Princeton, NJ, United States
Princeton, NJ, United States

Covance Inc. with headquarters in Princeton, New Jersey, is a contract research organization providing drug development and animal testing services. According to its website, it is one of the largest companies of its kind in the world, with annual revenues of over $2 billion, and over 11,000 employees in more than 60 countries. It claims to provide the world's largest central laboratory network. It became a publicly traded company after being spun off by Corning Incorporated in 1996. In 2011 it was listed as one of the top 100 employers by the Diversity Employers Magazine.Under the name Covance Research Products Inc., based in Denver, Pennsylvania, the company also deals in the import, breeding and sale of laboratory animals. It breeds dogs, rabbits, guinea pigs, non-human primates, and pigs, and runs the largest non-human primate laboratory in Germany. The company became the subject of controversy following allegations in 2003–2005 by the British Union for the Abolition of Vivisection and People for the Ethical Treatment of Animals that non-human primates were being abused in its laboratories in Germany and the United States. No violations of the law were found by the authorities in the first case, and a small fine was levied in the second. In response, the company drew up a new welfare code to guide its treatment of laboratory animals.On November 3rd, 2014, Labcorp announced it would be purchasing Covance for $6.1bn. Wikipedia.

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News Article | May 25, 2017
Site: globenewswire.com

BEVERLY, Mass. and TORONTO, May 25, 2017 (GLOBE NEWSWIRE) -- Hamilton Thorne Ltd. (TSX-V:HTL), a leading provider of precision instruments, consumables, software and services to the Assisted Reproductive Technologies (ART) and developmental biology research markets, today reported operational and financial results for the quarter ended March 31, 2017. Sales increased 62% to $3.28 million for the quarter ended March 31, 2017 led by the contribution from its recently acquired Embryotech business, as well as strong growth in sales of clinical laser systems and increased revenues from after sale services. Net income and EBITDA for the quarter improved significantly to $405,237 and $635,275 versus $23,147 and $116,423, respectively in the prior year quarter. Cash flow from operations was $1.29 million, and total cash at quarter end was $2.22 million. David Wolf, President and Chief Executive Officer stated, “We achieved solid growth in our instrument business as a result of the significant investments in sales and support resources and market development funding made over the past 6-12 months. Sales into our core in vitro fertilization (IVF) clinic market enhanced our growth, driven by the contribution of a full quarter of Embryotech sales plus a substantial increase in sales of our clinical laser systems. Margins were up at 68.0% versus 63.7% for the prior year quarter due to product mix and the impact of higher Embryotech margins.” Mr. Wolf added, “We continue to make progress on our active acquisition program. Following the quarter end, we completed the acquisition of Gynemed GmbH & Co. KG, a leading manufacturer and distributor of consumables and equipment for the IVF clinic and laboratory markets in the well-established European ART market. This transaction adds a portfolio of premium products that are highly complementary to our existing product and service offerings and provides us with a profitable base of operations in Germany. We expect this transaction to be materially accretive to revenue and EBITDA and look forward to the opportunity to expand Gynemed product offerings into additional international markets and to increase European sales of existing Hamilton Thorne products.” All amounts are in US dollars, unless specified otherwise, and results, with the exception of EBITDA, are expressed in accordance with the International Financial Reporting Standards ("IFRS"). The Company reported that operating expenses were generally in line with expectations, reflecting added expenses from the Embryotech business and continued investment in R&D, staffing, sales and marketing, and $55,000 of expenses related to its acquisition program. Financial statements and accompanying Management Discussion and Analysis for the periods are available on www.sedar.com and the Hamilton Thorne website. Hamilton Thorne is a leading world-wide provider of precision instruments, consumables, software and services that reduce cost, increase productivity, improve results and enable breakthroughs in Assisted Reproductive Technologies (ART) and developmental biology research markets. Hamilton Thorne's laser products attach to standard inverted microscopes and operate as micro-surgical devices, enabling a wide array of scientific applications and In Vitro Fertilization (IVF) procedures. Its image analysis systems are designed to bring quality, efficiency and reliability to studies of reproductive cells in the human fertility, animal sciences and reproductive toxicology fields. Hamilton Thorne’s standardized toxicology assays and quality control testing services help to improve outcomes in human IVF clinics. Hamilton Thorne’s growing worldwide customer base consists of pharmaceutical companies, biotechnology companies, fertility clinics, university research centers, animal breeding companies, and other commercial and academic research establishments, including Harvard, MIT, Yale, McGill, Oxford, Cambridge, the Smithsonian Institution, Charles River Labs, Covance, ABS Global, Sexing Technologies, Merck, Cook Medical, Novartis, Pfizer, and Dow Chemical. Neither the Toronto Venture Exchange, nor its regulation services provider (as that term is defined in the policies of the exchange), accepts responsibility for the adequacy or accuracy of this release. The Company has included earnings before interest, income taxes, depreciation and amortization, (“EBITDA”) as a non-IFRS measure, which is used by management as a measure of financial performance. See section entitled “Use of Non-IFRS Measures” in the Company’s Management Discussion and Analysis for the periods covered for further information. Certain information in this press release may contain forward-looking statements. This information is based on current expectations that are subject to significant risks and uncertainties that are difficult to predict including the risk that the Company may not be able to obtain the necessary regulatory approvals, as applicable. Actual results might differ materially from results suggested in any forward-looking statements. The Company assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those reflected in the forward-looking statements unless and until required by securities laws applicable to the Company. Additional information identifying risks and uncertainties is contained in filings by the Company with the Canadian securities regulators, which filings are available at www.sedar.com


News Article | May 23, 2017
Site: www.prnewswire.com

"We are pleased to expand our relationship with BCSI, the leader in pH measurement," said David Wolf, President and CEO of Hamilton Thorne. "This agreement allows us to provide monitoring solutions to existing and new customers in to the IVF community." TrakStation and TrakPod are the latest generation of continuous pH monitoring laboratory instruments from BCSI. With the capability of monitoring and logging pH data from one (1) to eight (8) chambers simultaneously, the system provides the lab manager or clinician with assurance of a stable incubator pH environment throughout the five (5) to seven (7) day IVF cycle. In contrast to systems that spot monitor pH, this unique surrogate continuous pH monitoring approach does not require opening and closing of incubator doors, thus allowing an uninterrupted incubation cycle and promoting better outcomes for IVF procedures. The system requires no expensive calibration or adjustments during its use. One disposable sensor lasts the entire 7-day cycle and is replaced between cycles. A reusable QC alignment tool adjusts the instrument to factory specifications in under ten (10) seconds after each cycle is complete; the QC alignment tool is replaced annually. "Hamilton Thorne is one of the most trusted suppliers of in vitro fertilization (IVF) products. They provide superior support, marketing and sales to clinics," said Russ Aldrich, CEO of BCSI. "pH is the most trusted indicator of incubation stability during the IVF process. Having the ability to measure, record and archive pH during a cycle provides the lab staff with extra assurance." About Hamilton Thorne Ltd. (www.hamiltonthorne.com)  Hamilton Thorne is a leading world-wide provider of precision instruments, consumables, software and services that reduce cost, increase productivity, improve results and enable breakthroughs in Assisted Reproductive Technologies (ART) and developmental biology research markets. Hamilton Thorne's laser products attach to standard inverted microscopes and operate as micro-surgical devices, enabling a wide array of scientific applications and In Vitro Fertilization (IVF) procedures. Its image analysis systems are designed to bring quality, efficiency and reliability to studies of reproductive cells in the human fertility, animal sciences and reproductive toxicology fields. Hamilton Thorne's standardized toxicology assays and quality control testing services help to improve outcomes in human IVF clinics. Hamilton Thorne's growing worldwide customer base consists of pharmaceutical companies, biotechnology companies, fertility clinics, university research centers, animal breeding companies, and other commercial and academic research establishments, including Harvard, MIT, Yale, McGill, Oxford, Cambridge, the Smithsonian Institution, Charles River Labs, Covance, ABS Global, Sexing Technologies, Merck, Cook Medical, Novartis, Pfizer, and Dow Chemical. About BCSI (www.safesens.com) Blood Cell Storage Inc. (BCSI), based in Seattle, Washington, is an international laboratory instrument and medical devices company. BCSI's patented technology and products benefit patients, clinicians, researchers, pathologists and doctors. In addition to IVF monitors, the company's fluorescent dyes, micro-fluidics, nucleic acid extraction capabilities and automated systems reduce healthcare costs and improve patient outcomes. Neither the Toronto Venture Exchange, nor its regulation services provider (as that term is defined in the policies of the exchange), accepts responsibility for the adequacy or accuracy of this release.  Certain information in this press release may contain forward-looking statements. This information is based on current expectations that are subject to significant risks and uncertainties that are difficult to predict. Actual results might differ materially from results suggested in any forward-looking statements. The Company assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those reflected in the forward-looking statements unless and until required by securities laws applicable to the Company. Additional information identifying risks and uncertainties is contained in filings by the Company with the Canadian securities regulators, which filings are available at www.sedar.com. For more information, please contact: To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/hamilton-thorne-and-bcsi-announce-distribution-agreement-300461833.html


News Article | May 25, 2017
Site: globenewswire.com

BEVERLY, Mass. and TORONTO, May 25, 2017 (GLOBE NEWSWIRE) -- Hamilton Thorne Ltd. (TSX-V:HTL), a leading provider of precision instruments, consumables, software and services to the Assisted Reproductive Technologies (ART) and developmental biology research markets, today reported operational and financial results for the quarter ended March 31, 2017. Sales increased 62% to $3.28 million for the quarter ended March 31, 2017 led by the contribution from its recently acquired Embryotech business, as well as strong growth in sales of clinical laser systems and increased revenues from after sale services. Net income and EBITDA for the quarter improved significantly to $405,237 and $635,275 versus $23,147 and $116,423, respectively in the prior year quarter. Cash flow from operations was $1.29 million, and total cash at quarter end was $2.22 million. David Wolf, President and Chief Executive Officer stated, “We achieved solid growth in our instrument business as a result of the significant investments in sales and support resources and market development funding made over the past 6-12 months. Sales into our core in vitro fertilization (IVF) clinic market enhanced our growth, driven by the contribution of a full quarter of Embryotech sales plus a substantial increase in sales of our clinical laser systems. Margins were up at 68.0% versus 63.7% for the prior year quarter due to product mix and the impact of higher Embryotech margins.” Mr. Wolf added, “We continue to make progress on our active acquisition program. Following the quarter end, we completed the acquisition of Gynemed GmbH & Co. KG, a leading manufacturer and distributor of consumables and equipment for the IVF clinic and laboratory markets in the well-established European ART market. This transaction adds a portfolio of premium products that are highly complementary to our existing product and service offerings and provides us with a profitable base of operations in Germany. We expect this transaction to be materially accretive to revenue and EBITDA and look forward to the opportunity to expand Gynemed product offerings into additional international markets and to increase European sales of existing Hamilton Thorne products.” All amounts are in US dollars, unless specified otherwise, and results, with the exception of EBITDA, are expressed in accordance with the International Financial Reporting Standards ("IFRS"). The Company reported that operating expenses were generally in line with expectations, reflecting added expenses from the Embryotech business and continued investment in R&D, staffing, sales and marketing, and $55,000 of expenses related to its acquisition program. Financial statements and accompanying Management Discussion and Analysis for the periods are available on www.sedar.com and the Hamilton Thorne website. Hamilton Thorne is a leading world-wide provider of precision instruments, consumables, software and services that reduce cost, increase productivity, improve results and enable breakthroughs in Assisted Reproductive Technologies (ART) and developmental biology research markets. Hamilton Thorne's laser products attach to standard inverted microscopes and operate as micro-surgical devices, enabling a wide array of scientific applications and In Vitro Fertilization (IVF) procedures. Its image analysis systems are designed to bring quality, efficiency and reliability to studies of reproductive cells in the human fertility, animal sciences and reproductive toxicology fields. Hamilton Thorne’s standardized toxicology assays and quality control testing services help to improve outcomes in human IVF clinics. Hamilton Thorne’s growing worldwide customer base consists of pharmaceutical companies, biotechnology companies, fertility clinics, university research centers, animal breeding companies, and other commercial and academic research establishments, including Harvard, MIT, Yale, McGill, Oxford, Cambridge, the Smithsonian Institution, Charles River Labs, Covance, ABS Global, Sexing Technologies, Merck, Cook Medical, Novartis, Pfizer, and Dow Chemical. Neither the Toronto Venture Exchange, nor its regulation services provider (as that term is defined in the policies of the exchange), accepts responsibility for the adequacy or accuracy of this release. The Company has included earnings before interest, income taxes, depreciation and amortization, (“EBITDA”) as a non-IFRS measure, which is used by management as a measure of financial performance. See section entitled “Use of Non-IFRS Measures” in the Company’s Management Discussion and Analysis for the periods covered for further information. Certain information in this press release may contain forward-looking statements. This information is based on current expectations that are subject to significant risks and uncertainties that are difficult to predict including the risk that the Company may not be able to obtain the necessary regulatory approvals, as applicable. Actual results might differ materially from results suggested in any forward-looking statements. The Company assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those reflected in the forward-looking statements unless and until required by securities laws applicable to the Company. Additional information identifying risks and uncertainties is contained in filings by the Company with the Canadian securities regulators, which filings are available at www.sedar.com


BURLINGTON, N.C.--(BUSINESS WIRE)--LabCorp® (NYSE: LH) today announced it will participate at the Bank of America Merrill Lynch 2017 Health Care Conference. LabCorp’s presentation is scheduled for Tuesday, May 16, 2017, at 10:40 a.m. PT. A live audio webcast of the presentation will be available via the Company website at www.labcorp.com and archived for replay. LabCorp (NYSE: LH), an S&P 500 company, is a leading global life sciences company that is deeply integrated in guiding patient care, providing comprehensive clinical laboratory and end-to-end drug development services. With a mission to improve health and improve lives, LabCorp delivers world-class diagnostic solutions, brings innovative medicines to patients faster and uses technology to provide better care. LabCorp reported net revenues of nearly $9.5 billion for 2016 through the contributions of 52,000 employees in approximately 60 countries. To learn more about LabCorp, visit www.labcorp.com, and to learn more about Covance Drug Development, visit www.covance.com. This press release contains forward-looking statements including with respect to estimated 2017 guidance and the impact of various factors on operating and financial results. Each of the forward-looking statements is subject to change based on various important factors, including without limitation, competitive actions in the marketplace, and adverse actions of governmental and other third-party payers. Actual results could differ materially from those suggested by these forward-looking statements. The Company has no obligation to provide any updates to these forward-looking statements even if its expectations change. Further information on potential factors that could affect operating and financial results is included in the Company’s Form 10-K for the year ended December 31, 2016, and subsequent Forms 10-Q, including in each case under the heading risk factors, and in the Company’s other filings with the SEC. The information in this press release should be read in conjunction with a review of the Company’s filings with the SEC including the information in the Company’s Form 10-K for the year ended December 31, 2016, and subsequent Forms 10-Q, under the heading MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS.


Grant
Agency: European Commission | Branch: FP7 | Program: CP-IP | Phase: HEALTH.2010.4.2-9-1 | Award Amount: 9.40M | Year: 2011

In the development of products for use by humans it is vital to identify compounds with toxic properties at an early stage of their development, to avoid spending time and resource on unsuitable and potentially unsafe candidate products. Human pluripotent stem cell lines offer a unique opportunity to develop a wide variety of human cell-based test systems because they may be expanded indefinitely and triggered to differentiate into any cell type. SCR&Tox aims at making use of these two attributes to provide in vitro assays for predicting toxicity of pharmaceutical compounds and cosmetic ingredients. The consortium has been designed to address all issues related with biological and technological resources to meet that goal. In order to demonstrate the value of pluripotent stem cells for toxicology, the consortium will focus on four complementary aspects: Relevance i.e. establishing and maintaining discrete cell phenotypes over long-term cultures; providing large versatility to adapt to assays of specific pathways. Efficiency for i) automated cell production and differentiation, ii) cell engineering for differentiation and selection iii) multi-parametric toxicology using functional genomic, proteomic and bioelectronics. Extension i.e. i) scalability through production of cells and technologies for industrial-scale assays, and ii) diversity of phenotypes (5 different tissues), and of genotypes (over 30 different donors). Normalization validation and demonstration of reproducibility and robustness of cell-based assays on industrial-scale platforms, to allow for secondary development in the pharmaceutical and cosmetic industry. SCR&Tox will be intricately associated to other consortia of the Alternative Testing call, sharing biological, technological and methodological resources. Proof of concept of the proposed pluripotent stem cell-based assays for toxicology will be provided on the basis of toxicity pathways and test compounds identified by other consortia.


Grant
Agency: European Commission | Branch: FP7 | Program: CP-FP | Phase: HEALTH.2011.1.4-3 | Award Amount: 8.73M | Year: 2011

The consortium aims to develop and produce an Anticalin, a member of a novel high-affinity scaffold derived from the lipocalin protein family. The Anticalin is specific for hepcidin which is a central regulator of iron homeostasis, and will be used to antagonize hepcidin for the treatment of anemia of chronic disease (ACD). Anticalins are genetically modified lipocalins that can target almost any desired molecule. Unlike Immunoglobulins, they can be produced at low cost in microbial expression systems, are expected to be non immunogenic and offer therapeutic advantages where antibody effector functions are not desired. ACD, the most frequent anemia in hospitalized patients, develops in subjects suffering from infections, inflammatory and auto-immune disease, cancer and chronic kidney disease. It is often successfully treated by administering Erythropoiesis-Stimulating Agents. However, a significant number of patients are hypo- or non-responsive to ESA. Anti-hepcidin therapies, alone or together with ESAs, may improve anemia and the patients erythropoietic response and enable the use of no or even much lower ESA doses, avoiding the potential detrimental effects of high doses of ESA. The Consortium has already generated proof-of-concept data in an animal model with early candidates. The project aims at identifying, validating, and developing a specific, high affinity drug candidate based on the lipocalin scaffold as promising alternatives to immunoglobulins and a therapeutic approach based on the neutralization of hepcidin. Animal models will be developed and utilized to characterize pharmacokinetic and pharmacodynamic relationships, optimize dosing, to determine safety, biomarker responses and potential synergy with ESAs. Furthermore, production processes will be optimized leading to a scalable GMP process which provides material for preclinical and clinical studies to establish the safety, tolerability, and PK/PD of an Anticalin hepcidin blocker (Phase Ia/b).


The commonly held assumption that rodent mammary tumors resulting from elevated prolactin are species-specific, or not biologically relevant to humans, is incorrect. Substantial epidemiological, clinical, and biological evidence now exists confirming the role of prolactin in human breast cancer. This evidence is evaluated and the argument presented that the tumorigenic risk from prolactin is therefore not species-specific to rodents but directly applies to humans. Further, as the mechanisms of prolactin-induced mammary tumor promotion and development appear analogous between rodents and humans, mammary tumorigenic findings in rodent carcinogenicity bioassays are both predictive and biologically relevant to the human response. Toxicologists and regulators need to consider this in carcinogenicity risk assessments. © 2011 John Wiley & Sons, Ltd.


Baldrick P.,Covance
Regulatory Toxicology and Pharmacology | Year: 2010

In pharmaceutical drug development, there has been increased interest in the need to perform juvenile animal studies to support the safety of use of new medicines in the pediatric population. Although such studies are not new, the increased interest has been " formalized" in recent regulatory guidelines. As a result, companies are now performing many more studies in juvenile animals, even when there is a lack of robust knowledge of cross-species functional and kinetic differences among juveniles that means extrapolation of any toxicology study finding to an immature human may not be easy or even relevant, especially if performed in the wrong species at the wrong time. It will be shown by presentation of some basic considerations needed in order to perform such testing, that juvenile animal studies are indeed feasible. However, it will also be highlighted that (based on available knowledge) there are currently not enough clear-cut examples to answer the question of whether juvenile animal toxicology studies to support pediatric development (by affecting the performance or design of a pediatric clinical trial or identifying a potential different-from-adult safety risk in clinical use) are truly useful or necessary. © 2010 Elsevier Inc.


Grant
Agency: European Commission | Branch: H2020 | Program: RIA | Phase: NMBP-10-2016 | Award Amount: 5.85M | Year: 2017

Lysosomal storage disorders (LSD) diseases are a group of rare diseases that currently lack a definitive cure. LSD incidence is about 1:5,000 - 1:10,000, representing a serious global health problem. In the case of Fabry LSD Disease (FD), the deficiency in -Galactosidase A (GLA) enzyme activity results in the cellular accumulation of neutral glycosphingolipids, leading to widespread vasculopathy with particular detriment to the kidneys, heart and nervous system. The current treatment for FD is the Enzyme Replacement Therapy (ERT), in which free GLA recombinant protein is administered intravenously to patients. ERT exhibits several drawbacks mainly related to the instability, high immunogenicity and low efficacy of the exogenously administered GLA to cross biological barriers, such as cell membranes and BBB.The aim of Samrt-4-Fabry project is to achieve excellent quality control over the assembly of the different molecular components of a new liposomal nanoformulation of GLA, nano-GLA, for the treatment of Fabry disease. Nanoformulated GLA has already shown to have better PK/PD profile than free GLA and higher efficacy in vivo. Smart-4-Fabry project will advance nano-GLA from an experimental PoC (TRL3) to preclinical regulatory phase (TRL5-6). A one-step method based on the use of green cCO2, will be used for the manufacturing of this novel nanoformulation under GMPs. The final GLA nanoformulation will have tailored transport of GLA through cell membranes and BBB. Fulfillment of Smart-4-Fabry will impact on a major health problem, the existence of new therapies for rare diseases, which constitutes a priority societal challenge as shown in the H2020 Work Programmes. Another important impact is related to its contribution to support the European Strategy for KETs, which aims to reverse the decline in manufacturing as this will stimulate growth and jobs. Smart-4-Fabry is strongly focusing on three KETs: nanotechnology, industrial biotechnology and advanced materials.

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