Immune Response BioPharma, Inc. Today Posts Full Year 2012 Results and provides a business update for the drug discovery pipeline and sees partnerships for both NeuroVax for MS, RAVAX for RA & Zorcell for Psoriasis by the end of first half 2013. IRBP is currently in discussions with several potential partners & strategic advisory business consultants and will select the best partner to help the company reach its goals of bringing its pipeline to market with the first Multiple Sclerosis Vaccine, the first Rheumatoid Arthritis Vaccine & the first Psoriasis Vaccine to Market.
IRBP 2012 Highlights
* IRBP Granted Ownership of the King Patent U.S. 8,053,197 for Auto-Immune Diseases Extends IP Coverage into 2027
*Initiated Plans for a New Clinical Study in MS with Phase 2b NeuroVax vs Avonex Study
*Initiated Plans for a New Clinical Study in RA with Phase 3 RAVAX + Methotrexate Study
*Initiated Plans for a New Clinical Study in Psoriasis with Phase 2b Zorcell + Methotrexate Study
* Filed for Orphan Designation for NeuroVax
* Filed for Orphan Designation for RAVAX in JRA
*Filed for Orphan Designation for REMUNE for Pediatric HIV/AIDS
* Applied for Grant funding with the U.S. Government for REMUNE & Stockpiling to Bring the First HIV/AIDS Vaccine to Commercialization
* Published Unbiased Full REMUNE 806 Phase III Study Results Proving REMUNE is a viable and effective Vaccine for HIV/AIDS Halting Disease Progression to Nil Progression Delaying Virologic Failure
* IRBP initiates plans for a new Vaccine formula DermaVax for Eczema
* IRBP Adopts Shareholder Rights Plan to Prevent Anti-Takeover Measures
IRBP Financial Guidance & Goals for 2013
* Upfront Partnership Revenues $25-100 Million for NeuroVax for Multiple Sclerosis 6-8% Royalty Rate Expected
* Upfront Partnership Revenues $25-100 Million for RAVAX for Rheumatoid Arthritis 6-8% Royalty Rate Expected
* Upfront Partnership Revenues $25-$50 Million for Zorcell for Psoriasis 6-8% Royalty Rate Expected
* Cash Usage for the NeuroVax Phase IIb Study $10-15M
* Cash Usage for the RAVAX Phase III Study $30-35M
* Cash Usage for Zorcell Phase IIb Psoriasis Study $5-10M
* Secure Partnerships for both NeuroVax, RAVAX & Zorcell total Study Costs $55M
* Sign CRO Contracts for both NeuroVax, RAVAX, & Zorcell Studies by the end of Q2 2013
* Explore Licensing of RAVAX, NeuroVax, & Psoriasis in Additional Markets Japan, China & Korea
* Expecting Allowance from Canada for Auto-Immune Diseases Patent
* File for Orphan Designation for Zorcell in Pediatric Psoriasis
* Pending Positive Response to our U.S. Government Grant Applications for REMUNE, IRBP will prepare for Vaccine Manufacturing Ramp Up
* Begin Manufacturing Planning for REMUNE with a Ramp up & Stock Piling of REMUNE and Prepare for FDA & EMA NDA Emergency Filings Cost $2-4M
* First Year REMUNE Revenues Estimated North of $1 Billion World Wide upon
successful Regulatory Filing Approval and Manufacturing & Stock Piling
* Capital Raising: Financing Equity and or Debt up to $150M
IRBP has all four of its late stage vaccines for MS, RA, Psoriasis and AIDS on track and now has positioned the company for growth with a solid plan of action to achieve its results by partnering with the right big pharma partners who have the same goals we have which are to drive revenues and profitability while helping society by treating unmet diseases worldwide.
"IRBP had a banner year in 2012 rebuilding Immune Response and positioning the company for record growth and profits in the future. We have perhaps the safest pipeline in all of pharma and biotech with vaccines primarily composed of all natural protein based peptides which makes our pipeline superior to current treatments. While our Flagship Vaccines for MS NeuroVax & RAVAX for RA await partnering, we have turned our focus to dermatology and have some exciting products in the first psoriasis vaccine Zorcell and next we will work on an eczema vaccine with our new vaccine DermaVax. I expect IRBP to have another record year in 2013 building and driving our small biopharma to new heights & becoming the defacto vaccine company in the U.S.A. and worldwide." Mr. Buswell CEO of IRBP.
Immune Response BioPharma, Inc. Maybe Found on the World Wide Web @ www.immuneresponse.net
