On October 22, 2021 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported U.S. Food and Drug Administration (FDA) approval of the VENTANA PD-L1 (SP263) Assay in non- small cell lung cancer (NSCLC) as a companion diagnostic test for Tecentriq, advancing the company’s commitment to guide clinical decision making through innovative, high quality assays that improve patient access to personalized healthcare (Press release, Hoffmann-La Roche, OCT 22, 2021, View Source [SID1234591765]).

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The current standard of care for patients with early stage lung cancer is surgery to remove the tumor, which may be followed by chemotherapy. Unfortunately, about half of these patients will have their cancer return following surgery.2 Tecentriq received FDA approval on 15 October 2021 as adjuvant treatment following surgery and platinum-based chemotherapy for adults whose Stage II-IIIA NSCLC tumors have PD-L1 expression on ≥1% of tumor cells. The VENTANA PD-L1 (SP263) Assay identifies NSCLC patients who may be eligible for Tecentriq (atezolizumab) monotherapy in this indication.

"Early detection of lung cancer can change the treatment pathway for patients and give them more treatment options," said Thomas Schinecker, CEO Roche Diagnostics. "We are proud to offer a companion diagnostic PD-L1 test that identifies lung cancer patients who may qualify for Tecentriq therapy. With the FDA approval of this companion diagnostic test, clinicians now have an effective tool for offering better patient care through targeted immunotherapy treatment."

The VENTANA PD-L1 (SP263) Assay was used as part of the IMpower010 study sponsored by Genentech, a member of the Roche Group, to identify patients whose tumors expressed the PD-L1 protein. The IMpower010 clinical study began in 2015 with the goal of understanding how patients would respond to treatment with Tecentriq following traditional surgery and chemotherapy. In 2021, Genentech reported a 34% reduction in the risk of disease recurrence or death amongst Tecentriq patients whose tumors were shown to express PD-L1 protein. For details of the study go to www.roche.com.

About the VENTANA PD-L1 (SP263) Assay
VENTANA PD-L1 (SP263) Assay is used to detect programmed death ligand-1 (PD-L1) protein in non-small cell lung carcinoma (NSCLC) patients. PD-L1 expression on tumor cells and immune cells has been shown in clinical studies to help predict the likelihood a patient may benefit from PD-L1/PD-1 immunotherapy drugs.3-6

VENTANA PD-L1 (SP263) Assay testing is performed on a BenchMark ULTRA instrument and is visualized using the OptiView DAB IHC Detection Kit.

Roche has developed a leading, comprehensive and differentiated lung cancer immunohistochemical portfolio, with biomarkers that support multiple guidelines for the diagnosis and stratification of lung cancers.7-9

On October 22, 2021 Thermo Fisher Scientific Inc. (the "Company") reported that issued $1,000,000,000 aggregate principal amount of 18-Month Floating Rate Senior Notes due 2023 (the "18-Month Floating Rate Notes"), $500,000,000 aggregate principal amount of Floating Rate Senior Notes due 2023 (the "2023 Floating Rate Notes"), $500,000,000 aggregate principal amount of Floating Rate Senior Notes due 2024 (the "2024 Floating Rate Notes" and, together with the 18-Month Floating Rate Notes and the 2023 Floating Rate Notes, the "Floating Rate Notes"), $1,350,000,000 aggregate principal amount of 0.797% Senior Notes due 2023 (the "2023 Notes") and $2,500,000,000 aggregate principal amount of 1.215% Senior Notes due 2024 (the "2024 Notes" and, together with the 2023 Notes, the "Fixed Rate Notes", and together with the Floating Rate Notes, the "Notes") in a public offering (the "Offering") pursuant to a registration statement on Form S-3 (File No. 333-229951) and a preliminary prospectus supplement and prospectus supplement related to the offering of the Notes, each as previously filed with the Securities and Exchange Commission (the "SEC") (Filing, 8-K, Thermo Fisher Scientific, OCT 22, 2021, View Source [SID1234591781]).

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The Notes were issued under an indenture, dated as of November 20, 2009 (the "Base Indenture"), and the Twenty-Third Supplemental Indenture, dated as of October 22, 2021 (the "Supplemental Indenture" and, together with the Base Indenture, the "Indenture"), between the Company, as issuer, and The Bank of New York Mellon Trust Company, N.A., as trustee.

The Floating Rate Notes are subject to a Calculation Agency Agreement, dated as of October 22, 2021, between the Company and The Bank of New York Mellon Trust Company, N.A., as calculation agent.

The 18-Month Notes will mature on April 18, 2023, the 2023 Floating Rate Notes will mature on October 18, 2023, the 2024 Floating Rate Notes will mature on October 18, 2024, the 2023 Notes will mature on October 18, 2023 and the 2024 Notes will mature on October 18, 2024. Interest on the Floating Rate Notes will be paid quarterly in arrears on January 18, April 18, July 18 and October 18 of each year, commencing on January 18, 2022. Interest on the Fixed Rate Notes will be paid semi-annually in arrears on April 18 and October 18 of each year, commencing on April 18, 2022.

Prior to October 18, 2022, the Company may redeem each series of Fixed Rate Notes, in whole at any time or in part from time to time, at a redemption price equal to the greater of (1) 100% of the principal amount of the Fixed Rate Notes to be redeemed and (2) the sum of the present values of the remaining scheduled payments of principal and interest in respect of the Fixed Rate Notes being redeemed (not including any portion of the payments of interest accrued but unpaid as of the date of redemption and assuming that such Fixed Rate Notes to be redeemed matured on October 18, 2022), discounted to the date of redemption on a semi-annual basis (assuming a 360-day year of twelve 30-day months), at the Treasury Rate (as defined in the Indenture) plus, in each case, 7.5 basis points and accrued and unpaid interest on the Fixed Rate Notes being redeemed, if any, to, but excluding, the date of redemption.

In addition, on and after April 18, 2022, with respect to the 18-Month Floating Rate Notes, and October 18, 2022, with respect to the 2023 Floating Rate Notes, the 2024 Floating Rate Notes and the Fixed Rate Notes, the Company may redeem some or all of each series of Notes at a redemption price equal to 100% of the principal amount of the Notes to be redeemed, plus accrued and unpaid interest, if any, to, but excluding the date of redemption.

In the event that the Company does not consummate the previously announced acquisition of PPD, Inc. (the "PPD Acquisition") on or prior to October 15, 2022 or the merger agreement related thereto is terminated at any time prior to such date, the Company will be required to redeem all of the 2023 Floating Rate Notes, the 2024 Floating Rate Notes, the 2023 Notes and the 2024 Notes (collectively, the "SMR Notes") on a special mandatory redemption date at a redemption price equal to 101% of the aggregate principal amount of the SMR Notes, plus accrued and unpaid interest, if any, to, but excluding, the special mandatory redemption date.

Upon the occurrence of a change of control (as defined in the Indenture) of the Company and a contemporaneous downgrade of the Notes below an investment grade rating by at least two of Moody’s Investors Service, Inc., S&P Global Ratings, a division of S&P Global, Inc., and Fitch Ratings, Limited, the Company will, in certain circumstances, be required to make an offer to purchase the Notes at a price equal to 101% of the principal amount of the Notes, plus any accrued and unpaid interest to, but excluding, the date of repurchase.

The Notes are general unsecured obligations of the Company. The Notes rank equally in right of payment with existing and any future unsecured and unsubordinated indebtedness of the Company and rank senior in right of payment to any existing and future indebtedness of the Company that is subordinated to the Notes. The Notes are also effectively subordinated to any existing and future secured indebtedness of the Company to the extent of the assets securing such indebtedness, and are structurally subordinated to all existing and any future indebtedness and any other liabilities of its subsidiaries.

The Indenture contains limited affirmative and negative covenants of the Company. The negative covenants restrict the ability of the Company and its subsidiaries to incur debt secured by liens on Principal Properties (as defined in the Indenture) or on shares of stock of the Company’s Principal Subsidiaries (as defined in the Indenture) and engage in sale and lease-back transactions with respect to any Principal Property. The Indenture also limits the ability of the Company to merge or consolidate or sell all or substantially all of its assets.

Upon the occurrence of an event of default under the Indenture, which includes payment defaults, defaults in the performance of affirmative and negative covenants, bankruptcy and insolvency related defaults and failure to pay certain indebtedness, the obligations of the Company under the Notes may be accelerated, in which case the entire principal amount of the Notes would be immediately due and payable.

Wilmer Cutler Pickering Hale and Dorr LLP, counsel to the Company, has issued an opinion to the Company, dated October 22, 2021, regarding the Notes. A copy of this opinion is filed as Exhibit 5.1 hereto.

The foregoing description is qualified in its entirety by reference to the full text of the Base Indenture and the Supplemental Indenture, which are filed with this report as Exhibits 4.1 and 4.2 hereto, respectively. Each of the foregoing documents is incorporated herein by reference.

On October 22, 2021 Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) reported that it will report its third-quarter 2021 financial results on Tuesday, November 2, 2021 after the financial markets close (Press release, Vertex Pharmaceuticals, OCT 22, 2021, View Source [SID1234591785]). The company will host a conference call and webcast at 4:30 p.m. ET. To access the call, please dial (866) 501-1537 (U.S.) or +1 (720) 545-0001 (International).

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The conference call will be webcast live and a link to the webcast can be accessed through Vertex’s website at www.vrtx.com in the "Investors" section. To ensure a timely connection, it is recommended that participants register at least 15 minutes prior to the scheduled webcast. An archived webcast will be available on the company’s website.

On October 22, 2021 Servier, a global independent pharmaceutical group, reported that the primary objective (progression free survival) of the Phase III SOLSTICE trial has not been met (Press release, Servier, OCT 22, 2021, View Source [SID1234591789]). SOLSTICE was designed to evaluate the superiority of LONSURF (trifluridine/tipiracil) + bevacizumab over capecitabine + bevacizumab in 1st line unresectable metastatic colorectal cancer (mCRC) in patients non-eligible for intensive therapy. The trial will continue as planned given that no deleterious effects and no new safety issues have been raised in either study arm.

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Data from the primary analysis will be presented at an upcoming medical congress.

"We remain committed to improving outcomes in mCRC and we will continue to follow patients as planned in order to perform the main secondary endpoint analysis on overall survival in 2023," said Patrick Therasse, M.D., Ph. D., Head of Late Stage and Life Cycle Management, and Deputy Head Oncology and Immuno-Oncology Therapeutic Area, Servier. "The clinical value of LONSURF in its current indications remains unchanged, and the ongoing Phase III SUNLIGHT trial (LONSURF + bevacizumab versus LONSURF in 3rd line mCRC) is proceeding as planned."

Nearly 1.4 million people are diagnosed with colorectal cancer (CRC) each year worldwide,1 equating to 10% of the global cancer cases.1 In Europe, CRC is the second most common cause of cancer death,2 and metastatic (when the cancer has spread from the primary site to other parts of the body) patients have a 5-year survival rate of just 11%.2 Standard chemotherapy regimens for mCRC include fluoropyrimidines, oxaliplatin, irinotecan or targeted treatments, such as those that target vascular endothelial growth factors (VEGF) or endothelial growth factor receptors (EGFR).

"Metastatic colorectal cancer patients who are not well enough to undergo intensive chemotherapy have limited options, and quality of life is a priority," said Professor Thierry André, MD, Saint Antoine Hospital, Paris, France, and Lead Investigator for the SOLSTICE study. "We are continuously searching for new ways to give these patients efficient treatment with low toxicities."

Servier is committed to developing new treatments to support patients in their fight against gastrointestinal cancer.

About SOLSTICE
SOLSTICE is an open-label, randomized, multicentre Phase III trial in 856 unresectable metastatic colorectal cancer patients who are not candidates for, or do not require, intensive therapy. Patients were randomized 1:1 to receive 1st line LONSURF + bevacizumab versus capecitabine + bevacizumab. The primary objective is to demonstrate superior progression free survival with LONSURF + bevacizumab over capecitabine + bevacizumab. The first patient was enrolled in March 2019.

For more information on SOLSTICE, please visit www.ClinicalTrials.gov (View Source). The ClinicalTrials.gov Identifier is NCT03869892.

About LONSURF
LONSURF consists of a thymidine-based nucleoside analog, trifluridine, and the thymidine phosphorylase (TP) inhibitor, tipiracil, which increases trifluridine exposure by inhibiting its metabolism by TP. Trifluridine is incorporated into DNA, resulting in DNA dysfunction and inhibition of cell proliferation.

In the EU, LONSURF is indicated as monotherapy for the treatment of adult patients with mCRC who have been previously treated with, or are not considered candidates for, available therapies including fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapies, anti- VEGF agents, and anti-EGFR agents. LONSURF is also indicated as monotherapy for the treatment of adult patients with metastatic gastric cancer (mGC), including adenocarcinoma of the gastroesophageal junction (mGEJC), who have been previously treated with at least two prior systemic treatment regimens for advanced disease.

As of October 2021, LONSURF has been approved in 96 countries for the treatment of advanced mCRC and in 80 countries for the treatment of advanced mGC/mGEJC.

LONSURF was discovered and developed by Taiho Pharmaceutical Co., Ltd. In June 2015, Taiho Pharmaceutical and Servier entered into an exclusive license agreement for the co-development and commercialization of LONSURF in Europe and other countries outside of the United States, Canada, Mexico, and Asia.

On October 22, 2021 Chugai Pharmaceutical Co., Ltd. reported that has revised the full-year financial forecasts for the fiscal year ending December 2021 announced on February 4, 2021, considering the recent trend of business results, as follows (Press release, Chugai, OCT 22, 2021, View Source [SID1234591869]).

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1. Revised consolidated financial forecasts for the full fiscal year ending December 2021 (January 1 to December 31, 2021)

2. Reasons for the revisions
Forecast of Revenues has been revised to ¥970.0 billion, an increase of ¥170.0 billion from the previous forecast. For domestic sales, forecasted sales amount attributable to the supply of Ronapreve to the government for the fiscal year has been included, and the progress and revised assumptions for each product including Avastin and Tecentriq, which have progressed better than the previous forecast have been reflected. For overseas sales, exports of Actemra and Hemlibra to Roche have been forecasted to be higher than the previous forecast. For royalties and other operating income, the forecast of income and one-time income for Actemra and Hemlibra has also been updated.

Core operating profit forecast has also been revised to ¥400.0 billion, an increase of ¥80.0 billion from the previous forecast. In addition to the above-mentioned revision of revenue forecast, higher cost to sales ratio due to a change in the product mix from the original assumption, etc., foreign exchange effects and increases in some expenses attributable to increased sales and profits have been included.

Core EPS is forecasted to be ¥178.00, an increase of ¥37.00 from the previous forecast. Year-end dividend forecast and the forecast for the Core dividend payout ratio have not been determined at this time.

The revised full-year consolidated forecasts are based on updated foreign exchange rate assumptions: 1CHF = 117 JPY, 1EUR = 130 JPY, 1USD = 107 JPY, and 1SGD = 81 JPY.