On October 26, 2016 Varian Medical Systems (NYSE:VAR) reported GAAP net earnings of $1.24 per diluted share and non-GAAP net earnings of $1.38 per diluted share for the fourth quarter of fiscal year 2016 (Filing, Q3, Varian Medical Systems, 2016, OCT 26, 2016, View Source [SID1234516023]). For the full fiscal year 2016, GAAP net earnings were $4.19 per diluted share, and non-GAAP net earnings were $4.68 per diluted share. Varian’s revenues totaled $912 million for the fourth quarter of fiscal year 2016, up 12 percent in dollars from the year-ago quarter and up 11 percent in constant currency. Varian’s revenues for the full fiscal year were $3.2 billion, up 4 percent in dollars versus fiscal year 2015 and up 5 percent in constant currency. The company ended the fourth quarter with a $3.5 billion backlog, down 1 percent from the end of fiscal year 2015 with a gain in Oncology business offset by declines in the Particle Therapy and Imaging Components backlogs.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"The company finished the year on a strong note with solid growth in revenues and margins for both of its major businesses," said Dow R. Wilson, CEO of Varian Medical Systems. "For the fourth quarter, total company gross margin increased by nearly four percentage points over the year-ago quarter. Weak oncology orders in EMEA, where we had tough year-ago comparisons, offset gross order growth in the Americas and in Asia."

The company finished the fiscal year with $844 million in cash and cash equivalents and
$667 million of debt. Cash flow from operations was $152 million for the fourth quarter and $356 million for the fiscal year. During the quarter, the company spent $87 million to repurchase about 1 million shares of common stock.

Oncology Systems
Oncology Systems’ fourth quarter revenues totaled $678 million, up 7 percent in dollars from the same quarter of fiscal year 2015 and up 6 percent in constant currency. Annual revenues were $2.5 billion, up 5 percent in dollars from the prior fiscal year and up 6 percent in constant currency.

Fourth-quarter gross orders were $897 million, down 2 percent in dollars from the year-ago quarter and down 4 percent in constant currency. For the full fiscal year 2016, Oncology gross orders were $2.7 billion, up 1 percent in dollars and up 2 percent in constant currency. Oncology gross orders in the Americas rose 4 percent in dollars and increased 3 percent in constant currency for the fourth quarter. For fiscal year 2016, Americas gross orders rose 4 percent both in dollars and constant currency. Gross orders in Asia rose 8 percent in dollars and fell 1 percent in constant currency in the fourth quarter. For the fiscal year 2016, gross orders in Asia rose 5 percent in dollars and 3 percent in constant currency. Gross orders in EMEA fell 17 percent in both dollars and constant currency for the quarter. For the fiscal year, Oncology gross orders in EMEA fell 6 percent in dollars and 4 percent in constant currency.

"Oncology Systems generated healthy revenue growth, and strong gains in both its gross and operating margins with a favorable product mix and a sharp focus on product cost initiatives during the quarter," said Wilson. "We saw respectable gross orders growth in the Americas and in emerging markets during the quarter while facing challenging conditions in Western Europe where we had record-setting growth in the year ago period. Gross orders in North America were down 2 percent in the quarter but up 5 percent for the full fiscal year."

Imaging Components
Imaging Components revenues were $166 million for the fourth quarter, up 7 percent from the year-ago period, and $598 million for the fiscal year, down 2 percent from fiscal year 2015. Gross orders totaled $168 million for the fourth quarter, up 2 percent from the year-ago period, and totaled $571 million for the fiscal year, down 6 percent from fiscal year 2015.

"Our Imaging Components business continued to strengthen in the second half of the fiscal year with ongoing revenue growth driven in part by recent acquisitions and with solid improvements in its gross and operating margins," said Wilson. "This business has successfully weathered some severe challenges in the first half of the year and finished a fiscal year highlighted by two consecutive quarters of strong revenue growth and favorable product mix as well as several key new product introductions."

Varian intends to establish the Imaging Components business as a new, independent publicly-traded company, Varex Imaging Corporation, through a tax-free spin.

Other
The company’s Other category, including the Varian Particle Therapy business and the Ginzton Technology Center, recorded fourth quarter revenues of $68 million, up $38 million from the prior year period. Revenues for fiscal year 2016 were $163 million, up 13 percent from fiscal year 2015. During the quarter, the Particle Therapy business booked its first order for its Compact single room system. However, proton system gross orders were down from the prior year quarter and prior fiscal year when the company booked an unusually high number of orders. "While gross orders remain lumpy and timing is difficult to forecast, the sales funnel remains strong," said Wilson.

Outlook
"We believe that for the first quarter of fiscal year 2017, non-GAAP earnings for the total company, including the Imaging Components business and ramp-up costs for its separation, will be in the range of $1.03 to $1.07 per diluted share and revenues will increase by about 1 to 2 percent," said Wilson. "As we announced earlier, we will not give earnings guidance for the full fiscal year until after we have completed the separation of the Imaging Components business. For the full fiscal year 2017, we expect that Varian revenues, excluding the Imaging Components business, will rise by 3 to 4 percent. We expect that Imaging Components revenues for the full fiscal year 2017 will also rise by 3 to 4 percent."

Please refer to the attached "Discussion of Non-GAAP Financial Measures" for a description of items excluded from expected non-GAAP earnings.

On October 26, 2016 Active Biotech AB (NASDAQ OMX NORDIC: ACTI) and NeoTX Therapeutics Ltd. reported that they have entered into a licensing agreementfor Active Biotech’s investigational compound Naptomumab estafenatox ("ANYARA") for cancer immunotherapy (Press release, Active Biotech, OCT 26, 2016, View Source [SID1234523671]). NeoTX will be responsible for the worldwide clinical development and commercialization of the drug.This partnership is a key milestone in NeoTX’s strategy to bring tumor recognition enhancing therapeutics to the market.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We are very enthusiastic about our collaboration with Active Biotech. At NeoTX, we are strongly committed to developing innovative immunotherapies for unmet medical needs. "Active Biotech brings to our collaboration outstanding scientific and intellectual capital, and a powerful commitment to positively impact the treatment of cancer," said Asher Nathan, Chief Executive Officer of NeoTX.

Dr. Marcel Rozencweig, Chief Medical Officer of NeoTX and former Head of Global Clinical Oncology Research at BMS said "We are looking forward to developing ANYARA for immuno-oncology applications. We believe that the ANYARA technology is well suited to increase tumor recognition by the immune system and has demonstrated synergistic activity in combination with checkpoint inhibitors in animal models. As such, ANYARA would be attractive in combination with checkpoint inhibitors whose efficacy can be limited by poor tumor recognition".

"We are excited about the partnership with NeoTX, who we consider as an ideal partner for ANYARA. This partnership constitutes the next step in the clinical development, as well as the commercialization strategy, for the project." said Tomas Leanderson, President & CEO of Active Biotech.

About the agreement
Under the terms of the agreement, Active Biotech grants NeoTX exclusive rights to develop and commercialize ANYARA worldwide in cancer indications. The total deal value amounts to $71 million and is contingent upon achievement of clinical, regulatory and commercial milestones whereof Active Biotech will receive $250 000 as an initial payment upon signing. In addition, NeoTX will pay Active Biotech progressive, double-digit royalties on its net sales.

About ANYARA
ANYARA is a TTS (Tumor Targeting Superantigen) compound that increases the ability of the immune system to recognize the tumor. Synergy has been reported in vivo with a combination of ANYARA and a checkpoint inhibitor in an experimental tumor model. Clinically, the development of ANYARA has primarily been focused on cancer indications with a high unmet medical need. Positive data was reported from clinical Phase I trials in lung cancer, renal cell cancer and pancreatic cancer, where ANYARA was studied both as a single agent (monotherapy) and in combination with an established tumor therapy – docetaxel (Taxotere) – in patients with advanced cancer. The results showed that ANYARA was well tolerated both as monotherapy and in combination with docetaxel, and increased tumor recognition by T cells.

A Phase 2/3 trial of ANYARA in combination with interferon alpha in renal cell cancer demonstrated acceptable safety but did not meet its primary efficacy endpoint in the ITT population. The upcoming clinical trial will be done in combination with drugs that inhibit checkpoint dampening of the immune system, a combination strategy in line with the mode of action of ANYARA and supported by preclinical data.

On October 26, 2016 Dong-A ST Co., Ltd. (170900: Korea SE), the Korean pharmaceutical company, and Beactica AB, the Swedish fragment-based drug discovery company, reported a new multi-year research and drug discovery collaboration and licensing agreement (Press release, Dong-A ST, OCT 26, 2016, View Source [SID1234535725]). Beactica and Dong-A ST will jointly develop novel anti-cancer drugs against certain disease-related oncology targets.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Under the terms of the agreement, Dong-A ST will gain exclusive global rights for the further development and commercialization of Beactica’s small molecule inhibitors against multiple members of a family of epigenetic enzymes. The partnership will pool existing compound series from both companies and combine Beactica’s unique early-stage lead generation capabilities with DONG-A ST’s strengths in downstream pre-clinical and clinical development of new therapeutic agents.

Beactica will receive an undisclosed upfront payment and is eligible to receive research funding as well as potential milestone payments for certain research, preclinical, clinical and regulatory milestones. In addition, Beactica is eligible to receive royalties on commercial sales of the products resulting from the partnership. Beactica is also entitled to a revenue share from any related future licensing activities by Dong-A. Full financial details remain undisclosed.

"This global research collaboration between Dong-A ST and Beactica which specializes in developing novel drug targets marks a big step forward in development of next generation anti-cancer therapeutics" said Dr Soo-Hyoung Kang, President and CEO of Dong-A ST. "This collaboration and licensing of Beactica’s small molecule inhibitors will greatly strengthen Dong-A ST’s current oncology pipeline and will further enhance Dong-A ST’s global competitiveness in the pharmaceutical industry."

"We’ve been impressed by Dong-A’s commitment to benefiting cancer patients through therapeutics that modulate epigenetic pathways and are excited to initiate this collaboration." said Dr Per Källblad, CEO of Beactica. "This is a ground-breaking partnership in terms of structure, scope and the potential clinical impact of therapeutics created through our complementary capabilities."

Epigenetics is the study of physiological changes caused by altered gene expressions originating from inherited changes other than the DNA sequence itself. Cancer epigenetics is a rapidly emerging research area with potential to provide new treatments for patients by modifying DNA and chromatin, both of which play important roles in tumour development.

On October 26, 2016 Lion Biotechnologies, Inc. (NASDAQ: LBIO), a biotechnology company developing novel cancer immunotherapies based on tumor-infiltrating lymphocyte technology (TIL), reported that presentations related to the Company’s TIL technology will be made at the upcoming Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting & Associated Programs, being held on November 9-13, 2016 in National Harbor, MD (Press release, Lion Biotechnologies, OCT 26, 2016, View Source [SID1234516025]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Presentations at SITC (Free SITC Whitepaper) relate to:

Feasibility of growing TIL from non-melanoma solid tumors and development of TIL therapies for other solid tumors – Lion cultured TIL from non-melanoma solid tumors including bladder, cervical, head and neck, lung and triple negative breast cancer (TNBC) to investigate the feasibility of using adoptive cell therapy (ACT) as a therapy for patients in other cancer types (poster #42, Sethuraman, Saturday, November 12, 7:00 a.m. to 8:00 p.m. ET)

Evaluation of artificial antigen presenting cells (aAPC) as a potential substitute for allogeneic peripheral blood mononuclear cells (PBMC) – Preclinical evaluation of artificial antigen presenting cells as a substitute for PBMC (peripheral blood mononuclear cells) was conducted with a novel aAPC CD64+ MOLM-14 human leukemia cell line (poster #47, Veerapathran, Friday, November 11, 12:00 p.m. to 8:00 p.m ET)

Addressing the need to assess lytic potential of TILs – In order to test the potency of TILs that are infused into patients, a surrogate target cell line was developed that can be used to assess the lytic potential of TILs in a BRLA (poster #14, Gokuldass, Saturday, November 12, 7:00 a.m. to 8:00 p.m. ET)

Effect of cryopreservation on the measured phenotypic characteristics of TIL – Lion tested if cryopreservation affected the measured phenotypic characteristics of TIL which could enable Lion to further investigate the possibility of using cryopreserved TIL in a clinical setting (poster #11, Frank, Friday, November 11, 12:00 p.m. to 8:00 p.m ET)

Additional information, including a presentation schedule, titles and abstracts, can be found at View Source

On October 26, 2016 Varian Medical Systems (NYSE: VAR) and McKesson Specialty Health reported a strategic agreement for the deployment and servicing of Varian advanced radiotherapy equipment and software over a three-year period across The US Oncology Network and Vantage Oncology affiliated sites of care (Press release, Varian Medical Systems, OCT 26, 2016, View Source [SID1234516101]). This multiyear agreement delivers significant value to oncology providers in The US Oncology Network, which now operates the largest system of radiotherapy facilities in the U.S. following the acquisition of Vantage Oncology earlier this year.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Over the next two years, seven Varian TrueBeam and five VitalBeam medical linear accelerators will be installed in The US Oncology Network and Vantage Oncology affiliated cancer centers across the U.S. In addition, McKesson and Varian will collaborate to establish interoperability between McKesson Specialty Health’s iKnowMedSM electronic health record (EHR) system and Varian’s ARIA oncology information system. The interoperability aims to deliver direct value to all physicians using these information systems in managing patient care.

"McKesson Specialty Health and The US Oncology Network offer robust, comprehensive practice management capabilities, value-based care expertise, and state-of-the-art technology solutions to its affiliated practices, providing support as they navigate today’s challenging healthcare landscape," said Kirk Kaminsky, president of The US Oncology Network and Practice Management for McKesson Specialty Health. "Combined, Vantage Oncology and The US Oncology Network support more than 1,300 affiliated physicians and approximately 400 affiliated sites of care. Bringing them together earlier this year and now executing this strategic agreement with Varian will help our affiliated practices simultaneously enhance clinical capabilities, workflow for physicians, and the quality of patient care while improving the cost-effectiveness of their operations. The specialized hardware, service offerings and roadmap for interoperability with iKnowMed gives clinicians greater efficiency and increased quality of patient care benefits."

"We are honored by the long-term commitment McKesson Specialty Health is making in Varian equipment and technology as part of this agreement," said Kolleen Kennedy, president of Varian’s Oncology Systems business. "Our companies share a common goal to develop and deliver the highest level of care. Through this strategic agreement, we are increasing the ability of patients to access the most advanced treatments in their fight against cancer."