MDGH discloses Novo Nordisk as purchaser of its prv

Medicines Development for Global Health discloses Novo Nordisk as purchaser of its priority review voucher

Significant portion of proceeds will be reinvested in neglected disease research and control efforts, fully realizing the original intent of this important public health funding mechanism.

Melbourne, Australia, 9 August 2019‍

Today, in conjunction with its second quarter financial results, Novo Nordisk disclosed that it purchased a priority review voucher (PRV) in the current reporting period, and Medicines Development for Global Health (MDGH) confirms it was the seller. The PRV allows Novo Nordisk to receive priority review designation on a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA), which provides for an accelerated six-month review timeline.

MDGH received the PRV under an incentive program designed to stimulate the development of new medicines for neglected diseases. The voucher was awarded to MDGH when the U.S. FDA approved moxidectin as a new treatment for onchocerciasis, a debilitating parasitic worm infection also known as river blindness. Moxidectin is the first new FDA-approved treatment for onchocerciasis in more than 20 years, and the $13 million of financing required for the final stages of development was enabled entirely as a result of the PRV incentive program.

MDGH received the PRV under an incentive program designed to stimulate the development of new medicines for neglected diseases. The voucher was awarded to MDGH when the U.S. FDA approved moxidectin as a new treatment for onchocerciasis, a debilitating parasitic worm infection also known as river blindness. Moxidectin is the first new FDA-approved treatment for onchocerciasis in more than 20 years, and the $13 million of financing required for the final stages of development was enabled entirely as a result of the PRV incentive program.

MDGH and its financing partners at the Global Health Investment Fund (GHIF) plan to apply a significant portion of the PRV sale proceeds toward additional research on moxidectin as well as its deployment in key underserved markets, where nearly 200 million individuals are at risk for river blindness. The balance will be returned to the pioneering impact investors at GHIF who financed moxidectin’s U.S. FDA approval, many of whom are reinvesting their returns in GHIF’s second fund (which has been rebranded as Adjuvant) to support further innovations for neglected public health challenges. GHIF was created by the Bill & Melinda Gates Foundation and J.P. Morgan in 2012, and its investors include the International Finance Corporation, the Children’s Investment Fund Foundation, and Germany’s Federal Ministry for Economic Cooperation and Development, among others.

“This is a very positive win-win situation; I truly believe that moxidectin is going to make an impact in reducing river blindness,” said Novo Nordisk Chief Science Officer Mads Krogsgaard Thomsen. “I hope our acquisition will help Medicines Development for Global Health in their endeavors to eliminate this debilitating disease affecting millions of people in low-income countries.”

This outcome is a flagship example of the innovative investment model pioneered at GHIF, where impact investors are earning healthy returns on their capital while those at risk of neglected diseases will soon have access to improved therapies. It is also an excellent case study for the PRV program operating as it was originally intended: bringing new medicines for neglected diseases to market and providing the financial resources necessary to make those innovations accessible to those who need them most.

“We are delighted to have achieved this key milestone in the moxidectin story, a medicine that would have been left on the shelf without the PRV funding mechanism enabling a bold group of impact investors to finance the development of this asset,” said Mark Sullivan, Managing Director of MDGH.

“Ultimately, we are all doing this for the communities affected by river blindness and other neglected diseases and we look forward to working towards further development and delivery of this medicine. We particularly acknowledge our partnership with TDR (the Special Programme for Research and Training in Tropical Diseases) in gaining the FDA approval that resulted in the PRV award, the U.S. government for putting the PRV mechanism in place, and the U.S. FDA for administering it.”

About Medicines Development for Global Health

MDGH is a not-for-profit biopharmaceutical company headquartered in Melbourne, Australia. Established in 2005, this unique organization is dedicated to the development of affordable medicines and vaccines for neglected diseases prevalent in low- and middle-income countries. The company works on the development of a portfolio of products, including vaccines, small molecules and biological therapies targeting predominantly infectious, immunologic, and oncologic diseases. For additional information about MDGH, please visit www.medicinesdevelopment.com.

About TDR

TDR (the Special Programme for Research and Training in Tropical Medicine), who funded the development of moxidectin for onchocerciasis through Phase III, is a global programme of scientific collaboration that helps facilitate, support and influence efforts to combat diseases of poverty. It is hosted by the Worth Health Organization and is sponsored by the United nations Children’s Fund, the United Nations Development Programme, the World Bank and WHO.

About Novo Nordisk

Novo Nordisk is a global healthcare company with more than 95 years of innovation and leadership in diabetes care. This heritage has given us experience and capabilities that also enable us to help people defeat obesity, haemophilia, growth disorders and other serious chronic diseases. Headquartered in Denmark, Novo Nordisk employs approximately 41,600 people in 80 countries and markets its products in more than 170 countries. For more information, visit novonordisk.com.
Media inquiries: Charlotte Zarp-Andersson, czpa@novonordisk.com, +4530797603

About the Priority Review Voucher (PRV) Program

More information on the priority review voucher program is available at www.priorityreviewvoucher.org. For more information about the earlier stages of development of moxidectin and the importance of the PRV for the completion of its registration, see the recent article in PLoS.