MicroPharm Ltd.

MicroPharm is pleased to announce that ANSM have approved the Marketing Authorisation Variation for Viperfav (MA 34009 5509195 0). This variation covers the change of manufacturing site from Sanofi Pasteur, France to MicroPharm, Wales and the change in primary packaging from glass vial to glass ampoule. Ian Cameron, MicroPharm’s CEO, commented: “This represents the final milestone in the establishment of commercial antivenom manufacture at MicroPharm’s new manufacturing facility at Cilgerran, Wales. I am grateful to all the staff at MicroPharm for their contribution to the success of this project.”

MicroPharm Limited is pleased to announce that it has been awarded funding from Wellcome to undertake a Phase II clinical trial of an oral therapeutic (OraCAb®) for the treatment of non-life-threatening C. difficile (C. diff.) infection (CDI). OraCAb is a polyclonal antibody-based therapeutic, comprising highly potent antibodies targeting C. diff. toxins and formulated to ensure gut activity. OraCAb was developed in collaboration with the United Kingdom Health Security Agency (UKHSA), Porton Down. MicroPharm will be the Sponsor of the multi-country trial with harmonised trial sites across Kenya and Australia to facilitate assessment of globally circulating C. diff. strains. The Kenyan trial will be undertaken in Nairobi and led by clinicians from the University of Nairobi acting in conjunction with the University of Texas Health Science Center, Houston, USA. The Australian trial will be undertaken by clinicians at the Fiona Stanley Hospital, Perth. C. diff. infection places huge burden on global health systems, is a driver of drug resistance and is the most common cause of infectious diarrhoea in healthcare settings. It is increasingly recognised as a significant cause of diarrhoea in the general community and a major health burden in many Low-and-Middle-Income Countries (LMIC) for example in Kenya where 25% of all patients with diarrhoea are positive for C. diff. toxic strains. It is estimated that in the United States alone, C. diff. accounts for nearly 700,000 infections and 29,000 deaths annually whilst in the UK, there are around 18,000 CDI cases annually with a case fatality rate of around 14%. An affordable and highly effective antibody therapy that has low or minimal risk of developing antimicrobial resistance and is suitable for use in clinical and outpatient settings globally could have huge patient benefit. OraCAb is highly specific in targeting C. diff. toxins TcdA and TcdB and the innovative formulation is designed to maintain OraCAb integrity through the gastrointestinal tract with a view to ensuring activity at the site of C. diff. toxin production. Toxin neutralisation by OraCAb prevents damage to the gut wall and limits disruption to the natural gut flora caused by infection. Importantly, OraCAb offers the potential for global use in neutralising the large variety of 34 different TcdA and TcdB toxinotypes secreted by circulating pathogenic C. diff. strains. A successful trial would demonstrate the power of coupling an antibody platform for oral administration to target enteric and diarrhoeal diseases, paving the way for further development towards treating additional unmet medical need in LMICs such as Shigellosis. Professor John Landon, (MicroPharm Chairman), commented, “We are grateful for Wellcome’s support for this important project, which we believe will be of profound benefit to patients with this globally recognised cause of morbidity and mortality with devastating effects on health-related quality of life. Wellcome Quote: “I’m delighted that Wellcome is investing in the clinical development of OraCAb” said Dr Pete Gardner, Research Lead within Wellcome’s Infectious Disease team. “Supporting the acceleration of new interventions to control infectious disease is critical to Wellcome’s mission and new antibody-based medicines offer a much-needed complementary approach to antibiotics in tackling drug resistant bacterial infections. This partnership with MicroPharm for a Phase II clinical trial is especially exciting as it includes sites in Kenya where OraCAb has the potential to be cost-effective, signalling intent that if shown to be safe and efficacious OraCAb could also be accessible to all who may benefit most from it”.

MicroPharm Limited is pleased to announce that its new manufacturing site at Cilgerran, North Pembrokeshire, UK has now been granted a Manufacturing / Importers Authorisation (MIA) licence, MIA Investigational Medicinal Products (IMP) licence and a “Specials” licence by the Medicines & Healthcare products Regulatory Agency (MHRA), UK. The site is in production and is initially being used for the manufacture of Viperfav™ and Bothrofav™. The manufacturing site comprises 473 m2 of Class C and Class D cleanrooms, walk in fridges, Quality Control and development laboratories, a warehouse and offices. From initial design, the project has taken 5 years and included the transfer of the manufacturing technology and products from Sanofi Pasteur. CEO, Ian Cameron, commented: “The successful conclusion to this project is the result of the expertise, professionalism and hard work of the staff. MicroPharm now has the infrastructure in place to facilitate further growth. We will retain our existing manufacturing site at Newcastle Emlyn where we will manufacture EchiTAbG, Fav-Afrique and Favirept and where all products are filled. The Cilgerran project has been made possible by the significant investment by MicroPharm’s majority shareholder, Flynn Pharma (Holdings) Limited.” David Fakes (CEO & Chairman) added: “We are delighted to reach this milestone and thank all our colleagues who made this possible. MicroPharm is now uniquely positioned to make an important contribution to the treatment of snakebite envenomation in Sub-Saharan Africa, the Middle East and North Africa”. MicroPharm is a major employer in West Wales and is the leading manufacturer of antivenom for the European market.