Organon Announces Proposed Senior Notes Offering

On April 6, 2021 Merck (NYSE: MRK), known as MSD outside the United States and Canada, reported that Organon Finance 1 LLC plans to offer, subject to market conditions, euro-denominated senior secured notes due 2028, U.S. dollar-denominated senior secured notes due 2028 and U.S. dollar-denominated senior unsecured notes due 2031 (collectively, the "notes"), in connection with the previously announced spinoff of Organon & Co. ("Organon") from Merck (Press release, Merck & Co, APR 6, 2021, View Source [SID1234577617]). As part of the spinoff, the notes will be assumed by Organon and a Dutch private limited company and wholly owned subsidiary of Organon which will act as co-issuer of the notes.

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Organon intends to use the net proceeds from the notes offering, together with available cash on its balance sheet and borrowings under senior secured credit facilities which Organon anticipates entering into, to repay one or more intercompany loans or notes owed by Organon to a Merck affiliate and to pay fees and expenses related to the spinoff. The proceeds of the notes offering will be held in escrow until satisfaction of the conditions precedent to the spinoff and certain other escrow release conditions.

The notes have not been and will not be registered under the U.S. Securities Act of 1933, as amended (the "Securities Act"), any state securities laws or the securities laws of any other jurisdiction, and may not be offered or sold in the United States absent registration or an applicable exemption from registration. Accordingly, the notes are being offered and sold only to persons reasonably believed to be qualified institutional buyers in accordance with Rule 144A under the Securities Act and to non-U.S. persons outside the United States in reliance on Regulation S under the Securities Act.

This announcement is an advertisement and is not a prospectus for the purposes of Regulation (EU) 2017/1129 (as amended, the "Prospectus Regulation") or Regulation (EU) 2017/1129 as it forms part of domestic law by virtue of the European Union (Withdrawal) Act 2018 (the "UK Prospectus Regulation").

In member states of the European Economic Area, this announcement is directed only at persons who are "qualified investors" within the meaning of the Prospectus Regulation. In the United Kingdom, this announcement is directed only at persons who are "qualified investors" within the meaning of the UK Prospectus Regulation.

Manufacturer target market (MiFID II product governance / UK MiFIR product governance) is eligible counterparties and professional clients only (all distribution channels). No PRIIPs key information document has been prepared as not available to retail in the EEA. No UK PRIIPs key information document has been prepared as not available to retail in the UK.

In the United Kingdom, this announcement is directed only at persons (i) that have professional experience in matters relating to investments falling within Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005, as amended (the "Order"); (ii) falling within Article 49(2)(a) to (d) ("high net worth companies, unincorporated associations etc.") of the Order; or (iii) at whom this announcement may otherwise be directed without contravention of Section 21 of the Financial Services and Markets Act 2000, as amended (all such persons together being referred to as "relevant persons"). This announcement must not be acted on or relied on by persons who are not relevant persons. Any investment or investment activity to which this announcement relates is available only to relevant persons and will be engaged in only with relevant persons.

This press release does not constitute an offer to sell, or the solicitation of an offer to buy, any security and shall not constitute an offer, solicitation or sale in any jurisdiction in which such offer, solicitation or sale would be unlawful.

Regeneron to Report First Quarter 2021 Financial and Operating Results and Host Conference Call and Webcast on May 6, 2021

On April 6, 2021 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported that it will report its first quarter 2021 financial and operating results on Thursday, May 6, 2021, before the U.S. financial markets open (Press release, Regeneron, APR 6, 2021, View Source [SID1234577616]). The Company will host a conference call and simultaneous webcast at 8:30 AM Eastern Time that day.

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Conference Call Information
To access this call, dial (888) 660-6127 (U.S.) or (973) 890-8355 (International), conference ID 7794757. A link to the webcast may be accessed from the ‘Investors and Media’ page of Regeneron’s website at View Source A replay of the conference call and webcast will be archived on the Company’s website for at least 30 days.

Bio-Techne Completes Acquisition of Asuragen, Inc.

On April 6, 2021 Bio-Techne Corporation (NASDAQ: TECH) reported it has completed the acquisition of Asuragen, Inc. The transaction included initial consideration of $215 million in cash plus contingent consideration of up to $105 million upon the achievement of certain future milestones (Press release, Bio-Techne, APR 6, 2021, View Source [SID1234577614]). The Asuragen acquisition adds a leading portfolio of best-in-class molecular diagnostic and research products, including genetic screening and oncology testing kits, molecular controls, a Good Manufacturing Practice (GMP)-compliant 50,000 square foot manufacturing facility and a CLIA-certified laboratory, plus a team with deep expertise navigating products through the global diagnostic regulatory environment. Bio-Techne sees multiple growth synergies as a result of this acquisition, including capabilities in productizing lab-developed tests and commercializing innovative molecular products for broader market adoption. Bio-Techne also gains an attractive pipeline of expanded carrier screening panels for various pathologies recognized by The American College of Obstetricians and Gynecologists (ACOG) as areas of concern for prospective new parents. Following this acquisition, Bio-Techne now has a global workforce of more than 2,400 team members.

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Lilly Confirms Date and Conference Call for First-Quarter 2021 Financial Results Announcement

On April 6, 2021 Eli Lilly and Company (NYSE: LLY) reported its first-quarter 2021 financial results on Tuesday, April 27, 2021 (Press release, Eli Lilly, APR 6, 2021, View Source [SID1234577613]). Lilly will also conduct a conference call on that day with the investment community and media to further detail the company’s financial performance.

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The conference call will begin at 9 a.m. Eastern time. Investors, media and the general public can access a live webcast of the conference call through a link that will be posted on Lilly’s website at View Source A replay will also be available on the website following the conference call.

HUYABIO International Submits HBI-8000 Monotherapy for Peripheral T-cell Lymphoma for Regulatory Approval in Japan

On April 6, 2021 HUYABIO International (HUYABIO), the leader in accelerating global development of China’s pharmaceutical innovations, reported the submission of a regulatory application to the Japanese Pharmaceuticals and Medical Devices Agency for HBI-8000 monotherapy for relapsed or refractory (R/R) peripheral T-cell lymphoma (PTCL) (Press release, HUYA Bioscience, APR 6, 2021, View Source [SID1234577612]).

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"R/R PTCL carries a poor prognosis. The benefit of chemotherapy diminishes with each subsequent relapse. Data from the Phase 2 study of HBI-8000 has demonstrated meaningful tumor response and progression-free duration despite the advanced stage of disease, to address an important unmet medical need in this patient population ", said Dr. Kensei Tobinai, visiting scientist of the National Cancer Center Hospital in Japan and medical expert of HBI-8000 Phase 2 study.

The new drug application is based on data from a Phase 2b study of 55 patients with aggressive PTCL in Japan. These patients all had advanced disease, refractory or relapsed relative to prior therapies. HBI-8000 40mg orally administered twice weekly resulted in disease response in a clinically meaningful proportion of patients with an acceptable safety profile.

Dr. Mireille Gillings, CEO & Executive Chair of HUYABIO said, "This is an important Public Health contribution as R/R PTCL patients will have an effective treatment alternative. It is our second regulatory submission for drug approval in Japan in 6 months and we continue to work hard to benefit patients with difficult to treat diseases."

About HBI-8000

HBI-8000 is an epigenetic immunomodulator approved for the treatment of lymphoma and metastatic breast cancer in China. This oral agent targets class I histone deacetylase (HDAC) enzymes to induce cell cycle arrest, suppress the expression of a number of oncogenes and modulate the of acetylation of PD-L1 to enhance the activity of immune checkpoint inhibitors. The drug also has immunomodulatory impact by increasing the efficacy of checkpoint inhibitors in preclinical animal models.