Nuke, I didn’t initially catch how high the jump in Avid/GOV’T services were for FY10Q3(q/e1-31-10) – recall, Avid services to the DTRA/TMTI Govt contract show under GOVT-REVs, not under AVID-REVs in the financials. These 2 snapshots clearly show the jump in Avid work for the Gov’t in Q3:
You’re right, that IS an awful lot of Bavi Juice (or FH-Bavi Juice) to produce for the Gov’t in this last quarter. “Animal Rule” progress picking up steam?? Man, that’d be nice…
SK SAID THIS ABOUT POTENTIAL BAVI APPROVAL FOR VHF ON 2-9-10 (BIO-CEO): SK 2-9-10, Slide8: “Innovative Science Portfolio. . . And then, we have another interesting opportunity from a product dev. standpoint, and that is Bavi for the treatment of VHF. So, this pathway for product approval will be quite different than the Ph1-Ph2 and then Pivotal trial type approach to getting drugs approved. But rather we’ll probably end up going thru an Animal Rule to eventually get approval.” http://tinyurl.com/ykxznha
AND THEN ON 3-17-10, SK EXPANDED ON GOVT/VHF POSSIBILITIES A BIT MORE: SK 3-17-10, Slide7: “…And then we have a real interesting part of the portfolio, which is our Bavituximab Viral Hemorrhagic Fever (VHF) Infection program. This is completely funded by the DOD in evaluating Bavi for the treatment or prevention of VHF. What’s interesting about this compound is this would not take a typical Phase1-2-3 approval approach, but rather likely go thru the FDA’s “Animal Rule”, which means that it basically would have animal efficacy data, combined with human safety data, which we’re obviously generating a lot of, and then it would be applied for approval based on those 2 things. So this could be a much shorter entry point into an actual product that could be acquired by the gov’t to stockpile as part of its biodefense efforts.” http://tinyurl.com/ye9v7jq
= = = = = = = = = = = = = IT ALL GOES BACK TO THIS: BIOWORLD Today - Jul. 03, 2008 (2 days after the DTRA VHF Award): … “Solid tumors will more than likely be the first indication Peregrine seeks, he [CEO Steve King] noted. However, because of the expedited process in developing products under the govt's animal efficacy rule, the viral hemorrhagic fevers indication potentially could be the first approved use for Bavituximab”… http://tinyurl.com/5kr6xk
BACKGROUND: 7-1-08: PPHM Awarded 5-yr $44mm DTRA/TMTI Contract for Anti-PS vs. Hemorrhagic Fevers http://tinyurl.com/5dxpup …”Contract to test & develop bavituximab and an equivalent fully human antibody as potential broad-spectrum treatments for viral hemorrhagic fever infections”
10-2009: U-PITT REPORT FOR DARPA ON BIOLOGICS DEMAND REF’S BAVI: Pg.39: Table: Ensuring Biologics Advanced Dev. & Mfg. Capability for the USGovt: A Summary of Key Findings & Conclusions Agent: “Broad Spectrum Viral Inhibitor” (#3 of 13) Class: Therapeutic DoD(Regimens/TED): 100,000 (C)6 HHS(Regimens): 100,000 (C)6 Note (C): No defined requirement, partial info. provided during interviews Note#6: “Demand is modeled on products like Bavituximab under development by Peregrine Pharmaceuticals Inc. This monoclonal product targets aminophospholipids exposed on surface of host cells infected with enveloped viruses. Minimum estimated requirement for broad-spectrum biologic derived anti-viral based on PHEMCE (Public Health Emergency Medical Countermeasures Enterprise) implementation plan prioritization of broad-spectrum, DoD R&D funding priorities, and interviews with HHS & DoD personnel. It is likely the demand would be higher, but estimate is based on the consensus of the interviewees.” Pg.150: Agent: “Broad Spectrum Viral Inhibitor” Class: Therapeutic • Dose-Stockpile= 200,000 • Dose-Surge= 5,328,000 • Fill-Stockpile= 16,667 • Fill-Surge= 1,065,600 http://tinyurl.com/yaefb4j
11-18-09: PPHM PRESENTS ANTIPS/VHFS PRE-CLIN. DATA AT DTRA/TMTI CONF. “Researchers presented interim data from Peregrine's multi-year program to assess the company's PS-targeting antibodies as broad-spectrum agents for the treatment of viral hemorrhagic fevers, a potential biodefense threat. The studies evaluated the activity of Peregrine's PS-targeting antibodies against representatives of major VHF virus families. In these studies, researchers confirmed broad spectrum PS-targeting antibody binding to VHF viral particles and also demonstrated that Peregrine's PS-targeting antibodies bind to mammalian cells infected with hemorrhagic fever viruses. Initial pharmacokinetic and dosing studies also showed that the PS-targeting antibodies are sustainable in the blood at therapeutically relevant concentrations. Importantly, initial antiviral efficacy studies reported at the conference were encouraging, showing that a single dose of a PS-targeting antibody increased the survival of hamsters infected with lethal doses of viruses from two different VHF virus families. Based on these positive findings, additional efficacy studies, including repeat dose and combination therapy studies, are now underway.” http://tinyurl.com/ycrrwub
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