THOUSAND OAKS, Calif. and MELBOURNE, Australia, Dec. 22, 2020 /PRNewswire/ -- Amgen (NASDAQ:AMGN) and Medicines Development for Global Health (MDGH), a non-profit biopharmaceutical company, today announced that the companies have entered into a license agreement for AMG 634, a phosphodiesterase type 4 (PDE4) inhibitor being investigated for the treatment of tuberculosis (TB) and erythema nodosum leprosum (ENL), an inflammatory cutaneous and systemic complication of leprosy. The compound is in Phase 2 development with studies led by the Aurum Institute NPC (TB study) and The Leprosy Mission Nepal (ENL study). Amgen had acquired AMG 634 (formerly CC-11050) as part of its acquisition of Otezla® (apremilast) from Celgene in 2019. Under the terms of the agreement, MDGH will assume full responsibility for the further development and commercialization of AMG 634.
"Since tuberculosis and erythema nodosum leprosum remain challenging diseases in many countries around the world, Amgen sought an organization that could support the development of AMG 634 to address the global health unmet need," said David M. Reese, M.D., executive vice president of Research and Development at Amgen. "MDGH's track record and experience in product development, global health, and neglected infectious diseases makes them an ideal company to further develop AMG 634 for the benefit of patients."
Amgen will continue to support the two Phase 2 clinical trials in ENL and TB set to begin in 2021 by providing study drug to both studies and funding the ENL study. This support will help ensure a seamless transition in development to MDGH.
"We are excited by the potential of AMG 634 for patients with ENL and TB and are honored to take over the stewardship of this compound from Amgen," said Mark Sullivan, founder and managing director of MDGH. "MDGH is dedicated to developing and delivering medicines for diseases that disproportionally affect people in low- and middle-income countries. We broke new ground as the first not-for-profit biopharmaceutical company to achieve FDA approval for a treatment for river blindness in 2018 and we will now undertake full development of AMG 634 in hopes of bringing it to patients in need of a treatment for their disease."
According to the World Health Organization (WHO), in 2019, an estimated 10 million people were infected with TB, including over 1 million children, and 1.4 million people died of TB.1 Leprosy, also known as Hansen's disease, affects the skin, peripheral nerves mucosal surfaces of the upper respiratory tract and the eyes.2 ENL is an autoimmune complication that can occur many years after being cured of leprosy, and can cause permanent nerve damage and disability.3
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
About Medicines Development for Global Health
MDGH is an independent 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 infectious and neglected diseases prevalent in low- and middle-income countries.
For additional information about MDGH, please visit www.medicinesdevelopment.com.
Amgen Forward-Looking Statements
This news release contains forward-looking statements that are based on the current expectations and beliefs of Amgen. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including any statements on the outcome, benefits and synergies of collaborations, or potential collaborations, with any other company, including BeiGene, Ltd. or any collaboration or potential collaboration in pursuit of therapeutic antibodies against COVID-19 (including statements regarding such collaboration's, or our own, ability to discover and develop fully-human neutralizing antibodies targeting SARS-CoV-2 or antibodies against targets other than the SARS-CoV-2 receptor binding domain, and/or to produce any such antibodies to potentially prevent or treat COVID-19), or the Otezla® (apremilast) acquisition (including anticipated Otezla sales growth and the timing of non-GAAP EPS accretion), as well as estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes, effects of pandemics or other widespread health problems such as the ongoing COVID-19 pandemic on our business, outcomes, progress, or effects relating to studies of Otezla as a potential treatment for COVID-19, and other such estimates and results. Forward-looking statements involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission reports filed by Amgen, including our most recent annual report on Form 10-K and any subsequent periodic reports on Form 10-Q and current reports on Form 8-K. Unless otherwise noted, Amgen is providing this information as of the date of this news release and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.
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Amgen, Thousand Oaks
Megan Fox, 805-447-1423 (media)
Trish Rowland, 805-447-5631 (media)
Arvind Sood, 805-447-1060 (investors)
MDGH, Melbourne, Australia
Mark Sullivan, +61 419 576575 (media)
Ranya Alkadamani, +61 434 664 589 (media)
1 World Health Organization website https://www.who.int/tb/publications/factsheet_global.pdf?ua=1 (last accessed Dec. 15, 2020)
2 World Health Organization website https://www.who.int/health-topics/leprosy#tab=tab_1 (last accessed Dec. 15, 2020)
3 Saunderson P, Gebre S, Byass P. ENL reactions in the multi bacillary cases of the AMFES cohort in central Ethiopia: incidence and risk factors. Lepr Rev (2000) 71, 3 1 8-324