Entry into a Material Definitive Agreement

On February 22, 2022, Amgen Inc. (the "Company") reported that issued and sold $750,000,000 aggregate principal amount of the Company’s 3.000% Senior Notes due 2029 (the "2029 Notes"), $1,000,000,000 aggregate principal amount of the Company’s 3.350% Senior Notes due 2032 (the "2032 Notes"), $1,000,000,000 aggregate principal amount of the Company’s 4.200% Senior Notes due 2052 (the "2052 Notes"), and $1,250,000,000 aggregate principal amount of the Company’s 4.400% Senior Notes due 2062 (the "2062 Notes" and, together with the 2029 Notes, the 2032 Notes and the 2052 Notes, the "Notes") (Filing, 8-K, Amgen, FEB 22, 2022, View Source [SID1234608848]). The Notes are registered under an effective Registration Statement on Form S-3 (Registration No. 333-236351) (the "Registration Statement"), filed on February 10, 2020, and were issued pursuant to an indenture, dated as of May 22, 2014 (the "Indenture"), between the Company and The Bank of New York Mellon Trust Company, N.A., as trustee, and an officer’s certificate, dated as of February 22, 2022 (the "Officer’s Certificate"), setting forth the terms of the Notes. Net proceeds to the Company from the offering were approximately $3,949,135,700, after deducting underwriters’ discounts and estimated offering expenses payable by the Company.

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The relevant terms of the Notes are set forth in the Indenture, included as Exhibit 4.1 of the Company’s Current Report on Form 8-K, filed on May 22, 2014, and incorporated herein by reference, and the Officer’s Certificate (including the forms of the Notes) attached hereto as Exhibit 4.2 and incorporated herein by reference.

The 2029 Notes will pay interest at the rate of 3.000% per annum, the 2032 Notes will pay interest at the rate of 3.350% per annum, the 2052 Notes will pay interest at the rate of 4.200% per annum and the 2062 Notes will pay interest at the rate of 4.400% per annum, which shall be payable in cash semi-annually in arrears on February 22 and August 22 of each year, beginning on August 22, 2022. The 2029 Notes will mature on February 22, 2029, the 2032 Notes will mature on February 22, 2032, the 2052 Notes will mature on February 22, 2052 and the 2062 Notes will mature on February 22, 2062.

In the event of a change in control triggering event, as defined in the Officer’s Certificate, the holders of the Notes may require the Company to purchase for cash all or a portion of their Notes at a purchase price equal to 101% of the principal amount of Notes, plus accrued and unpaid interest, if any. The descriptions of the Indenture, the Officer’s Certificate and the Notes in this report are summaries and are qualified in their entirety by the terms of the Indenture, the Officer’s Certificate and the Notes, respectively.

The Notes will rank equal in right of payment to all of the Company’s other existing and future senior unsecured indebtedness, senior in right of payment to all of the Company’s existing and future subordinated indebtedness, effectively subordinated in right of payment to all of the Company’s subsidiaries’ obligations (including secured and unsecured obligations) and subordinated in right of payment to the Company’s secured obligations, to the extent of the assets securing such obligations.

Mevion Selected to Equip Proton Therapy Center at Tongji Hospital in China

On February 21, 2022 Mevion Medical Systems reported it has been selected by Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology to equip their new proton therapy center with a MEVION S250i Proton Therapy System in Wuhan, China (Press release, Mevion Medical Systems, FEB 21, 2022, View Source [SID1234608360]).

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The system at Tongji Hospital will feature Mevion’s industry leading HYPERSCAN Pencil Beam Scanning (PBS) technology, coupled with the industry’s only proton multi-leaf collimator, the Adaptive Aperture. This powerful duo provides faster and more precise targeted dose delivery to tumors thus further minimizing the damage to surrounding healthy tissue and organs at risk. The system also integrates a diagnostic CT imaging system and a surface tracking system for high precision patient positioning and intra-fraction motion management.

Founded in 1900 and listed as the 6th top hospital in Fudan’s 2020 China Hospital Ranking, Tongji Hospital provides over 6 million annual outpatient visits. The contract for the new proton therapy center was completed in late 2021, and construction of the new 135,000 square-foot proton therapy center at Tongji Hospital’s Optics Valley campus is expected to be completed by December 2022. The installation of the MEVION S250i is planned to commence in July.

Tongji Hospital will build a second proton vault simultaneously, making it China’s first proton center applying the One Plus One multi-system installation approach. This allows Tongji Hospital the flexibility to add a second system in the future to correspond to the growth of patient volume and clinical expertise. This staged installation significantly reduces the financial burden at the start of the clinical proton therapy program and minimizes the risk of technology obsolescence.

"Mevion is proud to partner with the distinguished Tongji Hospital to provide accessible proton therapy to their patients," said Tina Yu, Ph.D., chief executive officer and president of Mevion. "Mevion strongly believes health care systems will greatly benefit from expanding their proton centers at their optimal pace with the most advanced technology to best serve their patients."

Binnopharm Group enters into agreement to acquire two anti-bacterial brands from Dr. Reddy’s in the Russia & CIS region

On February 21, 2022 The Sistema Group company (LSE: SSA, MOEX: AFKS), Binnopharm Group, one of the leading pharmaceutical production companies in Russia via its affiliate Joint Stock Company ‘Alium’, and Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY, along with its subsidiaries together referred to as "Dr. Reddy’s"), an integrated global pharmaceutical company, reported the signing of a deal that will allow Binnopharm Group to acquire anti-bacterial medicines under the Ciprolet and Levolet brands from Dr. Reddy’s in Russia, Uzbekistan and Belarus (Press release, Dr Reddy’s, FEB 21, 2022, View Source [SID1234608345]). The portfolio includes various dosage forms such as tablets, solution for infusions and eye drops.

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Rustem Muratov, CEO of the Binnopharm Group said: "The acquisition of Ciprolet and Levolet is an important step to enhance our position in the antibiotics market, one of the key market segments for Binnopharm Group. These strong brands have already had the trust of millions of consumers – according to independent analyst estimation they are leaders in their market segments. They will be a valuable complement to our portfolio of antibacterial products. We are also acquiring rights to these products in Belarus and Uzbekistan in line with our strategic goal to strengthen presence in the international markets."

M.V. Ramana, CEO – Branded Markets (India & Emerging Markets), said: "Our Russia and CIS markets continue to be strong performers for the company. This deal is a step towards divesting brands in non-core areas in order to consolidate and strengthen our play further in our key focus therapy areas of gastro-enterology, pain management, cold and flu, allergy, oncology, neurology, paediatrics and women’s health. This will help us accelerate access to affordable and innovative medicines in the region in these segments in keeping with our purpose of ‘Good Health Can’t Wait’."

During the transition period, Dr. Reddy’s will continue to supply the product to Binnopharm Group to ensure availability in the market.

U.S. FDA Approves FoundationOne®CDx as a Companion Diagnostic for KEYTRUDA® (pembrolizumab) to Identify Patients with Microsatellite Instability-High (MSI-H) Solid Tumors

On February 21, 2022 Foundation Medicine, Inc. reported that it received approval from the U.S. Food and Drug Administration (FDA) for FoundationOne CDx to be used as a companion diagnostic to identify patients with Microsatellite Instability High (MSI-H) status solid tumors who may be appropriate for treatment with Merck’s KEYTRUDA (pembrolizumab) (Press release, Foundation Medicine, FEB 21, 2022, View Source [SID1234608361]). FoundationOne CDx is the first and only FDA-approved companion diagnostic to aid in identifying patients with MSI-H solid tumors for whom treatment with KEYTRUDA may be appropriate.

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In tumors that are defined as MSI-H, the DNA repair mechanisms are faulty, and as a result, tumor cells can acquire a significant number of mutations that can make them recognizable by the immune system. MSI-H status is more commonly found in colorectal, endometrial and gastrointestinal cancers, but it can also be seen in other types of cancer.1 KEYTRUDA was granted accelerated approval to treat certain patients with MSI-H solid tumors in May 2017, making it the first targeted therapy approved to treat patients based on a genomic signature, instead of where the tumor originated in the body.

"Immunotherapy has huge promise as a potential treatment option for patients with advanced cancer; however, identifying those who may benefit is complex and requires high-quality diagnostics," said Mia Levy, M.D., Ph.D., chief medical officer at Foundation Medicine. "Not only could this approval allow more patients to benefit from KEYTRUDA, but it also underscores an important shift toward tumor-agnostic cancer care."

Foundation Medicine is committed to providing oncologists and patients with the insights they need to make informed treatment decisions. This FDA approval of FoundationOne CDx to identify patients with MSI-H solid tumors, and its previous approval of the test to identify patients with TMB-H solid tumors who may benefit from treatment with KEYTRUDA, reinforces the assay’s analytical and clinical validity for guiding immunotherapy treatment decisions and therapy development. This is the third tumor agnostic companion diagnostic approval for FoundationOne CDx, which now has 26 companion diagnostic claims and two group claims across 27 targeted therapies.

"We’re proud to see this collaboration with Foundation Medicine, which drew on the deep scientific expertise of both organizations, result in another companion diagnostic approval for use in identifying patients who may be appropriate for KEYTRUDA," said Eric Rubin, senior vice president, early-stage development, clinical oncology, Merck Research Laboratories.

Labcorp Completes Acquisition of Personal Genome Diagnostics

On February 21, 2022 Labcorp (NYSE: LH), a leading global life sciences company, reported that it has closed its acquisition of Personal Genome Diagnostics Inc. (PGDx), a leader in cancer genomics with a portfolio of comprehensive liquid biopsy and tissue-based products (Press release, LabCorp, FEB 21, 2022, View Source [SID1234608347]). The addition of PGDx and its technology complements and accelerates Labcorp’s existing liquid biopsy capabilities and expands Labcorp’s leading oncology portfolio of next-generation sequencing (NGS)-based genomic profiling capabilities, positioning Labcorp at the forefront of driving better patient outcomes in oncology.

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The definitive agreement for the transaction was announced on Dec. 23, 2021.