Immupharma Regulatory News (IMM)

8 July 2013

ImmuPharma PLC

IMMUPHARMA APPOINTS WORLDWIDE KEY OPINION LEADERS TO SCIENTIFIC ADVISORY BOARD FOR LUPUZOR PHASE III

ImmuPharma plc (LSE:IMM) ("ImmuPharma" or the "Company" or the "Group"), the specialist drug discovery and development company, is delighted to announce that it has appointed some of the world's most eminent physicians to provide scientific advice and support for Lupuzor's pivotal phase III programme.

The Five Scientific Advisory Board members are:

Dr. Daniel J. Wallace, M.D., F.A.C.P., F.A.C.R (USA)

Associate Director, Rheumatology Fellowship Program, Cedars-Sinai Medical Center, Los Angeles, Clinical Professor of Medicine, David Geffen School of Medicine at UCLA and Expert Reviewer, Medical Board of California.

Prof. David Isenberg, MD, FRCP, FAMS (U.K.)

Professor of Rheumatology, University College Hospital, London

Prof. Vibeke Strand, MD, FACP, FACR (USA)

Clinical Professor, Adjunct, Division of Immunology and Rheumatology, Stanford University School of Medicine

Prof. Cees GM Kallenberg, M.D., Ph.D. (Netherlands)

Professor, Department of Rheumatology and Clinical Immunology, University Medical Center Groningen

Dr. Lee S. Simon, MD, FACP, FACR (USA)

Principal, SDG LLC and former FDA Division Director

Commenting on the announcement, Dr Robert Zimmer, President & Chief Scientific Officer of ImmuPharma, said: "We are delighted and honoured to be associated and have the support of such a group of prominent physicians in the area of lupus. It has to be noted that Dan Wallace was a co-author of a publication Zimmer et al. ACR 2012 showing that Lupuzor was able to improve (according to the standard criteria) more than 60% of the patients after only 3 injections and that this number increased up to 80% in a sub-set of the patient population 3 months thereafter even without treatment. These results are by far the best ever seen in a Lupus study and are due to the novel mechanism of action of Lupuzor which tackles specifically the intrinsic biological events constitutive of the Lupus disease at a very upstream level, which is not the case for the currently approved Monoclonial Antibody therapies which act downstream with poorer efficacy results. It is an important step as we go forward with Lupuzor towards starting phase III and we look forward to announcing further news of our progress in due course."

Detailed biographies of the five Scientific Advisors are shown below.

Dr. Daniel J. Wallace, M.D., F.A.C.P., F.A.C.R (USA)

Associate Director, Rheumatology Fellowship Program, Cedars-Sinai Medical Center, Los Angeles, Clinical Professor of Medicine, David Geffen School of Medicine at UCLA and Expert Reviewer, Medical Board of California.

Dan Wallace was raised in the Carthay Circle/Fairfax area of Los Angeles. After attending Fairfax High School, he received his undergraduate and medical education at the University of Southern California, graduating with an MD. His graduate medical training included an internship at Brown University in Providence, Rhode Island, medical residency at Cedars-Sinai Medical Center in Los Angeles and a fellowship in rheumatology at UCLA. He is Board Certified in both Internal Medicine and Rheumatology.

While a fellow at UCLA, he conducted pioneering arthritis research that landed his picture in Time magazine and developed a close relationship with his mentor, Edmund Dubois. Dr Dubois had the largest lupus practice in the United States at the time and was the principal editor of the only lupus textbook. Dr. Wallace entered private practice in 1979 with his father, a cardiologist, but assumed Dr. Dubois' practice on his passing in 1985. He is the author of 6 medical textbooks (including the last 6 editions of Dubois' Lupus Erythematosus, All About Fibromyalgia, The Lupus Book, All About Osteoarthritis, The New Sjogren's Syndrome Handbook, and Fibromyalgia & Other Central Pain Syndromes), 25 book chapters, and over 300 medical publications. The latter have appeared in the New England Journal of Medicine, Annals of Internal Medicine, the Lancet, Journal of Clinical Investigation, Journal of Immunology, and Journal of the American Medical Association.

Wallace's academic efforts include having served as Chief of Rheumatology at Cedars-Sinai Medical Center, Century City Hospital, and the City of Hope Medical Center in Duarte, CA. He is currently a Clinical Professor of Medicine at the David Geffen School of Medicine at UCLA. His clinical practice is based at Cedars-Sinai, where he is involved in the care of 2,000 lupus patients, the largest practice of its kind in the United States and co- directs the Cedars Sinai Rheumatology fellowship program. The Wallace Rheumatic Disease Research Center currently runs over 30 clinical trials for patients with rheumatoid arthritis, lupus, ankylosing spondylitis, psoriatic arthritis and fibromyalgia. The center has been the recipient of multiple National Institute of Health grants. 20% of his time is spent in teaching and research, providing free medical care.

Dr. Wallace's volunteer work has entailed serving as Chairman of the Lupus Foundation of America, the Research and Education Foundation of the American College of Rheumatology, and on the Board of Directors of the United Scleroderma Foundation, the Lupus Research Institute and the American Society for Apheresis. He has served on the Medical Advisory Board of the Sjogren's Syndrome Foundation and the American Fibromyalgia Syndrome Association. His service has been recognized by being named as among the 200 best doctors in the nation by Town and Country Magazine, best doctors in Los Angeles by Los Angeles Magazine, Best Doctors in America editions since 1994. Dr. Wallace is the recipient of the Lupus Foundation of America Humanitarian Award, Achievement award of the Lupus Research Institute, Spirit Award of the Scleroderma Foundation and the Jane Wyman Humanitarian Award of the Arthritis Foundation. His efforts have raised over $20 million for various rheumatic disease organizations.

Prof. David Isenberg, MD, FRCP, FAMS (U.K.)

Professor of Rheumatology, University College Hospital, London

Professor Isenberg graduated from St Bartholomew's Hospital in 1973. He trained in General Medicine, Rheumatology, Neurology, Psychiatry and Gastroenterology becoming a Research Fellow at UCL/the Middlesex Hospital in 1979. Awarded an MD Thesis (in 1984), based on studies of myositis. During a year of research at Tufts University, Boston, he became interested in autoantibody structure/function and origin. Appointed Consultant Rheumatologist in November 1984 becoming a professor in 1991 and was given the arc's Diamond Jubilee chair of Rheumatology at UCL London in 1996. Has been elected to Fellowships of both the Royal College of Physicians and the Academy of Medical Sciences. His specialist involvement is in autoimmune rheumatic diseases, notably systemic lupus erythematosus, Sjögren's syndrome, myositis and the anti-phospholipid antibody syndrome.

His principal clinical interests have been in the development of disease activity and damage assessment tools in patients with lupus. Chair of the British Isles Assessment Group and also the Chair (1998-2003) of the Systemic Lupus International Collaborating Clinics group (SLICC). Has undertaken many roles for the arc in the past 20 years and is the past president of the British Society for Rheumatology (2004-2006) and is currently chairing the Society's Biologics Register Committee. He is the 2010 recipient of the Evelyn Hess Prize from the Lupus Foundation of America for his contribution to lupus research and treatment.

Prof. Vibeke Strand, MD, FACP, FACR (USA)

Clinical Professor, Adjunct, Division of Immunology and Rheumatology, Stanford University School of Medicine

Vibeke Strand, MD, is an adjunct clinical professor in the Division of Immunology and Rheumatology at Stanford University School of Medicine. She has been a clinical rheumatologist for 32 years, previously in subspecialty practice in San Francisco and as a clinical research investigator, and senior director of clinical research at 3 pharmaceutical and biotech companies.

Since 1991, she has led a consulting practice offering clinical research and regulatory strategy expertise to pharmaceutical and biotech companies focusing to translate basic research into rational design of randomized controlled trials, evaluate their results, and defend approval of novel products to the FDA and EMA for autoimmune diseases, including rheumatoid arthritis [RA], osteoarthritis [OA], systemic lupus erythematosus {SLE], gout and fibromyalgia [FMS]. Over the past 20 years she has participated in the development of all the approved biologic agents and synthetic DMARDs in RA and SLE.

Dr. Strand's commitment to promoting forums for the discussion of rational product development among industry, FDA, and academia led to her establishing and co-chairing the biyearly "Innovative Therapies in Autoimmune Disease" meetings [1988 - 2007]. She has been an invited speaker at FDA Arthritis Advisory Committee meetings discussing Guidance Documents for RA, OA, SLE, FMS, and pain. Since 1992 she has served as a member of the Executive Organizing Committee of the international Outcomes in Rheumatology Clinical Trials [OMERACT] consensus conferences [1992 - 2014]; co-chairing OMERACT 7 (2004) and 11 (2012); with a strong interest in patient-reported outcomes. She helped found and co-chaired the Clinical Immunology Society Spring Fellows School. She is on the Board of the Northern California chapter of the Arthritis Foundation and their Medical and Scientific Committee, and the Scientific Advisory Board of CORRONA. She has authored over 265 original publications, is a Fellow of the American College of Physicians (1982), the American College of Rheumatology (1986) and is a member of the Cosmos Club (1994). She graduated from Swarthmore College with honors in a double major: Zoology and Sociology/Anthropology and from the University of California San Francisco School of Medicine.

Prof. Cees GM Kallenberg, M.D., Ph.D. (Netherlands)

Professor, Department of Rheumatology and Clinical Immunology, University Medical Center Groningen

Professor Cees GM Kallenberg received his medical training at the Medical School of the University of Leiden, The Netherlands. After getting his degree as an MD in 1972, he got additional training in surgery and served as a military MD in the Dutch Army. In 1975 he started his training as a resident in Internal Medicine at the Groningen University Hospital and was registered as internist in 1980. He worked as an internist and finished his PhD studies on the subject 'Raynaud's phenomenon and Systemic Autoimmune Disease' successfully in 1982. He further trained in immunology and medical immunology and was registered as immunologist and medical immunologist. He was appointed as associate professor in Internal Medicine - Clinical Immunology in 1985 and as a full professor in 1993.

He has written more than 500 articles in international peer-reviewed journals, gives lectures as an invited speaker on his research topics on all major international meetings, and is an editorial board member of several journals in clinical immunology, nephrology and rheumatology.

Dr. Lee S. Simon, MD, FACP, FACR (USA)

Principal, SDG LLC and former FDA Division Director

Dr. Simon is a Rheumatologist and has been the Division Director of Analgesic, Anti-inflammatory and Ophthalmologic Drug Products (DAAODP) (2001-2003), within the Center for Drug Evaluation and Research (CDER), FDA. He has been the recipient of several Quality Performance Awards and a Faculty Recognition Award from the FDA. He has served on and has been the Acting Chair of the Arthritis Advisory Committee of the DAAODP (1993-2001). He has also served on the advisory committees for the Division of Over the Counter Drugs (1996), Center for Devices (1995), and for the Division of Hematologic and Gastroenterologic Drug Products (1996). He has also served as a consultant for DDMAC (1993), the American Hospital Formulary (1990) and AMA Drug Products (1990). He is presently a Principal in SDG LLC, a consulting firm helping companies to create successful drug development programs through good designs and using insightful regulatory strategy (2004-).

He has been a clinical Rheumatologist for 25 years. He is a fellow of the American College of Physicians (1991) and the American College of Rheumatology (1986). Dr. Simon has had extensive experience in drug development in the US, and has served on consulting advisory boards for many different companies. This experience includes drugs and other therapeutics used for pain, anti-inflammatory effects, alteration of bone turnover, as well as modifying inflammatory disease states. He was a National Institutes of Health (NIH) funded investigator for 12 years working at the "wet bench" developing methodologies for in vitro measures approximating collagen turnover including the development of a commercial assay for measuring the carboxy-terminal portion of type I procollagen as a marker of new bone synthesis (1981-1993).

He has served for two terms on the Board of Directors of the American College of Rheumatology (ACR) (1991-1993, 1994-1997), served as the Chair of Education for the ACR and on the committee of the National Arthritis Foundation. He has served as the Scientific Abstract Selection Chair of the Annual Meeting of the ACR (2002). He has been awarded the 2003 Distinguished Service Award of the ACR and has been awarded the 2003 Scientific Leadership Award of the Lupus Research Institute. He served on the Steering Committee of IMPAACT, a group developing recommendations for the design and implementation of clinical trials investigating pain. He is on the Steering Committee and was Co-chair of the 2004 and 2012 OMERACT (Outcome Measures in Rheumatology) Biannual Meeting. OMERACT is a constituent group of the World Health Organization (WHO) through the International League of Associations of Rheumatology (ILAR). He served on the Steering Committee of the NIH Osteoarthritis Initiative (2001-2003). Dr. Simon has served as Chair of the biannual "Innovative Therapies in "Autoimmune Disease" conference sponsored by the ACR, FDA, NIH, and the Arthritis Foundation (2001-2005).

He has been on the editorial board of multiple journals and has authored more than 110 original publications, review articles and chapters, and has served as a co-editor of 4 books. He was Co-chair of the American Pain Society Guideline on the Treatment of Chronic Pain in Chronic Arthritis (1999-2001). He has presented on topics related to drug development, Rheumatology, the assessment and treatment of pain and bone disease. He served on the Scientific Advisory Committee of the National Osteoporosis Foundation, has been the Vice Chair of Medical Affairs of the Arthritis Foundation, Massachusetts Chapter as well as serving on its Board of Trustees (1992-2001). He was an Associate Professor of Medicine at Harvard Medical School (1995-2003) where he had been full time faculty since 1981, an Associate Chief of Medicine, Beth Israel Deaconess Medical Center (BIDMC) (1999-2001), Director of the Core Medicine Clerkship (1986-2000), Director of Clinical Rheumatology Research (1995-2001), Director of Graduate Medical Education at the BIDMC and the Deaconess Hospital (1989-2001), and Chair of Rehabilitation Services at the Deaconess Hospital (1986-1995), Harvard Medical School before joining the FDA. He served as a voluntary faculty member at Harvard and the BIDMC from 2004-2009 at which time he left to pursue a full time consulting practice in drug development and regulatory strategies.

For further information please see the Group's web site, www.immupharma.org, or contact:

Notes to Editors

ImmuPharma

ImmuPharma is focusing on developing novel medicines with high sales potential in specialist markets with serious unmet need. ImmuPharma has five drug candidates in development, two platform technologies and approximately 70 patents. The Company's most advanced drug candidate, LupuzorTM a potential blockbuster drug for Lupus, a chronic autoimmune disease has recently received the approval from the US FDA to enter phase III with a Special Protocol Assessment and "Fast Track" designation. The Company's second potential blockbuster compound in cancer "IPP-204106" is completing a new Phase I/ II clinical trial with the next generation of "polyplexed Nucant". ImmuPharma was founded and is led by a commercially focused Board and management team with extensive experience. For more information on ImmuPharma please go to: www.immupharma.org