Immune Response BioPharma, Inc., Notifies the FDA Remune HIV/AIDS Vaccine Pricing Likely to Exceed $30k Per Injection.
* IRBP informed the FDA that due to significant manufacturing outlay costs of strategic partners the Remune HIV/AIDS vaccine will likely exceed north of $30k per injection for adults in combination use of HAART drugs.
* IRBP is committed to manufacturing the Remune vaccine & the required three commercial lot batches to secure marketing authorization in the U.S.A. and will begin commercial manufacturing once they have an agreement with their vendors and financing is secured.
* IRBP estimates a minimum of 18 months to manufacture new vaccine once manufacturing begins with a time frame of 18-24 months before vaccine is available.
* 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.
* The FDA PDUFA Goal Date has been updated to November 26th, 2015.
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 100?g 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-naive 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.
Contact via Email
Read the full story here: http://www.pr.com/press-release/624695
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|Publication:||PR.com (Press Releases)|
|Date:||Jun 20, 2015|
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