Bob White Named Executive Vice President and President of Medtronic’s Minimally Invasive Therapies Group; Chris Lee to Assume Leadership of Medtronic’s Asia Pacific Region

On December 19, 2017 Medtronic plc (NYSE: MDT) reported that Bob White, previously Senior Vice President and President of Medtronic’s Asia Pacific (APAC) Region, has been named Executive Vice President and President of Medtronic’s Minimally Invasive Therapies Group (MITG) (Press release, Medtronic, DEC 19, 2017, View Source;p=RssLanding&cat=news&id=2323341 [SID1234522698]). In addition, the company announced that Chris Lee, Senior Vice President and President of Medtronic’s Greater China Region, will assume the position of APAC Region President. Lee will remain the Interim President of the Greater China Region until a permanent successor is named in the coming weeks. These leadership changes are effective immediately.

The leadership changes are a result of Bryan Hanson’s departure to become President and CEO of another public, medical technology company, effective today. Hanson was the former Executive Vice President of MITG.

"We are pleased to name Bob White and Chris Lee to these new leadership assignments. Their extensive knowledge and expertise of the Medtronic businesses and regions involved – as well as their demonstrated track records of success – will ensure continuity to our overall business strategies and objectives," said Omar Ishrak, Chairman and CEO of Medtronic. "Bob is uniquely qualified to take on the MITG role given his prior leadership experience in the former Covidien company and his most recent role as President of our APAC region, where he was responsible for advancing MITG and our three other groups in the region. Chris has strong experience across Asia Pacific, having previously led the operations of several leading pharmaceutical companies in the region. Both Bob and Chris have strong records of delivering results, and I look forward to working with them in their new roles."

"We thank Bryan for his contributions to Medtronic through the Covidien acquisition, its integration into Medtronic and to its current, solid performance as the Minimally Invasive Therapies Group," added Ishrak. "We wish him and his family well with his new endeavor."

Bob White joined Medtronic upon the close of the Covidien acquisition by Medtronic in 2015 as President for the APAC Region, based in Singapore. In this role, White was responsible for the commercial growth of Medtronic’s business in the region, including leadership for Medtronic’s four main product and therapy groups, regional business development efforts, government and partner development strategies, talent development and retention, and the operations of the company’s enabling functions. Under White’s leadership, the region has grown its revenue from $2.1 billion in fiscal year 2015 to $3.4 billion in fiscal year 2017.

White’s previous leadership positions with Covidien included serving as President of the Respiratory and Monitoring business and President of Emerging Markets. Prior to his time at Covidien, White held various leadership positions with General Electric and IBM.

Chris Lee joined Medtronic from Bayer HealthCare in 2012 and has served as the President of the Greater China Region, based in Shanghai, since that time. Medtronic’s Greater China Region includes China, Hong Kong, and Taiwan. Lee is responsible for all Medtronic commercial operations in the region, talent development and retention, and has served as the principal liaison with the Chinese government. Under Lee’s leadership, the region has maintained double digit revenue growth, having grown its revenue from $0.6 billion in fiscal year 2012 to $1.6 billion in fiscal year 2017.

Prior to joining Medtronic, Lee worked for Bayer HealthCare, where he led their Asia Pacific region, based in Singapore, and their Greater China Region, based in Beijing. In previous assignments, Lee led operations for Korea, Vietnam, Japan, Australia and New Zealand and other sub-regions in Asia Pacific for both Bayer and Bristol Meyers Squibb.

About the Medtronic Minimally Invasive Therapies Group
The Minimally Invasive Therapies Group is organized into the Surgical Innovations and the Respiratory, Gastrointestinal & Renal divisions. The Group had revenues of $9.9 billion in fiscal year 2017.

Array BioPharma Announces Strategic Collaboration with Pfizer

On December 19, 2017 Array BioPharma (Nasdaq: ARRY) reported that it has entered into a clinical trial collaboration agreement with Pfizer to investigate the safety and efficacy of several novel anti-cancer combinations, including Array’s MEK inhibitor, binimetinib, with Pfizer’s investigational PARP inhibitor talazoparib, and avelumab*, a human anti-PD-L1 IgG1 monoclonal antibody (Press release, Array BioPharma, DEC 19, 2017, View Source;p=RssLanding&cat=news&id=2323331 [SID1234522694]).

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The companies are entering into this collaboration to explore the potential benefits of combining molecularly targeted therapeutics with the body’s innate cancer-fighting abilities using immunotherapy.

"Array is excited to announce this partnership with Pfizer, an established global leader in Oncology therapeutics," said Ron Squarer, Chief Executive Officer, Array BioPharma. "These novel approaches combining targeted therapy and immunotherapy hold great potential to help patients fighting cancer in different indications, with an initial main focus on lung and pancreatic cancer."

"Preclinical data indicate that combining binimetinib with an immune checkpoint inhibitor and talazoparib could be a rational combination to test in the clinic," said Chris Boshoff, M.D., Ph.D., Senior Vice President and Head of Immuno-Oncology, Early Development and Translational Oncology, Pfizer Global Product Development. "We are looking forward to initiating the clinical studies with Array BioPharma to explore anti-tumor activity across various novel combination strategies, including both doublet and triplet approaches."

Under the terms of the agreement, Array and Pfizer will collaborate on a Phase 1b clinical trial to explore a series of novel combinations, investigating the safety and efficacy of the combination of binimetinib, avelumab and talazoparib across various tumor types. A multi-arm clinical trial is expected to establish recommended doses of different regimens combining the drugs. Initially the focus will be in non-small cell lung cancer (NSCLC) and pancreatic cancer, and additional indications will be explored at a later stage. The study is expected to begin by the third quarter of 2018, and results will be used to determine optimal approaches to further clinical development of these combinations.

Under the collaboration agreement, the trial will be sponsored and funded by Pfizer, with Array providing binimetinib supply.

*Avelumab is jointly developed by Merck KGaA, Darmstadt, Germany and Pfizer. Avelumab is under clinical investigation for treatment of NSCLC and pancreatic cancer and has not been demonstrated to be safe and effective for these indications. There is no guarantee that avelumab will be approved for these indications by any health authority worldwide.

About Binimetinib
MEK is a key protein kinase in the MAPK signaling pathway (RAS-RAF-MEK-ERK). Research has shown this pathway regulates several key cellular activities including proliferation, differentiation, survival and angiogenesis. Inappropriate activation of proteins in this pathway has been shown to occur in many cancers, such as melanoma, colorectal and thyroid cancers. Binimetinib is a late-stage, small molecule MEK inhibitor which targets key enzymes in this pathway. Binimetinib is an investigational medicine and is not currently approved in any country.

Binimetinib is being studied in clinical trials in advanced cancer patients, including the Phase 3 COLUMBUS trial in patients with BRAF-mutant melanoma and the Phase 3 BEACON CRC trial in patients with BRAF V600E-mutant colorectal cancer.

About Avelumab
Avelumab is a human anti-programmed death ligand-1 (PD-L1) antibody. Avelumab has been shown in preclinical models to engage both the adaptive and innate immune functions. By blocking the interaction of PD-L1 with PD-1 receptors, avelumab has been shown to release the suppression of the T cell-mediated antitumor immune response in preclinical models. Avelumab has also been shown to induce NK cell-mediated direct tumor cell lysis via antibody-dependent cell-mediated cytotoxicity (ADCC) in vitro. In November 2014, Merck KGaA, Darmstadt, Germany, and Pfizer announced a strategic alliance to co-develop and co-commercialize avelumab.

Avelumab is currently being evaluated in the JAVELIN clinical development program, which involves at least 30 clinical programs, including nine Phase III trials, and more than 7,000 patients across more than 15 different tumor types, including gastric/gastroesophageal junction, non-small cell lung cancer, renal cell carcinoma and ovarian cancer. For a comprehensive list of all avelumab trials, please visit clinicaltrials.gov.

Indications in the US
The FDA granted accelerated approval for avelumab (BAVENCIO) for the treatment of (i) adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (MCC) and (ii) patients with locally advanced or metastatic urothelial carcinoma (UC) who have disease progression during or following platinum-containing chemotherapy, or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. These indications are approved under accelerated approval based on tumor response rate and duration of response. Continued approval for these indications may be contingent upon verification and description of clinical benefit in confirmatory trials.

Important Safety Information from the US FDA Approved Label
The warnings and precautions for BAVENCIO include immune-mediated adverse reactions (such as pneumonitis, hepatitis, colitis, endocrinopathies, nephritis and renal dysfunction and other adverse reactions), infusion-related reactions and embryo-fetal toxicity.

Common adverse reactions (reported in at least 20% of patients) in patients treated with BAVENCIO for mMCC and patients with locally advanced or metastatic UC include fatigue, musculoskeletal pain, diarrhea, nausea, infusion-related reaction, peripheral edema, decreased appetite/hypophagia, urinary tract infection and rash.

For full prescribing information and medication guide for BAVENCIO, please see www.BAVENCIO.com.

About Talazoparib
Talazoparib is an investigational anti-cancer compound called a PARP (poly ADP ribose polymerase) inhibitor. Preclinical studies suggest that talazoparib is highly potent and has a dual mechanism of action, with the potential to induce tumor cell death by blocking PARP enzyme activity and trapping PARP on the sites of DNA damage. Talazoparib is currently being evaluated in advanced germline (inherited) BRCA+ breast cancer as well as other cancer types with deficiencies in DNA damage repair (DDR). Talazoparib has not been approved by any regulatory authorities for the treatment of any disease.

Saniona Spin-Out, Scandion Oncology Raises DKK 2 Million and Prepares for a Potential Public Listing

On December 19, 2017 Saniona, a leading biotech company in the field of ion channels, reported that its spin-out company, Scandion Oncology, has raised DKK 2 million in a private placement. Scandion intends to use the proceeds to develop its lead compound, SCO-101, for the treatment of chemotherapy resistant cancer and to mature the company for a potential public listing (Press release, Scandion Oncology, DEC 19, 2017, View Source;lang=en-GB&companycode=s-sanion&v= [SID1234522693]).

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Scandion Oncology raised DKK 2 million from a group of investors including member of the management and board of directors. The company expects to raise additional financing during spring 2018 either through an additional private placement or a public listing. Saniona owns 47.3% of Scandion Oncology following this initial financing round. The founders, management and the other shareholders of Scandion Oncology are independent of Saniona’s board, management and major shareholders of Saniona.

"Our clinical candidate SCO-101 represents a first-in-class treatment for chemotherapy resistant cancer, which is one of the most important challenges in modern oncology. With the successful closing of this private placement, we can now initiate the development of SCO-101 and prepare for the Phase 2a study in chemotherapy resistant cancer. In parallel, we are preparing for our next financing round and are diligently working to mature the company for a potential public listing," said Kim Arvid Nielsen, CEO of Scandion Oncology.

Jørgen Drejer, CEO of Saniona, added, "I am very pleased with the progress in our spin-out, Scandion Oncology. We believe that Scandion Oncology’s development of innovative therapies for chemotherapy resistant cancers will benefit not only cancer patients but also Saniona’s shareholders. Scandion Oncology has established the company within its own facilities and appointed an independent board of directors. Furthermore, the company has acquired a complementary asset from a third party and entered into a collaboration with Cambrex for the manufacture of GMP material for SCO-101."

Scandion Oncology was founded in May 2017 and subsequently acquired Saniona’s clinical candidate, SCO-101, which has been evaluated in Phase 1 studies for another indication. In 2015 Saniona granted scientists at the University of Copenhagen, Denmark rights to test SCO-101 and related compounds in their screening systems. This led to the discovery that certain compounds displayed the potential to overcome chemotherapy resistance by restoring the sensitivity of cancer cells toward standard chemotherapy. The parties filed a patent and formed Scandion Oncology for further development and commercialisation of this discovery. In addition to SCO-101, Scandion acquired a platform comprised of a large series of chemical analogues and associated knowledge.

For more information, please contact

Thomas Feldthus, EVP and CFO, Saniona, Mobile: +45 2210 9957, E-mail: [email protected]

Kim Arvid Nielsen, CEO, Scandion Oncology, Mobile: +45 2143 1017, E-mail: [email protected]

This information is such information as Saniona AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 09:45 CET on December 19, 2017.

Illumina to Webcast Upcoming Investor Conference Presentations

On December 19, 2017 Illumina, Inc. (NASDAQ:ILMN) reported that its executives will be presenting at the following investor conference and invited investors to participate via webcast (Press release, Illumina, DEC 19, 2017, View Source [SID1234522735]).

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J.P. Morgan Healthcare Conference Presentation, San Francisco, California
Monday, January 8, 2018 at 3:30 pm Pacific Time

J.P. Morgan Healthcare Conference Question & Answer Session, San Francisco, California
Monday, January 8, 2018 at 4:00 pm Pacific Time

The webcasts can be accessed in the Investor Relations section of Illumina’s web site under the "company" tab at www.illumina.com.

Navidea Biopharmaceuticals to Present at Biotech Showcase 2018

On December 19, 2017 Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB), a company focused on the development of precision immunodiagnostic agents and immunotherapeutics, reported that it will be presenting at the Biotech Showcase in San Francisco, CA being held on January 8-10, 2018 (Press release, Navidea Biopharmaceuticals, DEC 19, 2017, View Source [SID1234522712]). Dr. Michael Goldberg, Chief Executive Officer of Navidea, will be giving a presentation and meeting with investors.

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Event: Biotech Showcase
Presentation Date: Monday, January 8, 2018
Presentation Time: 10:00 am PT
Location: Hilton San Francisco Union Square, San Francisco, CA

For investors attending the Biotech Showcase, please contact Navidea Investor Relations to schedule a meeting with management at [email protected].

The presentation will be webcast live and remain available for 90 days following the presentation. To access the webcast, please visit the Investors presentations tab of the Investors section of the Navidea website at www.navidea.com.