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Amgen Licenses AMG 634, An Investigational Cure For Tuberculosis And Leprosy, To Medicines Enhancement for Global Health

THOUSAND OAKS, Calif. and MELBOURNE, Australia, Dec. 22, 2020 /PRNewswire/ — Amgen (NASDAQ:AMGN) and Medicines Progress for World Well being (MDGH), a non-income biopharmaceutical enterprise, currently declared that the corporations have entered into a license agreement for AMG 634, a phosphodiesterase kind 4 (PDE4) inhibitor staying investigated for the cure of tuberculosis (TB) and erythema nodosum leprosum (ENL), an inflammatory cutaneous and systemic complication of leprosy. The compound is in Stage 2 enhancement with experiments led by the Aurum Institute NPC (TB examine) and The Leprosy Mission Nepal (ENL review). Amgen had acquired AMG 634 (formerly CC-11050) as portion of its acquisition of Otezla® (apremilast) from Celgene in 2019. Under the conditions of the settlement, MDGH will assume total accountability for the further advancement and commercialization of AMG 634.

“Since tuberculosis and erythema nodosum leprosum continue to be hard conditions in a lot of countries about the earth, Amgen sought an firm that could guidance the improvement of AMG 634 to handle the world wide overall health unmet require,” said David M. Reese, M.D., government vice president of Exploration and Enhancement at Amgen. “MDGH’s observe history and experience in item growth, world-wide wellness, and neglected infectious health conditions can make them an ideal company to further more build AMG 634 for the profit of clients.”

Amgen will keep on to help the two Phase 2 clinical trials in ENL and TB established to start off in 2021 by delivering analyze drug to the two research and funding the ENL examine. This assistance will enable be certain a seamless transition in improvement to MDGH.

“We are fired up by the opportunity of AMG 634 for patients with ENL and TB and are honored to acquire around the stewardship of this compound from Amgen,” stated Mark Sullivan, founder and handling director of MDGH. “MDGH is focused to producing and delivering medicines for diseases that disproportionally impact men and women in lower- and center-revenue countries. We broke new floor as the to start with not-for-earnings biopharmaceutical corporation to attain Fda acceptance for a procedure for river blindness in 2018 and we will now undertake complete growth of AMG 634 in hopes of bringing it to clients in have to have of a treatment for their disease.”

In accordance to the World Well being Group (WHO), in 2019, an approximated 10 million persons have been infected with TB, like about 1 million little ones, and 1.4 million people today died of TB.1 Leprosy, also acknowledged as Hansen’s condition, influences the skin, peripheral nerves mucosal surfaces of the higher respiratory tract and the eyes.2 ENL is an autoimmune complication that can come about lots of many years just after being healed of leprosy, and can result in long lasting nerve destruction and incapacity.3

About Amgen
Amgen is committed to unlocking the probable of biology for individuals struggling from critical sicknesses by finding, creating, producing and delivering impressive human therapeutics. This tactic begins by using tools like highly developed human genetics to unravel the complexities of condition and have an understanding of the fundamentals of human biology.

Amgen focuses on places of higher unmet healthcare have to have and leverages its expertise to try for options that improve health and fitness results and substantially boost people’s life. A biotechnology pioneer because 1980, Amgen has developed to be a person of the world’s primary independent biotechnology corporations, has achieved thousands and thousands of individuals around the globe and is developing a pipeline of medicines with breakaway opportunity.

For additional information and facts, go to www.amgen.com and stick to us on www.twitter.com/amgen.

About Medications Improvement for World wide Well being
MDGH is an impartial not-for-revenue biopharmaceutical firm headquartered in Melbourne, Australia. Recognized in 2005, this unique business is focused to the improvement of very affordable medicines and vaccines for infectious and neglected diseases prevalent in very low- and center-cash flow international locations.

For additional information and facts about MDGH, be sure to pay a visit to www.medicinesdevelopment.com.

Amgen Ahead-Searching Statements
This news release is made up of forward-wanting statements that are based mostly on the recent expectations and beliefs of Amgen. All statements, other than statements of historical truth, are statements that could be deemed ahead-on the lookout statements, including any statements on the result, benefits and synergies of collaborations, or opportunity collaborations, with any other firm, including BeiGene, Ltd. or any collaboration or likely collaboration in pursuit of therapeutic antibodies versus COVID-19 (like statements regarding such collaboration’s, or our individual, ability to discover and create totally-human neutralizing antibodies focusing on SARS-CoV-2 or antibodies against targets other than the SARS-CoV-2 receptor binding domain, and/or to develop any this sort of antibodies to likely reduce or deal with COVID-19), or the Otezla® (apremilast) acquisition (like expected Otezla product sales progress and the timing of non-GAAP EPS accretion), as well as estimates of revenues, operating margins, money expenditures, dollars, other economic metrics, expected legal, arbitration, political, regulatory or clinical effects or techniques, client and prescriber patterns or procedures, reimbursement activities and outcomes, consequences of pandemics or other popular overall health complications this sort of as the ongoing COVID-19 pandemic on our enterprise, results, progress, or consequences relating to reports of Otezla as a possible cure for COVID-19, and other these estimates and outcomes. Forward-on the lookout statements involve significant hazards and uncertainties, together with those people discussed under and far more entirely explained in the Securities and Trade Commission experiences submitted by Amgen, together with our most current once-a-year report on Type 10-K and any subsequent periodic reports on Variety 10-Q and current studies on Variety 8-K. Until usually pointed out, Amgen is offering this facts as of the day of this information release and does not undertake any obligation to update any ahead-seeking statements contained in this document as a final result of new facts, long term occasions or usually.

No forward-wanting assertion can be guaranteed and precise effects might vary materially from these we undertaking. Discovery or identification of new products candidates or growth of new indications for existing solutions are unable to be certain and movement from strategy to item is unsure for that reason, there can be no ensure that any particular merchandise prospect or growth of a new sign for an present merchandise will be successful and turn out to be a industrial solution. Further more, preclinical results do not ensure protected and efficient efficiency of products candidates in people. The complexity of the human human body cannot be beautifully, or from time to time, even sufficiently modeled by computer system or cell culture units or animal types. The length of time that it can take for us to total scientific trials and acquire regulatory acceptance for solution advertising has in the past diverse and we count on related variability in the foreseeable future. Even when clinical trials are productive, regulatory authorities could problem the sufficiency for approval of the demo endpoints we have selected. We produce products candidates internally and through licensing collaborations, partnerships and joint ventures. Merchandise candidates that are derived from relationships could be issue to disputes involving the get-togethers or might prove to be not as powerful or as risk-free as we may have considered at the time of coming into into these connection. Also, we or other people could establish basic safety, side effects or producing troubles with our goods, like our units, immediately after they are on the market place.

Our outcomes may possibly be afflicted by our means to effectively industry equally new and current solutions domestically and internationally, medical and regulatory developments involving existing and potential goods, sales development of recently introduced products, competitors from other items including biosimilars, problems or delays in manufacturing our merchandise and worldwide economic circumstances. In addition, revenue of our solutions are afflicted by pricing strain, political and general public scrutiny and reimbursement procedures imposed by 3rd-social gathering payers, together with governments, non-public coverage options and managed treatment vendors and may be afflicted by regulatory, clinical and guideline developments and domestic and international traits toward managed treatment and health care charge containment. In addition, our exploration, tests, pricing, advertising and other operations are issue to comprehensive regulation by domestic and foreign authorities regulatory authorities. Our company may possibly be impacted by governing administration investigations, litigation and solution liability statements. In addition, our business might be impacted by the adoption of new tax legislation or exposure to supplemental tax liabilities. If we are unsuccessful to meet up with the compliance obligations in the corporate integrity agreement between us and the U.S. govt, we could turn into issue to sizeable sanctions. Further more, although we routinely obtain patents for our solutions and technology, the security provided by our patents and patent programs could be challenged, invalidated or circumvented by our rivals, or we may possibly fall short to prevail in present and foreseeable future intellectual assets litigation. We perform a significant quantity of our industrial producing things to do at a handful of key amenities, such as in Puerto Rico, and also count on 3rd events for a portion of our production activities, and boundaries on supply may possibly constrain revenue of certain of our present-day solutions and products candidate development. An outbreak of illness or comparable general public well being threat, this kind of as COVID-19, and the public and governmental exertion to mitigate towards the unfold of this kind of ailment, could have a substantial adverse effect on the source of components for our producing actions, the distribution of our items, the commercialization of our merchandise candidates, and our scientific trial functions, and any these kinds of situations could have a product adverse influence on our product progress, product gross sales, organization and benefits of operations. We depend on collaborations with third parties for the improvement of some of our product or service candidates and for the commercialization and product sales of some of our professional solutions. In addition, we compete with other providers with regard to quite a few of our promoted products as properly as for the discovery and advancement of new goods. More, some raw materials, health care products and ingredient areas for our products and solutions are supplied by sole 3rd-party suppliers. Selected of our distributors, customers and payers have sizeable obtaining leverage in their dealings with us. The discovery of substantial complications with a item equivalent to a single of our solutions that implicate an complete class of products could have a materials adverse effect on profits of the afflicted products and solutions and on our organization and benefits of functions. Our efforts to collaborate with or obtain other businesses, products and solutions or know-how, and to combine the operations of businesses or to assistance the products and solutions or technological innovation we have acquired, might not be productive. A breakdown, cyberattack or details stability breach could compromise the confidentiality, integrity and availability of our devices and our details. Our stock value is volatile and might be afflicted by a number of functions. Our small business overall performance could influence or limit the skill of our Board of Administrators to declare a dividend or our potential to pay a dividend or repurchase our common inventory. We could not be able to entry the money and credit score markets on terms that are favorable to us, or at all.

The scientific information talked over in this news launch linked to our products candidates is preliminary and investigative. Such product or service candidates are not permitted by the U.S. Food stuff and Drug Administration, and no conclusions can or must be drawn about the security or effectiveness of the products candidates. Additional, any scientific information reviewed in this information launch relating to new indications for our solutions is preliminary and investigative and is not component of the labeling approved by the U.S. Meals and Drug Administration for the goods. The products and solutions are not accepted for the investigational use(s) discussed in this news release, and no conclusions can or really should be drawn relating to the basic safety or usefulness of the goods for these utilizes.

Make contact with:
Amgen, Thousand Oaks
Megan Fox, 805-447-1423 (media)
Trish Rowland, 805-447-5631 (media)
Arvind Sood, 805-447-1060 (traders)

MDGH, Melbourne, Australia
Mark Sullivan, +61 419 576575 (media)
Ranya Alkadamani, +61 434 664 589 (media)

1 World Health and fitness Business internet site https://www.who.int/tb/publications/factsheet_worldwide.pdf?ua=1 (final accessed Dec. 15, 2020)
2 Planet Wellbeing Organization internet site https://www.who.int/wellbeing-matters/leprosy#tab=tab_1 (final 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 components. Lepr Rev (2000) 71, 3 1 8-324

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