat en RFP1 igang siden deres tidligere leverandør fejlede fælt i hmm var det 2007
Vh
T.
Har hørt lidt om dem men det er ikke meget. Der hvor bava står stærkt er at deres anthrax vaccine jo er en kombination af smallpox og anthrax i én og samme vaccine. Og så det at myndighederne allerede kender MVA vektoren særdeles godt og dermed også Bavarian nordic. Og det skulle jo i følge Bavarian nordic selv også være de amerikanske myndigheder der har spurgt bava om de har mulighed for at lave en anthrax vaccine
Men hele anthrax programmet er langt bag smallpox. For mig bekendt har de ikke engang sat en RFP1 igang siden deres tidligere leverandør fejlede fælt i hmm var det 2007
Vh
T.
9/7 2009 13:36 Sukkeralf 014983 Det var nu ikke fordi jeg var specielt bange for BN´s Anthrax program, men mere fordi at HGS måske var en god case story at studere, når nu de også har fået en EUA godkendelse og skal have deres antistof godkendt på baggrund af "The Animal Rule".
Så måske man kunne lære lidt og få et indblik i hvad vi måske kan forvente os af fremtiden !
Nej mener ikke lige jeg har set ovenstående, så det er da også spændende - vil lige kigge lidt nærmere på det.
Har du iøvrigt en mening om hvornår EUA´en evt. kommer. AA udtalte for lidt tid siden, at han forventede det inden for 6 uger uger, mener jeg. Det er vist ca. 3 uger siden !!
Mvh
Sukkeralf
Så måske man kunne lære lidt og få et indblik i hvad vi måske kan forvente os af fremtiden !
Nej mener ikke lige jeg har set ovenstående, så det er da også spændende - vil lige kigge lidt nærmere på det.
Har du iøvrigt en mening om hvornår EUA´en evt. kommer. AA udtalte for lidt tid siden, at han forventede det inden for 6 uger uger, mener jeg. Det er vist ca. 3 uger siden !!
Mvh
Sukkeralf
9/7 2009 13:40 troldmanden 014984 God pointe med at studere hvorledes de klare sig med "the animal rule"
Kan du huske hvor du har set Asger Aamund udtale det? Jeg har nemlig ikke set det.
Jeg har ikke nogen nærmere indikationer andet end at den forventes på plads her i Q3
Kan du huske hvor du har set Asger Aamund udtale det? Jeg har nemlig ikke set det.
Jeg har ikke nogen nærmere indikationer andet end at den forventes på plads her i Q3
9/7 2009 14:23 Sukkeralf 014985 Det var i et interview på TV2 finans - det omhandlede hans tab de to seneste år !! Det var vist enten 6 eller 8 uger, så vidt jeg husker.
Mvh
Sukkeralf
Mvh
Sukkeralf
9/7 2009 13:30 troldmanden 014982 Sukkeralf har du så set FDA har sat gang i en ny RFP process for at skaffe antivirale koppevacciner? Altså en vaccine der kan bruges til folk der HAR fået kopper
New York, New York, March 12, 2009 - SIGA Technologies, Inc. (NASDAQ: SIGA), a company specializing in the development of pharmaceutical agents to fight biowarfare pathogens, today announced its intent to respond to the government's Request for Proposal (RFP) with respect to the procurement of 1.7 million courses of medical countermeasures that can specifically provide treatment courses for symptomatic individuals exposed to smallpox. The RFP indicates that up to 12 million courses may be procured. SIGA believes its smallpox antiviral drug candidate ST-246® is strongly and uniquely positioned to meet the RFP's specifications.
The Biomedical Advance Research and Development Authority (BARDA), an office within the Department of Health and Human Services (HHS) and the agency responsible for the RFP, has indicated that awards under this proposal would be granted in September 2009 to a single vendor. The RFP calls for a response via a statement of intent which is due by April 10, 2009, with the full proposal due by April 30, 2009. BARDA will hold a preproposal conference on or about March 31, 2009 to further discuss the RFP and help guide those companies that expect to respond.
The United States Government contemplates the award of a five-year, firm-fixed-price contract. for a drug product on a sliding scale for volumes up to 2 million courses and multiple breakpoints up to 12 million. The antiviral would be required to have at least a 36-month shelf-life.
There are also clearly stated optional interests in the RFP for a "warm production" capacity; an intravenous formulation; an oral suspension for both children and elderly adults; and pursuit of post-exposure prophylaxis.
In addition, BARDA would also monitor the antiviral as it moves along the FDA approval path and would require the company awarded the contract to implement an FDA Phase IV monitoring plan. The RFP also notes that the company awarded the contract would also receive funds for non-fixed pricing for factors like physical and informational security of the company and its suppliers.
Among the requirements in the RFP are that the purchased drug must have shown satisfactory results following both variola and lethal monkeypox challenges in non-human primates. SIGA believes that it is the only company that can meet this requirement.
Any award on the RFP would be subject to negotiation of final contract terms and specifications. Once final negotiations are completed, BARDA will issue a formal Notification of Award. It is anticipated that the RFP award will provide a commitment to purchase additional amounts of the antiviral following the initial procurement of 1.7 million courses.
Dr. Eric A. Rose, SIGA's Chief Executive Officer, commented, "Release of this RFP is a transformational step for SIGA that we view as firm confirmation that our future as a company is in plain sight and within our grasp. We will be working diligently over the next few weeks to make our view a reality. We anticipate that this is the beginning of what we hope will be the first of several government contracts for the purchase of multiple formulations of ST-246®, our smallpox antiviral, for multiple indications. Finding an antiviral for smallpox has been a high priority for the U.S. government in its effort to defend the country and the world against the mortality, morbidity, and potentially devastating social and economic consequences of a smallpox bioterror attack.
"SIGA will continue to pursue full FDA approval for ST-246® even as it responds to the Bioshield RFP. Full approval, if received, would open the door for stockpiling of ST‑246® by corporations for employee use and should ease the path to international approvals and sales."
Dr. Dennis E. Hruby, SIGA's Chief Scientific Officer, stated, "The years we have spent developing ST-246® have been well-worth the effort. The support that we have received from BARDA, the NIH and the military has been instrumental in the advancement of ST-246®. We will continue to collaborate with the U.S. government to develop ST-246® for use as a prophylaxis and in creating additional formulations. We will also continue to develop our pipeline of drug candidates, as we believe ST-246® is just the beginning of what we can accomplish in the development of agents to defend against serious viral pathogens like Dengue and Lassa fevers."
The RFP was issued under Project BioShield, a program administered by BARDA that is intended to encourage the development and procurement of medicines that can protect the population of the United States against chemical, biological, radiological and nuclear attacks. Project Bioshield permits BARDA to purchase both approved drugs and drugs that are within eight years of FDA approval. Smallpox has long been considered one of the leading biowarfare agents even though it has been eradicated from the natural environment, and there is no approved antiviral available against smallpox. SIGA's ST-246® has proven effective against orthopox virus infections, including smallpox, in several animal models, and has also done well in all human safety trials to date. SIGA believes that ST-246® is the most advanced smallpox antiviral in development.
Conference Call:
New York, New York, March 12, 2009 - SIGA Technologies, Inc. (NASDAQ: SIGA), a company specializing in the development of pharmaceutical agents to fight biowarfare pathogens, today announced its intent to respond to the government's Request for Proposal (RFP) with respect to the procurement of 1.7 million courses of medical countermeasures that can specifically provide treatment courses for symptomatic individuals exposed to smallpox. The RFP indicates that up to 12 million courses may be procured. SIGA believes its smallpox antiviral drug candidate ST-246® is strongly and uniquely positioned to meet the RFP's specifications.
The Biomedical Advance Research and Development Authority (BARDA), an office within the Department of Health and Human Services (HHS) and the agency responsible for the RFP, has indicated that awards under this proposal would be granted in September 2009 to a single vendor. The RFP calls for a response via a statement of intent which is due by April 10, 2009, with the full proposal due by April 30, 2009. BARDA will hold a preproposal conference on or about March 31, 2009 to further discuss the RFP and help guide those companies that expect to respond.
The United States Government contemplates the award of a five-year, firm-fixed-price contract. for a drug product on a sliding scale for volumes up to 2 million courses and multiple breakpoints up to 12 million. The antiviral would be required to have at least a 36-month shelf-life.
There are also clearly stated optional interests in the RFP for a "warm production" capacity; an intravenous formulation; an oral suspension for both children and elderly adults; and pursuit of post-exposure prophylaxis.
In addition, BARDA would also monitor the antiviral as it moves along the FDA approval path and would require the company awarded the contract to implement an FDA Phase IV monitoring plan. The RFP also notes that the company awarded the contract would also receive funds for non-fixed pricing for factors like physical and informational security of the company and its suppliers.
Among the requirements in the RFP are that the purchased drug must have shown satisfactory results following both variola and lethal monkeypox challenges in non-human primates. SIGA believes that it is the only company that can meet this requirement.
Any award on the RFP would be subject to negotiation of final contract terms and specifications. Once final negotiations are completed, BARDA will issue a formal Notification of Award. It is anticipated that the RFP award will provide a commitment to purchase additional amounts of the antiviral following the initial procurement of 1.7 million courses.
Dr. Eric A. Rose, SIGA's Chief Executive Officer, commented, "Release of this RFP is a transformational step for SIGA that we view as firm confirmation that our future as a company is in plain sight and within our grasp. We will be working diligently over the next few weeks to make our view a reality. We anticipate that this is the beginning of what we hope will be the first of several government contracts for the purchase of multiple formulations of ST-246®, our smallpox antiviral, for multiple indications. Finding an antiviral for smallpox has been a high priority for the U.S. government in its effort to defend the country and the world against the mortality, morbidity, and potentially devastating social and economic consequences of a smallpox bioterror attack.
"SIGA will continue to pursue full FDA approval for ST-246® even as it responds to the Bioshield RFP. Full approval, if received, would open the door for stockpiling of ST‑246® by corporations for employee use and should ease the path to international approvals and sales."
Dr. Dennis E. Hruby, SIGA's Chief Scientific Officer, stated, "The years we have spent developing ST-246® have been well-worth the effort. The support that we have received from BARDA, the NIH and the military has been instrumental in the advancement of ST-246®. We will continue to collaborate with the U.S. government to develop ST-246® for use as a prophylaxis and in creating additional formulations. We will also continue to develop our pipeline of drug candidates, as we believe ST-246® is just the beginning of what we can accomplish in the development of agents to defend against serious viral pathogens like Dengue and Lassa fevers."
The RFP was issued under Project BioShield, a program administered by BARDA that is intended to encourage the development and procurement of medicines that can protect the population of the United States against chemical, biological, radiological and nuclear attacks. Project Bioshield permits BARDA to purchase both approved drugs and drugs that are within eight years of FDA approval. Smallpox has long been considered one of the leading biowarfare agents even though it has been eradicated from the natural environment, and there is no approved antiviral available against smallpox. SIGA's ST-246® has proven effective against orthopox virus infections, including smallpox, in several animal models, and has also done well in all human safety trials to date. SIGA believes that ST-246® is the most advanced smallpox antiviral in development.
Conference Call:
