On September 5, 2016 Fresenius Helios reported that it has acquired IDC Salud Holding S.L.U. ("Quirónsalud"), Spain’s largest private hospital operator, for a purchase price of €5.76 billion2. Quirónsalud’s network is comprised of 43 hospitals, 39 outpatient centers and around 300 Occupational Risk Prevention ("ORP") centers located in all economically important areas in Spain (Press release, Fresenius, SEP 5, 2016, View Source [SID:1234514925]). The company has about 35,000 employees and offers the full spectrum of inpatient and outpatient care. Quirónsalud was created by the merger of IDC Salud ("IDC") and Grupo Hospitalario Quirón ("GHQ") in 2014.

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Quirónsalud has posted organic sales growth of more than 5% p.a. in recent years. Growth is driven by an above-market increase of patient admissions due to excellent quality of care combined with consistently short waiting times.

Quirónsalud is also a pioneer in public-private partnership ("PPP") models, operating five hospitals (four in Madrid and one in Barcelona) that are integrated within the public healthcare network. Under the PPP agreements, Quirónsalud is assigned responsibility for the publicly insured inhabitants of certain coverage areas and receives remuneration based on capitation or activity performed.

Greenfield hospital projects and acquisitions have also contributed to Quirónsalud’s overall strong sales growth. Going forward, cross-selling between the recently acquired ORPs and Quirónsalud’s hospitals are expected to be yet another growth driver.
For 2016, Quirónsalud expects sales of approximately €2.5 billion and EBITDA of €460 to €480 million. In 2017, EBITDA is expected to be in the range of €520 to €550 million. The purchase price corresponds to approximately 10.8x at the mid-point of the 2017 EBITDA range.

Key drivers of the anticipated EBITDA growth are already implemented synergy projects related to the 2014 merger of IDC and GHQ, recent acquisitions, well-advanced efficiency projects as well as operating leverage. Neither greenfield projects, further acquisitions nor synergies with HELIOS are included in the 2017 projections. In the medium-term, the merger of HELIOS and Quirónsalud is expected to lead to incremental pre-tax synergies of approximately €50 million p.a. without meaningful implementation expenses.

Stephan Sturm, CEO of Fresenius, said: "This acquisition combines two leaders in terms of quality and size. Our patients will benefit from the exchange of knowledge and ideas. For Fresenius, this acquisition is another strategic step towards offering quality and yet affordable care for patients worldwide."

Francesco De Meo, CEO of Fresenius Helios, said: "We are acquiring the largest private hospital operator in Spain, Europe’s number four. Quirónsalud has shown an impressive development and stands for best-in-class quality in patient care. Quirónsalud and HELIOS perfectly fit together as we can leverage on each other’s experience and knowledge. The new group will preserve both brands, Quirónsalud in Spain and Helios in Germany. I am particularly delighted that Víctor Madera will, beyond his ongoing role as CEO of Quirónsalud, play a very active role in our combined group. We aim to achieve the best for our patients in Germany and Spain, and, together with our Spanish partners, intend to leave a mark in the European health care system."

Víctor Madera, founder and CEO of Quirónsalud, said: "I am extremely pleased to join such a splendid organization as HELIOS and very much look forward to a fruitful cooperation with Francesco De Meo. I am firmly convinced that HELIOS and Quirónsalud are ideal partners to achieve the best care for our patients in both Germany and Spain."

Fresenius Helios acquires 100% of the share capital in Quirónsalud. Sellers are the private equity group CVC Capital Partners, Víctor Madera and other members of Quirónsalud’s management board.

Fresenius will issue 6,108,176 shares valued at €400 million to Víctor Madera who has agreed to a two year lock-up period. The balance of the purchase price will be debt-financed.

Group net debt/EBITDA will temporarily increase to approximately 3.1. Already in mid-2017, the leverage ratio is expected to return to the 2.5 to 3.0 target range.

The transaction is subject to regulatory approval by the relevant antitrust authorities and is expected to close in Q4/2016 or Q1/2017.

The transaction is expected to be highly accretive to Group net income3 and EPS3 already in 2017.

Given the expected meaningful accretion to Group sales and earnings, Fresenius will publish new mid-term targets as part of its full-year 2016 reporting.

On September 2, 2016 LeadArtis reported its participation as coordinator of the IBIMAB project (Cancer immunotherapy with bispecific costimulatory antibodies) funded by the Spanish Ministry of Economy and Competitiveness (MINECO) under the RETOS 2016 Collaboration program (Press release, LeadArtis, SEP 2, 2016, View Source [SID:SID1234515139]). IBIMAB counts with collaborators such as the internationally regarded research institutions: Centro de Investigación Médica Aplicada-CIMA (Pamplona, Spain), Hospital Universitario Puerta de Hierro-HUPH (Madrid, Spain) and Instituto de investigaciones biomédicas Alberto Sols-IIBm-CSIC (Madrid, Spain). The MINECO’s funding demonstrates the support of LeadArtis technology and main objectives.

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Some of the most effective cancer immunotherapy strategies are based on the modulation of molecular interactions dubbed immune check-points using monoclonal antibodies (mAbs). LeadArtis generates bispecific hexavalent trimerbodies (BHTs) exploiting the expression of two cell surface antigens, one a costimulatory molecule on the T cells and the other a tumor-associated antigen (TAA) on the tumor cells. The anti-TAA specificity allows efficient location of the BHT into the tumor deposits, providing a more efficient interaction with the costimulatory antigen expressed on the surface of tumor infiltrating T lymphocytes. Our company focuses on two clinically validated mechanisms of action synergistic when combining individual mAbs (IgG type). LeadArtis will use its proprietary trimerbody technology to generate a fully human bispecific hexavalent antibody as candidate for development.

LeadArtis is the leading company aiming to bring to the market cancer immunotherapeutic trimerbodies. Despite recent advances in the field, most of the current initiatives are early stage and exploratory. Currently, most of current immune-checkpoint blockers in development are conventional monoclonal antibodies (mAbs); comparatively, recombinant antibody technologies are strongly positioned and shortly will become preferred for clinically validated mechanisms of action. The trimerbody added value is multivalence and multispecificity, small size & ease of manufacturing to generate more effective compounds.

On September 2, 2016 CEL-SCI Corporation (NYSE MKT: CVM) ("CEL SCI" or the "Company") reported that during the month of August it has enrolled 28 patients in its ongoing Phase 3 trial of its investigational immunotherapy Multikine* (Leukocyte Interleukin, Injection) in patients with advanced primary head and neck cancer (Press release, Cel-Sci, SEP 2, 2016, View Source [SID:1234514890]). Total patient enrollment for the trial is now 905 as of August 31, 2016.

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The Multikine Phase 3 study is enrolling patients with advanced primary (not yet treated) squamous cell carcinoma of the head and neck. The objective of the study is to demonstrate a statistically significant improvement in the overall survival of enrolled patients who are treated with the Multikine treatment regimen plus standard of care ("SOC") vs. subjects who are treated with SOC only.

About Multikine

Multikine is an investigational immunotherapeutic agent that is being tested in an open-label, randomized, controlled, global pivotal Phase 3 clinical trial as a potential first-line (before any other, right after diagnosis) treatment for advanced primary squamous cell carcinoma of the head and neck. Multikine is designed to be a different type of therapy in the fight against cancer: one that appears to have the potential to work with the body’s natural immune system in the fight against tumors.

Multikine is also being tested in a Phase 1 study at University of California, San Francisco (UCSF), as a potential treatment for peri-anal warts in HIV/HPV co-infected men and women. Dr. Joel Palefsky, a world-renowned scientist and Key Opinion Leader (KOL) in human papilloma virus (HPV) research and the prevention of anal cancer, is the Principal Investigator at UCSF.

On September 1, 2016 Novocure (NASDAQ: NVCR) reported that data showing Tumor Treating Fields (TTFields) in combination with paclitaxel is therapeutically effective against ovarian cancer cells in vitro and in vivo has been published by the International Journal of Cancer (Press release, NovoCure, SEP 1, 2016, View Source [SID:1234514873]). This Novocure preclinical research is the first to demonstrate that TTFields in combination with paclitaxel may be a potentially effective strategy for the treatment of ovarian cancer.

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In vitro application of TTFields alone to human ovarian cancer cell lines led to significant reductions in cell counts compared to untreated cells. TTFields treatment combined with paclitaxel resulted in additive and even synergistic efficacy depending on the ovarian cell line treated. In vivo, TTFields plus paclitaxel led to a significantly larger anti-tumor effect than either treatment alone.

Novocure also examined the feasibility of local delivery of TTFields to the human abdomen using finite element mesh simulations, a commonly used technique for calculating electric field distribution in complex geometries like the human body. These simulations demonstrated that electric fields intensities inside and in the vicinity of the ovaries are within the range of intensities required for effective treatment with TTFields.

"Treatment with TTFields is broadly applicable and has shown a consistent antimitotic effect in our preclinical and clinical research over the last 16 years," said Eilon Kirson, Novocure’s Chief Science Officer and Head of Research and Development. "Novocure is committed to increasing the understanding of the mechanisms of action and potential clinical utility of TTFields in multiple solid tumors through the presentation and peer-reviewed publication of high quality data."

Based on these preclinical results, Novocure initiated the INNOVATE trial, an open-label, phase 2 pilot study of TTFields in combination with weekly paclitaxel for the treatment of recurrent ovarian cancer. The INNOVATE trial is fully enrolled, and Novocure expects to share data at its research and development day on Monday, Dec. 12, 2016.

About Ovarian Cancer

Ovarian cancer is the fifth most common cause of cancer death in women in the United States. The National Cancer Institute estimated that in 2015, there were approximately 21,000 new cases of ovarian cancer diagnosed and approximately 14,000 deaths in the United States. Ovarian cancer incidence increases with age, and the median age at time of diagnosis is 63 years old. The five-year survival rate is 44 percent, and the majority of patients present at advanced stage with 60 percent having metastatic disease. TTFields therapy is not approved for the treatment of ovarian cancer by the U.S. Food and Drug Administration. The safety and effectiveness of TTFields therapy for ovarian cancer has not been established.