PRIMA BIOMED

FAQ

General Information
Q1. Who is Prima BioMed?
Q2. What is Prima BioMed’s primary business focus?
Q3. What is Prima BioMed’s corporate mission?
Q4. What makes Prima BioMed unique from other drug discovery and development companies?
Q5. What unique or competitive advantages does Prima BioMed hold?
Q6. When and where was Prima BioMed founded?
Q7. Where is Prima BioMed located?
Q8. What is Prima BioMed’s relationship with the University of New South Wales and the University of Queensland?

Alliances
Q1. Has Prima BioMed initiated any partnerships with big pharma?
Q2. Does Prima BioMed have alliances with other research institutions or individuals?

Patents
Q1. What is Prima BioMed’s patent position? Is Prima in a competitive position/why?

R&D
Q1. What role does Prima BioMed play in the current field of drug discovery?
Q2. Where is Prima BioMed’s R&D performed?
Q3. What is Prima BioMed’s current R&D strategy?
Q4. Does Prima BioMed discover novel drug targets? Do you have any internal target generation capabilities?
Q5. Does Prima BioMed have any drugs currently in clinical trials?
Q6. Why target ovarian cancer?
Q7. What is the demand for CVac™?

Definitions
Q1. What is Human Papilloma Virus (HPV)?
Q2. What is CVac™?
Q3. What is immunotherapy?
Q4. What is cell therapy?
Q5. What is “Orphan Drug Designation??
Q6. What are monoclonal antibodies?
Q7. What are dendritic cells?
Q8. What are antigens?

General Information

Q1. Who is Prima BioMed?

A1. Prima BioMed is a publicly-owned ASX-listed Australian biotechnology company and an emerging leader in cancer treatment. Prima is developing anti-cancer therapeutics based on the technologies of immunotherapy and immunology.
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Q2. What is Prima BioMed’s primary business focus?

A2. Prima’s primary focus is to develop anticancer therapeutics and innovative technologies for the treatment of cancer. Our goal is to develop effective medicines to address diseases with the greatest unmet need. Further, our intent is to enable the effective oral administration of medications across the globe where an injected administration is currently the only option, and therefore remains difficult to administer in many parts of the world.
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Q3. What is Prima BioMed’s corporate mission?

A3. Prima BioMed strives to be part of the cutting-edge for the fight against cancer by transforming the promise of science and biotechnology into therapies that have the power to restore health or even save lives of cancer patients. In everything we do, we aim to fulfill our mission to serve patients; from funding the next cutting-edge medical innovation to creatively working on patient treatment delivery.
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Q4. What makes Prima BioMed unique from other drug discovery and development companies?

A4. Prima BioMed’s leading drug, CVac™ targets cancer cells expressing mucin-1 which are prolific on the surface of many cancers. Mucin-1 protein is not only common in ovarian cancer; it is also expressed in prostate, kidney, pancreatic, breast, colon, and lung cancer cells. This significantly opens the market for CVac™ to be applied to a variety of cancer types which is unique compared to other drug discovery and development companies.
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Q5. What unique or competitive advantages does Prima BioMed hold?

A5. Prima was granted “Orphan Medicinal Product Designation and Small and Medium Sized Enterprise status for CVac™” by the European Medicines Agency for Europe in June 2010. More recently, the US Food and Drug Administration also granted Prima’s CVac™ “Orphan Drug Designation”. These designations are a significant milestone for Prima and may offer major benefits during CVac™’s development process which could include priority review, research support, protocol assistance and possible regulatory fee exemptions.
Prima’s CVac™ is administered post-surgery and post-chemotherapy to delay the relapse of, and control the metastases of ovarian cancer. There are currently no maintenance-based therapy products commercially available. There is a large unmet need for new treatments for ovarian cancer, which has a very high mortality rate.
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Q6. When and where was Prima BioMed founded?

A6. Prima BioMed was created as a mining company in Australia in 1987, and was first publicly traded in 1988 on the Australian Stock Exchange. The corporate focus changed radically in 2001 with the acquisition of the rights to develop technologies from the Austin Research Institute (now the Burnet Institute) including the CVac™ immune therapeutic vaccine.
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Q7. Where is Prima BioMed located?

A7. Prima BioMed’s corporate headquarters are in Sydney, Australia. Additional offices are located in the United States, Dubai and Germany.
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Q8. What is Prima BioMed’s relationship with the University of New South Wales and the University of Queensland?

A8. Prima is in a collaborative venture with the University of New South Wales and University of Queensland to create a technology enabling oral administration of vaccines that are currently administered through injection. The lead target for this program is to create an oral vaccine against Human Papilloma Virus (HPV), a virus associated with development of cervical cancer.
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Alliances

Q1. Has Prima BioMed initiated any partnerships with big pharma?

A1. Prima BioMed has had several discussions with prospective partners and continues to do so. At this time, the company has sufficient resources to complete the CVac™ program, and will entertain discussions with partners which add value for shareholders.
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Q2. Does Prima BioMed have alliances with other research institutions or individuals?

A2. Prima is in a collaborative venture with the University of New South Wales and University of Queensland to create a technology enabling oral administration of vaccines that are currently administered through injection. The lead target for this program is to create an oral vaccine against Human Papilloma Virus (HPV), a virus associated with the development of cervical cancer.
Prima has also entered into an agreement with the Fraunhofer Institute, a leading German research institute for cell therapy and immunology, to produce the CVac™ vaccine for Prima’s upcoming European Phase III Clinical Trial.
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Patents

Q1. What is Prima BioMed’s patent position? Is Prima in a competitive position/why?

A1. Pivotal to the development and commercialization of the Prima BioMed Ltd (Prima) product portfolio is strong intellectual property protection for the underlying technology and product opportunities. Prima has secured, under license from the Burnet Institute, five patent families at various stages of prosecution. These patents are being prosecuted worldwide in the major market jurisdictions to maximize market coverage and underpin future incomes from licensing agreements.
As of June 2011, the patent portfolio under management contains 40 granted patents and 12 applications under prosecution.
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R&D

Q1. What role does Prima BioMed play in the current field of drug discovery?

A1. Prima BioMed’s key focus is to develop anti-cancer therapeutics based on the emerging technology of immunotherapy. Scientific research, product development and clinical trials are the essential of what we call “the cutting edge” of the fight ऀagainst cancer. Our goal is to develop effective medicines which can ultimately be efficiently delivered to cancer patients worldwide.
Prima’s lead drug candidate, Cvac™ has completed Phase IIa clinical trials and focuses of the development of an ex-vivo immunotherapy for ovarian cancer. Prima is now undertaking a Phase IIb clinical study in the US and Australia, and aims to commence global Phase III programs in Q3 2011, with a goal of commercialization of CVac™ in multiple world markets.
Prima’s is also focusing on the identification and development of a monoclonal antibody to cripto-1. Monoclonal antibodies have been a major success in recent improvements of cancer treatment. Cripto-1 is a component of the endothelial growth ऀfactor complex, and neutralizing this important protein will enable Prima to target multiple tumor types.
Prima is in a collaborative venture with the University of New South Wales and University of Queensland to create a technology enabling oral administration of vaccines that are currently injected. The lead target for this program is to create an oral vaccine against Human Papilloma Virus (HPV), a virus associated with development of cervical cancer.
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Q2. Where is Prima BioMed’s R&D performed?

A2. Prima BioMed operates as a global company. We are proud of our Australian heritage and continue to support research and development in Australia, but we have expanded our focus conduct a clinical research program for CVac™ that will take place in 22 countries in Europe, Australasia and the United States.

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Q3. What is Prima BioMed’s current R&D strategy?

A3. Prima BioMed’s key focus is to develop anti-cancer therapeutics based on the emerging technology of immunotherapy. Scientific research, product development and clinical trials are the essential of what we call “the cutting edge” of the fight against cancer. Our goal is to develop effective medicines which can ultimately be efficiently delivered to cancer patients worldwide and to help prevent cancer.
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Q4. Does Prima BioMed discover novel drug targets? Do you have any internal target generation capabilities?

A4. Prima BioMed has licensed its key technologies from research institutes in Australia. We have no ongoing discovery research at this time.

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Q5. Does Prima BioMed have any drugs currently in clinical trials?

A5. Prima BioMed’s lead drug candidate, CVac™ has completed Phase IIa clinical trials and focuses of the development of an ex-vivo immunotherapy for ovarian cancer. Prima is now undertaking a Phase IIb clinical study in the US and Australia, and aims to commence global Phase III programs in summer 2011, with a goal of commercialization of CVac™ in multiple world markets.
Additionally, pre-clinical studies are focusing on the identification and development of a monoclonal antibody to cripto-1. Monoclonal antibodies have been a major success in recent improvements of cancer treatment. Cripto-1 is a component of the endothelial growth factor complex, and neutralizing this important protein will enable Prima to target multiple tumor types.
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Q6. Why target ovarian cancer?

A6. Each year 73,000 women are diagnosed with ovarian cancer in the US, Europe, Australia and Japan and 318,000 women globally. Since ovarian cancer is generally diagnosed at a late stage, only 20-30% of patients with late stage disease Does survive for 5 years.
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Q7. What is the demand for CVac™?

A7.The global market size for ovarian cancer therapy was estimated to be US $3.6 billion in 2010. A maintenance-style treatment like CVac™ would be the first of its type in the market and Prima BioMed believes the company has potential to achieve 10% of market penetration within the first year. 10% market penetration could generate $500 million+ in sales in the developed world.
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Definitions

Q1. What is Human Papilloma Virus (HPV)?

A1. Human Papilloma Virus (HPV) is a virus associated with the development of cervical cancer.
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Q2. What is CVac™?

A2. CVac™ is Prima BioMed’s core product. It is a vaccine therapy treatment for ovarian cancer patients administered post-surgery and post-chemotherapy to delay the relapse of, and control the metastases of the cancer.
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Q3. What is immunotherapy?

A3. Immunotherapy is a treatment that seeks to make use of the immune system to manage a disease condition.
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Q4. What is cell therapy?

A4. Cell therapy is the process of introducing new cells into a tissue in order to treat a disease. Prima’s CVac™ is a cell therapy in that it introduces MFP into the body to generate an anti-cancer immune response.
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Q5. What is “Orphan Drug Designation??

A5. Prima was granted “Orphan Medicinal Product Designation and Small and Medium Sized Enterprise” status for CVac™” by the European Medicines Agency for Europe in June 2010. In Europe, in order to be classified in this way, a drug must be intended for the diagnosis, prevention or treatment of a life-threatening or chronically debilitating condition affecting no more than 5 in 10000 people in the EU at the time of submission of the designation application.
More recently, the US Food and Drug Administration also granted Prima’s CVac™ “Orphan Drug Designation”. In the US, this classification requires that there be fewer than 200,000 new cases of the targeted disease reported each year.
These designations are a significant milestone for Prima and may offer major benefits during CVac™’s development process which could include priority review, research support, protocol assistance and possible regulatory fee exemptions.
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Q6. What are monoclonal antibodies?

A6. A monoclonal antibody is an antibody produced by cell clone: an antibody with ऀऀ unique amino acid sequences derived from a single cell clone or cell line.
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Q7. What are dendritic cells?

A7. Dendritic cells are antigen–presenting cells which play a vital role in regulating the adaptive immune response. The adaptive immune response provides the immune system with the ability to recognize specific pathogens. Dendritic cells act as messengers to process antigen material and present the material to the cell surface for other cells. Once dendritic cells are stimulated they migrate to the lymph nodes where they interact with T cells “killer cells” to initiate an immune response.
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Q8. What are antigens?

A8. Antigen is the “bad guy” substance that stimulates the immune system to respond to a perceived threat.
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