On February 20, 2018 Medtronic plc (NYSE: MDT) reported financial results for its third quarter of fiscal year 2018, which ended January 26, 2018 (Press release, Medtronic, FEB 20, 2018, View Source;p=RssLanding&cat=news&id=2333238 [SID1234524055]).

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The company reported third quarter worldwide revenue of $7.369 billion, an increase of 1 percent as reported, or 7 percent on a comparable, constant currency 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 $177 million positive impact from foreign currency.

As reported, third quarter GAAP net loss and loss per share (LPS) were $1.389 billion and $1.03, respectively. GAAP results included a $2.2 billion net charge primarily related to the U.S. transition tax charge as part of U.S. tax reform. As detailed in the financial schedules included through the link at the end of this release, third quarter non-GAAP net income and diluted EPS were $1.592 billion and $1.17, increases of 3 percent and 4 percent, respectively. Adjusting for the divestiture and a negative 1 cent impact from foreign currency, third quarter non-GAAP diluted EPS increased 12 percent.

Third quarter U.S. revenue of $3.912 billion represented 53 percent of company revenue and decreased 5 percent as reported, or increased 6 percent on a comparable basis. Non-U.S. developed market revenue of $2.355 billion represented 32 percent of company revenue and increased 7 percent as reported, or 5 percent on a comparable, constant currency basis. Emerging market revenue of $1.102 billion represented 15 percent of company revenue and increased 12 percent on both a reported and a comparable, constant currency basis.

"Our results reflect a solid quarter for Medtronic, and as we expected, a strong turnaround from the first half of our fiscal year," said Omar Ishrak, Medtronic chairman and chief executive officer. "We continue to execute on our broad, sustainable growth strategy, driving therapy innovation and global market penetration, while delivering enterprise synergies to enable margin improvement."

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 third quarter revenue of $2.800 billion increased 10 percent, or 7 percent on a constant currency basis. CVG revenue performance was driven by strong, mid-teens growth in CSH and mid-single digit growth in CRHF and APV, all on a constant currency basis.

CRHF third quarter revenue of $1.457 billion increased 6 percent, or 4 percent on a constant currency basis. Arrhythmia Management grew in the low-single digits on a constant currency basis, driven by high-teens constant currency growth in AF Solutions, as well as strong adoption of the Micra Transcatheter Pacing System and TYRX absorbable antibacterial envelope. Heart Failure grew in the mid-single digits on a constant currency basis, driven by strong double digit constant currency growth in Mechanical Circulatory Support from sales of the HVAD(TM) System, as well as continued solid demand for the company’s portfolio of quadripolar cardiac resynchronization therapy pacemakers (CRT-P).
CSH third quarter revenue of $886 million increased 18 percent, or 14 percent on a constant currency basis, led by low-thirties constant currency growth in transcatheter aortic valves on the strength of the CoreValve Evolut PRO and U.S. intermediate risk indication. Coronary grew in the low-double digits 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 third quarter revenue of $457 million increased 7 percent, or 5 percent on a constant currency basis. Aortic grew in the low-single digits on a constant currency basis, driven by the performance of the Valiant Captivia thoracic stent graft system. Peripheral grew in the mid-single digits on a constant currency basis, driven by double digit growth in both PTA balloons and drug-coated balloons. High-single digit growth in endoVenous was driven by a strong performance of 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 third quarter revenue of $2.041 billion decreased 16 percent as reported, or increased 6 percent on a comparable, constant currency basis. MITG revenue performance was driven by high-single digit growth in SI and low-single digit growth in RGR, both on a comparable, constant currency basis.

SI third quarter revenue of $1.384 billion increased 7 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 third quarter revenue of $657 million increased 3 percent on a comparable, constant currency basis. GI and Hepatology grew in the low-double digits on a comparable, constant currency basis, with 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 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 third quarter revenue of $1.944 billion increased 7 percent, or 5 percent on a constant currency basis. Group results were driven by low-double digit growth in Brain Therapies, high-single digit growth in Pain Therapies, and mid-single digit growth in Specialty Therapies, offsetting flat results in Spine, all on a constant currency basis.

Spine third quarter revenue of $661 million increased 1 percent, or was flat on a constant currency basis. Mid-single digit constant currency growth in bone morphogenetic protein (BMP) partially offset low-single digit declines in Core Spine, which were consistent with the Core Spine market.
Brain Therapies third quarter revenue of $585 million increased 13 percent, or 10 percent on a constant currency basis. Neurovascular grew in the high-teens on a constant currency basis, with strength across its stroke product portfolio. Neurosurgery grew in the low-double digits on a constant currency basis, led by strong sales of the StealthStation S8 surgical navigation system and O-arm2 surgical imaging system.
Specialty Therapies third quarter revenue of $398 million increased 8 percent, or 6 percent on a constant currency basis. High-single digit growth in Pelvic Health and ENT was partially offset by low-single digit declines in Transformative Solutions, all on a constant currency basis.
Pain Therapies third quarter revenue of $300 million increased 10 percent, or 8 percent on a constant currency basis. The division returned to growth on the strength of the recently launched Intellis(TM) platform for spinal cord stimulation, as well as growth in drug pumps.
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 third quarter revenue of $584 million increased 17 percent, or 13 percent on a constant currency basis. The group is experiencing strong global demand for its new sensor-augmented insulin pump systems, and has made great progress on its ability to meet this demand, as evidenced by the improved sequential revenue growth.

IIM third quarter revenue grew in the high-teens 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 CGM. In international markets, IIM delivered low-twenties constant currency growth on the continued strength of the MiniMed 640G system.
DSS third quarter revenue grew in the mid-single digits on a constant currency basis, with growth in consumables benefitting from customer base growth and improved patient utilization.
NDT third quarter revenue declined in the mid-single digits on a constant currency basis, given the commercial focus on the MiniMed 670G launch and competitive pressures.
Guidance
Medtronic today reiterated its fiscal year 2018 revenue and non-GAAP guidance. The company’s guidance is given on a comparable, constant currency basis, which accounts for the divestiture of certain businesses from its prior period Patient Monitoring & Recovery division by removing the financial impact of these businesses from the second, third, and fourth quarters of fiscal year 2017, as well as removing the impact of foreign currency.

In fiscal year 2018, the company continues to expect comparable, constant currency revenue growth to be in the range of 4 to 5 percent. While the impact of foreign currency remains fluid, if current exchange rates remain similar for the remainder of the fiscal year, the company’s revenue would be positively affected by approximately $480 million to $500 million for the fiscal year, including an approximate $300 to $320 million positive impact in the fourth fiscal quarter.

In fiscal year 2018, the company continues to expect diluted non-GAAP EPS growth to be in the range of 9 to 10 percent on a comparable, constant currency basis from the prior year comparable EPS of $4.37. Assuming current exchange rates remain similar for the rest of the year, the foreign exchange impact on the company’s non-GAAP EPS would be approximately negative 4 cents for the fiscal year, including an approximate 2 cent negative impact in the fourth fiscal quarter.

"Looking ahead, we are confident in our ability to deliver mid-single digit constant currency revenue growth and strong constant currency EPS leverage, this fiscal year and beyond," said Ishrak. "We remain keenly focused on executing to deliver dependable results as we continue to leverage our global diversification and scale to fulfill our Mission of alleviating pain, restoring health, and extending life for millions of people around the world."

Webcast Information
Medtronic will host a webcast today, February 20, at 8:00 a.m. EST (7:00 a.m. CST) 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 third quarter financial schedules and non-GAAP reconciliations, click here. To view the third quarter earnings presentation, click here. Both documents can also be accessed by visiting newsroom.medtronic.com.

On February 20, 2018 Nordic Nanovector ASA (OSE: NANO) reported its fourth quarter and full year 2017 results on Tuesday, 27th of February 2018 (Press release, Nordic Nanovector, FEB 20, 2018, View Source [SID1234553512]).

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A presentation by Nordic Nanovector’s senior management team will take place at 8:30 am CET at:

Thon Hotel Vika Atrium, Munkedamsveien 45, 0250 Oslo

Meeting Room: NYLAND

The presentation will be recorded as a webcast and will be available at www.nordicnanovector.com in the section: Investors & Media

The results report and the presentation will be available at www.nordicnanovector.com in the section: Investors & Media/Reports and Presentation/Interim Reports/2017 from 7:00 am CET the same day.

On February 20, 2018 Actinium Pharmaceuticals, Inc. (NYSE American:ATNM) ("Actinium" or "the Company") reported that representatives from the Company’s executive and clinical development teams will be attending the BMT Tandem Meetings, the combined annual meetings of the American Society of Blood and Marrow Transplantation (ASBMT) and the Center for International Blood & Marrow Transplant Research (CIBMTR) (Press release, Actinium Pharmaceuticals, FEB 20, 2018, View Source [SID1234524062]).The conference is being held February 21 through February 25, 2018, at the Salt Palace Convention Center in Salt Lake City, Utah.

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Actinium’s planned Phase 2 trial for Actimab-MDS will be highlighted in the Company’s Product Theater, Actimab for CD33 Expressing Hematologic Malignancies, which will feature Dr. Sergio Giralt, Chief, Adult Bone Marrow Transplant Service at Memorial Sloan Kettering Cancer Center and Dr. Koen van Besien, Director, Stem Cell Transplant Program at Weill Cornell Medical Center. The planned Phase 2 trial for Actimab-MDS will study Actinium’s anti-CD33-actinium-225 antibody radio-conjugate (ARC) as a myeloablative agent prior to a bone marrow transplant for patients with high-risk myelodysplastic syndrome (MDS) with a p53 genetic mutation. Actinium will be conducting an investigator meeting with representatives from current and prospective clinical trial sites from the Company’s pivotal Phase 3 SIERRA trial for Iomab-B. Also, Actinium will formally meet with the Iomab-B Scientific Advisory Board (SAB) to discuss the ongoing SIERRA trial and other initiatives in improved myeloablation.

Dr. Mark Berger, Chief Medical Officer of Actinium said, "With our mission at Actinium to improve the pathway for patients undergoing bone marrow transplants, the annual BMT Tandem Meetings is a critical forum that enables us to meet with Key Opinion Leaders (KOLs) in the area of bone marrow transplant medicine to share our latest research findings and learn from others. Our attendance at this event offers a rich opportunity to gain insight into the latest developments in our field of science. We are very much looking forward to our investigator and SAB meetings that will provide us with the opportunity to further highlight Iomab-B’s highly differentiated profile and discuss certain aspects of the SIERRA trial such as our recent protocol amendment, crossover rates and case studies with representatives from leading bone marrow transplant centers."

The BMT Tandem Meetings include an exciting scientific program that addresses state-of-the-art issues in bone marrow transplant. Meeting attendees include investigators, clinicians, laboratory technicians, clinical research professionals, nurses, pharmacists, administrators and allied health professionals seeking to benefit from its hematopoietic cell transplantation focused program.

Sandesh Seth, Actinium’s Executive Chairman said, "Our Iomab-B and Actimab-MDS drug candidates are critical elements to our overall strategy at Actinium to improve transplant access and outcomes via improved myeloablation. We anticipate this year’s conference to be even more productive for us than last year as we are attending as the only company with a multi-disease, multi-product pipeline focused on improved myeloablation."

About BMT Tandem Meetings

Annually, the BMT Tandem Meetings are the largest gathering in North America of worldwide experts in blood and marrow transplant patient care, clinical investigation and laboratory research. Over 3,000 transplant physicians in over 500 transplant centers from >50 countries participate in the CIBMTR. The ASBMT has a membership of over 2,300 clinicians and researchers. By combining our meetings, we expect over 3,200 participants at next year’s meetings representing more than 50 countries, with approximately 20% coming from outside the United States.

On February 20, 2018 Fate Therapeutics, Inc. (NASDAQ:FATE), a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for cancer and immune disorders, announced today that the first subject has been treated in the DIMENSION study of FATE-NK100 for the treatment of advanced solid tumors (Press release, Fate Therapeutics, FEB 20, 2018, View Source [SID1234524182]). The clinical trial is intended to evaluate the safety and determine the maximum dose of FATE-NK100, the Company’s first-in-class, allogeneic donor-derived adaptive memory natural killer (NK) cell cancer therapy, when administered as a monotherapy and in combination with trastuzumab or cetuximab, two FDA-approved targeted monoclonal antibody therapies that are widely used today to treat various cancers.

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"Patients with cancer often have deficient or dysfunctional natural killer cells. The co-administration of FATE-NK100 alongside a targeted monoclonal antibody therapy is a novel approach to restore a patient’s immune cell function and to selectively recognize and kill antibody-coated tumor cells," said Manish R. Patel, D.O., Assistant Professor of Medicine, Division of Hematology, Oncology and Transplantation at the University of Minnesota and the lead investigator of the clinical trial at the Masonic Cancer Center. "We are excited to have initiated what we believe to be the first clinical investigation of healthy allogeneic donor NK cell therapy in combination with FDA-approved monoclonal antibody therapy for solid tumor malignancies. This new treatment paradigm holds great promise for cancer patients who have progressed on or failed monoclonal antibody therapy and have no other therapeutic options."

Monoclonal antibodies are a well-established class of cancer immunotherapy agents designed to selectively target and bind to proteins on the surface of tumor cells. Compelling clinical data indicate that NK cells mediate the therapeutic effect of monoclonal antibody therapy by recognizing and efficiently killing antibody-coated tumor cells via a potent immune response mechanism known as antibody-dependent cellular cytotoxicity (ADCC). The combination of FATE-NK100 and monoclonal antibody therapy is designed to enhance ADCC by administering an activated population of healthy allogeneic donor NK cells to augment the killing of antibody-coated tumor cells. It is estimated that the worldwide market for cancer monoclonal antibodies is over $30 billion, and is poised to reach $45 billion by the end of 2020.

DIMENSION is the third clinical trial of FATE-NK100 currently being conducted. FATE-NK100 is also being clinically investigated in the VOYAGE study for the treatment of refractory or relapsed acute myelogenous leukemia and in the APOLLO study for the treatment of ovarian cancer resistant to, or recurrent on, platinum-based treatment.

About DIMENSION
DIMENSION is a multi-center, open-label, accelerated dose-escalation Phase 1 clinical trial of FATE-NK100 in subjects with advanced solid tumors who have progressed on or failed available approved therapies. The clinical trial is designed to evaluate the safety and determine the maximum dose of a single intravenous infusion of FATE-NK100 when administered as a monotherapy and in combination with monoclonal antibody therapy after outpatient lymphoconditioning therapy followed by sub-cutaneous IL-2 administration. Other endpoints to be assessed include objective response rates and progression-free and overall survival.

The clinical trial is being conducted across three independent treatment arms: (i) as a monotherapy for advanced solid tumor malignancies, including small cell lung cancer and hepatocellular carcinoma; (ii) in combination with trastuzumab for advanced human epidermal growth factor receptor 2 positive (HER2+) cancers, including breast and gastric cancers; and (iii) in combination with cetuximab for advanced epidermal growth factor receptor 1 positive (EGFR1+) cancers, including colorectal and head and neck cancers. In the combination arms, subjects will receive the monoclonal antibody therapy two days prior to and seven days following administration of FATE-NK100. Subjects with evidence of tumor shrinkage at Day 29 following administration of FATE-NK100 may be considered for retreatment.

Up to three dose levels in the monotherapy arm, and up to four dose levels in the monoclonal antibody therapy arms, of FATE-NK100 are intended to be assessed. In the event a dose limiting toxicity is observed in an arm, the arm will convert to a 3+3 design. Following dose escalation, expansion cohorts of 20 subjects per arm may be enrolled.

About FATE-NK100
FATE-NK100 is a first-in-class, allogeneic donor-derived natural killer (NK) cell cancer immunotherapy comprised of adaptive memory NK cells, a highly specialized and functionally distinct subset of activated NK cells expressing the maturation marker CD57. Higher frequencies of CD57+ NK cells in the peripheral blood or tumor microenvironment in cancer patients have been linked to better clinical outcomes. In preclinical studies, FATE-NK100 has demonstrated enhanced anti-tumor activity across a broad range of hematologic and solid tumors, with augmented cytokine production, improved persistence, enhanced antibody-dependent cellular cytotoxicity and increased resistance to immune checkpoint pathways compared to other NK cell therapies that are being clinically administered today. FATE-NK100 is produced through a feeder-free, seven-day manufacturing process during which NK cells sourced from a healthy allogeneic donor are activated ex vivo with pharmacologic modulators. In August 2017, non-clinical data describing the unique properties and anti-tumor activity of FATE-NK100 were published by Cancer Research (doi:10.1158/0008-5472.CAN-17-0799), a peer-reviewed journal of the American Association of Cancer Research.

On February 20, 2018 Athenex (Nasdaq:ATNX), a global biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies for the treatment of cancer and related conditions, reported that the Phase II clinical study data for KX2-391 for the treatment of actinic keratosis was presented by Dr. Seth Forman of Forward Clinical Trials, Tampa, at the American Academy of Dermatology Annual Meeting on February 17, 2018 in San Diego, California (abstract ID 6134) (Press release, Athenex, FEB 20, 2018, View Source;p=RssLanding&cat=news&id=2333323 [SID1234524063]).

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Actinic keratosis is a common skin condition that is induced through ultra-violet light damage, resulting in patches of thick, scaly or crusty skin. Left untreated, the lesions have risk of progression to squamous cell carcinoma and consequently treatment by a dermatologist is recommended. Actinic keratosis is the most common pre-cancerous condition in dermatology and affects more than 55 million Americans. Actinic keratosis constitutes between 14-29% of dermatologist visits in the USA1.

KX2-391, also known as KX-01, is a first-in-class dual Src kinase and tubulin polymerization inhibitor being developed as a topical medicinal product for the treatment of actinic keratosis.

This Phase II clinical study aims to determine the activity, safety and pharmacokinetics of KX2-391 ointment 1% (5 days or 3 days) in adults with actinic keratosis on the face or scalp. This is an open-label, multicenter study conducted in adults who had 4-8 actinic keratosis lesions within a 25 cm2 area on the face or scalp. A cohort of subjects was given once daily application for 5 days and was assessed through Day 57 for actinic keratosis lesion counts, local skin reactions (LSRs), and adverse events (AEs). LSRs were scored on a scale of 0 to 4 (worst). A second cohort of 3-day treatment was enrolled after the 5-day treatment regimen demonstrated activity and safety.

A total of 168 patients were recruited (84 for each cohort) from 16 US clinical sites. Subjects were mostly white males, with a mean age of 68 years, skin type I to III and median baseline number of actinic keratosis lesions of 6 for the 5-day treatment cohort and 5 for the 3-day treatment cohort. The 5-day treatment cohort achieved a higher overall 100 percent clearance of actinic keratosis lesions at Day-57 (i.e. 8 weeks after the initiation of treatment) than the 3-day treatment cohort (43% vs. 32%). In the 5-day treatment cohort, 23 of 44 subjects (52%) with actinic keratosis on face and 13 of 40 (33%) on scalp attained 100 percent clearance at Day-57. LSRs were mild and mostly erythema, flaking/scaling, crusting and swelling with the majority of the LSRs scores of <2 and resolved rapidly. Only one subject scored 4 in erythema and flaking/scaling, which both resolved rapidly without concomitant medications. Erosions/ulcers and vesicles/pustules were observed in only 15% and 5% of subjects, respectively. No subjects scored ≥3 in erosions/ulcers/vesicles/pustules. Treatment related AEs were few and predominately mild transient application site pruritus, tenderness and pain. There were no treatment related serious AEs or discontinuations. Plasma levels of KX2-391 were low to undetectable.

Dr. Seth Forman, the presenting investigator for the Phase II study, commented, "This study demonstrated that KX2-391 ointment 1% is well tolerated and active as a field treatment of actinic keratosis of the face and the scalp with LSRs that are mostly mild and transient. KX2-391 ointment 1% daily for 5 consecutive days is currently being investigated in two Phase III placebo-controlled trials."

Dr. Rudolf Kwan, Athenex’s Chief Medical Officer, commented, "We are excited to see the excellent efficacy and safety profile of KX2-391 ointment 1% for the treatment of actinic keratosis. KX01 treatment may have the potential to change the paradigm of topical therapy for actinic keratosis."

Athenex and the FDA previously had an end of Phase II meeting regarding the program for the design of the Phase III studies. Two placebo-controlled Phase III studies, with a total target of 600 patients (300 patients for each study) were initiated on September 25, 2017 and the enrollment was completed rapidly ahead of an aggressive schedule. Athenex expects topline data of the Phase III studies to be available in the third quarter of 2018.

As previously announced on December 11, 2017, Athenex and Almirall, a leading skin-health focused global pharmaceutical company and one of the leaders in the field of actinic keratosis treatment, entered into a license agreement in which Athenex granted Almirall an exclusive license under the Athenex Intellectual Property to research, develop and commercialize KX2-391 in the United States of America and European countries, including Russia. Athenex will receive an upfront fee and near-term payments of up to USD $55 million, and additional indications milestones payment and a royalty payment starting at 15% based on annual net sales, with incremental increases in royalty rates with increased sales. Athenex retains certain co-promotion rights in the USA and retains the rights for other parts of the world including Canada, Central and South America, Japan, Asia and China, Australia and New Zealand, and Africa including South Africa. Almirall will employ its expertise to support the development in Europe and also to commercialize the product in the defined territories. Milestones were established to encourage the joint effort of Athenex and Almirall to develop additional indications and additional formulations.

Mr. Peter Guenter, Chief Executive Officer of Almirall, stated, "As one of the leaders of the medical treatment of actinic keratosis, we were excited by the potential profile of KX2-391, as demonstrated in this Phase II clinical study. We are also impressed by the Athenex team’s capabilities in drug development execution. We are pleased that the Athenex team has already completed the enrollment of the two Phase III studies of 600 patients in the USA. We are fully committed to this collaboration and will assist in the European development and registration strategy. We believe that KX2-391 has the potential to change the standard of care for actinic keratosis and look forward to combining our leadership abilities in the field with the drug development expertise of Athenex."

References

E. Stockfleth et al. Physician perceptions and experience of current treatment in actinic keratosis. JEADV 2015, 29, 298–306