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Taconic Biosciences Expands Humanized Mouse Model Production

Local Production of Critical Immuno-oncology Models Now Available in Europe

RENSSELAER, N.Y., Feb. 14, 2020 (GLOBE NEWSWIRE) — Taconic Biosciences, a global leader in providing drug discovery animal model solutions, announces its humanized immune system mice models are now being produced in Europe.  Local production provides European drug discovery researchers with easier access to this critical oncology research tool.

Humanized immune system mice enable drug discovery research by modeling various aspects of the human immune system.  These models are critical for immuno-oncology studies, which leverage a patient’s own immune system to fight cancer.  This approach is helping to create effective new treatments against various cancer forms.  Taconic’s humanized models are built upon the NOG Portfolio, a suite of immunodeficient mice that support engraftment and/or differentiation of various human immune cells.  Both the huNOG and huNOG-EXL models are now available for off the shelf sales from local European inventory.  Having Taconic’s humanized animal model portfolio produced proximal to European researchers reduces the transit time for these incredibly valuable assets.

“The human immune system is incredibly complex and immuno-oncology may be the starkest example of how animal models contribute to scientific breakthroughs by helping researchers understand, and even leverage that complexity,” comments Dr. Michael Seiler, vice president of commercial models at Taconic.  “It is only when these great tools are combined with the right scientific expertise do we see success.  Taconic leverages internal expertise plus external collaborations to provide insightful data on these critical models.”

According to the American Cancer Society, there will be 1.8 million new cancer diagnoses in 2020.  Thus, global biopharmaceutical industry continues its focus on cancer, and immuno-oncology specifically. According to a September 2019 report in Nature, the number of immuno-oncology drugs in development has grown 91% just since 2017.

To learn more about Taconic Biosciences’ humanized model portfolio, please contact Taconic at 1-888-TACONIC (888-822-6642) in the US, +45 70 23 04 05 in Europe, or email info@taconic.com.

About Taconic Biosciences, Inc.

Taconic Biosciences is a fully-licensed, global leader in genetically engineered rodent models and services. Founded in 1952, Taconic provides the best animal solutions so that customers can acquire, custom-generate, breed, precondition, test, and distribute valuable research models worldwide. Specialists in genetically engineered mouse and rat models, microbiome, immuno-oncology mouse models, and integrated model design and breeding services, Taconic operates three service laboratories and six breeding facilities in the U.S. and Europe, maintains distributor relationships in Asia and has global shipping capabilities to provide animal models almost anywhere in the world.

Media Contact:

Kelly Owen Grover

Director of Marketing Communications

(518) 697-3824

kelly.grover@taconic.com

New Insights on Mechlorethamine/Chlormethine gel presented at 4th World Congress of Cutaneous Lymphomas

New Insights on Mechlorethamine/Chlormethine gel presented at 4th World Congress of Cutaneous Lymphomas

Lugano, Switzerland, February 14, 2020 – Helsinn, the Swiss pharmaceutical group focused on building quality cancer care products, today announces that scientific abstracts have been accepted for oral presentation and one abstract for poster presentation at the World Congress of Cutaneous Lymphomas (WCCL) taking place from 12-14th February 2020 in Barcelona, Spain.

The first oral presentation, entitled “The PROVe study: real-world experience with chlormethine gel1 and other therapies in the treatment of mycosis-fungoides cutaneous T-cell lymphoma patients,” outlines results from the largest prospective, open label, single arm, multicenter observational study (NCT02296164),  assessing treatment patterns and efficacy, safety, and health-related quality of life (HR-QoL) outcomes in 298 MF-CTCL patients treated with chlormethine gel and other therapies in a real-world setting in the US.

Two additional presentations, one oral presentation and one poster, explore preliminary data from the Mechlorethamine Induced Contact Dermatitis Avoidance Study (MIDAS), an ongoing, open-label investigator-initiated study (IIS) investigating the incidence and types of contact dermatitis (CD) following treatment with mechlorethamine/chlormethine gel in patients with MF-CTCL.

One last presentation reports outcomes of a retrospective analysis evaluating the association of patient volume with early discontinuation and overall treatment duration for clinicians prescribing standardized 0.016% gel formulation mechlorethamine.

In the EU clinical study for LEDAGA:  a randomized-controlled trial (n=128 exposed to Ledaga for a median duration of 52 weeks), the most frequent adverse reactions were skin related: dermatitis (54.7%; e.g., skin irritation, erythema, rash, urticaria, skin-burning sensation, pain of the skin), pruritus (20.3%), skin infections (11.7%), skin ulceration and blistering (6.3%), and skin hyperpigmentation (5.5%). Cutaneous hypersensitivity reactions were reported in 2.3% of the treated patients.”

Dr. Silvia Sebastiani, Head of Medical Affairs at Helsinn, commented:As further information emerges from the PROVe and MIDAS studies, we continue exploring the potential of Valchlor®/Ledaga® for the treatment of this rare skin disease. We remain committed to offering the highest quality in care for patients.”

Dr. Ellen J. Kim, University of Pennsylvania, Professor of Dermatology, Penn Cutaneous Lymphoma Program, PROVe principal investigator, said: “There remains a distinct lack of knowledge regarding this rare disease thus our observational PROVe study of nearly 300 patients provides valuable information to the medical community. The PROVe results confirm that mechlorethamine/chlormethine gel treatment is effective in the management of MF-CTCL.

In the EU

About Ledaga®

Ledaga® gel is an alkylating drug indicated for the topical treatment of MF-CTCL in adult patients. Ledaga® is a gel which is applied topically once a day. The drug has been approved by the European Commission (for the treatment of MF-CTCL in adult patients). Since June 2019, Ledaga® is commercialized in Germany, The Netherlands, France and Italy.

For additional information please see the EU Summary of Product Characteristics.

In the US:

About Valchlor®

INDICATION

VALCHLOR® (mechlorethamine) gel is indicated for the topical treatment of Stage IA and IB mycosis fungoides-type cutaneous T-cell lymphoma (MF‑CTCL) in patients who have received prior skin-directed therapy.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

VALCHLOR is contraindicated in patients with known severe hypersensitivity to mechlorethamine. Hypersensitivity reactions, including anaphylaxis, have occurred with topical formulations of mechlorethamine.

WARNINGS AND PRECAUTIONS

  • Mucosal or eye injury: Exposure of mucous membranes to mechlorethamine such as the oral mucosa or nasal mucosa causes pain, redness, and ulceration, which may be severe. Exposure of the eyes causes pain, burns, inflammation, photophobia, and blurred vision. Blindness and severe irreversible anterior eye injury may occur. Should eye exposure or mucosal contact occur, immediately irrigate for at least 15 minutes with copious amounts of water, followed by immediate medical consultation
  • Secondary exposure: Avoid direct skin contact with VALCHLOR in individuals other than the patients due to risk of dermatitis, mucosal injury, and secondary cancers
  • Dermatitis: Dermatitis may be moderately severe or severe. Monitor patients for redness, swelling, inflammation, itchiness, blisters, ulceration, and secondary skin infections. Stop treatment with VALCHLOR or reduce dose frequency
  • Non‑melanoma skin cancer: Monitor patients during and after treatment with VALCHLOR
  • Embryo‑fetal toxicity: May cause fetal harm. Women should avoid becoming pregnant while using VALCHLOR due to the potential hazard to the fetus. For nursing mothers, do not breastfeed during treatment with VALCHLOR
  • Flammable gel: VALCHLOR is an alcohol‑based gel. Avoid fire, flame, and smoking until the gel has dried

ADVERSE REACTIONS

The most common adverse reactions (≥5%) were dermatitis (56%), pruritus (20%), bacterial skin infection (11%), skin ulceration or blistering (6%), and hyperpigmentation (5%). These reactions may be moderately severe or severe. Elderly patients aged 65 and older may be more susceptible. Depending on severity, treatment reduction, suspension, or discontinuation may be required.

USE IN SPECIFIC POPULATIONS

  • Contraception: Females who are able to become pregnant, and males with female partners who are able to become pregnant, should use a barrier method of contraception to avoid direct exposure of reproductive organs to VALCHLOR
  • Infertility: The reproductive effects of VALCHLOR have not been studied: however systemically administered mechlorethamine may impair fertility. The reversibility of the effect on fertility is unknown.

DOSING AND APPLICATION

VALCHLOR is for topical dermatologic use only. Apply a thin film of gel once daily to affected areas of the skin. VALCHLOR is a cytotoxic drug and special handling and disposal procedures should be followed during use. Caregivers must wear disposable nitrile gloves when applying VALCHLOR. Patients and caregivers must thoroughly wash hands after handling or applying VALCHLOR.

To report SUSPECTED ADVERSE REACTIONS, contact Helsinn Therapeutics (U.S.), Inc. at  1-855-482-5245 or FDA at 1‑800‑FDA‑1088 or visit www.fda.gov/medwatch.

Please see the VALCHLOR full Prescribing Information and Medication Guide.

About Mycosis Fungoides

Mycosis fungoides (MF) accounts for almost 50% of all primary cutaneous lymphomas, a form of non-Hodgkin’s lymphoma. The cause of MF remains unknown and there are no curative treatments. MF has an indolent clinical course, slowly progressing from patches to thicker plaques and eventually to tumours over years or decades. Signs include rash, patch and plaques with severe itch. MF typically affects older adults (median age at diagnosis: 55-60 years) with male predominance.

About the Helsinn Group

Helsinn is a privately-owned pharmaceutical group with an extensive portfolio of marketed cancer care products and a robust drug development pipeline. Since 1976, Helsinn has been improving the everyday lives of patients, guided by core family values of respect, integrity and quality. The Group works across pharmaceuticals, biotechnology, medical devices and nutritional supplements and has expertise in research, development, manufacture and the commercialization of therapeutic and supportive care products for cancer, pain and inflammation and gastroenterology. In 2016, Helsinn created the Helsinn Investment Fund to support early-stage investment opportunities in areas of unmet patient need. The company is headquartered in Lugano, Switzerland, with operating subsidiaries in Switzerland, Ireland, the U.S., Monaco and China, as well as a product presence in approximately 190 countries globally.

To learn more about Helsinn Group please visit www.helsinn.com

For more information:

Helsinn Group Media Contact:

Paola Bonvicini

Group Head of Communication

Lugano, Switzerland

Tel: +41 (0) 91 985 21 21

Email: Info-hhc@helsinn.com

For more information, please visit www.helsinn.com and follow us on Twitter, LinkedIn and Vimeo

HELS-US-0050

1 Chlormethine gel, also referred as mechlorethamine, is approved in the US and Israel under the tradename Valchlor and in the EU under the tradename Ledaga.

Light Chain Bioscience successfully completes Factor VIII mimetic bispecific antibody discovery for Takeda

GENEVA, Switzerland, Feb. 14, 2020 (GLOBE NEWSWIRE) — Light Chain Bioscience, a company developing bispecific antibodies with a pipeline focused in immuno-oncology, announced that it has achieved a milestone and received a payment under its research and collaboration agreement with Takeda Pharmaceutical Company Limited (Takeda). The milestone was achieved upon the successful completion of the discovery phase and designation by Takeda of undisclosed bispecific antibodies as clinical development candidates with approval to advance to IND-enabling studies. The collaboration aims at developing bispecific antibodies with Factor VIII mimetic activity for the treatment of hemophilia A patients.

“We are extremely excited to have reached this important milestone in our collaborative program. The successful identification and optimization of new therapeutic candidates adds to the validation of our bispecific antibody discovery expertise. It has been a very fruitful collaboration and a unique learning experience for us to work with Takeda to develop a bispecific approach for an indication such as hemophilia A,” said Nicolas Fischer, Light Chain Bioscience’s Chief Executive Officer.

About Light Chain Bioscience

Light Chain Bioscience is a brand of Novimmune SA, a company focused on the discovery and development of therapies based on bispecific and multispecific antibody formats. Its proprietary κλ body platform allows for the identification of bispecific antibodies that fully retain the native sequence and structure on human antibodies. This unique property is of interest for long term treatment of patients. In immuno-oncology, Light Chain Bioscience focuses on the selective targeting of the checkpoint CD47 as well as T cell redirecting strategies. For more information, please visit www.lightchainbio.com

Press Contact:

Nicolas Fischer, Ph.D. 
Chief Executive Officer 
Nicolas.Fischer@lightchainbio.com
+41 22 552 7222

AIR Worldwide Estimates Insured Losses for Winter Storm Ciara-Sabine Will Be Between EUR 1.1 Billion and EUR 1.9 Billion

BOSTON, Feb. 14, 2020 (GLOBE NEWSWIRE) — Catastrophe risk modeling firm AIR Worldwide estimates that insured losses due to wind from Winter Storm Ciara-Sabine will range between EUR 1.1 billion and EUR 1.9 billion, the majority of which are expected in Germany, France, and the United Kingdom. AIR Worldwide is a Verisk (Nasdaq:VRSK) business.

Storm Ciara was officially named on Wednesday, February 5, by the UK Met Office, the third windstorm the agency has named this season. Ciara struck parts of Ireland and the UK on Sunday, February 9, then moved to Europe where it was named Sabine in Germany and also impacted France, the Netherlands, Belgium, Poland, the Czech Republic, Slovenia, Sweden, Denmark, and Norway (where it was named Elsa), and other European countries.

In addition to significant wind damage, Storm Ciara has caused coastal and inland flooding in the UK and downed trees and power lines, which caused 675,000 homes to lose electricity there, in addition to 10,000 in Ireland. Power outages affected tens of thousands of homes in Germany and France as well, with power cuts affecting nearly 500,000 people across Europe.

Hundreds of flights were canceled in the UK, Germany, Belgium, and the Netherlands; long-distance train service was suspended in Germany; and the ports of Dover, England, and Calais, France, were shut down. In addition, storm surge affected Hamburg after Sabine caused the Elbe River to rise.

AIR’s modeled insured loss estimates include:

  • Insured physical damage from wind to property (residential, commercial, industrial, agricultural, and auto), including structures and their contents, as well as business interruption and additional living expenses

AIR’s modeled insured loss estimates do not include:

  • Losses due to coastal or inland flooding
  • Additional living expenses (ALE) for residential claims for all modeled countries, except the UK
  • Losses to uninsured properties
  • Losses to infrastructure
  • Demand surge

About AIR Worldwide
AIR Worldwide (AIR) provides risk modeling solutions that make individuals, businesses, and society more resilient to extreme events. In 1987, AIR Worldwide founded the catastrophe modeling industry and today models the risk from natural catastrophes, terrorism, pandemics, casualty catastrophes, and cyber incidents. Insurance, reinsurance, financial, corporate, and government clients rely on AIR’s advanced science, software, and consulting services for catastrophe risk management, insurance-linked securities, longevity modeling, site-specific engineering analyses, and agricultural risk management. AIR Worldwide, a Verisk (Nasdaq:VRSK) business, is headquartered in Boston, with additional offices in North America, Europe, and Asia. For more information, please visit www.air-worldwide.com.

For more information, contact:

Kevin Long
AIR Worldwide
+1-617-267-6645
klong@air-worldwide.com

AKWEL SALES ROSE BY +3.7% IN 2019

13 February 2020

AKWEL SALES ROSE BY +3.7% IN 2019

Outperformance of about 9% compared to global automotive production

Confirmation of the target to increase operating profitability in 2019

Adjustment of the 2020 sales growth target to +5%

Akwel (FR0000053027, AKW, PEA-eligible), the automotive and HGV equipment and systems manufacturer specialising in fluid management and mechanisms, has posted consolidated turnover of €1,101.2m for 2019, up +3.7% compared to 2018 and up 4.4% like-for-like.

Consolidated turnover (from 1 January to 31 December 2019)

In € millions – unaudited 2019 2018 Variation Like-for-like variation (1)
1st half-year 566.5  559.3 +1.3% +3.4%
3rd quarter 259.8  240.6 +8.0% +6.6%
4th quarter 274.9  262.2 +4.9% +4.7%
Total for 12 months 1,101.2  1,062.1 +3.7% +4.4%

       (1)   Comparing like-for-like figures.

AKWEL’s consolidated sales over the full year 2019 grew by +3.7%. This growth should be seen against the backdrop of a global automotive industry down by about 5% over the year, implying over 9% outperfomance for the group in 2019.

AKWEL’s industrial strategy, namely to produce as close to its manufacturer clients’ assembly and delivery sites around the world as possible, is reflected in the changing breakdown of sales by region:

  • France: €331.5m (-7.5%)
  • Europe (excluding France), Russia and Africa: €335.3m (+5.3%)
  • North America: €269.6m (+9.1%)
  • Asia and the Middle East (including Turkey): €156.0m (+23.6%)
  • South America: €8.8m (-25.9%)

The group’s business in China rose by +39.5% despite a severe market slump.

The Group thereby generated positive free cash flow of €24.2m over the financial year and significantly reduced its net financial debt to €24.6m at the end of December 2019, excluding the impact of IFRS 15/16, compared with €40.6m a year earlier.

In view of its performance, AKWEL confirms its target of increasing operating profitability for 2019, and forecasts a further increase in consolidated revenue for 2020 and  is adjusting its sales forecast for 2020 and anticipates growth of around +5%.An independent family group, listed on the Euronext Paris Stock Exchange, AKWEL is an automotive and HGV equipment and systems manufacturer specialising in fluid management and mechanisms, offering first-rate industrial and technological expertise in applying and processing materials (plastics, rubber, metal) and mechatronic integration.

Operating in 20 countries across five continents, AKWEL employs almost 12,000 people worldwide.

 

Euronext Paris – Compartiment B – ISIN: FR0000053027 – Reuters: AKW.PA – Bloomberg: AKW:FP

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Hillbrook Partners Team to Join Global Infrastructure Partners

New York, NY, Feb. 13, 2020 (GLOBE NEWSWIRE) — Global Infrastructure Partners (“GIP”), a leading independent global infrastructure investor today announced that a team from Hillbrook Partners, including both of its founding partners, Charles Roast and Justin Symonds, have joined GIP in London. They will focus on infrastructure investments in the transportation sector.

Hillbrook Partners, which was formed in 2013, has provided independent mergers and acquisitions advice to its clients, with a particular focus on investments in transport assets including airports, ports, rail and road infrastructure. Speaking about the move, Hillbrook’s founding partners commented: “We have enjoyed working with our clients on a variety of interesting and complex transport transactions and we believe our move to GIP will enable us to work with them in new and different ways.”

Bayo Ogunlesi, Chairman and Managing Partner of GIP commented, “We are pleased that Charles, Justin and their team are joining GIP as we continue to invest in our best in class team. Their expertise and experience in the Transport industry will further enhance GIP’s capabilities as we identify opportunities to deliver attractive returns for our investors by investing in and managing high quality infrastructure assets in the sector.”

About Global Infrastructure Partners

Global Infrastructure Partners (“GIP”) is an independent infrastructure fund manager that makes equity and debt investments in infrastructure assets and businesses. GIP targets investments in the energy, transport and water/waste sectors in both OECD and select emerging market countries. GIP’s 41 portfolio companies employ over 67,000 people in over 50 countries.  GIP’s teams are located in 10 offices: London, New York, Stamford (Connecticut), Sydney, Melbourne, Brisbane, Mumbai, Delhi, Singapore and Hong Kong. For more information, visit www.global-infra.com.

Media Inquiries Team
Global Infrastructure Partners
646.282.1545
mediainquiries@global-infra.com

Two internationally recognized health standards organizations join the effort to manage an escalating global public health emergency

London, United Kingdom, Feb. 13, 2020 (GLOBE NEWSWIRE) — The world is focused on the outbreak of respiratory illness caused by a novel coronavirus.  The World Health Organization (WHO) has named the syndrome caused by this coronavirus “COVID-19”, and the International Committee on Taxonomy of Viruses (ICTV) has named the virus “Severe acute respiratory syndrome coronavirus 2” or SARS-CoV-2.

As part of the global effort to manage and contain this global public health emergency, two global health standards organizations, Regenstrief Institute and SNOMED International, are doing their part to support care teams globally to code and track SARS-CoV-2 testing and COVID-19 cases, and by extension support clinicians and researchers in their efforts to address its containment.

Both subject matter experts in coding and structuring clinical information, Regenstrief Institute and SNOMED International have recently introduced new content to their respective products, a laboratory and health observations oriented coding system in the case of LOINC, and a broad spectrum clinical terminology in the case of SNOMED CT. With the high rate of global adoption for both standards, LOINC and SNOMED CT have taken swift action to make this content immediately available to support those on the ground in tackling the virus.

“With novel viruses that appear to be easily transmittable, such as the coronavirus, it is vitally important that all identified cases be reported quickly for public health tracking,” said Regenstrief Research Scientist Theresa Cullen, M.D., M.S., global health expert with the Regenstrief Institute. Don Sweete from SNOMED International says “the creation of new COVID-19 and SARS-CoV-2 codes and concepts from LOINC and SNOMED CT introduce the structure in coding needed for health systems internationally to manage the outbreak. Both Cullen and Sweete agree that in possessing superior data, health leaders worldwide can engage in a higher degree of analysis to inform their outbreak management approach. Based on the formal naming of the syndrome and virus by WHO and ICTV, both organizations are presently updating their respective code and concepts to reflect the change.

For more information on the specific actions that each organization has taken, visit Regenstrief Institute and SNOMED International respectively.

Regenstrief Institute and SNOMED International mutually recognize the importance of interoperability through standardization in the pursuit of timely, safe and efficient health care and continue to work collaboratively to achieve this end.

About Regenstrief Institute and LOINC  l  https://loinc.org/

Founded in 1969 in Indianapolis, the Regenstrief Institute is a local, national and global leader dedicated to a world where better information empowers people to end disease and realize true health. A key research partner to Indiana University, Regenstrief and its researchers are responsible for a growing number of major healthcare innovations and studies. Examples range from the development of global health information technology standards that enable the use and interoperability of electronic health records to improving patient-physician communications, to creating models of care that inform practice and improve the lives of patients around the globe.

LOINC was created in 1994 at Regenstrief Institute in an effort to facilitate interoperability in healthcare. There was a growing trend to send clinical data electronically between healthcare entities, a practice that is integral today. The LOINC coding system contains more than 92,000 terms for everything from a serum alpha 1 antitrypsin level to a zygomatic arch x-ray report. For each concept, LOINC covers many other rich details, such as synonyms, units of measure, and carefully crafted descriptions.

About SNOMED International and SNOMED CT  l  www.snomed.org 

SNOMED International is a not-for-profit organization that owns, administers and develops SNOMED CT, the world’s most comprehensive clinical terminology. The safe, accurate and effective exchange of health information is an essential part of the foundation to improve healthcare around the world. We strive to determine the best global standards for health terminology, and to engage with the global healthcare community to improve SNOMED CT and patient safety.

We work to ensure that SNOMED CT can be routinely integrated into healthcare information systems. With SNOMED CT, users can record patient data more accurately and comprehensively – and use tools and analytics to provide better patient care and health management.

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Kelly Kuru
SNOMED International
+1 (416) 566-8725
kku@snomed.org

John Erickson
Regenstrief Institute
+1 (317) 643-2313
prteam@regenstrief.org