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HEALTH CANADA APPROVES LUMAKRASTM (SOTORASIB), THE FIRST AND ONLY TARGETED TREATMENT FOR PATIENTS WITH KRAS G12C-MUTATED LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER

Once daily dosing option now available to address KRAS G12C, a driver of tumour growth found in an estimated 10% - 15% of patients with non-small cell lung cancer1

MISSISSAUGA, ON, September 14, 2021 – Amgen today announced that Health Canada has approved LUMAKRASTM (sotorasib) for the treatment of adult patients with KRAS G12C-mutated locally advanced (not amenable to curative therapy) or metastatic non-small cell lung cancer (NSCLC) who have received at least one prior systemic therapy. LUMAKRAS was granted a Notice of Compliance with Conditions (NOC/c) based on overall response rate (ORR) and duration of response (DoR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

KRAS is a puzzle cancer researchers have been trying to solve for four decades,” said Suna Avcil, executive medical director, Amgen Canada. “The first and only targeted therapy for patients with NSCLC who carry the KRAS G12C mutation, LUMAKRAS is a new option for these patients whose cancer has progressed beyond first-line therapy.”

Health Canada based its approval of LUMAKRAS on results from a subset of patients in the phase 2 CodeBreaK 100 trial, the largest clinical trial conducted to date exclusively for patients with the KRAS G12C mutation.

The trial investigated efficacy and tolerability in 126 patients with KRAS G12C mutation-positive advanced NSCLC who had disease progression after receiving an immunotherapy and/or chemotherapy. The most common adverse reactions (≥ 20%) were diarrhea, musculoskeletal pain, nausea, fatigue, hepatotoxicity and cough. Adverse reactions resulting in permanent discontinuation of LUMAKRAS occurred in 9% of patients.

“Facing a difficult condition and an often-poor prognosis, patients with KRAS G12C-mutated non-small cell lung cancer have been in dire need of additional treatment options,” says Dr. Mark Vincent, MB, ChB, MRCP(UK), FRCPC, medical oncologist, London Health Sciences Centre, London Regional Cancer Program. “Innovative treatments like LUMAKRAS (sotorasib) offer physicians and patients a new and important therapeutic option for these patients.”

“Lung cancer is the leading cause of cancer-related deaths worldwide, and it accounts for more deaths worldwide than colon cancer, breast cancer and prostate cancer combined,” says Shem Singh, Executive Director, Lung Cancer Canada. “We are pleased to see continued innovation, like this one in the area of KRAS G12C-mutated non-small cell lung cancer, that offers patients a treatment new choice as they and their physicians work together to manage their condition.”

NSCLC accounts for approximately 84% of the 2.2 million new lung cancer diagnoses each year worldwide.2,3 KRAS G12C is one of the most prevalent driver mutations in NSCLC, with approximately 10% - 15% of patients with non-squamous NSCLC having the KRAS G12C mutation.1

About LUMAKRASTM (sotorasib)

LUMAKRAS was the first KRAS G12C inhibitor to enter the clinic and is being studied in the largest clinical trial conducted to date exclusively for patients with the KRAS G12C mutation.

LUMAKRAS has demonstrated a positive benefit-risk profile with rapid, deep and durable anticancer activity in patients with locally advanced and metastatic non-small cell lung cancer (NSCLC) harboring the KRAS G12C mutation with a once daily oral formulation.

As part of the evaluation for the conditional approval of LUMAKRAS in Canada as a second line therapy for adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC) who have received at least one prior systemic therapy, Health Canada requires verification and description of clinical benefit in confirmatory trials.

LUMAKRAS is also being studied in multiple other solid tumours.4

Amgen submitted Marketing Authorization Applications (MAAs) for sotorasib in Australia, Brazil, Canada and the United Kingdom in January 2021 to participate in the FDA’s Project Orbis initiative – a pilot program that aims to explore a more efficient review process that ensures treatments are made available to patients as early as possible.

Consult the LUMAKRAS Product Monograph for more information.

About Non-Small Cell Lung Cancer and the KRAS G12C Mutation

Overall survival rates for non-small cell lung cancer are improving, but remain poor for patients with advanced disease.5

KRAS G12C is the most common KRAS mutation in NSCLC.6 Approximately 10% - 15% of patients with non-squamous NSCLC harbor the KRAS G12C mutation.1 Unmet medical need remains high and treatment options are limited for NSCLC patients with the KRAS G12C mutation whose first-line treatment has failed to work or has stopped working. The outcomes with current therapies are suboptimal with a median progression-free survival of approximately 4 months following second-line treatment of KRAS G12C-mutated NSCLC.7

About CodeBreaK
The CodeBreaK clinical development program for Amgen's drug sotorasib is designed to treat patients with an advanced solid tumour with the KRAS G12C mutation and address the longstanding unmet medical need for these cancers. As the most advanced KRAS G12C clinical development program, CodeBreaK has enrolled more than 800 patients across 13 tumour types since its inception.

CodeBreaK 100, the Phase 1 and 2, first-in-human, open-label multicenter study, enrolled patients with KRAS G12C-mutant solid tumours. Eligible patients must have received a prior line of systemic anticancer therapy, consistent with their tumour type and stage of disease. The primary endpoint for the Phase 2 study was centrally assessed objective response rate. The Phase 2 trial in NSCLC enrolled 126 patients, 124 of whom had centrally evaluable lesions by RECIST at baseline. The Phase 2 trial in colorectal cancer (CRC) is fully enrolled and topline results are expected later in 2021.

A global Phase 3 randomized active-controlled study comparing sotorasib to docetaxel in patients with KRAS G12C-mutated NSCLC (CodeBreaK 200) has completed enrollment. Amgen also has several Phase 1b studies investigating sotorasib monotherapy and sotorasib combination therapy across various advanced solid tumours (CodeBreaK 101) open for enrollment.

For information, please visit www.hcp.codebreaktrials.com.

About Amgen Canada
As a leader in innovation, Amgen Canada understands the value of science. With main operations located in Mississauga, Ont.'s vibrant biomedical cluster, and its research facility in Burnaby, B.C., Amgen Canada has been an important contributor to advancements in science and innovation in Canada since 1991. The company contributes to the development of new therapies and new ways of using existing medicines in partnership with many of Canada's leading healthcare, academic, research, government and patient organizations. To learn more about Amgen Canada, visit www.amgen.ca and follow us on www.twitter.com/amgencanadagm.

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 to manufacture therapeutic antibodies against COVID-19), the integration of Otezla® (apremilast) into our business (including anticipated Otezla sales growth and the timing of non-GAAP EPS accretion), or the Five Prime Therapeutics, 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, 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.

No forward-looking statement can be guaranteed and actual results may differ materially from those we project. Discovery or identification of new product candidates or development of new indications for existing products cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate or development of a new indication for an existing product will be successful and become a commercial product. Further, preclinical results do not guarantee safe and effective performance of product candidates in humans. The complexity of the human body cannot be perfectly, or sometimes, even adequately modeled by computer or cell culture systems or animal models. The length of time that it takes for us to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and we expect similar variability in the future. Even when clinical trials are successful, regulatory authorities may question the sufficiency for approval of the trial endpoints we have selected. We develop product candidates internally and through licensing collaborations, partnerships and joint ventures. Product candidates that are derived from relationships may be subject to disputes between the parties or may prove to be not as effective or as safe as we may have believed at the time of entering into such relationship. Also, we or others could identify safety, side effects or manufacturing problems with our products, including our devices, after they are on the market.

Our results may be affected by our ability to successfully market both new and existing products domestically and internationally, clinical and regulatory developments involving current and future products, sales growth of recently launched products, competition from other products including biosimilars, difficulties or delays in manufacturing our products and global economic conditions. In addition, sales of our products are affected by pricing pressure, political and public scrutiny and reimbursement policies imposed by third-party payers, including governments, private insurance plans and managed care providers and may be affected by regulatory, clinical and guideline developments and domestic and international trends toward managed care and healthcare cost containment. Furthermore, our research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. Our business may be impacted by government investigations, litigation and product liability claims. In addition, our business may be impacted by the adoption of new tax legislation or exposure to additional tax liabilities. If we fail to meet the compliance obligations in the corporate integrity agreement between us and the U.S. government, we could become subject to significant sanctions. Further, while we routinely obtain patents for our products and technology, the protection offered by our patents and patent applications may be challenged, invalidated or circumvented by our competitors, or we may fail to prevail in present and future intellectual property litigation. We perform a substantial amount of our commercial manufacturing activities at a few key facilities, including in Puerto Rico, and also depend on third parties for a portion of our manufacturing activities, and limits on supply may constrain sales of certain of our current products and product candidate development. An outbreak of disease or similar public health threat, such as COVID-19, and the public and governmental effort to mitigate against the spread of such disease, could have a significant adverse effect on the supply of materials for our manufacturing activities, the distribution of our products, the commercialization of our product candidates, and our clinical trial operations, and any such events may have a material adverse effect on our product development, product sales, business and results of operations. We rely on collaborations with third parties for the development of some of our product candidates and for the commercialization and sales of some of our commercial products. In addition, we compete with other companies with respect to many of our marketed products as well as for the discovery and development of new products. Further, some raw materials, medical devices and component parts for our products are supplied by sole third-party suppliers. Certain of our distributors, customers and payers have substantial purchasing leverage in their dealings with us. The discovery of significant problems with a product similar to one of our products that implicate an entire class of products could have a material adverse effect on sales of the affected products and on our business and results of operations. Our efforts to collaborate with or acquire other companies, products or technology, and to integrate the operations of companies or to support the products or technology we have acquired, may not be successful. A breakdown, cyberattack or information security breach could compromise the confidentiality, integrity and availability of our systems and our data. Our stock price is volatile and may be affected by a number of events. Global economic conditions may magnify certain risks that affect our business. Our business performance could affect or limit the ability of our Board of Directors to declare a dividend or our ability to pay a dividend or repurchase our common stock. We may not be able to access the capital and credit markets on terms that are favorable to us, or at all.

CONTACT: Natasha Bond, Head of Corporate Affairs
Amgen Canada
905-285-3007
natasha.bond@amgen.com

References
1. Amgen. Data on File. 2020.
2. American Cancer Society. Key Statistics for Lung Cancer. 2021. https://www.cancer.org/cancer/lung-cancer/about/key-statistics.html. Accessed May 20, 2021.
3. Sung H, et al. CA Cancer J Clin. 2021;71(3):209-249.
4. Hong DS, et al. N Engl J Med. 2020;383:1207-1217.
5. American Cancer Society. Lung Cancer Survival Rates. 2021. https://www.cancer.org/cancer/lung-cancer/detection-diagnosis-staging/survival-rates.html. Accessed May 20, 2021.
6. Arbour KC, et al. Clin Cancer Res. 2018;24(2):334-340.
7. Aggarwal S, et al. Poster presentation at ESMO Virtual Congress 2020, Sep. 19-21, 2020. Poster 1339P.