Amgen Is Supporting Advancement Of AMG 634 For Global Health Diseases In Developing Countries

THOUSAND OAKS, CA, USA I June 22, 2020 I Amgen (NASDAQ: AMGN) today announced it is supporting the further study of AMG 634, a phosphodiesterase type 4 (PDE4) inhibitor, for the treatment of tuberculosis (TB) and erythema nodosum leprosum (ENL), an inflammatory cutaneous and systemic complication of leprosy.  Amgen acquired AMG 634 (formerly CC-11050) as part of its acquisition of Otezla® (apremilast) from Celgene in 2019. AMG 634 is currently in Phase 2 studies led by The Aurum Institute NPC (TB study) and The Leprosy Mission Nepal (ENL study).

"AMG 634 could have potential for patients suffering from ENL and TB, two diseases that continue to challenge many countries around the world," said David M. Reese, M.D. executive vice president of Research and Development at Amgen. "We believe that the right organization focused on global health will be able to help further develop the molecule and get it directly into the hands of those patients in need of treatment options."

Approximately 225,000 new cases of leprosy are identified every year1, and a significant number of leprosy patients suffer from ENL, an autoimmune complication that can occur many years after being cured of leprosy and can cause permanent nerve damage and disability2. Tuberculosis affects 10.4 million patients every year and causes over one million deaths. Current treatments are often inadequate and can leave patients with permanent, clinically significant lung damage3.

While intending to support the two Phase 2 clinical trials in ENL and TB set to begin in 2021 by providing study drug, Amgen is interested in partnering these programs with a non-government organziation (NGO) for further development. 

More information about the clinical trial in ENL can be found here and in TB can be found here.

About Amgen
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. 

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1 World Health Organization website (last accessed June 15, 2020)
2 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
3 Bloom BR, Atun R, Cohen T, et al. Tuberculosis. In: Holmes KK, Bertozzi S, Bloom BR, et al., editors. Major Infectious Diseases. 3rd edition. Washington (DC): The International Bank for Reconstruction and Development / The World Bank; 2017 Nov 3. Chapter 11. Available from: doi: 10.1596/978-1-4648-0524-0_ch11


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