Medtronic Announces Pricing of €5 Billion of Senior Notes

On June 25, 2019 Medtronic plc (NYSE:MDT) reported that its wholly-owned subsidiary, Medtronic Global Holdings S.C.A. ("Medtronic Luxco"), has priced an offering (the "Offering") of €250,000,000 principal amount of floating rate senior notes due 2021, €750,000,000 principal amount of 0.00% senior notes due 2022, €1,000,000,000 principal amount of 0.25% senior notes due 2025, €1,000,000,000 principal amount of 1.00% senior notes due 2031, €1,000,000,000 principal amount of 1.50% senior notes due 2039, and €1,000,000,000 principal amount of 1.75% senior notes due 2049(collectively, the "Notes") (Press release, Medtronic, JUN 25, 2019, View Source;p=RssLanding&cat=news&id=2402331 [SID1234537264]).The floating rate senior notes due 2021 are further issuances of, fully fungible with, rank equally in right of payment with and form a single series with the €500,000,000 principal amount of floating rate senior notes due 2021 initially issued by Medtronic Luxco on March 7, 2019. All of Medtronic Luxco’s obligations under the Notes will be fully and unconditionally guaranteed by Medtronic plc (the "Company") and Medtronic, Inc., a wholly-owned indirect subsidiary of Medtronic Luxco, on a senior unsecured basis.

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The net proceeds of the Offering will be used to fund the previously announced cash tender offers (the "Tender Offers") for several series of outstanding notes issued by Medtronic, Inc., Medtronic Luxco and Covidien International Finance S.A., a wholly-owned indirect subsidiary of the Company, and to pay accrued and unpaid interest, premiums, fees and expenses in connection with the Tenders Offers. Any remaining net proceeds of the Offering will be used for repayment of other indebtedness and general corporate purposes. The Offering is expected to close on July 2, 2019, subject to customary closing conditions. The joint book-running managers for the Offering are Barclays Bank PLC, Goldman Sachs & Co. LLC and Merrill Lynch International.

The Offering is being made only by means of a prospectus dated February 3, 2017 and prospectus supplement (together, the "Prospectus"). You may get these documents for free by visiting EDGAR on the Securities and Exchange Commission website at www.sec.gov. Alternatively, copies of the Prospectus for the Offering may be obtained by contacting Barclays Bank PLC, toll free at +1-888-603-5847, Goldman Sachs & Co. LLC, toll-free at +1-866-471-2526 and Merrill Lynch International, toll-free at +1-800-294-1322.

Celldex Therapeutics Appoints Diane C. Young, M.D. as Senior Vice President, Chief Medical Officer

On June 24, 2019 Celldex Therapeutics, Inc. (NASDAQ:CLDX) reported the appointment of Diane C. Young, M.D., as Senior Vice President, Chief Medical Officer, effective July 8, 2019 (Press release, Celldex Therapeutics, JUN 24, 2019, View Source [SID1234537232]). Over the span of a 30 year career, Dr. Young, a medical oncologist, has led clinical and cross-functional research and development teams responsible for the global development of numerous novel therapies from Phase 1 through successful product registrations.

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"Dr. Young’s notable career and strong track record of successful drug development make her an important addition to Celldex," said Anthony Marucci, Co-founder, President and Chief Executive Officer of Celldex Therapeutics. "Her proven leadership will strengthen our clinical development efforts and support the continued progress of our product pipeline."

"I look forward to working with the Celldex team to advance a novel pipeline that I believe holds significant opportunity for patients and their families," said Dr. Young. "Celldex’s scientific vision and emerging data from the CDX-3379 and CDX-1140 programs make this an exciting time to be joining the organization, and I look forward to helping to advance these compounds and earlier stage candidates to their full potential."

Dr. Young most recently served as the Chief Medical Officer of GTx, Inc., a public biopharmaceutical company focused on developing small molecules that target nuclear hormone receptors. Previously, she spent 13 years at Novartis Oncology in senior leadership roles in global clinical development and medical affairs. As the Head of Oncology Clinical Development, she directed the clinical programs leading to successful regulatory approvals for EXJADE, GLIVEC, FEMARA, AFINITOR, RYDAPT, JAKAVI and FARIDAK among others. Prior to Novartis, Diane held senior leadership positions in clinical development at the R.W. Johnson Pharmaceutical Research Institute of Johnson & Johnson, Hoffman-La Roche and Sandoz.

Dr. Young received her A.B. in Biochemical Sciences at Harvard University and her M.D. from Harvard Medical School. Her postdoctoral training included an Internal Medicine Residency at Johns Hopkins Hospital and Vanderbilt Hospital, followed by an Oncology Fellowship at the Dana-Farber Cancer Institute. She is board certified in Internal Medicine and Medical Oncology.

Exjade, Glivec, Femara, Afinitor, Rydapt, Jakavi and Faridak are registered trademarks of Novartis.

Oncology Venture gets European patent on its AI powered method to find patients who will benefit from LiPlaCis

On June 24, 2019 Oncology Venture A/S (Nasdaq First North Stockholm: OV.ST) reported that the European Patent Office will grant Oncology Venture a patent on the LiPlaCis Drug Response Prediction (DRP) (Press release, Oncology Venture, JUN 24, 2019, View Source [SID1234537233]). The LiPlaCis DRP covers 205 genes and predicts the response in individual patients to the anti-cancer drug LiPlaCis based on a pre-treatment biopsy.

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LiPlaCis is an intelligent, target controlled liposome formulation of one of the world’s most widely used chemotherapies, cisplatin. The specific LiPlaCis formulation allows delivery of LiPlaCis directly at the tumor site. Oncology Venture’s drug specific diagnostic tool DRP selects the patients who are expected to benefit from the treatment. LiPlaCis is showing strong results in an ongoing Phase 2 study in patients with metastatic breast cancer.

The patent from the European Patent Office provides key intellectual property protection in Europe.

"The patent approval is an important value driver in the development of LiPlaCis, since our AI powered DRP technology is instrumental for the strong results we have seen so far in the ongoing Phase 2 study. Together with the well-defined regulatory route towards marketing approval, as announced earlier this month, the new patent provides us with an exceptionally solid platform for the ongoing partnering process", says Peter Buhl Jensen, M.D., CEO of Oncology Venture.

For further information, please contact:

For investor inquiries
Ulla Hald Buhl, IR & Communications
E-mail: [email protected]
Telephone +45 21 70 10 49

For media inquiries
Thomas Pedersen, Carrotize PR & Communications
E-mail: [email protected]
Telephone +45 60 62 93 90

About the Drug Response Predictor – DRP Companion Diagnostic
Oncology Venture uses its multi gene DRP to select those patients who by the genetic signature of their cancer are found to have a high likelihood of responding to the drug. The goal is developing the drug for the right patients, and by screening patients before treatment the response rate can be significantly increased. The DRP method builds on the comparison of sensitive vs. resistant human cancer cell lines, including genomic information from cell lines combined with clinical tumor biology and clinical correlates in a systems biology network. DRP is based on messenger RNA from the patient’s biopsies.
DRP has proven its ability to provide a statistically significant prediction of the clinical outcome from drug treatment in cancer patients in 29 out of 37 clinical studies that were examined and is currently demonstrating promising results in an ongoing phase 2 study prospectively using LiPlaCis and its DRP to track, match and treat patients with metastatic breast cancer.
The DRP platform, i.e. the DRP and the PRP tools, can be used in all cancer types and is patented for more than 70 anti-cancer drugs in the US. The PRP is used by Oncology Venture for Personalized Medicine. The DRP is used by Oncology Venture for drug development.

Avid Bioservices to Report Financial Results for Quarter and Fiscal Year Ended April 30, 2019 After Market Close on June 27, 2019

On June 24, 2019 Avid Bioservices, Inc. (NASDAQ:CDMO) (NASDAQ:CDMOP), a dedicated contract development and manufacturing organization (CDMO) working to improve patient lives by providing high quality development and manufacturing services to biotechnology and pharmaceutical companies, reported that it will report financial results for the quarter and fiscal year (FY) ended April 30, 2019 on June 27, 2019 after market close and will host a conference call and webcast at 1:30 PM Pacific Time (4:30 PM Eastern Time) (Press release, Avid Bioservices, JUN 24, 2019, View Source [SID1234539008]). Members of Avid’s senior management will discuss financial results for the quarter and FY ended April 30, 2019 and review recent corporate developments.

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To listen to the live webcast, or access the archived webcast, please visit: View Source

To listen to the conference call, please dial (877) 312-5443 or (253) 237-1126 and request the Avid Bioservices call.

Anwita entered collaboration with Junshi Biosciences, Co Ltd.

On 24 June 2019, Junshi Biosciences reported that they entered into a stock purchase agreement with Anwita Biosciences,Inc. ("Anwita"), pursuant to which the Company agreed to subscribe for 2,990,162 Series APreferred Stock in Anwita, representing approximately 20% of its outstanding shares, at a cashconsideration of US$10,000,000 (Press release, Anwita Biosciences, JUN 24, 2019, View Source [SID1234573150]). Anwita is a company headquartered in San Francisco Bay Area,focused on innovative protein engineering to generate best-in-class cytokines for immuno-oncology(IO).

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The Company and Anwita also entered into a license agreement (the "License Agreement") on 24June 2019 for the Company to develop and commercialize Anwita’s AWT008, a novel IL-21 fusionprotein, in the greater China territories (including mainland China, Taiwan, Macau, and HongKong). In consideration of the grant of the license by Anwita, the Company agreed to pay Anwitaan aggregate of US$2 million in cash after execution of the License Agreement and completionof technology transfer of AWT008. Also under the License Agreement, if AWT008 fulfills therequirement for IND filing, the Company may approve to proceed to file the IND and to conductsubsequent clinical trials to get regulatory approval for its commercial sales. In such event, Anwitawill be eligible to receive up to US$64.5 million in aggregate in development milestones for theAWT008 program.

IL-21 is an active cytokine to stimulate the activation of innate and adaptive immune cells, suchas natural killer (NK) cells and cytotoxic T cells. AWT008 is Anwita’s proprietary IL-21 fusionprotein with a prolonged half-life and improved in vivo antitumor activities in animal models, andis intended for development as single agent or in combination with other therapeutic agents due toits proposed mechanism.

This foreign investment needs to be approved or filed by the Commission of Commerce, theNational Development and Reform Commission and other government departments. The Companywill actively handle the approval or filing procedures of the Commission of Commerce, theNational Development and Reform Commission and other government departments involved in thisforeign investment. However, there are still certain uncertainties as to whether such approval orfiling can be ultimately obtained.

Cautionary Statement required by Rule 18A.05 of the Listing Rules of the Stock Exchange:The Company may not be able to ultimately develop and market AWT008 successfully. Investorsare reminded to exercise caution.