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Immune Response BioPharma Announces FDA BLA Fee Waiver Granted Clears Path For REMUNE Approval

4/2/2014 9:14:46 AM

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Apr. 1, 2014 - NEW CITY, N.Y. -- Immune Response BioPharma, Inc. today, Announces the FDA has granted IRBP a SBA BLA Fee Waiver which clears a path for the REMUNE HIV/AIDS vaccine approval.

*IRBP has until December 20th 2014 to submit its BLA filing for the REMUNE HIV/AIDS vaccine.

*IRBP expects to file its BLA application by around the June 1st 2014 timeframe. Regulatory and weather delays have pushed back IRBP's time line for completion of its marketing application.

*Acceptance of IRBP's BLA application by the FDA for marketing authorization review of the REMUNE HIV/AIDS Vaccine would result in the first HIV/AIDS vaccine to reviewed for approval for therapeutic use.

*Continued cooperation between IRBP and the FDA are paramount for the government and the public to have access to its first HIV/AIDS vaccine approved for commercialization.

*A total of six corporations and cooperation with the government will be required to manufacture, distribute, and market REMUNE on a commercial basis, it will be a colossal undertaking to achieve this goal a true public/private partnership to bring the first HIV/AIDS vaccine to market.

*IRBP warns any interference by anyone or entity in IRBP's business developing REMUNE and impeding the access of the REMUNE HIV/AIDS vaccine to the sick HIV/AIDS positive population will result in endless civil and criminal complaints with the DOJ. IRBP views denying sick HIV/AIDS patients access to REMUNE as criminal & illegal actions given no alternative to the toxic HAART drugs.

*IRBP sets REMUNE quarterly vaccination pricing in the USA between $75-250 depending upon many variables, venders,suppliers, and cooperation between six corporations.

"IRBP thanks the FDA & the SBA for cooperation on this important matter and working together with the government we can bring the first HIV/AIDS vaccine REMUNE for therapeutic use to market. REMUNE is the most tested HIV/AIDS vaccine in history with over 25 clinical studies it has been proven safe and effective increasing white blood cell counts by nearly 60 million cells. You can never be sure your government is going to do the right thing for its people and provide relief to the sick HIV/AIDS postive population. The government has been and is largely ineffective in developing an HIV/AIDS vaccine and the public needs the wisdom of experts in vaccine development like Dr. Salk at this time. Mr. Buswell CEO IRBP commented.

"It is now or never for an HIV/AIDS vaccine the government is experimenting and wasting time and money with its current policy, until REMUNE is approved and something else is developed it would be in the best interest of the public to have access to REMUNE. The taxpayers have funded many of the REMUNE studies north of $100M has been spent on this vaccines development and the public has nothing to show for it. The government is on a course for bankruptcy with the costs of the drugs, it should finally act responsibily and move REMUNE to approval" Mr. Buswell CEO IRBP further commented.

"HIV/AIDS positive patients have been denied access to REMUNE and should seek class action lawsuits if the government doesn't provide access later this year with approval. Keeping sick HIV/AIDS patients hooked on drugs for life is not acceptable in a modern society, what we have here is an axis of evil led by big pharma to keep REMUNE off the market, so they can profit off of billions of dollars worth of drug sales. HIV/AIDS patients have been punished enough & should demand access to REMUNE and its in their best interest to be able to get off the drugs at some point to give their immune systems a break from the toxic drugs".

"The right thing for the government to do is to further cooperate with IRBP and move REMUNE to approval otherwise the government may never see another suitable vaccine come up for approval in this decade or perhaps ever. The ball is in the governments court, i hope they don't fumble and drop the ball for protecting the public again. Should the government deny sick HIV/AIDS patients access to REMUNE the public should hold the government personally responsible" Mr. Buswell CEO IRBP further commented.

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.

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. An augmentation of cellular immune responses has also been demonstrated, as measured by lymphocyte proliferation to HIV-1 and p24 antigens, as well as greater DTH reactivity to HIV-1 antigen. HIV-1 DTH reactivity in immunized subjects has also been shown to correlate with a more favorable clinical course. 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 3,000 patients, 18,000 injections 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.

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