New York, NY, July 28, 2015 –(PR.com)– First Half 2015 Highlights:
* IRBP met with the FDA in late March 2015 which resulted in a constructive path forward for the Remune HIV/AIDS vaccine FDA BLA.
* IRBP’s FDA BLA for Remune HIV/AIDS vaccine for treatment of adults in combination with current HAART drugs was accepted on March 27th 2015.
* Remune FDA PDUFA goal date changed to November 26th 2015.
* IRBP met with the Seppic executives & Seppic has agreed to donate the IFA adjuvant for the commercial manufacturing of Remune HIV/AIDS vaccine.
* IRBP has voluntarily agreed to an FDA black box warning label for Remune to be used in conjunction with current FDA approved HAART drugs.
* IRBP is in discussions with leading pharmacies to be the pharmacy manager for Remune HIV/AIDS vaccine distribution whether for expanded IND or compassionate use treatment prior to FDA approval or FDA BLA commercialization.
*IRBP continues to have a constructive dialogue with the FDA on moving the Remune BLA forward & towards approval contingent upon commercial manufacturing of the three lot batches required for licensure & approval.
* Remune will likely be only available in the U.S.A. once new commercial & compassionate use vaccine batches are manufactured & until commercial manufacturing can be done on a sufficient scale.
* Remune vaccine pricing will likely exceed $30k per injection.
IRBP Second Half 2015 Guidance:
* IRBP expects the FDA to be cooperative & provide a constructive path forward to move the Remune FDA BLA towards approval.
* IRBP continues to be focused on Remune commercialization and FDA approval of the FDA BLA & will be the main focus of the company.
“IRBP had a great start to 2015 with the first FDA BLA HIV/AIDS vaccine accepted by the agency for approval and commercial marketing authorization. I am energized by our FDA BLA filing and FDA acceptance of our application, the road to a true pure whole killed HIV vaccine for the government comes through IRBP & Remune. The government would be smart to move quickly to recommend approval of Remune and get its first HIV vaccine approved. IRBP has voluntarily agreed to a black box warning label that Remune must be used in conjunction with current FDA approved HAART drugs which should resolve all concerns & conflicts of interest. IRBP continues to have a constructive dialogue with the FDA on approving the Remune BLA, & continues to work to resolve commercial manufacturing of Remune for FDA marketing authorization. IRBP looks forward to an amicable resolution with the FDA for all HIV/AIDS stakeholders,” IRBP CEO Mr. Buswell commented.
Remune has FDA orphan pediatric designation granted in February of 2014.
The FDA review period for the Remune HIV/AIDS therapeutic vaccine in adults BLA began on March 27th, 2015 & is the first FDA accepted BLA HIV/AIDS vaccine to be filed for marketing approval with the FDA & the most tested HIV/AIDS vaccine in history is a first in class & best in class vaccine used in combination with HAART to elicit immune responses against a wide variety of HIV antigens.
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 safely to over 3,500 patients in over 15,000 injections with no adverse events & 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. may be found on the world wide web @ www.immuneresponse.net
Immune Response BioPharma, Inc.