Chugai and Welby Launch a Treatment Support Personal Health Record Service for Cancer Patients to Promote Proper Use of Tecentriq

On October 19, 2020 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) and Welby Inc. reported that they launched a patient support program to promote proper use of Tecentriq, an immune checkpoint inhibitor marketed by Chugai (Press release, Chugai, OCT 19, 2020, View Source [SID1234568637]).. The program is based on "Welby MyKarte ONC," (hereafter, MyKarte ONC), a free personal health record (PHR) service by Welby to support treatment for cancer patients.

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MyKarte ONC is a PHR service to support cancer patients and healthcare professionals. Patients can easily enter and access data on their daily symptoms and treatment status to centrally manage such information. Also, the program provides optimized information according to cancer types and symptoms based on the patient’s record. The PHR service aims at achieving better treatment outcome through these functions which will help patients deepen understanding of the treatment and assist healthcare professionals to see changes in patients’ conditions (including adverse reactions and worsening of symptoms) sooner.

With the use of MyKarte ONC, Chugai started to offer the patient support program as described below, starting from October 2020. The objective of the program is to promote proper use of Tecentriq in patients with breast cancer receiving therapy with Tecentriq. The safety profile of Tecentriq, including development of immune-related adverse events (irAE), is different from that of the conventional chemotherapies. Our key challenge, therefore, is the prevention of severe irAE by early detection and management. MyKarte ONC is a platform-based PHR service that can be used regardless of cancer types and medications. It provides proper information based on an individual patient’s health information recorded by the patient. The service will become available for lung and liver cancers in due course so that more patients can receive proper treatment with Tecentriq utilizing the unique advantage of the PHR service.

1) Self-check functions: Patients on treatment with Tecentriq can self-monitor if they have symptoms related to irAE which requires attention by using self-check functions offered by MyKarte ONC. If severe symptoms (according to PRO-CTCAE*) are recorded, a message will be displayed to urge the patient to contact a medical institution for telephone counseling, etc. In addition, the patient can report his/her conditions to the physician with the severity based on PRO-CTCAE. By performing the self-check on a regular basis, patients can raise their awareness of important adverse reactions and deepen their understanding of the disease.

* Patient-Reported Outcome Common Terminology Criteria for Adverse Events

2) Information service functions: For the patients who have selected "Tecentriq/breast cancer" as a drug they currently use when upon registration for MyKarte ONC, the information page on Tecentriq provided by Chugai will be displayed. The seamless access to the information page via MyKarte ONC will increase convenience in gaining information. Comments are also displayed according to the state of entries, which enables patients to further understand their treatments.

Image (Japanese only)

Reference: Introduction page for patients of "Welby MyKarte ONC" View Source (Japanese only)

"Under CHUGAI DIGITAL VISION 2030, we aim to transform our business by using digital technologies to make Chugai a top innovator in the provision of society-changing healthcare solutions. To achieve this goal, the Value Delivery functions of Chugai consisted of Drug Safety Division, Marketing & Sales Division, and Medical Affairs Division will collaborate to broaden the use of the PHR service," said Satoko Shisai, Chugai’s Vice President, Head of Digital & IT Supervisory Division. "COVID-19 has brought rapid changes in our lifestyle. Similarly, the communication between patients and healthcare professionals will shift to contactless communication, including online clinical practice. Through this PHR service, patients can routinely record their daily status and share necessary information with healthcare professionals even under the situation where face-to-face communication is limited. In addition, it will contribute to realization of patient-centric healthcare by supporting patients to understand their treatments and proactively engage in their own treatment. Chugai will approach various needs in clinical settings by means of digital technologies, and continue to make efforts to realize patient-centric healthcare."

Takeru Hiki, Representative Director of Welby, commented, "Welby launched MyKarte ONC service in February 2020 as a PHR platform to help patients on cancer therapies monitor symptoms to be noted according to their conditions and treatments, as well as access necessary information. It has already been introduced to multiple key partner hospitals for cancer treatment and used by many patients. A range of pharmaceutical companies and their affiliates are participating in MyKarte ONC as a PHR platform to support cancer patients and healthcare professionals, which covers treatments of multiple cancer types. Chugai understood the concept ahead, which resulted in the release of MyKarte ONC to patients with breast cancer as a patient support program. Welby will cooperate with Chugai to further improve MyKarte ONC to popularize PHR among patients."

Trademarks used or mentioned in this release are protected by law.

Constellation Pharmaceuticals to Host Conference Call to Discuss Third Quarter 2020 Results

On October 19, 2020 Constellation Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company using its expertise in epigenetics to discover and develop novel therapeutics, will host a conference call at 8:00 AM EDT on October 29, 2020, to discuss its third quarter 2020 results and progress in its clinical programs (Press release, Constellation Pharmaceuticals, OCT 19, 2020, https://ir.constellationpharma.com/news-releases/news-release-details/constellation-pharmaceuticals-host-conference-call-discuss-third [SID1234568636]). The event will be webcast live and can be accessed on the Investor Relations section of Constellation’s website at View Source To participate in the live question-and-answer session, please dial (877) 473-2077 (domestic) or (661) 378-9662 (international) and refer to conference ID 7374769.

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TARGOVAX ASA – APPROVAL AND PUBLICATION OF PROSPECTUS

On October 19, 2020 Targovax ASA (OSE:TRVX) ("Targovax" or the "Company"), a clinical stage biotechnology company developing oncolytic viruses to target hard-to-treat solid tumors, on 14 October 2020 regarding the successfully completed private placement of new shares in the Company, reported that it raising gross proceeds of approximately NOK 75 million (the "Private Placement") (Press release, Targovax, OCT 19, 2020, View Source [SID1234568635]).

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Approved prospectus and publication:

The Financial Supervisory Authority of Norway (Nw.: Finanstilsynet) has today, on 19 October 2020, approved a prospectus prepared by the Company in connection with the listing on the Oslo Stock Exchange of the 10,344,828 new shares pertaining to the Private Placement (the "Private Placement Shares"), which comprises a registration document, a securities note and a summary (jointly, the "Prospectus").

Subject to applicable local securities law, the Prospectus will be made available at the website of the Company (www.targovax.no) no later than at 08:00 (CEST) tomorrow, on 20 October 2020.

The private placement shares:

The share capital increase pertaining to the Private Placement Shares is expected to be registered with the Norwegian Register of Business Enterprises on or about 21 October 2020, and the Private Placement Shares are expected to be listed and tradable on the Oslo Stock Exchange later on the same date.

Recombinetics to Partner with American Preclinical Services to Improve Glioblastoma Outcomes

On October 19, 2020 Recombinetics Inc., a leading gene editing company with platform technology applied to biomedicine and animal agriculture, reported that it has partnered with American Preclinical Services in a first of its kind study to improve Glioblastoma outcomes (Press release, Recombinetics, OCT 19, 2020, View Source [SID1234568633]).

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Surrogen, a subsidiary of Recombinetics Inc., is focused on developing large animal models of human disease for use in medical research. In September, Surrogen displayed the world’s first genetically engineered large animal model of Glioblastoma, which develops in a predictable and reproducible timeframe. This important scientific advancement was achieved through somatic cell gene editing to engineer the precise genetic changes seen in human tumors.

Glioblastoma, or GBM, is a devastating disease which results in a cancerous tumor that develops in the brain. GBM is the most common and aggressive of all brain tumors, with few effective treatment options available, and a five-year survival rate of less than 5%.

One of the most significant challenges for the development of new therapies or treatments is the lack of reliable and reproducible animal models of the disease for use in pre-clinical studies. With this breakthrough, that is no longer the case. This technology presents a unique opportunity to impact the lives of those diagnosed with Glioblastoma and to give families hope.

According to Dr. Adrienne Watson, Recombinetics’ Vice President of Research and Development, "This new model of glioblastoma gives us the opportunity to better understand this disease and improve patient outcomes by identifying tumor biomarkers, developing new surgical and imaging technologies, and most importantly, creating new therapeutic techniques to treat these tumors."

"The goal is to improve the therapeutic development landscape by being able to reproduce the effects of therapies effective in animals, in human patients, as well as improve dose selection prior to entering clinical trials. Overall, the technology may speed up the process of bringing viable therapies to market," says CEO, Mark Platt.

"One of the most difficult tasks in preclinical research today is developing models of human disease in animals that can then be dependably used to test the effectiveness of novel methods for treatment. These new large-animal disease models will introduce a new paradigm for evaluating new medical devices, new surgical techniques, new drugs or drug delivery systems with substantially higher degree of translatability to clinical outcomes. These models have the potential to reduce both the development times for new therapies and the risk of failure of a new modality in very expensive clinical trials," states Jim Pomonis, CSO, American Preclinical Services.

AbbVie Announces Commencement of Registered Exchange Offers

On October 19, 2020 AbbVie reported the commencement of its offers to exchange (the "Registered Exchange Offers") any and all of its outstanding (i) $30,000,000,000 aggregate principal amount of senior unsecured notes previously issued on November 21, 2019 (the "2019 USD Notes"), (ii) $13,251,781,000 aggregate principal amount of senior unsecured notes previously issued on May 14, 2020 (the "2020 USD Notes" and, together with the 2019 USD Notes, the "USD Notes") and (iii) €2,517,066,000 aggregate principal amount of senior unsecured notes previously issued on May 14, 2020 (the "Euro Notes" and, together with the USD Notes, the "Original Notes"), each issued pursuant to an exemption from the registration requirements of the Securities Act of 1933, as amended (the "Securities Act"), for an equal principal amount of new notes in a transaction registered under the Securities Act (the "Registered Notes") (Press release, AbbVie, OCT 19, 2020, View Source [SID1234568630]).

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The 2019 USD Notes were issued in a private offering to fund a portion of the aggregate cash consideration payable in connection with AbbVie’s acquisition of Allergan plc ("Allergan") and to pay related fees and expenses. The 2020 USD Notes and the Euro Notes were issued in a private offering upon the completion of AbbVie’s offers to exchange (the "prior exchange offers") any and all outstanding notes issued by certain of Allergan’s subsidiaries.

AbbVie is offering to issue the Registered Notes to satisfy its obligations under the registration rights agreement entered into with the initial purchasers of the 2019 USD Notes and the registration rights agreement entered into with the dealer managers for the prior exchange offers. The Registered Exchange Offers do not represent a new financing transaction.

The terms of the Registered Notes to be issued in the Registered Exchange Offers are substantially identical to the terms of the corresponding series of Original Notes, except that the offering of the Registered Notes will be registered under the Securities Act and the transfer restrictions, registration rights and additional interest provisions applicable to the Original Notes will not apply to the Registered Notes. AbbVie will issue the Registered Notes under the same indentures that govern the applicable series of Original Notes.

The following table sets forth the outstanding aggregate principal amount of each series of Original Notes. The Registered Exchange Offers consist of offers to exchange up to the entire aggregate principal amount of each series of Original Notes for an equal principal amount of the corresponding series of Registered Notes.

Title of Series of Original Notes

Amount
Outstanding

Senior Floating Rate Notes due May 2021

$750,000,000

Senior Floating Rate Notes due November 2021

$750,000,000

2.150% Senior Notes due 2021

$1,750,000,000

5.000% Senior Notes due 2021

$1,175,701,000

3.450% Senior Notes due 2022

$2,627,036,000

3.250% Senior Notes due 2022

$1,462,358,000

Senior Floating Rate Notes due 2022

$750,000,000

2.300% Senior Notes due 2022

$3,000,000,000

2.800% Senior Notes due 2023

$244,575,000

3.850% Senior Notes due 2024

$945,394,000

2.600% Senior Notes due 2024

$3,750,000,000

3.800% Senior Notes due 2025

$2,890,467,000

2.950% Senior Notes due 2026

$4,000,000,000

3.200% Senior Notes due 2029

$5,500,000,000

4.550% Senior Notes due 2035

$1,681,354,000

4.050% Senior Notes due 2039

$4,000,000,000

4.625% Senior Notes due 2042

$389,217,000

4.850% Senior Notes due 2044

$1,008,583,000

4.750% Senior Notes due 2045

$827,096,000

4.250% Senior Notes due 2049

$5,750,000,000

0.500% Senior Notes due 2021

€539,018,000

1.500% Senior Notes due 2023

€433,228,000

1.250% Senior Notes due 2024

€603,389,000

2.625% Senior Notes due 2028

€427,893,000

2.125% Senior Notes due 2029

€513,538,000

AbbVie will accept for exchange any and all Original Notes validly tendered and not validly withdrawn prior to 5:00 p.m., New York City time, on November 17, 2020 (as the same may be extended by AbbVie with respect to one or more series of Original Notes, the "Expiration Date"). Prior to the Expiration Date, tenders of Original Notes may be withdrawn according to the procedures described in the Prospectus (as defined below). Promptly after the Expiration Date, AbbVie will settle the Registered Exchange Offers by issuing Registered Notes pursuant to the terms of the Registered Exchange Offers.

A Registration Statement on Form S-4 (File No. 333-249277) (the "Registration Statement") relating to the Registered Exchange Offers was filed with the Securities and Exchange Commission on October 2, 2020 and was declared effective on October 16, 2020. The Registered Exchange Offers are being made pursuant to the terms and subject to the conditions set forth in a prospectus dated October 19, 2020 (as the same may be amended or supplemented, the "Prospectus"), which has been filed with the Securities and Exchange Commission and forms a part of the Registration Statement. The complete terms and conditions of the Registered Exchange Offers, including instructions regarding procedures for tendering Original Notes, are described in the Prospectus, the Registration Statement and related letter of transmittal, copies of which may be obtained by contacting (i) U.S Bank National Association, the exchange agent in connection with the Registered Exchange Offers for the USD Notes, at (800) 934-6802 or (ii) Elavon Financial Services DAC, the exchange agent in connection with the Registered Exchange Offers for the Euro Notes, at +44 (0) 207 330 2000.

This press release is not an offer to sell or exchange or a solicitation of an offer to buy or exchange any of the securities described herein. The Registered Exchange Offers are being made solely pursuant to the terms and conditions of the Prospectus, the Registration Statement, the related letter of transmittal and the other related materials.