– New data on tumor growth rate and lenvatinib efficacy in radioiodine-refractory differentiated thyroid cancer to be presented in oral Proffered Paper session on Monday, Oct. 22 at 3:09 p.m. CEST
Eisai Inc. announced today the presentation of six abstracts featuring data and analyses on its cancer treatments at the European Society of Medical Oncology (ESMO) 2018 Congress taking place in Munich from October 19-23. The results to be presented highlight new data for the company’s oncology agents, lenvatinib (marketed as LENVIMA®) and eribulin (marketed as HALAVEN®) for approved and investigational uses, respectively.
Presentations of interest include:
- An oral presentation on tumor growth rate and lenvatinib efficacy in radioiodine-refractory differentiated thyroid cancer.
- Correlative analyses of serum biomarkers and efficiency outcomes for lenvatinib, everolimus and the combination of these two agents in patients with metastatic renal cell carcinoma.
- A final analysis of serum biomarkers from a Phase III study of lenvatinib vs. sorafenib in unresectable hepatocellular carcinoma.
- Early results of a Phase Ib/II study on the combination of eribulin and PEGPH20 (PEGylated recombinant human hyaluronidase) in patients with HER2-negative, high hyaluronan metastatic breast cancer.
“Our data at ESMO include insights into the potential of lenvatinib and eribulin both as monotherapies and in combination with other agents across a variety of difficult-to-treat cancers,” said Alton Kremer, MD, PhD, Chief Clinical Officer and Chief Medical Officer, Oncology Business Group at Eisai. “As part of our human health care mission and dedication to patient access, we are committed to continually exploring ways to improve understanding of Eisai’s oncology treatments for the medical community and the patients impacted by these advanced cancers.”
This release discusses investigational compounds that are not Food and Drug Administration (FDA)-approved and investigational uses for FDA-approved products. It is not intended to convey conclusions about efficacy and safety. There is no guarantee that any investigational uses of FDA-approved products will successfully complete clinical development or gain FDA approval.
The full list of Eisai presentations along with the time and location of each session is included below.
In March 2018, Eisai and Merck (known as MSD outside of the United States and Canada), through an affiliate, entered into a strategic collaboration for the worldwide co-development and co-commercialization of lenvatinib.
Wuhan Lays Out Construction of Guanggu Nanda Health Industrial Park
Wuhan, capital city of central China’s Hubei province, has attracted ten major healthcare industry companies, including Taikang Group and China Biotech, to participate in building its Health Industrial Park.
The Health Industrial Park is being created with the goal of becoming a 100 billion yuan (about 15 billion U.S. dollars) hotspot of biomedicine, medical equipment, and healthcare by 2030, according to a local official at the ongoing First World Health Expo.
Wuhan‘s Jiangxia District, known as China Guanggu, or China’s “Optics Valley,” has formed a health-centered industrial cluster of bio-pharmaceutical, diagnostic equipment, and drug manufacturers. The planned Guanggu Health Industrial Park will cover 98.1 square kilometers.
Compared with Wuhan Guanggu Bio-City, which brings in revenue in excess of 100 billion yuan, the park will focus on the research and development of cutting-edge technologies in the fields of life and health while incubating key healthcare enterprises.
The Health Industry Park is positioned as a “production-research interaction” space which integrates R&D and manufacturing activities in harmony. The park will partner with Guanggu Bio-City to facilitate active industrial collaboration.
Jiangxia District will offer a preferential policy support package to health industry enterprises interested in the area, which will include financial services and R&D incentives.
Zhang Li, Jiangxia District mayor, said that Optics Valley Nanda Health Industrial Park would provide preferential policies and financial support to enterprises interested in the area. The value of a single-item policy fund is over 100 million yuan, or around 15 million U.S. dollars.
The Wuhan Health Industry Development Plan specifies that Guanggu Nanda Health Industry Park intends to introduce 100 enterprises over the next 10 years in building a 100 billion yuan-level center of business. 50,000 employees are projected to participate in establishing the fifth national industrial park in Wuhan, reaching an important milestone for Wuhan’s healthcare industry.
SOURCE: Wuhan Jiangxia District Government
CannTrust Receives Health Canada Approval for Phase 2 Expansion
CannTrust Holdings Inc. (“CannTrust” or the “Company”) (TSX: TRST) (NYSE: CTST) is pleased to announce that its cultivation and processing permit under Health Canada Cannabis Regulations was amended to include the final 20% of its Phase 2 expansion. The entire 450,000 sq. ft. of its perpetual harvest greenhouse in Pelham, Ontario, is now fully licensed.
“We have always been confident that our processes meet and exceed regulatory standards, and we now have further validation of this from our regulators,” said Peter Aceto, Chief Executive Officer. “With this approval, CannTrust is set to meet its plan to reach 50,000kg of annualized capacity at the perpetual harvest greenhouse and continue providing award-winning products in a cost-effective manner.”
CannTrust’s expected production ramp is as follows:
- The last 20% of the Phase 2 expansion is expected to be operating at full capacity by the end of Q2 2019.
- Pending Health Canada approval, the Company anticipates planting on its previously announced outdoor land acquisition of 81 acres in Q2 2019 and expects to realize a yield of approximately 1,000kg per acre in 2019. Total 2019 production from this harvest is expected to be approximately 75,000kg.
- With additional land under letter of intent anticipated to be secured in the near term, the Company’s outdoor cultivation operation is expected to total 100,000kg to 200,000kg of production in the second half of 2020. Production from outdoor cultivation will primarily be used for extraction purposes for products that we anticipate will be permitted based on proposed regulations for additional cannabis products, which include edibles and inhaled extract products.
- The Company’s Phase 3 expansion of its perpetual harvest greenhouse is expected to add a further 50,000kg of capacity beginning in the second half of 2020. Phase 3 includes productivity and automation enhancements over Phases 1 and 2. Production from the Phase 3 expansion is also subject to Health Canada approval.
- CannTrust’s combined cultivation operations are expected to reach a total annualized capacity of 200,000kg to 300,000kg in the second half of 2020.
SOURCE CannTrust Holdings Inc.
Partnership to focus on Alzheimer’s disease, breast cancer, diabetes, obesity
Centene Corporation (NYSE: CNC) and Washington University School of Medicine in St. Louis announced today a partnership to transform and accelerate research into treatments for Alzheimer’s disease, breast cancer, diabetes and obesity. All are common, debilitating and often deadly diseases that affect millions of people worldwide, at all levels of income.
As part of the partnership, Centene will fund up to $100 million over 10 years in research at Washington University. The funding will galvanize the School of Medicine’s Personalized Medicine Initiative, which aims to develop customized disease treatment and prevention for patients. Innovations that arise from the initiative will be commercialized through the ARCH Personalized Medicine Initiative, a joint venture between the School of Medicine and Centene. Reflecting the philosophy of both institutions, ARCH is designed to accelerate the development and implementation of affordable and accessible health solutions to the public using the intellectual property developed from this research.
“We share the goal of helping to improve the health of our communities through research, education and customized treatment for people suffering from chronic illnesses,” said Michael F. Neidorff, chairman and CEO for Centene. “We believe personalized medicine is the path to ensure patients get the targeted health care they need to fight disease, and we look forward to partnering with such a renowned medical school to initially focus on four diseases that impact millions of Americans, including many of our health plan members.”
The investment will leverage the university’s cutting-edge research and biomedical capabilities, including state-of-the-art technologies such as CRISPR, and internationally known scientists in the areas of the microbiome, immunomodulatory therapies, cancer genomics, neurodegeneration, cellular reprogramming, chemical biology, informatics and others. In addition, the funds will strengthen resources at more than a dozen centers and institutes at the School of Medicine, including the Edison Family Center for Genome Sciences & Systems Biology; the Andrew M. and Jane M. Bursky Center for Human Immunology and Immunotherapy Programs; Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine; the Elizabeth H. and James S. McDonnell III Genome Institute; the Institute for Informatics; and the Center of Regenerative Medicine.
“We will be bringing together world-class resources and intellectual horsepower from every basic and clinical scientific discipline to urgently accelerate the timeline for developing therapies that are more precisely targeted, with aspirations to do so in the next five to seven years,” said David H. Perlmutter, MD, executive vice chancellor for medical affairs, the George and Carol Bauer Dean, and the Spencer T. and Ann. W. Olin Distinguished Professor at the School of Medicine. “I believe the most important advances that will evolve from the personalized medicine paradigm will come from harnessing genome engineering technologies to build better model systems of each human disease, and utilizing deep genomic and clinical characterization to enable more effective and less expensive clinical trials.”
Perlmutter continued, “The partnership supports our global leadership in understanding sequence variants in biological systems that will pave the way for new therapeutic targets, as well as learning more about our own innate biology. Once personalized medicine becomes common practice, health-care workers may examine each patient’s genome — as well as information regarding his or her environment, lifestyle and social network — to identify a customized, affordable approach to optimizing health and medical care.”
Centene and Washington University will host a press briefing at a later date to be determined.
About Centene Corporation
Centene Corporation, a Fortune 100 company, is a diversified, multi-national healthcare enterprise that provides a portfolio of services to government sponsored and commercial healthcare programs, focusing on under-insured and uninsured individuals. Many receive benefits provided under Medicaid, including the State Children’s Health Insurance Program (CHIP), as well as Aged, Blind or Disabled (ABD), Foster Care and Long-Term Services and Supports (LTSS), in addition to other state-sponsored programs, Medicare (including the Medicare prescription drug benefit commonly known as “Part D”), dual eligible programs and programs with the U.S. Department of Defense. Centene also provides healthcare services to groups and individuals delivered through commercial health plans. Centene operates local health plans and offers a range of health insurance solutions. It also contracts with other healthcare and commercial organizations to provide specialty services including behavioral health management, care management software, correctional healthcare services, dental benefits management, commercial programs, home-based primary care services, life and health management, vision benefits management, pharmacy benefits management, specialty pharmacy and telehealth services.
Centene uses its investor relations website to publish important information about the Company, including information that may be deemed material to investors. Financial and other information about Centene is routinely posted and is accessible on Centene’s investor relations website, http://www.centene.com/investors.
About Washington University School of Medicine in St. Louis
Washington University School of Medicine’s 1,500 faculty physicians also are the medical staff of Barnes-Jewish and St. Louis Children’s hospitals. The School of Medicine is a leader in medical research, teaching and patient care, ranking among the top 10 medical schools in the nation by U.S. News & World Report. Through its affiliations with Barnes-Jewish and St. Louis Children’s hospitals, the School of Medicine is linked to BJC HealthCare.
Cautionary Statement on Forward-Looking Statements
All statements, other than statements of current or historical fact, contained in this communication are forward-looking statements. Without limiting the foregoing, forward-looking statements often use words such as “believe,” “anticipate,” “plan,” “expect,” “estimate,” “intend,” “seek,” “target,” “goal,” “may,” “will,” “would,” “could,” “should,” “can,” “continue” and other similar words or expressions (and the negative thereof). We intend such forward-looking statements to be covered by the safe-harbor provisions for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995, and Centene Corporation is including this statement for purposes of complying with these safe-harbor provisions. In particular, these statements include, without limitation, statements about Centene’s future operating or financial performance, market opportunity, growth strategy, competition, expected activities in completed and future acquisitions, including statements about the impact of Centene’s proposed acquisition of WellCare Health Plans, Inc. (the “WellCare Transaction”), Centene’s recent acquisition (the “Fidelis Care Transaction”) of substantially all the assets of New York State Catholic Health Plan, Inc., d/b/a Fidelis Care New York (“Fidelis Care“), investments and the adequacy of Centene’s available cash resources.
These forward-looking statements reflect Centene’s current views with respect to future events and are based on numerous assumptions and assessments made by us in light of Centene’s experience and perception of historical trends, current conditions, business strategies, operating environments, future developments and other factors Centene believes appropriate. By their nature, forward-looking statements involve known and unknown risks and uncertainties and are subject to change because they relate to events and depend on circumstances that will occur in the future, including economic, regulatory, competitive and other factors that may cause Centene’s or its industry’s actual results, levels of activity, performance or achievements to be materially different from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. These statements are not guarantees of future performance and are subject to risks, uncertainties and assumptions.
All forward-looking statements included in this filing are based on information available to us on the date of this communication. Except as may be otherwise required by law, Centene undertakes no obligation to update or revise the forward-looking statements included in this communication, whether as a result of new information, future events or otherwise, after the date of this filing. You should not place undue reliance on any forward-looking statements, as actual results may differ materially from projections, estimates, or other forward-looking statements due to a variety of important factors, variables and events including, but not limited to, the following: (i) the risk that regulatory or other approvals required for the WellCare Transaction may be delayed or not obtained or are obtained subject to conditions that are not anticipated that could require the exertion of management’s time and Centene’s resources or otherwise have an adverse effect on Centene; (ii) the risk that Centene’s stockholders do not approve the issuance of shares of Centene common stock in the WellCare Transaction; (iii) the risk that WellCare’s stockholders do not adopt the merger agreement; (iv) the possibility that certain conditions to the consummation of the WellCare Transaction will not be satisfied or completed on a timely basis and accordingly the WellCare Transaction may not be consummated on a timely basis or at all; (v) uncertainty as to the expected financial performance of the combined company following completion of the WellCare Transaction; (vi) the possibility that the expected synergies and value creation from the WellCare Transaction will not be realized, or will not be realized within the expected time period; (vii) the exertion of management’s time and Centene’s resources, and other expenses incurred and business changes required, in connection with complying with the undertakings in connection with any regulatory, governmental or third party consents or approvals for the WellCare Transaction; (viii) the risk that unexpected costs will be incurred in connection with the completion and/or integration of the WellCare Transaction or that the integration of WellCare will be more difficult or time consuming than expected; (ix) the risk that potential litigation in connection with the WellCare Transaction may affect the timing or occurrence of the WellCare Transaction or result in significant costs of defense, indemnification and liability; (x) a downgrade of the credit rating of Centene’s indebtedness, which could give rise to an obligation to redeem existing indebtedness; (xi) unexpected costs, charges or expenses resulting from the WellCare Transaction; (xii) the possibility that competing offers will be made to acquire WellCare; (xiii) the inability to retain key personnel; (xiv) disruption from the announcement, pendency and/or completion of the WellCare Transaction, including potential adverse reactions or changes to business relationships with customers, employees, suppliers or regulators, making it more difficult to maintain business and operational relationships; and (xv) the risk that, following the WellCare Transaction, the combined company may not be able to effectively manage its expanded operations.
Additional factors that may cause actual results to differ materially from projections, estimates, or other forward-looking statements include, but are not limited to, the following: (i) Centene’s ability to accurately predict and effectively manage health benefits and other operating expenses and reserves; (ii) competition; (iii) membership and revenue declines or unexpected trends; (iv) changes in healthcare practices, new technologies, and advances in medicine; (v) increased healthcare costs, (vi) changes in economic, political or market conditions; (vii) changes in federal or state laws or regulations, including changes with respect to income tax reform or government healthcare programs as well as changes with respect to the Patient Protection and Affordable Care Act and the Health Care and Education Affordability Reconciliation Act, collectively referred to as the Affordable Care Act (“ACA”), and any regulations enacted thereunder that may result from changing political conditions or judicial actions, including the ultimate outcome of the District Court decision in “Texas v. United States of America” regarding the constitutionality of the ACA; (viii) rate cuts or other payment reductions or delays by governmental payors and other risks and uncertainties affecting Centene’s government businesses; (ix) Centene’s ability to adequately price products on federally facilitated and state-based Health Insurance Marketplaces; (x) tax matters; (xi) disasters or major epidemics; (xii) the outcome of legal and regulatory proceedings; (xiii) changes in expected contract start dates; (xiv) provider, state, federal and other contract changes and timing of regulatory approval of contracts; (xv) the expiration, suspension, or termination of Centene’s contracts with federal or state governments (including but not limited to Medicaid, Medicare, TRICARE or other customers); (xvi) the difficulty of predicting the timing or outcome of pending or future litigation or government investigations; (xvii) challenges to Centene’s contract awards; (xviii) cyber-attacks or other privacy or data security incidents; (xix) the possibility that the expected synergies and value creation from acquired businesses, including, without limitation, the Fidelis Care Transaction, will not be realized, or will not be realized within the expected time period; (xx) the exertion of management’s time and Centene’s resources, and other expenses incurred and business changes required in connection with complying with the undertakings in connection with any regulatory, governmental or third party consents or approvals for acquisitions, including the Fidelis Care Transaction; (xxi) disruption caused by significant completed and pending acquisitions, including, among others, the Fidelis Care Transaction, making it more difficult to maintain business and operational relationships; (xxii) the risk that unexpected costs will be incurred in connection with the completion and/or integration of acquisition transactions, including, among others, the Fidelis Care Transaction; (xxiii) changes in expected closing dates, estimated purchase price and accretion for acquisitions; (xxiv) the risk that acquired businesses, including Fidelis Care, will not be integrated successfully; (xxv) the risk that, following the Fidelis Care Transaction, Centene may not be able to effectively manage its expanded operations; (xxvi) restrictions and limitations in connection with Centene’s indebtedness; (xxvii) Centene’s ability to maintain the Centers for Medicare and Medicaid Services (CMS) Star ratings and maintain or achieve improvement in other quality scores in each case that can impact revenue and future growth; (xxviii) availability of debt and equity financing, on terms that are favorable to us; (xxxix) inflation; and (xxx) foreign currency fluctuations.
This list of important factors is not intended to be exhaustive. We discuss certain of these matters more fully, as well as certain other factors that may affect Centene’s business operations, financial condition and results of operations, in Centene’s filings with the Securities and Exchange Commission (the “SEC”), including Centene’s Annual Report on Form 10-K, quarterly reports on Form 10-Q and current reports on Form 8-K. Due to these important factors and risks, Centene cannot give assurances with respect to Centene’s future performance, including without limitation Centene’s ability to maintain adequate premium levels or Centene’s ability to control its future medical and selling, general and administrative costs.
SOURCE: Centene Corporation
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