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Newsletter volume 4. September 2021
Dear <<First Name>>

Welcome to our Q3 2021 Newsletter, highlighting the latest activities for Medicines Development for Global Health.
Expansion of MDGH footprint
Medicines Development for Global Health (MDGH) today announces its further expansion with the opening of Medicines Development for Global Health, Inc in the United States. “These are exciting times for MDGH and establishing a formal presence in the United States enables us to be closer to our North American network,” said Mark Sullivan, Managing Director of MDGH. “We have been working closely for some time with a large number of key contributors in the Americas and hope that this will allow us to both consolidate our existing relationships as well as create many new connections.”

The makeup of the MDGH, Inc’s Board of Directors will be three members of MDGH Australia's board, Dr Lorna Meldrum (Chair), Mark Sullivan and Professor Andrew Wilks (University of Melbourne; SYNthesis med chem), and two directors based in the United States: Lawrence V. Stein (former Executive Vice President, General Counsel and Corporate Secretary at Celgene Corporation; former Senior Vice President and General Counsel at Wyeth Corp.), and Dr Joseph Camardo (former Senior Vice President and Head of Global Health at Celgene Corp.; former Senior Vice President of Global Medical Affairs and Senior Vice President of Clinical Research and Development at Wyeth Corp.).
“These are exciting times for MDGH and establishing a formal presence in the United States enables us to be closer to our North American network,”
Mark Sullivan, Managing Director, MDGH
The company’s focus in the United States will be to create a stronger presence in the global health sector, as well as consolidating the project leadership of the CC-11050 development program for leprosy type 2 reaction and tuberculosis. The new company, headquartered in New Jersey, builds upon the longstanding presence of advisors and partners in New York and New Jersey, where current global marketing and communications efforts are driven by Jed Beitler and Ben Wills, co-VPs, Commercial, North America. MDGH, Inc has also hired Dr Vikram Khetani as the Project Leader for the CC-11050 development program following his stellar 27-year career with Celgene Corp. Most recently, Dr Khetani was Executive Director for Global Health at Bristol Myers Squibb.

The establishment of the United States office follows more than 5 years of MDGH corporate presence in the United Kingdom and comes ahead of the company’s planned expansion into the European Union in 2022.
Clinical Development update: Impact of COVID-19
Many regions around the world are still suffering from the devastating effects of COVID-19, with case numbers continuing to grow due to the Delta variant. The impact of the pandemic has not only been felt within the healthcare delivery arena but more broadly. While COVID-19 vaccine and therapeutic trials continue with pace, non-COVID-19-related medical research and clinical trials are two of the healthcare industry's most significantly affected sectors. For most non-COVID-19 products in research and development (R&D), the diversion of resources, and various lockdowns and other pandemic control measures have caused significant cancellations, delays, or postponements, including to our own ongoing studies. That said, MDGH study teams have been working hard to mitigate these impacts and continue to work towards the successful progress of all its clinical trials.
Social impact investment opportunity: a potential Priority Review Voucher, and lasting impact
The development of new medicines is a complex and expensive process, with the substantial investment requirement underpinned by future potential revenues. In neglected disease R&D, this financial model starts to fall apart. And although regulatory approval feels like the ultimate objective, it is just a step towards delivery of medicines and achieving impact. Acknowledging this challenge in financing, the United States Food and Drug Administration's (FDA) tropical disease priority review voucher (PRV) program was established in 2007 to encourage companies to develop new drugs for neglected tropical diseases for which traditional market forces do not apply. Under the program, when a company achieves FDA approval for a new medicine for one of these neglected diseases, the company receives a transferrable PRV. The voucher is then used to accelerate FDA's review of another drug by four months, which has significant value to pharmaceutical companies. The current selling range for the PRV is between US$80 million and US$120 million.

MDGH leveraged the potential value of the PRV to obtain an investment from the Global Health Investment Fund to complete development of moxidectin for river blindness. Furthermore, in 2017, funding for moxidectin as a potential treatment for scabies was raised from Australian social impact investors. All investors had capital plus returned in 2019 when MDGH sold its PRV to Novo Nordisk. MDGH committed the balance of the proceeds to future global health projects – funding the supply and further development of moxidectin in other neglected diseases.
'Creative use of the priority review voucher by public and not-for-profit actors delivers the first new FDA-approved treatment for river blindness in 20 year'. Olliaro PL et al. PLOS Neglected Tropical Diseases 2018
MDGH has received an exclusive, global license for the development and commercialisation of CC-11050 from Amgen, Inc. CC-11050 is an investigational medicine currently undergoing Phase 2 clinical trials for a complication of leprosy called leprosy type 2 reaction as well as for tuberculosis. The first part of a two-part Phase 2 study in leprosy type 2 reaction suggests that CC-11050 may resolve this debilitating disease for which very few treatment options exist. The second half of the study is due to commence early 2022. Additionally, CC-11050 has shown promising results in improving lung function in patients with tuberculosis (Wallis RS et al., 2021, The Lancet Respiratory Medicine).

The addition of CC-11050 to the MDGH portfolio marks a new era in the company's growth, requiring new investment and new development personnel. MDGH is seeking to raise social impact investment for its work on leprosy and tuberculosis against the potential award of a PRV for CC-11050. The new funding will be used to fund CC-11050 development activities leading towards Phase 3 clinical trials, including new formulation work, manufacturing, and additional nonclinical safety and toxicology studies. The funding round, which launched in Q3 2021, was well received, and now exceeds 50% of the target amount.
For more information on specific details of the CC-11050 investment opportunity, please contact Ronan Lehane on (+61) 425 326 367 or ronan@capitalcollaboration.com
Prix Galien Award nomination, 2021
MDGH and its collaborators at TDR, the Special Programme for Research and Training in Tropical Diseases (co-sponsored by the United Nations Children’s Fund, the United Nations Development Programme, the World Bank and the World Health Organization) have, once again, been honoured by the Galien Foundation with a nomination for moxidectin for Best Pharmaceutical Product at the 2021 Prix Galien Awards. The aim of this prestigious annual award is to promote significant advances in pharmaceutical research. A prominent jury is brought together each year, including clinicians, toxicologists, pharmacologists, and pharmacists. The award gives credit to the most important drugs introduced into the public market as well as to the achievements of the best research team in the pharmaceutical field. It is considered the pharmaceutical industry’s equivalent of the Nobel prize and the highest accolade for research and product development.
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