On May 24, 2018 Genmab A/S (Nasdaq Copenhagen: GEN) reported that topline results from the Phase III study of Arzerra (ofatumumab) plus bendamustine did not meet the primary endpoint of improved progression-free survival (PFS) in patients with indolent B-cell non-Hodgkin’s lymphoma (iNHL) who were unresponsive to rituximab or a rituximab-containing regimen, compared to those given bendamustine alone (Press release, Genmab, MAY 24, 2018, View Source [SID1234527081]). The safety profile observed in this study was consistent with that observed in other trials of ofatumumab and no new safety signals were observed.

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 disappointed that the ofatumumab treatment regimen did not meet the primary endpoint in this trial. The completion of this Phase III study, which began in 2010, would not have been possible without the generous participation of the patients and their families, and we are most grateful for this. The full data will be submitted for publication at a future medical conference and we hope that these will provide a better understanding of this result," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

The results from this Phase III study do not impact any other ongoing studies with ofatumumab.

About the study (COMPLEMENT A+B)
The study is an open-label, two-arm, randomized, Phase III study that included 346 patients with indolent B-cell non-Hodgkin’s lymphoma who were unresponsive to rituximab or a rituximab-containing regimen. Patients in the study were randomized 1:1 to treatment with up to eight cycles of bendamustine given in combination with 12 doses of ofatumumab (1,000 mg) or up to eight cycles with bendamustine alone. The primary endpoint of the study was PFS.

Ofatumumab is not approved for the treatment of indolent non-Hodgkin’s Lymphoma.

About Ofatumumab (Arzerra)
Ofatumumab is a human monoclonal antibody that is designed to target the CD20 molecule found on the surface of normal B lymphocytes and on B cell malignancies (including chronic lymphocytic leukemia and non-Hodgkin’s lymphomas).

In the United States, Arzerra is approved for use in combination with chlorambucil for the treatment of previously untreated patients with CLL for whom fludarabine-based therapy is considered inappropriate, in combination with fludarabine and cyclophosphamide for the treatment of patients with relapsed CLL and for extended treatment of patients who are in complete or partial response after at least two lines of therapy for recurrent or progressive CLL. In the European Union, Arzerra is approved for use in combination with chlorambucil or bendamustine for the treatment of patients with CLL who have not received prior therapy and who are not eligible for fludarabine-based therapy and in combination with fludarabine and cyclophosphamide for adult patients with relapsed CLL. In more than 60 countries worldwide, including the United States and EU member countries, Arzerra is also indicated as monotherapy for the treatment of patients with CLL who are refractory after prior treatment with fludarabine and alemtuzumab. On January 22, 2018, it was announced that Novartis intends to transition Arzerra for the treatment of CLL indications from commercial availability to limited availability via compassionate use programs in non-U.S. markets.

Please see full Prescribing Information, including Boxed WARNING for Arzerra (ofatumumab).

Arzerra is marketed under a collaboration agreement between Genmab and Novartis. A subcutaneous formulation of ofatumumab is also being investigated in two Phase III clinical studies in relapsing multiple sclerosis.

On May 24, 2018 VAXIMM AG, a Swiss/German biotech company focused on developing oral T-cell immunotherapies, reported that the final results from a Phase I study in recurrent glioblastoma with its lead product candidate, oral VXM01, are being presented at the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting being held June 1-5, 2018 in Chicago, IL, USA (Press release, Vaximm, MAY 24, 2018, View Source [SID1234526877]).

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!

Abstract #2017, Poster Board #175

A poster entitled, "VXM01 phase I study in patients with progressive glioblastoma: final results," will be presented during the Central Nervous System Tumors Session on Saturday, June 2nd, 1:15-4:45 PM CDT, as well as during a poster discussion session that day, 4:45 PM – 6:00 PM CDT. The abstract (#2017) is available on the ASCO (Free ASCO Whitepaper) website here.

The Phase I trial was designed to evaluate the safety and tolerability of VXM01, as well as clinical and immunogenic response, in patients with recurrent glioblastoma whose disease had progressed following treatment with radiochemotherapy including temozolomide, which is the standard of care. Fourteen patients were treated with VXM01, including three who were also treated with the anti-PD-1 checkpoint inhibitor, nivolumab. Patients were given VXM01 on days 1, 3, 5 and 7. Tumor resection was then performed on eight patients. During the follow-up period, patients could receive oral VXM01 every four weeks. Median dosage was eight vaccinations. VXM01 appeared to be well tolerated, both as monotherapy or in combination with nivolumab. ELISpot analysis showed detectable VEGFR-2-specific T-cell responses.

Of the fourteen patients treated, one patient experienced an objective response with VXM01 monotherapy and a durable response with the addition of nivolumab. During the observation period of up to 20 months, seven patients were still alive, all of them living for more than one year. Survival seemed to be correlated with a higher CD8/Treg ratio in the progressive and primary tumors. The ratio further increased after VXM01 treatment. In patients with prolonged survival, a decrease in intratumoral PD-L1 was observed, which supports the rationale for combining VXM01 with an anti-PD-L1 checkpoint inhibitor.

Prof. Wolfgang Wick, MD, Chairman, Department of Neurology, Heidelberg University Hospital, Heidelberg, Germany, and principal investigator of the study, said: "The results of this trial are promising and support advancing the development of VXM01 for the treatment of glioblastoma, a deadly form of brain cancer, where there is an urgent need to find more effective treatments to help prevent recurrence. We are particularly excited about the early clinical signals we have seen with VXM01 and we look forward to the start of a planned trial combining VXM01 with a PD-L1 inhibitor."

In 2017, VAXIMM entered into a collaboration agreement with Merck KGaA, Darmstadt, Germany and Pfizer Inc. to evaluate VXM01 in combination with avelumab, a human anti-PD-L1 antibody. The clinical combination trial in glioblastoma is expected to be initiated this year.

About VXM01:

VXM01 is an oral T-cell immunotherapy that is designed to activate T-cells to attack the tumor vasculature, and, in several tumor types, attack cancer cells directly. It is based on a live attenuated, safe, orally available, bacterial vaccine strain, which is modified to carry vascular endothelial growth factor receptor-2 (VEGFR2) as the target gene. VXM01 stimulates the patient’s immune system to activate VEGFR2-specific, cytotoxic T-cells (so-called killer cells). These immune killer cells then actively destroy cells in the tumor vasculature, leading to an increased infiltration of various immune cells into the tumor. In several tumor types, including brain cancer, VEGFR2 is highly over-expressed on the cancer cells themselves. In preclinical studies, a murine analog VXM01 vaccine showed broad anti-tumor activity in different tumor types. This activity was linked to a VEGFR2-specific T-cell response and was accompanied by the destruction of the tumor vasculature and increased immune cell infiltration. In a Phase I double-blind, randomized, placebo-controlled study in 71 patients with advanced pancreatic cancer, VXM01 appeared to be safe and well tolerated and led to the activation of VEGFR2-specific cytotoxic T-cells, which was associated with significantly improved patient survival.

About VAXIMM:

VAXIMM is a privately held, Swiss/German biotech company that is developing oral T-cell immunotherapies for patients suffering from cancer. VAXIMM’s product platform is based on a live attenuated, safe, orally available bacterial vaccine strain, which is modified to stimulate patients’ cytotoxic T-cells to target specific structures of the tumor. VAXIMM’s lead product candidate, oral VXM01, activates killer cells targeting tumor-specific vasculature and certain immune-suppressive cells, thereby increasing immune cell infiltration in solid tumors. VXM01 is currently in clinical development for several tumor types, including pancreatic, colorectal and brain cancer. In addition to VXM01, VAXIMM has a pipeline of complementary development candidates targeting different tumor structures. VAXIMM’s investors include BB Biotech Ventures, Merck Ventures, Sunstone Capital and BioMed Partners. VAXIMM AG is headquartered in Basel, Switzerland. Its wholly owned subsidiary, VAXIMM GmbH, located in Mannheim, Germany, is responsible for the Company’s operations. For more information, please see www.vaximm.com.

On May 24, 2018 West Pharmaceutical Services, Inc. (NYSE: WST), a global leader in innovative solutions for injectable drug administration, reported that its Management Team will present an overview of the Company’s business at two investor conferences in June (Press release, West Pharmaceutical Services, MAY 24, 2018, View Source;p=RssLanding&cat=news&id=2350600 [SID1234526878]). Management will present at the Jefferies 2018 Global Healthcare Conference in New York, New York at 8:00 a.m. EDT on Tuesday, June 5, 2018; and at the Goldman Sachs 39th Annual Global Healthcare Conference in Rancho Palos Verdes, California at 10:00 a.m. PDT on Thursday, June 14, 2018.

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!

A live audio webcast of the presentation and a copy of the presentation will be accessible from the Company’s website at www.westpharma.com/en/investors.

On May 24, 2018 Medtronic plc (NYSE: MDT) reported financial results for its fourth quarter and fiscal year 2018, which ended April 27, 2018 (Press release, Medtronic, MAY 24, 2018, View Source;p=RssLanding&cat=news&id=2350610 [SID1234526879]).

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 reported fourth quarter worldwide revenue of $8.144 billion, an increase of 2.9 percent as reported, or 6.5 percent on an organic basis, which adjusts for the divestiture of its Patient Care, Deep Vein Thrombosis (Compression), and Nutritional Insufficiency businesses to Cardinal Health that occurred in the second quarter, and a $315 million positive impact from foreign currency. As reported, fourth quarter GAAP net income and diluted earnings per share (EPS) were $1.460 billion and $1.07, respectively. As detailed in the financial schedules included through the link at the end of this release, fourth quarter non-GAAP net income and diluted EPS were $1.942 billion and $1.42, increases of 6 percent and 7 percent, respectively. Adjusting for the divestiture and a negative 2 cent impact from foreign currency, fourth quarter non-GAAP diluted EPS increased 15 percent.

Fourth quarter U.S. revenue of $4.187 billion represented 52 percent of company revenue and decreased 4.9 percent as reported, while it increased 5.3 percent on a comparable basis, which adjusts for the divestiture. Non-U.S. developed market revenue of $2.718 billion represented 33 percent of company revenue and increased 10.8 percent as reported and 4.6 percent on a comparable, constant currency basis. Emerging market revenue of $1.239 billion represented 15 percent of company revenue and increased 16.8 percent as reported and 15.5 percent on a comparable, constant currency basis.

Medtronic’s fiscal year 2018 revenue of $29.953 billion increased 0.8 percent, or 4.6 percent on an organic basis, adjusting for the divestiture, acquisitions, and the $494 million positive impact from foreign currency. As reported, fiscal year 2018 net earnings were $3.104 billion or $2.27 per diluted share. As detailed in the link at the end of this release, fiscal year 2018 non-GAAP earnings and diluted EPS were $6.530 billion and $4.77, representing increases of 2 percent and 4 percent, respectively. Adjusting for the divestiture and a negative 4 cent impact from foreign currency, fiscal year 2018 non-GAAP diluted EPS increased 10 percent.

Fiscal year 2018 cash flow from operations was $4.7 billion, which includes a $1.1 billion pre-payment the company elected to make late in the fourth quarter to the U.S. IRS related to in-process litigation on Puerto Rico transfer pricing. Excluding the $1.1 billion payment, fiscal year 2018 free cash flow would have been $4.7 billion. The expense associated with this payment was recognized in prior quarters’ earnings, and the payment was made to eliminate the timing uncertainty of the cash outflow, as well as stop the accrual of significant interest.

"Looking at our fourth quarter results, we delivered another strong quarter, as we continue to execute on our sustainable growth strategy, driving therapy innovation and global market penetration, while delivering enterprise synergies to expand margins," said Omar Ishrak, Medtronic chairman and chief executive officer. "We overcame several challenges in the first half of our fiscal year to deliver a strong second half, led by 6.5 percent organic revenue growth. We came in at the high end of both the revenue and EPS guidance we established at the start of the year."

Cardiac and Vascular Group
The Cardiac and Vascular Group (CVG) includes the Cardiac Rhythm & Heart Failure (CRHF), Coronary & Structural Heart (CSH), and Aortic & Peripheral Vascular (APV) divisions. CVG worldwide fourth quarter revenue of $3.135 billion increased 10.1 percent, or 5.4 percent on a constant currency basis. CVG revenue performance was driven by strong, low-teens growth in CSH, mid-single digit growth in APV, and low-single digit growth in CRHF, all on a constant currency basis.

CRHF fourth quarter revenue of $1.633 billion increased 5.8 percent, or 1.5 percent on a constant currency basis. Arrhythmia Management grew in the low-single digits on a constant currency basis, driven by high-single digit growth in Pacing, led by the strong adoption of the Micra Transcatheter Pacing System and the launch of the Azure wireless pacemaker. Results were also driven by double digit growth in AF Solutions, Mechanical Circulatory Support, and TYRX in Infection Control.
CSH fourth quarter revenue of $1.005 billion increased 18.7 percent, or 12.8 percent on a constant currency basis, led by low-twenties constant currency growth in transcatheter aortic valves on the global strength of the CoreValve Evolut PRO. Coronary grew in the mid-teens on a constant currency basis, driven by strong demand for the company’s Resolute Onyx(TM) drug-eluting stent in the U.S. and Japan.
APV fourth quarter revenue of $497 million increased 8.8 percent, or 4.8 percent on a constant currency basis. Aortic grew in the low-single digits on a constant currency basis, driven by customer adoption of its endoanchor fixation solutions for short necks. Peripheral grew in the low-single digits on a constant currency basis, driven by strong PTA balloon growth in the United States and drug-coated balloon growth in international markets. Mid-teens constant currency growth in endoVenous was driven by strong demand for the VenaSeal(TM) closure system.
Minimally Invasive Therapies Group
The Minimally Invasive Therapies Group (MITG) includes the Surgical Innovations (SI) and the Respiratory, Gastrointestinal & Renal (RGR) divisions. MITG worldwide fourth quarter revenue of $2.237 billion decreased 14.1 percent as reported, or increased 4.8 percent on a comparable, constant currency basis. MITG revenue performance was driven by mid-single digit growth in SI and low-single digit growth in RGR, both on a comparable, constant currency basis.

SI fourth quarter revenue of $1.513 billion increased 5.9 percent on a comparable, constant currency basis, driven by growth from new products in Advanced Energy and Advanced Stapling, including LigaSure(TM) vessel sealing instruments with nano-coating, endo stapling specialty reloads, and the Signia(TM) powered stapler.
RGR fourth quarter revenue of $724 million increased 2.5 percent on a comparable, constant currency basis. GI and Hepatology grew in the low-double digits on a comparable, constant currency basis, with continued strength across the GI therapeutics, diagnostics, and ablation product lines. Respiratory and Patient Monitoring grew in the low-single digits on a comparable, constant currency basis, with continued strength in Nellcor(TM) pulse oximetry sensors given the strong incidence of influenza in the U.S.
Restorative Therapies Group
The Restorative Therapies Group (RTG) includes the Spine, Brain Therapies, Specialty Therapies, and Pain Therapies divisions. RTG worldwide fourth quarter revenue of $2.127 billion increased 9.0 percent, or 6.1 percent on a constant currency basis. Group results were driven by low-double digit growth in Brain Therapies and Pain Therapies, mid-single digit growth in Specialty Therapies, and low-single digit growth in Spine, all on a constant currency basis.

Spine fourth quarter revenue of $699 million increased 3.4 percent, or 1.0 percent on a constant currency basis. Spine’s growth was driven by high-single digit constant currency growth in bone morphogenetic protein (BMP) offset by low-single digit declines in Core Spine.
Brain Therapies fourth quarter revenue of $672 million increased 14.9 percent, or 11.3 percent on a constant currency basis. Neurovascular grew in the high-teens on a constant currency basis, with strong growth in stents and access products. Neurosurgery grew in the low-double digits on a constant currency basis, led by strong sales of the StealthStation S8 surgical navigation system, Mazor X(TM) robotic guidance system, and Visualase MRI-guided laser ablation system.
Specialty Therapies fourth quarter revenue of $424 million increased 7.1 percent, or 4.3 percent on a constant currency basis. Results were led by mid-single digit growth in Pelvic Health and ENT and low-single digit growth in Transformative Solutions, all on a constant currency basis.
Pain Therapies fourth quarter revenue of $332 million increased 12.9 percent, or 9.9 percent on a constant currency basis. The division had strong mid-teens growth in Pain Stimulation on the strength of the recently launched Intellis(TM) platform for spinal cord stimulation, as well as mid-single digit growth in Targeted Drug Delivery and Interventional Pain.
Diabetes Group
The Diabetes Group includes the Intensive Insulin Management (IIM), Diabetes Service & Solutions (DSS), and Non-Intensive Diabetes Therapies (NDT) divisions. Diabetes Group worldwide fourth quarter revenue of $645 million increased 26.0 percent, or 21.3 percent on a constant currency basis. The group is experiencing strong global demand for its new sensor-augmented insulin pump systems.

IIM fourth quarter revenue grew in the high-twenties on a constant currency basis, driven by the U.S. launch of the MiniMed 670G hybrid closed loop insulin pump system with the Guardian sensor 3 continuous glucose monitor (CGM). In international markets, IIM delivered mid-twenties constant currency growth on the continued strength of the MiniMed 640G system.
DSS fourth quarter revenue grew in the low-double digits on a constant currency basis, with strong growth in consumables benefitting from customer base growth and improved patient utilization.
NDT fourth quarter revenue declined in the low twenties on a constant currency basis, given the commercial focus on the MiniMed 670G launch and competitive pressures.
Guidance
The company today issued its fiscal year 2019 revenue and EPS growth guidance.

In fiscal year 2019, the company expects organic revenue growth to be in the range of 4.0 to 4.5 percent. If current exchange rates remain similar for the fiscal year, the company’s fiscal year 2019 revenue would be negatively affected by approximately $50 million to $150 million.

In fiscal year 2019, the company expects diluted non-GAAP EPS in the range of $5.10 to $5.15, which implies 10 percent growth at the mid-point of the range and assumes a 5 cent benefit from foreign exchange based on current exchange rates.

"Looking ahead, we feel good about the growth opportunities in our markets and our competitive position in these markets. We expect continued revenue growth and margin expansion. We are also focused on improving free cash flow conversion and making the right investments to drive shareholder value," said Ishrak. "We look forward to discussing our long-term strategies and providing our long-range outlook at our biennial institutional investor and analyst meeting on June 5th."

Webcast Information
Medtronic will host a webcast today, May 24, at 8:00 a.m. EDT (7:00 a.m. CDT) to provide information about its businesses for the public, analysts, and news media. This quarterly webcast can be accessed by clicking on the Investor Events link at investorrelations.medtronic.com and this earnings release will be archived at newsroom.medtronic.com. Medtronic will be live tweeting during the webcast on our Newsroom Twitter account, @Medtronic. Within 24 hours of the webcast, a replay of the webcast and transcript of the company’s prepared remarks will be available by clicking on the Investor Events link at investorrelations.medtronic.com.

Financial Schedules
To view the fourth quarter and fiscal year 2018 financial schedules and non-GAAP reconciliations, click here. To view the fourth quarter and fiscal year 2018 earnings presentation, click here. Both documents can also be accessed by visiting newsroom.medtronic.com

On May 24, 2018 Incyte Corporation (Nasdaq:INCY) reported that it will present at the following investor conferences during the month of June (Press release, Incyte, MAY 24, 2018, View Source;p=RssLanding&cat=news&id=2350636 [SID1234527086]):

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!

Goldman Sachs 39th Annual Global Healthcare Conference on Tuesday, June 12, 2018 at 2:40 pm (PDT) / 5:40 pm (EDT) in Rancho Palos Verdes; and

William Blair’s 38th Annual Growth Stock Conference on Wednesday, June 13, 2018 at 12:40 pm (CDT) / 1:40 pm (EDT) in Chicago

The presentations will be webcast live and can be accessed at www.incyte.com in the Investors section under "Events and Presentations." Investors interested in listening to the live webcasts should log on before the start time in order to download any software required.