Amgen and Generate Biomedicines Announce Multi-Target, Multi-Modality Research Collaboration Agreement

Companies Partner to Leverage Generate’s Machine Learning-Enabled Technology Platform to Discover and Create Protein Therapeutics for Patients

Amgen (NASDAQ: AMGN) and Generate Biomedicines today announced a research collaboration agreement to discover and create protein therapeutics for five clinical targets across several therapeutic areas and multiple modalities. As part of the research collaboration, Amgen will pay $50 million in upfront funding for the initial five programs with a potential transaction value of $1.9 billion plus future royalties, and will have the option to nominate up to five additional programs, at additional cost. For each program, Amgen will pay up to $370 million in future milestones and royalties up to low double digits. Amgen will also participate in a future financing round for Generate. Additional terms were not disclosed.

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“We are now at a scientific hinge point, where computational approaches can advance our knowledge of biology and further drive our ability to design the right molecule for some of the most challenging targets,” said David M. Reese, M.D., executive vice president of Research and Development at Amgen. “We believe Generate Biomedicine's integrated in silico design and wet lab capabilities combined with Amgen’s strength in protein engineering can accelerate our drug discovery efforts, generating novel protein sequences with optimal therapeutic properties.”

Recognizing the unique discovery challenges in multispecific drug discovery, Amgen has invested over the last decade in the marriage of wet lab high throughput automation and dry lab computational biology. Amgen’s generative biology strategy has led to the building of a Digital Biologics Discovery group, to harness the Company’s pioneering strength in biology, automation, and protein engineering. The goal of generative biology at Amgen is to take this experience and expertise in biologics combined with emerging sequence-based drug design technologies to deliver complex multispecific medicines against a variety of difficult-to-treat diseases. Combining Amgen’s biologics drug discovery expertise with the power of Generate Biomedicines Artificial Intelligence (AI) platform provides the opportunity to further facilitate multispecific drug design by shaving time off discovery timelines and generating potential lead molecules that have predictable manufacturability and clinical behavior.

Generate Biomedicines is pioneering the field of generative biology – a revolutionary approach to drug discovery and development that leverages machine learning and AI to program novel protein therapeutics. The company’s machine learning algorithms analyze hundreds of millions of known proteins, looking for statistical patterns linking amino acid sequence, structure and function, and its technology platform has been enhanced by closed-loop learning on tens of thousands of computationally generated and broadly experimental characterized novel proteins over the past three years. Combined with the company’s wet lab research, the platform can rapidly generate antibodies, peptides, enzymes, cell and gene therapies to potentially meet a wide variety of therapeutic needs. This has enabled the company to learn the generalizable rules by which a linear amino acid sequence encodes protein structure and function and design therapeutics for previously intractable targets at an unprecedented speed and scale.

“This agreement is a recognition of the transformative power of our generative biology platform,” said Mike Nally, chief executive officer, Generate Biomedicines and CEO-partner, Flagship Pioneering. “We’re proud to partner strategically with Amgen to combine their world-leading expertise in engineering protein-based therapies with our unique machine learning-enabled drug generation platform. With our technology platform, we are able to expand beyond just proteins that are found in nature – creating de novo, purpose-built proteins capable of performing any desired function under timelines that have not been possible through other approaches.”

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.

Amgen is one of the 30 companies that comprise the Dow Jones Industrial Average and is also part of the Nasdaq-100 index. In 2021, Amgen was named one of the 25 World’s Best Workplaces™ by Fortune and Great Place to Work™ and one of the 100 most sustainable companies in the world by Barron’s.

For more information, visit www.amgen.com and follow us on www.twitter.com/amgen.

About Generate Biomedicines

Generate Biomedicines is the first drug generation company, pioneering a machine learning-powered multimodality Generative Biology platform with the ability to generate new drugs on demand across a wide range of biologic modalities. The platform can drastically improve the speed at which targets and therapeutics are identified and validated, the specificity of target engagement by generated proteins, and the cost of identifying and developing clinical candidates. The company’s platform represents a potentially fundamental shift in what’s possible in the field of therapeutic development, addressing key challenges of drug discovery and drastically expanding the available search space for novel biomedicines. Generate Biomedicines was founded by Flagship Pioneering after two years of foundational research in its Labs unit and launched in 2020. Learn more about Generate Biomedicines by visiting https://generatebiomedicines.com/ or following the company on Twitter and LinkedIn.

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., Kyowa-Kirin Co., Ltd., Generate Biomedicines, Inc., or any collaboration to manufacture therapeutic antibodies against COVID-19), the performance of Otezla^® (apremilast) (including anticipated Otezla sales growth and the timing of non-GAAP EPS accretion), the Five Prime Therapeutics, Inc. acquisition, or the Teneobio, Inc. acquisition, 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, 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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