2nd Half & Full Year 2013 Highlights:
* Executed Two CDA's with Potential Partners
* NeuroVax CDA Executed for Partnering with Pharmaceutical potential partner
* REMUNE CDA Executed for Partnering with Big Pharma for Commercialization Partnership
* IRBP secured three CGMP manufacturers for REMUNE commercial manufacturing of the HIV/AIDS Vaccine
* NeuroVax Granted Orphan Designation for Pediatric MS
* REMUNE Granted Orphan Designation for Pediatric HIV/AIDS
* IRBP Certified as a Small Business by the SBA
* FDA approved our Phase IIb NeuroVax SPMS Study
* IRBP Filed its New Patents For REMUNE, Zorcell, DermaVax, & RAVAX
* Initiated Remune Commercialization Plans
* Initiated Plans to submit BLA's for Remune with EMA, MCAZ, MCC & Thai FDA
* REMUNE U.S. Pricing set at $75-250
* IRBP Selected The American Stock Trust & Transfer Company as Transfer Agent of Record for its Stock
1st Half 2014 Guidance:
* Secure Partners for Remune Commercialization & NeuroVax co-development, Discussions continue with potential partners
* Use our SBA/FDA fee waiver on our first human vaccine BLA application for REMUNE
* File with the FDA our BLA for approval of marketing authorization of REMUNE
* Begin Manufacturing Planning for REMUNE with a Ramp up & Stock Piling of REMUNE once the FDA approves our BLA for REMUNE commercialization
* Prepare for BLA submission with the EMA, MCAZ, MCC of South Africa, FDA Thai, once partners are secured in those regions
* Partnering Revenues will vary contigent upon FDA REMUNE BLA Approval
* Initiate REMUNE Phase I/II Pediatric & Preventative Clinical Study Planning
* Prepare for our NeuroVax Phase IIb SPMS Study NeuroVax vs placebo
"IRBP has had a strong 2nd half and a great 2013 banner year achieving the majority of our goals. IRBP's initiatives are starting to payoff we completed our work in 2013 and the fruits of that hard work are starting to be realized in early 2014. IRBP has an unrivaled pipeline of vaccines and TCR peptides vaccine technology platform that will vault IRBP into one of the leading vaccine companies in the world. IRBP will be the first biotech or pharmaceutical company to submit for approval of the first HIV/AIDS vaccine for therapeutic vaccination with REMUNE. I am proud of the hard work the Immune Response team has acomplished in a short period of time, its a total team effort. IRBP thanks the FDA for working with us and their support. REMUNE is a great vaccine and HIV/AIDS positive patients deserve access to the vaccine and an alternative to the toxic drugs it is criminal to keep this vaccine from them. REMUNE is first in class & best in class and vaccine of choice for HIV/AIDS diseases" IRBP CEO Mr. Buswell commented.
REMUNE is a therapeutic vaccine designed to elicit immune responses against a variety of HIV antigens in patients with HIV. It consists of a suspension of killed HIV-1 virus particles that have been emulsified with Incomplete Freund’s Adjuvant (IFA, a mixture of mannide mono-oleate and a highly purified mineral oil).
REMUNE® is derived from Zairian HIV-1 strain HZ-321, composed of gp 120-depleted HIV-1 propagated in HUT-78 cells and inactivated in beta-propiolactone and irradiation. The inactivated material is emulsified with mineral oil (Incomplete Freund's Adjuvant) at 1:1 ratio. Each 1 ml dose (at least 100μg or 10 units) has viral protein and p24.
PAST USA TRIAL RESULTS:
These previous clinical studies of REMUNE®have demonstrated distinct benefits in both immunologic and virologic parameters in HIV-1 infected individuals undergoing treatment. Subjects undergoing treatment with REMUNE®showed improvements in percentage of CD4 cells, HIV-1 DNA in PBMCs, and weight. Previous studies also indicate that REMUNE®can safely be given in combination with antiviral drugs.
IR103/Remune,unlike antiviral drugs, can induce an HIV-specific response, which is now thought by numerous researchers to be important in controlling HIV replication. Remune has been administered to over 2,000 patients in over 25 separate clinical trials, has an excellent safety profile, is well tolerated and is easy to administer via intramuscular injection in the deltoid muscle.
Data from clinical trials of Remune suggest that it may:
Induce a HIV-specific T-cell response; work in Patients with Multi-Drug Resistance
Induce cytokines and chemokines, substances that interfere with the virus attaching to and infecting normal cells;
Work with antiretroviral drugs as a complementary treatment for HIV infection;
Work in drug-naïve patients to delay the need for initiation of HAART; and
Be safe with no adverse side effects, Reduce Viral Load, Increase CD4+ T cells & CD8+ T Cell Counts
Immune Response BioPharma, Inc. Maybe Found on the World Wide Web @ www.immuneresponse.net