Lung Cancer Study Shows Barriers in Patient Access to Care in Europe

On January 28, 2020 MSD, tradename of Merck & Co., Inc., Kenilworth, N.J., USA (NYSE: MRK), reported preliminary results from a study carried out by The Economist Intelligence Unit (The EIU) on lung cancer, which show a fragmented policy approach across Europe (Press release, Merck & Co, JAN 28, 2020, View Source [SID1234553625]). The study underlines that awareness needs to be addressed on multiple fronts to fight the stigma associated with this disease and to ensure patients receive timely access to the best possible care. The data were presented days before the European Commission’s official launch of the stakeholders’ consultation on Europe’s Beating Cancer Plan.

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"There is no room for complacency in lung cancer; 1 out of 5 of all cancer deaths in Europe is caused by lung cancer and it kills as many Europeans as breast, colon and prostate cancer combined. The study uncovers actionable solutions to empower countries and their health systems to better manage lung cancer, and ultimately, improve the lives of people living with a diagnosis of this treatable disease," commented Mary Bussell, Associate at The Economist Intelligence Unit.

The study shows that of the 27 countries participating, 15% (4 countries) do not have a National Cancer Control Plan (NCCP). 14 countries with existing NCCPs have not updated them within the past five years, and only one has a lung cancer-specific control plan.

National Lung Cancer Clinical Guidelines (NLCCGs) should include timeframes for fast-tracking people suspected of having lung cancer for diagnostic testing and provide a rapid referral for secondary or tertiary treatment for those diagnosed with lung cancer. Although 26 of the 27 countries covered in the study have national clinical guidelines for lung cancer, discrepancies remain:

11 countries do not include fast-tracking of suspected lung cancer patients to receive diagnostic testing;
12 do not include a timeframe within which diagnostic testing should be given to suspected lung cancer patients;
15 do not include rapid referral to secondary or tertiary care, once a diagnosis of lung cancer has been made; and
3 countries do not include fast-tracking for diagnosis within timeframes or rapid referral to secondary or tertiary care in their lung cancer clinical guidelines. However, they are included in government policies, national agreements, or are mandated by law.
"The presentation of this data is quite timely. While Europe has agreed on the need for a European Cancer Plan, the study draws attention to specific issues around lung cancer and its burden. Clearly, prevention and health promotion have important roles to play. At the same time, we know that early detection and fast referral to treatment are crucial to improve patient outcomes – lung cancer is a race against time. The study shows that we have plenty of work to do there," said Deepak Khanna, Senior Vice President and Regional President Oncology for Europe, Middle East, Africa and Canada, MSD.

"The data presented helps us understand the specificities of lung cancer better. As we design a European Cancer Plan aiming at reducing the cancer burden for patients, their families and health systems, and addressing cancer related inequalities, it is important to gather available information on best practices and knowledge from research and clinical experience, that can help us build a robust evidence base for better policy making", added Martin Seychell, Deputy Director General, DG SANTE, European Commission.

About the Study

The study analysed 17 performance indicators across 27 countries – Austria, Belgium, Bulgaria, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, the Netherlands, Norway, Poland, Portugal, Romania, Russian Federation, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. The indicators were categorised into five domains focused on the degree to which a country considers lung cancer to be a strategic priority and a public health issue, ensures timely diagnostic and treatment services and the quality of cancer registries which can help to facilitate high-quality research. Each country received a score for all 17 indicators. Once draft scores were assigned to each country, national workshops were conducted with external country-based experts to discuss the findings and develop recommendations for policy and programme improvements. Preliminary results of the first phase of the study were presented at the 2018 European Cancer Forum in Brussels. An additional 16 countries are being analysed and the preliminary results of this second phase were presented at the 2020 European Cancer Forum in Brussels. The final report with a full analysis of the results is expected in Spring 2020. The Economist Intelligence Unit benchmarking study is supported by MSD. Editorial decisions are the responsibility of The Economist Intelligence Unit.

About Lung Cancer

Lung cancer, which forms in the tissues of the lungs, usually within cells lining the air passages, is the leading cause of cancer death worldwide. According to WHO, in 2018 470,000 Europeans were diagnosed with lung cancer, and 388,000 Europeans died of the disease that year. The two main types of lung cancer are non-small cell and small cell. Non-small cell lung cancer (NSCLC) is the most common type of lung cancer, accounting for about 85% of all cases. Small cell lung cancer (SCLC) accounts for about 10 to 15% of all lung cancers.

CNS Pharmaceuticals Completes Pilot Manufacturing Steps Pursuant to FDA Pre-IND Guidance

On January 28, 2020 CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) ("CNS" or the "Company"), a biotechnology company specializing in the development of novel treatments for brain tumors, reported that Anthem Biosciences of Bangalore, India (Anthem) has completed a pilot run of the recrystallization of the Reata Pharmaceuticals, Inc. API (Reata) (Press release, CNS Pharmaceuticals, JAN 28, 2020, View Source [SID1234553624]). It has also completed a lyophilization of the API. Samples of the drug product, which include 299 capped vials, have been shipped to Intertek Pharmaceutical Services (Intertek) for further analysis and release.

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As previously announced, the FDA agreed in a preclinical submission that CNS could use Reata API as long as it was reprocessed and released under GMP conditions, and that the new lyophilized form of the drug product could be used during the Company’s upcoming clinical trial. Anthem, a full-service provider of GMP manufacturing for APIs, completed this pilot run of the Reata API. The pilot run recrystallization passed all specifications at Intertek. The recrystallized API was shipped to Lyophilization Technology, Inc. a leader of GMP lyophilization of Drug Products for clinical trials, which completed a pilot lyophilization. The pilot run of lyophilized API was successfully tested and released by Intertek. DavosPharma, a Davos Chemical Company, acted on behalf of the Company as the coordinating manufacturing broker for all of these processes.

"We are excited to achieve another important milestone in the development of Berubicin," stated John Climaco, CEO of CNS Pharmaceuticals. "We look forward to completing both GMP manufacturing processes and release for clinical trials."

About Berubicin
Berubicin is an anthracycline, a class of anticancer agents that are among the most powerful chemotherapy drugs and effective against more types of cancer than any other class of chemotherapeutic agents. Anthracyclines are designed to utilize natural processes to induce deoxyribonucleic acid (DNA) damage in targeted cancer cells by interfering with the action of topoisomerase II, a critical enzyme enabling cell proliferation. Berubicin treatment of brain cancer patients appeared to demonstrate positive responses that include one durable complete response in a Phase 1 human clinical trial conducted by Reata.

CohBar to Present at the 2020 BIO CEO & Investor Conference

On January 28, 2020 CohBar, Inc. (NASDAQ: CWBR), a clinical stage biotechnology company developing mitochondria based therapeutics (MBTs) to treat chronic diseases and extend healthy lifespan, reported that its Chief Executive Officer, Steven Engle, will present a company update at the 2020 BIO CEO & Investor Conference, which is being held February 10-11 at the Marriott Marquis in New York (Press release, CohBar, JAN 28, 2020, View Source [SID1234553623]). Now in its 22nd year, the BIO CEO & Investor Conference is one of the largest independent investor conferences focused on established and emerging publicly traded and select private biotech companies.

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Presentation Details
Monday, February 10 at 3:30 PM ET
New York Marriott Marquis, Wilder Room

Webcast
The presentation may be accessed via webcast at the scheduled time, or following the presentation, using the following link: https://veracast.com/webcasts/bio/ceoinvestor2020/33129128834.cfm.

Bavarian Nordic Announces Appointment of Laurence De Moerlooze as Chief Medical Officer

On January 28, 2020 Bavarian Nordic A/S (OMX: BAVA, OTC: BVNRY) reported the appointment of Dr. Laurence De Moerlooze to the position of Executive Vice President and Chief Medical Officer (CMO) (Press release, Bavarian Nordic, JAN 28, 2020, View Source [SID1234553622]). Dr. De Moerlooze joins Bavarian Nordic from Takeda Vaccines, where she has served since 2017 as Vice President and Global Program Lead for vaccines against Zika virus and Norovirus.

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Prior to joining Takeda, she worked at GlaxoSmithKline (GSK) for more than 15 years, holding various leading roles in medical affairs and vaccine development working with numerous life-saving vaccines including Rabipur/Rabavert and Encepur.

Dr. De Moerlooze will take up the position in April 2020.

"I am pleased to welcome Laurence to Bavarian Nordic and to our executive team. Laurence brings a wealth of knowledge from the vaccine industry and will add important and valuable R&D and commercial experience to our company as we continue to expand our business," said Paul Chaplin, President and CEO of Bavarian Nordic.

"I am delighted to join Bavarian Nordic at such a key time for the Company. I look forward to putting my experience and commitment to the service of the organization in the development of life-saving vaccines and immunotherapies. I am also eager to help bring the newly acquired rabies and tick-borne encephalitis vaccines to patients who need them most," said Laurence De Moerlooze.

West Recognized as a Top Company for Corporate Responsibility

On January 28, 2020 West Pharmaceutical Services, Inc. (NYSE: WST), a global leader in innovative solutions for injectable drug administration, reported that it was recently named as a Top Company for Corporate Responsibility practices by both Newsweek and Investor’s Business Daily (Press release, West Pharmaceutical Services, JAN 28, 2020, View Source [SID1234553621]).

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Newsweek has named West to its America’s Most Responsible Companies 2020 list. Newsweek’s partner, Statista Inc., who conducted the analysis, focused on areas such as Leadership Diversity, Employees and Philanthropy & Engagement as well as making a difference in local communities. After examining the top 2,000 public companies (by revenue), West was ranked #166 overall as among the "most committed to Corporate Responsibility" and was ranked in the Top 20 among companies in the Health Care & Life Sciences industry. West also ranked #9 overall for companies headquartered in Pennsylvania.

West is also honored to have been ranked #19 on Investor’s Business Daily’s 50 Best ESG Companies list. This recognition honors companies with strong financial performance that hold true to their ESG (environmental, social and governance) values. Among companies with ESG ratings of AAA or AA from MSCI ESG Research as of September 11, 2019, the top 50 recognized companies earned the highest IBD Composite Ratings, which is a marker of strong stock growth. West was ranked #3 in the Health Care sector.

"We are honored that West has been recognized for our Corporate Responsibility initiatives by these two publications," shared Steve Walton, VP, HSE & Corporate Responsibility. "This recognition is a testament to the great work our team members are doing to make their communities and the world a better place. I’m excited to keep the momentum going as we push forward with a continued focus and commitment into 2020 and beyond."

In addition to this Top Companies recognition, over the past year West has received several additional CR focused awards, recognizing the global efforts of the Company and its team members. These awards include: the CSR Initiative Award and Corporate Social Responsibility Programme of the Year Award, both presented to West’s Dublin, Ireland site; the Goodwill Employer of the Year Award, presented to West’s Kearney, NE site; the West Chester University Corporate President’s Award; and the Philadelphia Business Journal’s Faces of Philanthropy distinction.

West’s award-winning Corporate Responsibility Program is committed to nurturing a culture of diversity and inclusion and supporting the communities in which its team members live and work. One major element of the Program is West’s culture of giving. West targets its global philanthropic efforts to support children, people with disabilities, healthcare and education, with a focus on STEM. Health and Safety is also a key focus area, as West is committed to designing and operating its facilities to provide a healthy and safe workplace. In addition, environmental considerations are taken into account for every aspect of West’s business, and its Sustainability Program targets reductions in areas where West can make the greatest difference: greenhouse gas emissions, waste, energy and water usage, and increased recycling.