Israeli startup HIL Applied Medical Ltd. acquires US-Based Nanolabz Inc. – en route to developing advanced cancer radiotherapy systems

On May 26, 2016 HIL Applied Medical Ltd. a Jerusalem, Israel medical technology startup reported the acquisition of Nanolabz Inc. – a Reno, Nevada company born out of University of Nevada research and focused on developing and fabricating smart targets for laser-based proton acceleration (Press release, HIL Applied Medical, MAY 25, 2016, View Source [SID:1234512815]). HIL Applied Medical is developing a new class of ultra-compact, high-performance Proton Beam Therapy systems, based on high-intensity lasers and nano-engineered smart targetry.

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"Today’s announcement is important on several levels," Mr. Sagi Brink-Danan, Chief Executive Officer of HIL, said, "The acquisition immediately doubles HIL’s patent portfolio, thus further fortifying our already-strong IP position in our field. It also adds strong, complimentary talent to our team, and provides a strong base for HIL’s US operations. We are looking forward to working together with the NanoLabz and UNR teams towards our joint goal of building the world’s first laser-based cancer proton therapy system."
NanoLabz co-founders Dr. Jesse Adams and Mr. Steven Malekos said they are thrilled to have found a great partner for NanoLabz’ technology with HIL, adding that "we are looking forward to working with HIL’s world-class, committed and capable team on translating cutting-edge technology into products that will benefit cancer patients worldwide."

Co-founder and president of Nanolabz, Mr. Grant Korgan, added: "It’s a joy to see us reach this milestone. It is a testament to hard work and the power of positivity." Mr. Korgan suffered a major spinal cord injury in 2010, and has since become a local and global inspiration, TED-lecturer and sought-after public speaker.

UNR president Dr. Marc Johnson stated that he was pleased to see this milestone, which highlights the institution’s role as an internationally respected, high-impact research university.

What is Proton Therapy: A proton beam is a form of focused radiation used to treat solid tumors. It is superior to traditional radiation therapy (X-Ray, or Photons) in that it reduces damage to surrounding healthy tissue by 2X-6X, thereby reducing toxicities and improving patient survival and quality of life. Proton therapy is used routinely for treating many types of cancer; it is FDA-cleared (510k) and reimbursed by both Federal and private insurers.

Proton Therapy’s Unmet Need: Proton beam therapy can help an estimated 300,000 cancer patients every year in the US – yet last year only 10,000 received it (that’s less than 4%). Protons are arguably the most advanced form of radiation therapy – yet there are only 19 active proton-therapy centers in the US today; compare with over 2,700 traditional (X-Ray) radiation therapy centers. The main barrier to widespread adoption is the large size (football stadium) and high cost ($150-250M) of building and operating a proton therapy center. Single-room solutions are slowly being introduced by some vendors for $30-50M. The key to making protons available to every patient in every midsize hospital is a scalable, add-on, single-room solution for half the current price tag or less. HIL’s technological breakthrough promises to bring about this revolution.

8-K – Current report

On May 25, 2016 Medivation, Inc. (NASDAQ: MDVN) reported that it urged its stockholders to reject Sanofi’s attempt to replace the company’s entire Board of Directors with hand-picked nominees through a proposed consent solicitation, which Medivation believes is a tactic for Sanofi to facilitate its substantially inadequate and opportunistically-timed proposal to acquire Medivation (Filing, 8-K, Medivation, MAY 25, 2016, View Source [SID:1234512818]). Medivation expects to promptly file consent revocation materials with the U.S. Securities and Exchange Commission.

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On April 29, 2016, the Medivation Board unanimously rejected Sanofi’s unsolicited, non-binding proposal to purchase Medivation for $52.50 per share in cash because it substantially undervalues the company, its leading oncology franchise and its innovative, late-stage pipeline. The Medivation Board reached its conclusion about Sanofi’s proposal based on a thorough analysis of the commercial momentum and outlook of the company’s marketed product, XTANDI; its excellent pipeline of prospects; its track record of successful drug development; and its history of delivering superior returns to stockholders.

David Hung, M.D., Founder, President and Chief Executive Officer of Medivation, said, "Medivation’s experienced Board of Directors has been instrumental in overseeing a strategy that has created a leading oncology franchise, delivered consistently strong financial performance, and positioned the company for future growth through its innovative late-stage pipeline. Under the leadership of its Board of Directors, Medivation has achieved great success and rewarded its stockholders with extraordinary results, delivering total stockholder returns of more than 1,440% since 2009. In contrast, Sanofi has no duty to act in the best interests of Medivation or its stockholders. Its proposal to replace our existing directors with its own hand-picked nominees is simply a tactical maneuver to facilitate a transaction that will transfer value that rightly belongs to Medivation stockholders to Sanofi."

Kim Blickenstaff, Chairman of Medivation’s Board of Directors, said, "Sanofi is seeking to take control of our Board in a clear attempt to circumvent objective deliberations over what course of action is in the best interests of all Medivation stockholders. The unattractive economics of Sanofi’s proposal – which the Board has already determined to be substantially inadequate – have not changed. The Medivation Board remains committed to ensuring that our stockholders retain the ability to benefit from the significant value creation potential of our Company."

Evercore and J.P. Morgan are serving as financial advisors to Medivation, and Wachtell, Lipton, Rosen & Katz and Cooley LLP are acting as legal counsel.

Sunesis Pharmaceuticals Announces Support of First-Ever Acute Myeloid Leukemia Awareness Month in June

On May 25, 2016 Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) reported its support for the first-ever Acute Myeloid Leukemia Awareness Month to be held in June. The goal of the campaign, which is being sponsored by CancerCare, is to put a spotlight on the disease, a rare and difficult-to-treat blood cancer that typically affects older adults (Press release, Sunesis, MAY 25, 2016, View Source;p=RssLanding&cat=news&id=2172293 [SID:1234512773]).

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Acute Myeloid Leukemia (AML) is a cancer of the blood and bone marrow and can worsen quickly if left untreated. According to the National Institutes of Health, it is estimated that there will be 19,950 new cases of acute myeloid leukemia in 2016 and an estimated 10,430 people will die from the disease. AML is more common in older adults, who are also the most difficult to treat, with 67 as the median age of diagnosis. While progress in treating leukemia has been made, there has been only one AML treatment approved by the U.S. Food and Drug Administration in the past 30 years (and that drug was subsequently withdrawn from the market).

Patricia J. Goldsmith, CEO of CancerCare, said, "AML Awareness Month will feature in-depth information about AML on the organization’s website, including a video that features NBA broadcaster Craig Sager who is battling the disease, as well as his son, Craig, Jr., who donated his bone marrow twice in an effort to save his father. The website will also offer people living with AML and their caregivers easy-to-use, informative resources to understand their condition. We thank Sunesis Pharmaceuticals for their unrestricted educational grant which has helped to support the development of these resources."

"We are delighted to be supporting CancerCare’s efforts to raise awareness of acute myeloid leukemia," said Daniel Swisher, Chief Executive Officer of Sunesis. "Because it is a rare disease with an older patient population, there has been little attention focused on AML. As a company that is determined to deliver a new treatment option for this disease, we want to support the AML community by helping to provide more education and information for patients and caregivers."

Goldsmith added, "The AML community’s voice has not always been heard because the disease itself is so rare and the mortality rate is so high. We hope to put a spotlight on AML in June and help focus attention on the urgent need these patients and their families have for hope."

Patients and caregivers can find educational resources on AML online at www.cancercare.org; an unrestricted educational grant from Sunesis has helped to support the development of the informational resources on AML which also includes a patient and caregiver workshop webinar to be held on June 17.

About CancerCare

Founded in 1944, CancerCare is the leading national organization providing free, professional support services and information to help people manage the emotional, practical and financial challenges of cancer. Our comprehensive services include counseling and support groups over the phone, online and in-person, educational workshops, publications and financial and co-payment assistance. All CancerCare services are provided by oncology social workers and world-leading cancer experts. Headquartered in New York, NY, CancerCare maintains three additional locations in Norwalk, CT, Ridgewood, NJ and Syosset, NY.

EISAI TO PRESENT NEW RESEARCH ON ONCOLOGY PRODUCTS AND PIPELINE AT 52ND ASCO ANNUAL MEETING

On May 24, 2016 Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") reported that a series of abstracts highlighting new study results on Halaven (eribulin mesylate; halichondrin class microtubule dynamics inhibitor, "eribulin") and Lenvima (lenvatinib mesylate; selective inhibitor of receptor tyrosine kinases (RTKs) with a novel binding mode, "lenvatinib") will be presented during the 52nd Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), taking place in Chicago, the United States, from June 3 to 7, 2016 (Press release, Eisai, MAY 24, 2016, View Source [SID:1234512716]).

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Poster presentations for this year’s ASCO (Free ASCO Whitepaper) meeting include a presentation highlighting the results of a Phase I clinical study of eribulin liposomal formulation in solid tumors. Presentations for lenvatinib include updated results from the SELECT study regarding response to lenvatinib treatment in patients with radioiodine-refractory differentiated thyroid cancer as well as final analysis results of a Phase II study of lenvatinib in patients with differentiated, medullary, and anaplastic thyroid cancer.

Eisai positions oncology as a key franchise area. The company will continue to create innovation in the development of new drugs based on cutting-edge cancer research, and in doing so seeks to make further contributions to address the diversified needs of, and increase the benefits provided to, patients and their families as well as healthcare providers.

Major Poster Presentations:
Product Abstract title and scheduled presentation date and time (local time)
Eribulin
(Halaven)

Abstract No: 2524 Phase 1 multicenter, open-label study to establish the maximum tolerated dose (MTD) of two administration schedules of E7389 (eribulin) liposomal formulation in patients (pts) with solid tumors.

Poster Presentation | June 5 (Sun), 08:00-11:30
Eribulin
(Halaven)

Abstract No: 11015 Evaluation of quality of life at progression in patients with soft tissue sarcoma.

Poster Presentation | June 6 (Mon), 08:00-11:30
Eribulin
(Halaven)

Abstract No: 11037 Subtype-specific activity in liposarcoma (LPS) patients (pts) from a phase 3, open-label, randomized study of eribulin (ERI) versus dacarbazine (DTIC) in pts with advanced LPS and leiomyosarcoma (LMS).

Poster Presentation | June 6 (Mon), 08:00-11:30
Lenvatinib
(Lenvima)

Abstract No: 4553 Subgroup analyses and updated overall survival from the phase II trial of lenvatinib (LEN), everolimus (EVE), and LEN+EVE in metastatic renal cell carcinoma (mRCC).

Poster Presentation | June 6 (Mon), 13:00-16:30
Lenvatinib
(Lenvima)

Abstract No: 6088 Phase II study of lenvatinib in patients with differentiated, medullary, and anaplastic thyroid cancer: Final analysis results.

Poster Presentation | June 4 (Sat), 13:00-16:30
Lenvatinib
(Lenvima)

Abstract No: 6089 Response to lenvatinib treatment in patients with radioiodine-refractory differentiated thyroid cancer (RR-DTC): Updated results from SELECT.

Poster Presentation | June 4 (Sat), 13:00-16:30
(Note) SELECT Study: Study of E7080 "LEnvatinib" in Differentiated Cancer of the Thyroid

Lilly Details Robust R&D Pipeline to Investment Community

On May 24, 2016 In a presentation to the investment community today, Eli Lilly and Company (NYSE: LLY) reported it has the potential to launch 20 new products in the 10 years beginning in 2014 and extending through 2023 (Press release, Eli Lilly, MAY 24, 2016, View Source [SID:1234512717]). In addition, Lilly could launch an average of two new indications or line extensions for already-approved products per year during that same time period.

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"We’re pleased to share with investors the breadth and depth of the Lilly pipeline, which showcases our progress across our key therapeutic areas. This includes recent launches as well as a robust lineup of assets in late-stage development or already under regulatory review," said John C. Lechleiter, Ph.D., Lilly’s chairman, president and chief executive officer. "There are no guarantees given the nature of science and of our business; however, in looking at our recent launches and current pipeline, we believe we are in the midst of the most prolific period of new launches in our company’s 140-year history."

Lilly’s R&D efforts focus on five therapeutic areas where the company has assets and capabilities that enable it to compete successfully. These include four core areas—diabetes, oncology, immunology and neurodegeneration—and one emerging area—pain. Building upon a similar investment community meeting in December 2015 focused on neurodegeneration – specifically Alzheimer’s disease – as well as animal health, today’s presentation highlighted the company’s R&D strategy and progress in diabetes, oncology, immunology and pain.

"We have improved the productivity and success of our pipeline through discrete actions aimed at enhancing focus, quality and speed, and by positioning ourselves as an attractive partner for external innovation opportunities," said Jan Lundberg, Ph.D., executive vice president of science and technology and president of Lilly Research Laboratories. "These improvements have led to the potential for unprecedented R&D output."

Diabetes
Lilly’s long-standing commitment to diabetes care dates to 1923, when it was the first company to bring insulin to patients. Today, the company has the broadest range of diabetes therapies in the industry. Lilly’s R&D efforts in diabetes focus on differentiated therapeutics and delivery devices within three key areas of unmet need: glucose control, metabolic control and end-organ protection. The company aims to combine its strong in-house diabetes R&D capabilities with a comprehensive external network to deliver continued innovation in this important area of therapy.

Oncology
Lilly has a long history of leadership in oncology. The company has a balanced R&D approach across three key areas of disease modification: tumor cell signaling, tumor microenvironment and immuno-oncology. This approach allows for testing of combinations of internally-derived agents to address tumor heterogeneity and drug resistance. Lilly has a portfolio of differentiated assets across these approaches, including Cyramza (ramucirumab), Portrazza (necitumumab), olaratumab and abemaciclib. Lilly’s immuno-oncology portfolio will have five differentiated molecules in clinical testing by the end of 2016, and as many as 11 by the end of 2018.

Immunology
With the recent launch of Taltz (ixekizumab) and the submission of baricitinib for regulatory review, Lilly has designated immunology as the company’s newest core therapeutic area. While these assets represent the foundational first wave of innovation, Lilly has built a robust emerging pipeline of both internal assets and partnered molecules focusing on key pathways and interventions in multiple autoimmune diseases.

Neurodegeneration
Lilly’s commitment to Alzheimer’s disease is demonstrated by its more than 25 years of research and development in the field. As a result of this sustained effort and deep understanding of the disease, Lilly today has one of the industry’s most comprehensive Alzheimer’s portfolios, with seven molecules already in human testing. The company’s Alzheimer’s research includes disease prevention, detection and treatment.

Pain
Pain is an emerging research area for Lilly, focusing on non-opioid treatment for chronic pain. The two late-stage innovative medicines currently in development are galcanezumab (CGRP Ab), being studied for cluster headache and migraine, and tanezumab, being studied for osteoarthritis pain, chronic lower back pain and cancer pain in partnership with Pfizer.

A live audio webcast of today’s presentation is available on the "Webcasts & Presentations" section of Lilly’s investor website at View Source A replay will be available for approximately 90 days.