Iovance Biotherapeutics, Inc., Corporate Presentation – July 2019

On July 2, 2019, Iovance Biotherapeutics, Inc. (the "Company") presented its corporate presentation (Presentation, Iovance Biotherapeutics, JUL 2, 2019, View Source [SID1234537373]).

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Iovance Biotherapeutics Provides Cervical Cancer Program Updates Following End of Phase 2 Meeting with U.S. Food and Drug Administration (FDA)

On July 2, 2019 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a late-stage biotechnology company developing novel cancer immunotherapies based on tumor-infiltrating lymphocyte (TIL) technology, reported an update on the regulatory path for LN-145 in advanced cervical cancer (Press release, Iovance Biotherapeutics, JUL 2, 2019, View Source;p=RssLanding&cat=news&id=2402832 [SID1234537358]). Based on an End of Phase 2 meeting held with the U.S. Food and Drug Administration (FDA), the FDA has acknowledged that the ongoing innovaTIL-04 study of TIL therapy LN-145 may be sufficient to support registration in the treatment of patients with advanced cervical cancer. The study is being enrolled with a prospective definition of objective response rate (ORR) read out by a Blinded Independent Review Committee (BIRC) as the primary endpoint. In accordance with the FDA’s recommendation, the new version of the protocol will further define the patient population. Iovance plans to include in the Biologics License Application (BLA), patients who have progressed following initial systemic therapy for recurrent or metastatic disease, which constitutes almost all of the more advanced patients enrolled to date. In addition, the company announced that the innovaTIL-04 study is expected to enroll a total of 75 to 100 patients in order to support a BLA submission.

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"The FDA’s agreement to consider acceptability of the ongoing study in patients with cervical cancer significantly accelerates our path to BLA submission for LN-145," said Maria Fardis, Ph.D., president and chief executive officer of Iovance Biotherapeutics. "This feedback is encouraging. The ability to use the current study, as well as the Breakthrough Therapy designation recently granted to LN-145, allows us to plan on a path to BLA submission in the second half of 2020."

Varian to Expand Interventional Oncology Portfolio with Purchase of Embolic Bead Assets

On July 1, 2019 Varian (NYSE: VAR) reported it has signed an asset purchase agreement to acquire the Boston Scientific portfolio of drug-loadable microsphere and bland embolic bead products for treating arteriovenous malformations and hypervascular tumors (Press release, Varian Medical Systems, JUL 1, 2019, View Source [SID1234537374]). When completed, this acquisition, in combination with the recent acquisitions of Endocare and Alicon, will expand Varian’s portfolio of multidisciplinary integrated cancer care solutions.

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Varian’s planned acquisition of the Boston Scientific portfolio of drug-loadable microsphere (Oncozene/Embozene Tandem) and bland embolic (Embozene) bead products will enable Varian to extend its new interventional oncology platform, and the Company will benefit from the products’ regulatory clearances in more than 35 countries worldwide.

"This acquisition from Boston Scientific will strengthen Varian’s growing position in the high-value interventional oncology segment and is consistent with our long-term strategy to become a global leader in multidisciplinary, integrated cancer solutions," said Dow Wilson, president and chief executive officer of Varian. "We look forward to completing this acquisition and are excited to add these drug-loadable microsphere and bland embolic bead products to our portfolio to provide our clinical partners with expanded advanced treatment options."

Varian will not acquire any of the Boston Scientific operations. While Varian implements a plan to manufacture and distribute these products, it will work with Boston Scientific under transition services agreements to ensure uninterrupted delivery to customers.

Transaction and Financial Details

Varian is financing the purchase price of $90 million using cash and proceeds from borrowings. The transaction, which is expected to close around August 2019, is subject to the satisfaction or waiver of customary closing conditions, including approval of the U.S. Federal Trade Commission and the closing of the proposed acquisition of BTG PLC by Boston Scientific Corporation.

The combined assets generated revenue of $21.2 million in calendar 2018. Varian expects this transaction to have an immaterial impact on fiscal year 2019 financial results, and the assets to be accretive to GAAP and Non-GAAP earnings per share in fiscal 2020.

Varian has provided more information regarding this asset purchase on its investor relations website by updating the presentation regarding its recent acquisitions in interventional oncology. To view the presentation, visit www.varian.com/investors.

Incyte and Zai Lab Announce Collaboration and License Agreement for INCMGA0012 in Greater China

On July 2, 2019 Incyte (NASDAQ:INCY) and Zai Lab Ltd. (NASDAQ:ZLAB) reported that the companies have entered into a collaboration and license agreement for the development and commercialization of INCMGA0012, an investigational anti-PD-1 monoclonal antibody, in Greater China (Press release, Incyte, JUL 2, 2019, View Source [SID1234537359]).

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This press release features multimedia. View the full release here: View Source

Under the terms of the agreement, Zai Lab will pay Incyte US$17.5 million up front, and Incyte is eligible to receive up to an additional US$60 million in potential development, regulatory and commercial milestones, as well as tiered royalties from the low to mid-twenties, with Incyte responsible for all royalties and pass-through payments to its licensing partner, MacroGenics, Inc.Zai Lab will receive the rights to develop and exclusively commercialize INCMGA0012 in hematology and oncology in mainland China, Hong Kong, Macau and Taiwan. Incyte will retain an option to assist in the promotion of INCMGA0012 in Zai Lab’s licensed territories.

"The collaboration with Zai Lab further allows us to expand our potential to bring new medicines to patients with cancer around the world," said Hervé Hoppenot, Chief Executive Officer, Incyte. "We believe Zai Lab’s experienced team will be an important strategic partner in helping to support the expansion of our research and development efforts for INCMGA0012, and if approved, provide access to an important new therapy to patients and healthcare providers in Greater China." 

"Incyte is a leading biopharmaceutical company with a world class team. We are excited to enter into this partnership with Incyte for INCMGA0012, and we look forward to working together with them to conduct more global studies and bringing this important medicine to patients in Greater China," said Dr. Samantha Du, Founder and Chief Executive Officer of Zai Lab. "Anti-PD-1 therapies have become the backbone to many current and future immuno-oncology therapies. We believe the addition of a competitive anti-PD-1 like INCMGA0012 is critical to executing on Zai Lab’s long-term strategy and unlocking the full potential of our pipeline. We intend to rapidly explore the potential of INCMGA0012 as both monotherapy and combination therapy with several of our existing pipeline products."

The transaction is effective immediately upon the execution of the collaboration and license agreement.

About INCMGA0012

INCMGA0012 is an investigational monoclonal antibody that inhibits PD-1. INCMGA0012 is currently being evaluated as monotherapy in registration-directed trials for patients with MSI-high endometrial cancer, Merkel cell carcinoma and anal cancer.

In 2017, Incyte entered into an exclusive global collaboration and license agreement with MacroGenics, Inc. for global rights to INCMGA0012.

Medtronic Announces Closing of Public Offering of €5 Billion of Senior Notes

On July 2, 2019 Medtronic plc (the "Company") (NYSE:MDT) reported that its wholly-owned subsidiary Medtronic Global Holdings S.C.A. ("Medtronic Luxco") has closed a registered public 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, JUL 2, 2019, View Source;p=RssLanding&cat=news&id=2402852 [SID1234537360]). 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 are fully and unconditionally guaranteed by the Company and Medtronic, Inc. ("Medtronic, Inc."), a wholly-owned indirect subsidiary of Medtronic Luxco, on a senior unsecured basis.

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The net proceeds from the Offering will be approximately €4.9 billion, after deducting estimated underwriting discounts and commissions and expenses related to the Offering payable by Medtronic Luxco. 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 (the "Tender Offer Notes") issued by Medtronic, Inc., Medtronic Luxco and Covidien International Finance S.A. ("CIFSA"), a wholly-owned indirect subsidiary of Medtronic plc (collectively with Medtronic, Inc. and Medtronic Luxco, the "Offerors"), and to pay accrued and unpaid interest, premiums, fees and expenses in connection with the Tender Offers. The Tenders Offers were subject to a financing condition, which condition was satisfied by the closing of the Offering. Any remaining net proceeds of the Offering will be used for repayment of other indebtedness and general corporate purposes.

Information Relating to the Offering

Barclays Bank PLC, Goldman Sachs & Co. LLC and Merrill Lynch International were the joint book-running managers for the Offering. The Offering was made by means of a prospectus and prospectus supplement, copies of which may be obtained for free by visiting EDGAR on the U.S. Securities and Exchange Commission website at www.sec.gov. Alternatively, copies of the prospectus and prospectus supplement 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 or Merrill Lynch International, toll-free at +1-800-294-1322.

Information Relating to the Tender Offers

Barclays Capital Inc., BofA Merrill Lynch and Goldman Sachs & Co. LLC are acting as the dealer managers (the "Dealer Managers") for the Tender Offers. The information agent and tender agent is Global Bondholder Services Corporation ("Global Bondholder"). Copies of the Offer to Purchase and related offering materials are available by contacting Global Bondholder at +1-866-470-4200 (U.S. toll-free) or +1-212-430-3774 (banks and brokers). Questions regarding the Tender Offers should be directed to Barclays Capital Inc., Liability Management Group at +1-212-528-7581 (collect) or +1-800-438-3242 (toll-free), BofA Merrill Lynch, Liability Management Group, at +1-980-387-3907 (collect) or +1-888-292-0070 (toll-free) or Goldman Sachs & Co. LLC, Liability Management Group, at +1-212-357-0215 (collect) or +1-800-828-3182 (toll-free).

None of the Offerors, the Company or their affiliates, their respective boards of directors or managing members, the Dealer Managers, Global Bondholder or the trustee with respect to any series of Tender Offer Notes is making any recommendation as to whether holders of Tender Offer Notes ("Holders") should tender any Tender Offer Notes in response to any of the Tender Offers, and neither the Offerors nor any such other person has authorized any person to make any such recommendation. Holders must make their own decision as to whether to tender any of their Tender Offer Notes, and, if so, the principal amount of Tender Offer Notes to tender.

This press release shall not constitute an offer to sell, a solicitation to buy or an offer to purchase or sell any securities. The Tender Offers are being made only pursuant to the Offer to Purchase and only in such jurisdictions as is permitted under applicable law.

The full details of the Tender Offers, including complete instructions on how to tender Tender Offer Notes, are included in the Offer to Purchase. The Offer to Purchase contains important information that should be read by Holders of Tender Offer Notes before making a decision to tender any Tender Offer Notes. The Offer to Purchase may be downloaded from Global Bondholder’s website at View Source or obtained from Global Bondholder, free of charge, by calling toll-free at +1-866-470-4200 (bankers and brokers can call collect at +1-212-430-3774).