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Health Care

European Hantavirus Diagnostics Market Tops US Market as a Result of Higher Disease Prevalence

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— Frost & Sullivan says existing competitors’ dominance of the niche market raises entry barriers

MOUNTAIN VIEW, Calif., Jan. 27, 2015 /PRNewswire/ — The European Hantavirus diagnostics market is growing at a compound annual growth rate (CAGR) of 5.8 percent, outperforming the U.S. market, which registered 3.7 percent. The European market is more robust primarily due to Hantavirus’ high prevalence rates in Russia, Scandinavia, Finland and Belgium. However, the U.S. market has higher mortality rates (50 percent) associated with the disease, even though it has no more than 40 reported cases every year.

Frost & Sullivan (www.frost.com)

Frost & Sullivan (www.frost.com)

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New analysis from Frost & Sullivan finds the Hantavirus testing market in Europe and the U.S. were worth $5.5 million and $0.023 million respectively in 2013, and estimates this to reach $7.3 million and $0.028 million by 2018.

Gain complimentary access to portions of Frost & Sullivan’s European and US Hantavirus Diagnostics research: http://bit.ly/1CcRUYq

“Since Hantavirus diagnostics is a niche market, competitors such as Immunospec and FocusDx have an advantage in the U.S. because of their established clientele,” said Frost & Sullivan Healthcare Research Analyst Aishwarya Vivekanadan. “This is likely to raise the entry barriers for new participants.”

Owing to the severity of Hantavirus infections, there is an urgent need for rapid diagnostic tests that can be easily conducted and used in field conditions. Acknowledging this unmet demand, diagnostic companies have been striving to develop faster, sensitive and more accurate tests.

“Currently tests take hours to days to detect the virus, mainly due to the lack of sensitivity to the different strains of the disease,” said Vivekanadan. “There is a need for diagnostic tests that are not only efficient but can identify the various strains of this virus to better cure it. A faster and more sensitive diagnostic test will go long way in saving lives, especially in the U.S. where mortality rate is almost 50 percent.”

Scientists have already launched a new diagnostic method based on a highly dispersed immunoelectrode prototype amperometric immunosensor. This model has been employed successfully in field conditions for testing rodent sera.

The earnest research and development (R&D) initiatives of diagnostics companies can lead to the discovery of new ecological paradigms regarding the virus. It could also aid superior understanding of the nature of episodic zoonotic epidemics such as those caused by Ebola virus, SARS CoV, Nipah virus, Machupo virus, and hantaviruses that are still undiscovered.

European and US Hantavirus Diagnostics is part of the Life Sciences (http://www.lifesciences.frost.com) Growth Partnership Service program. Frost & Sullivan’s related studies include: Briefing for the Bracing Devices and Support Market in the United States, Long-term Care in Extended Facilities and Nursing Homes in the United States, Industry Financial Review of the Global Laboratory Research Tools Market, and Optimization and Efficiency Drive in Hospitals in Western Europe. All studies included in subscriptions provide detailed market opportunities and industry trends evaluated following extensive interviews with market participants.

About Frost & Sullivan

Frost & Sullivan, the Growth Partnership Company, works in collaboration with clients to leverage visionary innovation that addresses the global challenges and related growth opportunities that will make or break today’s market participants.

Our “Growth Partnership” supports clients by addressing these opportunities and incorporating two key elements driving visionary innovation: The Integrated Value Proposition and The Partnership Infrastructure.

  • The Integrated Value Proposition provides support to our clients throughout all phases of their journey to visionary innovation including: research, analysis, strategy, vision, innovation and implementation.
  • The Partnership Infrastructure is entirely unique as it constructs the foundation upon which visionary innovation becomes possible. This includes our 360 degree research, comprehensive industry coverage, career best practices as well as our global footprint of more than 40 offices.

For more than 50 years, we have been developing growth strategies for the global 1000, emerging businesses, the public sector and the investment community. Is your organization prepared for the next profound wave of industry convergence, disruptive technologies, increasing competitive intensity, Mega Trends, breakthrough best practices, changing customer dynamics and emerging economies?

Contact Us:     Start the discussion

European and US Hantavirus Diagnostics
9837-52

Contact:
Jennifer Carson
Corporate Communications – North America
P: 210.247.2450
E: jennifer.carson@frost.com

Twitter: @Frost_Sullivan
Facebook: facebook.com/FrostandSullivan
Linkedin: http://linkd.in/1nL4auZ

http://www.frost.com

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Health Care

The American Society of Clinical Oncology (ASCO) Recognizes Gensignia’s Research in Lung Cancer Screening

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SAN DIEGO and MILAN, Jan. 22, 2015 /PRNewswire/ — Gensignia scientific co-founders’ research has been recognized in Clinical Cancer Advances 2015: Annual Report on Progress Against Cancer From the American Society of Clinical Oncology published online in the Journal of Clinical Oncology (JCO) on January 20, 2015.1

The ASCO report states: “Additional recent research will help improve the efficacy of low-dose CT lung cancer screening and reduce potential harms by identifying the populations that stand to benefit the most from screening, and developing ways to reduce false-positive screening results.”

“A recent study addressed the problem of false-positive findings by developing a new diagnostic blood test for lung cancer (this study was funded in part by a grant from the NIH).2 The experimental test is noninvasive; it only requires a blood sample, rather than a potentially painful and risky biopsy. By analyzing molecules called microRNA in a patient’s blood, physicians can determine if the abnormality detected on a scan is truly lung cancer. In a large validation study, combination of the microRNA test and low-dose CT resulted in a five-fold reduction of false-positive screening rates (from 19.4% to 3.7%).”

Gensignia’s scientific co-founders, Gabriella Sozzi, Ph.D., Mattia Boeri, Ph.D., and Ugo Pastorino, M.D., are attributed with the discovery that the evaluation of certain microRNAs in the blood of subjects at high risk for lung cancer (heavy smokers) can be used to determine, with improved accuracy, the likelihood that lung cancer is developing or has already developed. The discovery was made in the context of screening high risk subjects using routine low-dose computed tomography (LDCT) scans for the presence of potentially cancerous lung masses. Their pioneering research was published in the Proceedings of the National Academy of Sciences (PNAS) in 2011.3

The microRNA assay was further validated in a large clinical study completed in 2013 and its results published in JCO in January 2014.2,4 This clinical validation was a correlative study from the Multicenter Italian Lung Detection (MILD) Trial that was published in the European Journal of Cancer Prevention in 2012.5 The authors concluded from the results of the clinical validation study that the MSC Lung Cancer assay had predictive, diagnostic, and prognostic value and reduced the high false-positive rate of LDCT, thus potentially improving the efficacy of lung cancer screening.

“We are honored to have Drs. Sozzi, Boeri and our team’s research included by ASCO as one of the most important cancer research advances in 2014,” stated Ugo Pastorino, M.D., Scientific Director, Fondazione IRCCS Istituto Nazionale dei Tumori, and Gensignia co-founder.

Lee R. McCracken, Gensignia’s Chief Executive Officer, further commented, “We are truly appreciative of ASCO’s acknowledgment of Gensignia’s clinical research and are committed to bringing the Gensignia™ miRNA Signature Classifier (MSC) Lung Cancer Test into clinical practice to improve lung cancer detection worldwide.”

About Gensignia
Gensignia Life Sciences, Inc. (Gensignia) is a privately held molecular diagnostics company advancing development and global commercialization of the Gensignia™ MSC Lung Cancer Test in 2015, and additional diagnostic tests in the future, through the establishment of a clinical laboratory in San Diego.

For more information visit www.gensignia.com.

Forward Looking Statements
Statements in this press release about the Company’s expectations, applications of its technology, markets, launch of tests and other statements that are not historical fact are “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and are based on management’s current beliefs, assumptions, estimates and projections. Actual results could differ materially from those projected in the forward-looking statements for various reasons, including risks associated with product and test development, test transfer to contracting labs, government regulation, market acceptance, limited commercial experience and dependence on key personnel and financing.

Contact
Clyde Shores
clyde.shores@gensignia.com

References

1

Masters, G., et al, Clinical Cancer Advances 2015: Annual Report on Progress Against Cancer From the American Society of Clinical Oncology, JCO.2014.59.9746; Published Ahead of Print on January 20, 2015.

2

Sozzi G, Boeri M, Rossi M, et al: Clinical Utility of a Plasma-Based miRNA Signature Classifier Within Computed Tomography Lung Cancer Screening: A Correlative MILD Trial Study. J Clin Oncol 32:768-773; published online on January 13, 2014.

3

Boeri, M., et al., MicroRNA Signatures In Tissues And Plasma Predict Development And Prognosis Of Computed Tomography Detected Lung Cancer. PNAS, 2011. 108(9): p. 3713-8. 

4

Massion, Biomarkers To The Rescue In A Lung Nodule Epidemic. J Clin Oncol 32:725-726; Published online February 10, 2014.

5

Pastorino U, Rossi M, Rosato V, et al: Annual Or Biennial CT Screening Versus Observation In Heavy Smokers: 5-Year Results Of The MILD Trial. Eur J Cancer Prev 21:308-315, 2012.

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Health Care

European Medicines Agency Accepts Samsung Bioepis’ Enbrel(R) Biosimilar Candidate, SB4, for Regulatory Review

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— First biosimilar from Samsung Bioepis to advance to EMA regulatory review —

— First Enbrel biosimilar to be filed in the EU —

— If authorized, SB4 will be marketed in Europe by Biogen Idec —

INCHEON, South Korea, Jan. 21, 2015 /PRNewswire/ — Samsung Bioepis Co., Ltd., today announced that the Marketing Authorization Application (MAA) for its Enbrel (etanercept) biosimilar candidate, SB4, has been validated and accepted for review by European Medicines Agency (EMA). The acceptance of the MAA marks the first Enbrel biosimilar to advance into regulatory review in the European Union (EU). The MAA is based on results from a Phase III clinical trial in patients with moderate-to-severe rheumatoid arthritis (RA).

In Europe, Enbrel is indicated for the treatment of a number of rheumatic diseases, including moderate to severe RA, certain forms of juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis and plaque psoriasis. If authorized by the EMA, SB4 could be available for use in all of the same indications as Enbrel.

“This MAA validation represents a significant milestone for Samsung Bioepis in our work to develop and manufacture world-class biosimilars. More significantly, it offers an opportunity to provide high-quality and effective therapies for broadening access to patients in Europe,” said Christopher Hansung Ko, chief executive officer of Samsung Bioepis.

If authorized by the EMA, SB4 will be commercialized in Europe by Biogen Idec. It will also be produced at the company’s manufacturing facility in Hillerød, Denmark which is one of the largest biologic manufacturing facilities in the world.

In addition to the European filings, Samsung Bioepis intends to move forward with additional applications for regulatory approvals in other territories worldwide.

About the SB4

Samsung Bioepis previously conducted SB4 Phase 1 and Phase 3 clinical studies. The MAA for the etanercept biosimilar was based on data from a Phase 3, controlled, randomized, multicenter study in Europe where SB4 demonstrated its comparability to Enbrel®. The primary and secondary endpoints of the study were assessed and met the qualification standard for the MAA submission. Full data from the study will be available later this year.

About Samsung Bioepis

The company was established in 2012 as part of the Samsung group, with the mission to produce affordable, high-quality biopharmaceutical products to many patients in need. The company aims to be the world leading biopharmaceutical company with its heritage of innovation and advanced technologies. Please visit www.samsungbioepis.com for more information.

Fashion

UltraShape Wins NewBeauty Magazine Beauty Choice Award For Best Body-Contouring Treatment

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– UltraShape Is Recognized As A Breakthrough In Non-Invasive Abdominal Fat Reduction Thanks To Its Painless And Effective Ultrasound Technology

WAYLAND, Mass., Jan. 16, 2015 /PRNewswire/ — Syneron Medical Ltd. (NASDAQ: ELOS), a leading global aesthetic device company, announced today that NewBeauty Magazine awarded UltraShape® the “Best Body-Contouring Treatment” in its annual 2014 Beauty Choice Awards. As a winner in the coveted “Beauty Game Changers” category, UltraShape is recognized for its innovative ultrasound-based treatment that painlessly and permanently destroys fat in the abdominal area where fat is most resistant to diet and exercise.

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Featured alongside an elite list of outstanding aesthetic products, NewBeauty notes that UltraShape was chosen by a panel of thousands of readers, editors and beauty industry experts for its ability to deliver real, noticeable and highly customizable results “without surgery or hours spent in the gym.”

“As the number of satisfied UltraShape users continues to grow, we are honored to earn recognition from NewBeauty Magazine, further validating our leading position in the body shaping space,” said Dr. Shimon Eckhouse, Chairman of the Board of Directors for Syneron. “UltraShape represents the next generation in body-shaping with proven clinical outcomes and a superior safety profile, underscoring Syneron’s ongoing commitment to advancing treatment outcomes through technological innovation.”

“What sets UltraShape apart from other body shaping solutions is its fast outcomes with results visible in often as little as 2 weeks post first treatment,” says Amit Meridor, Chief Executive Officer of Syneron. “With UltraShape’s customizable treatments, for the very first time physicians are able to truly sculpt instead of bulk heat or freeze fat. UltraShape is a painless solution for those who cannot get rid of stubborn fat resistant to diet and exercise.”

The UltraShape System is the first and only non-invasive body shaping treatment that uses pulsed focused ultrasound energy to precisely target subcutaneous fat, while keeping the surrounding tissue, vasculature, nerves and muscles intact. Unlike other body shaping technologies that use heat or freezing techniques, UltraShape uses a pure mechanical effect to destroy fat cells without inducing thermal damage. This unique feature of UltraShape technology results in a safe and comfortable treatment experience with no visible signs of treatment and no downtime.

The newest fat-blasting treatment on the block, UltraShape, with over 300,000 procedures performed worldwide, was cleared by the United States Food and Drug Administration (FDA) 510(k) for non-invasive reduction of abdominal circumference via fat cell destruction in April of last year.

About NewBeauty
NewBeauty® magazine is the definitive authority on all things beauty. Each issue of NewBeauty gives readers an in-depth look at the beauty industry’s latest products, cutting-edge innovations and breakthrough technologies. Whether it’s the latest high-powered skin care or in-office procedure, NewBeauty educates readers on the latest options for skin, face, hair, body, well-being and smile. The magazine’s comprehensive approach to its topics continues to solidify its reputation as the industry’s leading scientifically accurate, expert-driven and ethically balanced beauty resource. 

About Syneron Candela:

Syneron Candela is a leading global aesthetic device company with a comprehensive product portfolio and a global distribution footprint.  The Company’s technology enables physicians to provide advanced solutions for a broad range of medical-aesthetic applications including body contouring, hair removal, wrinkle reduction, tattoo removal, improving the skin’s appearance through the treatment of superficial benign vascular and pigmented lesions, and the treatment of acne, leg veins and cellulite. The Company sells its products under three distinct brands, Syneron, Candela and CoolTouch, and has a wide portfolio of trusted, leading products including UltraShape, VelaShape, GentleLase, VBeam Perfecta, PicoWay and elos Plus.

Founded in 2000, the corporate, R&D, and manufacturing headquarters for Syneron Candela are located in Israel. Syneron Candela also has R&D and manufacturing operations in the U.S.  The company markets, services and supports its products in 86 countries. It has offices in North America, France, Germany, Italy, Portugal, Spain, UK, Australia, mainland China, Japan, and Hong Kong and distributors worldwide.

For additional information, please visit http://www.syneron-candela.com.

SAFE HARBOR FOR FORWARD-LOOKING STATEMENTS

This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties. Such forward-looking statements include the expectations, plans and prospects for the Company, including product efficacy, market acceptance of new products, and projected revenues, margins, earnings and market shares. The statements made by the Company are based upon management’s current expectations and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include  the risk factors and other cautionary statements described in the Company’s filings with the SEC, including those described in the Company’s most recent Annual Report on Form 20-F, and in the filings that Syneron Medical makes with the SEC, and other factors beyond the Company’s control. If one or more of these factors materialize, or if any underlying assumptions prove incorrect, Syneron Medical Ltd.’s actual results, performance or achievements may vary materially from those expressed or implied by these forward-looking statements.  These forward-looking statements should not be relied upon as representing Syneron Medical Ltd.’s views as of any date after the date of this document. The Company does not intend to update these statements and undertakes no duty to any person to provide any such update under any circumstance.

Additional information can be found at www.syneron-candela.com

KELZ PR – +1-646-450-5359
Patty Mathews – pattymathews@kelzpr.com
Melissa Ben-Yoseph – Melissa@kelzpr.com 

Zack Kubow, The Ruth Group zkubow@theruthgroup.com, +1-646-536-7020
Hugo Goldman, Chief Financial Officer, Syneron Hugo.Goldman@syneron.com 
Syneron Medical Public Relations pr@syneron.com 

Health Care LIC

CROMSOURCE Supports Italian Cystic Fibrosis Society’s Clinical Research Training Initiative

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VERONA, Italy, Jan. 15, 2015 /PRNewswire/ — CROMSOURCE, an international provider of outsourced services to the pharmaceutical, biotechnology and medical device industries, today announced that it is delivering several modules of a training course on clinical research best practice organized by the SIFC (Italian Cystic Fibrosis Society). The course commenced in December 2014 and will complete in February 2015.

Effective development of therapies in rare diseases such as cystic fibrosis relies on the involvement of physicians working in specialized clinics. These clinicians are then able to offer participation in such research projects to patients under their care. By offering training in clinical research best practice, SIFC hopes that physicians and their teams may be able to engage even more in future clinical research programs and offer participation to more patients with cystic fibrosis.

As recognized experts in clinical research, with strong experience in cystic fibrosis, CROMSOURCE is well-placed to support this work. During the course, CROMSOURCE personnel are training physicians and their teams on topics including typical aspects of a clinical research study protocol, the responsibilities of the physician and clinical staff who are involved in clinical research and the regulatory application and approval process for clinical research.

Oriana Zerbini MD, founder and Chief Executive Officer of CROMSOURCE noted, “We are delighted to take part in this initiative and work alongside representatives from the Italian ISS (National High Health Commission), the US Cystic Fibrosis Foundation, Ethics Committees and various pharmaceutical companies. CROMSOURCE is committed to sharing our expertise in clinical research and fully recognize the importance of this training course. In this spirit we have pleasure in supporting this important initiative”.

About CROMSOURCE

Founded in 1994, CROMSOURCE is the leading independent provider of international outsourced services to the pharmaceutical, biotechnology and medical device industries, specialized in clinical development and staffing solutions across Europe and North America. CROMSOURCE is unique in providing clients with a guarantee that projects will be delivered according to agreed timelines and within the original contract budget.

Contact:

Margherita Mosconi
CROMSOURCE
Phone: +39-045-8222811
Fax: +39-045-8222812 (European Headquarters)
Via Giorgio De Sandre, 3
37135 Verona, Italy
http://www.cromsource.com

Health Care

PharmaMar Will Start a Phase III Study of PM1183 in Combination With Doxorubicin in Relapsed SCLC

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MADRID, Jan. 13, 2015 /PRNewswire/ —

  • The unparalleled results obtained in the Phase Ib study support the start of a head-to-head study in relapsed small-cell lung cancer (SCLC) patients that will compare the combination as second line therapy against topotecan, the only drug approved in the US and Europe for this indication  

Zeltia announces today that its pharmaceutical division PharmaMar will start a Phase III trial with PM1183 in combination with doxorubicin against topotecan in SCLC, given the activity observed in an interim analysis of an ongoing Phase Ib trial. The results of this study will be presented at a prominent international cancer meeting this year, which will be soon announced.

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Patients with small cell lung cancer (SCLC) after failure of standard chemotherapy, as well as bladder, gastric, breast, endometrial or ovarian cancer, neuroendocrine tumors and soft-tissue sarcomas were treated with the combination in a Phase I. The treatment showed efficacy across all cancer types, including several complete responses. This clinical response was remarkable in certain tumor types, particularly in SCLC, and consequently more patients with this type of tumor were enrolled. The treatment was generally well-tolerated, and these patients had marked objective tumor responses and were able to receive several cycles of treatment.

“The data we have are very exciting as patients with SCLC have the worst prognosis among lung cancer patient. There have been no significant advances in 25 years in this type of lung cancer.“ says Luis Mora, Managing Director, PharmaMar.

Topotecan, which is the only drug approved in the EU and the US for the treatment of SCLC in second line, achieved objective responses in only 20-25% of the patients (depending on the response to initial treatment)[1]. Preliminary results presented last year at the 15th world Conference on Lung Cancer showed that 71% of SCLC patients responded to PM1183 plus doxorubicin as second-line therapy. PharmaMar will start a head-to-head study to compare the combination against topotecan for this indication.

About small cell lung cancer 

SCLC is a very aggressive cancer that usually presents with distant metastases and has already spread at the time of diagnosis, thus limiting the role of traditional approaches and posing a worse prognosis compared to other lung cancer types. The 5-year survival rate is less than 5%. About 15% of all the lung cancer cases diagnosed are SCLC[2], and only in the US more than 34,000 new cases are recorded every year, which are strongly associated with tobacco smoking[3]. Mechanistically, PM1183 specifically inhibits active transcription, and regulates different components of the tumor microenvironment, such as tumor-associated macrophages.

Disclaimer 

PharmaMar, which is headquartered in Madrid (Spain), is a subsidiary of Zeltia, S.A. (Spanish stock exchange: ZEL), which has been listed on the Spanish Stock Exchange since 1963 and on Spain’s Electronic Market since 1998. This document is a press release, not a prospectus. This document does not constitute or form part of an offering or invitation to sell or a solicitation to purchase, offer or subscribe shares of the company. Moreover, no reliance should be placed upon this document for any investment decision or contract and it does not constitute a recommendation of any type with regard to the shares of the company.

PharmaMar Media Relations:
Carolina Pola
Phone:  +34-91-846-6108
Mobile: +34-608-93-36-77

Zeltia Investor Relations:
Phone: +34-914444500

Or please visit our website at http://www.pharmamar.com and http://www.zeltia.com

# # # 

[1]http://jco.ascopubs.org/content/17/2/658.long

[2] General information about Small Cell Lung Cancer. Available at: http://www.cancer.gov/cancertopics/pdq/treatment/small-cell-lung/healthprofessional

[3]http://www.jnccn.org/content/11/1/78.full.pdf

Health Care

A World First at the Montreal Heart Institute – Discovery of a personalized therapy for cardiovascular disease

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— Important reduction in events including heart attacks and deaths in patients with the appropriate genetic background to respond to a new medication

MONTREAL, Jan. 13, 2015 /PRNewswire/ — Researchers at the Montreal Heart Institute announced today results showing that patients with cardiovascular disease and the appropriate genetic background benefit greatly from the new medication dalcetrapib, with a reduction of 39% in combined clinical outcomes including heart attacks, strokes, unstable angina, coronary revascularizations and cardiovascular deaths. These patients also benefit from a reduction in the amount of atherosclerosis (thickened walls) in their vessels. The detailed results are published in the prestigious Journal Circulation Cardiovascular Genetics. This discovery may also pave the way for a new era in cardiovascular medicine, with personalized or precision drugs.

The team led by Drs Jean-Claude Tardif and Marie-Pierre Dube performed the analysis of 5,749 patients who received dalcetrapib or placebo and provided DNA in a clinical study. A strong association was discovered between the effects of dalcetrapib and a specific gene called ADCY9 (adenylate cyclase 9) on chromosome 16, particularly for a specific genetic variant (rs1967309). In patients with the genetic profile AA at rs1967309, there was a 39% reduction in the composite cardiovascular endpoint with dalcetrapib compared to placebo. Supporting evidence was also obtained from a second study, which showed that patients with the favourable genetic profile also benefited from a reduction in the thickness of their carotid artery walls with dalcetrapib.

“These results will lead to a genetics-guided clinical study in patients with the appropriate genetic background to allow review by health regulatory agencies and to provide personalized therapy with dalcetrapib. It also offers great hope for precision treatments for patients with cardiovascular diseases and for curbing atherosclerosis, the first cause of mortality in the world,” said lead investigator Jean-Claude Tardif MD, director of the Research Center at the Montreal Heart Institute and professor of medicine at the University of Montreal.

The investigators tested multiple genetic markers across the entire genome in a procedure called genome-wide association study. “We used state-of-the-art genetic and statistical techniques to demonstrate that the effect of the patient’s genetic profile was only observed in those treated with dalcetrapib and not placebo. We want to provide patients with additional personalized cardiovascular therapies in the years to come, for more efficacious and safer medicines,” commented Marie-Pierre Dube PhD, director of the Beaulieu-Saucier Pharmacogenomics Center at the Montreal Heart Institute and professor of medicine at the University of Montreal.

Dr. Jean-Claude Tardif is available for interviews.
To read the article: http://bit.ly/1tZSSG9
To consult the Journal of the American heart Association website : http://circgenetics.ahajournals.org

Media Invitation :

Wednesday January 14 2015 at 10:30 AM

Auditorium Jean Parisien at the Montreal Heart Institute

5000, Belanger street, Montreal, Quebec H1T 1C8

RSVP : Lise Plante +1-514-376-3330 ext 3898

Dr Jean-Claude Tardif will present the study highlights.

Dr Jean-Claude Tardif
https://www.icm-mhi.org/en/research/researchers/493-jean-claude-tardif

Dre Marie-Pierre Dube
https://www.icm-mhi.org/fr/recherche/chercheurs/501-marie-pierre-dube

About the Montreal Heart Institute : www.icm-mhi.org

About the Montreal Heart Institute Foundation
www.icm-mhi.org

Lise Plante MBA, Communications and Marketing Director, Montreal Heart Institute Foundation, Phone: +1-514-376-3330, ext. 3898, lise.plante@icm-mhi.org, facebook.com/institutcardiologiemontreal, @ICMtl

Health Care

From Volume to Value: Healthcare Reform Reshapes Delivery Models and Diagnostic Laboratories

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— Frost & Sullivan: Healthcare now geared toward tracking, predicting, intervening and managing disease conditions in a cost-effective manner

MOUNTAIN VIEW, Calif., Jan. 6, 2015 /PRNewswire/ — The in vitro diagnostics (IVD) industry and healthcare provider organizations are trying to function collaboratively to manifest a paradigm shift from routine disease management to prevention and wellness. Expectedly, enabling easy access to healthcare by offering advanced technologies at a lower cost is high on industry participants’ agenda.

Frost & Sullivan (www.frost.com)

Frost & Sullivan (www.frost.com)

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With the Affordable Care Act (ACA) bringing in a large number of new patients to the healthcare continuum, industry participants have to reevaluate their current business strategies. Clinical laboratories need to find alternative strategies to reduce the number of tests per patient as to avoid redundancy and save costs. In response, diagnostic laboratories will have to decrease costs and boost productivity to meet the expectation of lower reimbursement rates with increased testing volumes. Manufacturers too will have to support the labs with sophisticated technologies.

View the impacts of U.S. healthcare reform on the in vitro diagnostics market via Frost & Sullivan’s recent analysis: http://bit.ly/1JPevh9

“Healthcare reform is bringing in new delivery models such as accountable care organizations (ACOs); clinical laboratories will eventually blend in with ACOs to offer value-based healthcare,” said Frost & Sullivan Life Sciences Senior Industry Analyst Divyaa Ravishankar. “In fact, new schemes on outcome-based reimbursement have already triggered interest in a move away from the traditional fee-for-service models. While laboratories might lose money as an entity by adopting the value-based healthcare system, overall welfare will increase, with better treatments for patients, and higher patient and physician satisfaction.”

Electronic connectivity solutions will be the main tool to help eliminate unnecessary testing, provide seamless access to laboratory results throughout the continuum of care, improve the quality of testing, and reduce errors. Laboratories will opt for lean six sigma principles and connectivity solutions such as electronic medical records to access and upload test results from anywhere using the cloud and other applications. Clinical analytics will also become vital to bridge the existing gap between traditional laboratory testing and laboratory management (test utilization).

As such, the industry will see a rise in innovative partnership models among IVD manufacturers, diagnostic laboratories, software vendors and smartphone giants. Companies like Apple and Google are especially keen on rolling out disruptive technologies and supplemental modules for e-health.

“The market is ripe for IVD manufacturers that can invest to develop solutions that significantly lower turnaround times,” noted Ravishankar. “Thus, integrating lab-on-a-chip with smartphones, revolutionizing point-of-care testing and decentralized testing, and introducing more patient self-testing products and devices are important for diagnostic test developers to taste success.”

As patient self-testing and direct-to-consumer testing gains momentum, retail healthcare too will become a big business. Kroger has already taken a giant leap by installing pilot phase kiosks in its pharmacies and retail stores. Target has also been eyeing this market from the start of this year.

Frost & Sullivan has developed a highly successful IVD Market Intelligence Program to provide a comprehensive overview on the latest IVD market trends in global and emerging markets. IVD companies can leverage accurate and reliable market intelligence to develop goals and strategize. The studies offered include:

  • Analysis of the Global In Vitro Diagnostics Market
  • Impact of US Healthcare Reform on the In Vitro Diagnostics Market
  • US Hematology Diagnostics Market
  • Western European Companion Diagnostics Market
  • Analysis of the Global Tissue Diagnostics Market.

All the research deliverables are available in data packs (Excel format). The data tables will represent total installed base, revenue forecasts for different segments across selected geographies, market shares, and market trends for the forecast period.

For information or to be a part of our IVD Market Intelligence Program, please contact:

Jennifer Carson
Corporate Communications — North America
P: +1.210.247.2450
E: jennifer.carson@frost.com

Twitter: @Frost_Sullivan
Facebook: facebook.com/FrostandSullivan
Linkedin: http://linkd.in/1nL4auZ

http://www.frost.com

About Frost & Sullivan

Frost & Sullivan, the Growth Partnership Company, works in collaboration with clients to leverage visionary innovation that addresses the global challenges and related growth opportunities that will make or break today’s market participants.

Our “Growth Partnership” supports clients by addressing these opportunities and incorporating two key elements driving visionary innovation: The Integrated Value Proposition and The Partnership Infrastructure.

  • The Integrated Value Proposition provides support to our clients throughout all phases of their journey to visionary innovation including: research, analysis, strategy, vision, innovation and implementation.
  • The Partnership Infrastructure is entirely unique as it constructs the foundation upon which visionary innovation becomes possible. This includes our 360 degree research, comprehensive industry coverage, career best practices as well as our global footprint of more than 40 offices.

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Health Care

Jean Boulle Group Reports Successful First Clinical Trial Implant of the Tendyne Transcatheter Mitral Valve

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LUXEMBOURG, Dec. 30, 2014 /PRNewswire/ — Boulle Medtech Ltd, a Jean Boulle Group company focusing on medical technology and a founding investor of Tendyne Holdings, Inc. (“Tendyne”), is pleased to announce that the Tendyne Transcatheter Mitral Valve Implant (TMVI) was successfully placed in the first patient enrolled in a three-continent, multicenter trial being conducted as part of the Tendyne Feasibility Study. The study is to generate insight into the safety and performance of the Tendyne device in inoperable patients suffering from mitral regurgitation.

Drs. David Muller and Paul Jansz performed the procedure at St. Vincent’s Hospital in Sydney, Australia. Tendyne reports that the device was implanted transapically without cardiopulmonary bypass, performed as intended by completely eliminating mitral regurgitation, and that the patient was released from the hospital on day 5. Prior to this, the Tendyne device had been successfully implanted in London in three other persons under a compassionate use protocol in October and early November 2014 (see Boulle Medtech release of December 10, 2014).

The Tendyne TMVI is a fully retrievable and repositionable, apically tethered tri-leaflet porcine pericardial valve sewn onto a Nitinol (nickel/titanium) frame specifically designed to address the mitral anatomy of functional, degenerative and mixed etiology mitral regurgitation. Left untreated, mitral regurgitation can lead to heart failure and death.

About Boulle Medtech Ltd.

Boulle Medtech Ltd. is a Jean Boulle Group company focusing on medical technology. Its holdings include Tendyne Holdings, Inc. Boulle Medtech is a founding investor and major shareholder of Tendyne.

About Tendyne Holdings, Inc.

Tendyne Holdings, Inc is headquartered in Roseville, Minnesota and is a privately-held, clinical stage medical device company developing a unique Transcatheter Mitral Valve Implant (TMVI). Implanted in a beating heart in a hybrid operating room, the Tendyne design has proprietary and patented features that can treat a variety of mitral pathologies. With a less invasive approach than open cardiac surgery, TMVI may result in similar outcomes with fewer surgical complications.

For more information about the Jean Boulle Group or Boulle Medtech, contact Audrey Richardson at +352-222-512, audrey@jeanboullegroup.com, or go to our website http://www.jeanboullegroup.com.

For more information about Tendyne, go to http://www.tendyne.com.

Health Care

Eiger Bio Announces Positive Data in Patients Infected with Hepatitis Delta Virus (HDV) Treated with Lonafarnib — Results Presented at American Association for the Study of Liver Diseases (AASLD) Meeting

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PALO ALTO, Calif., Dec. 22, 2014 /PRNewswire/ — Eiger BioPharmaceuticals Incorporated announced the positive results of a Phase 2a study of lonafarnib in patients with chronic hepatitis delta virus (HDV) infection. The study was conducted at the National Institutes of Health (NIH) Clinical Center in Bethesda, Maryland. The double-blinded, randomized, placebo-controlled, dose ascending study evaluated two doses of lonafarnib, 100 mg twice daily and 200 mg twice daily for 28 days. “This proof-of-concept study is the first ever to evaluate lonafarnib, the first of a class of novel antiviral agents known as prenylation inhibitors, in patients infected with HDV,” said David Cory, President and Chief Executive Officer of Eiger. “Hepatitis Delta is the most severe form of human viral hepatitis and a therapy is sorely needed.”

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A significant decrease in HDV RNA viral levels was observed after treatment with lonafarnib for 28 days compared with placebo, including a statistically significant dose-dependent difference in decline in HDV RNA virus between the 100 mg twice daily and 200 mg twice daily doses compared with placebo. The decline in HDV RNA viral levels significantly correlated with serum lonafarnib drug levels, providing further evidence for the efficacy of lonafarnib in chronic HDV. In the study, lonafarnib was generally well tolerated, with the most common adverse events in the treatment group being gastrointestinal related. “The NIH Clinical Center has completed a study with significant implications for treatment of chronic hepatitis D, which often leads to cirrhosis and other life-threatening conditions,” said Theo Heller, MD, a Principal Investigator at the NIH. “We look forward to continued collaboration to potentially deliver an approved therapy to patients.” 

About Lonafarnib 
Lonafarnib is a well-characterized, late stage, orally active inhibitor of farnesyl transferase, an enzyme involved in modification of proteins through a process called prenylation. HDV uses this host cell process inside liver cells to complete a key step in its life cycle. Lonafarnib inhibits the prenylation step of HDV replication inside liver cells and blocks the ability of the virus to multiply.  Since prenylation is a host process, not under control of HDV, and lonafarnib inhibits prenylation, there is also a theoretical higher barrier to resistance with lonafarnib therapy. Virus mutation, a common pathway to drug resistance, is not expected to be a potential pathway to lonafarnib resistance by HDV.

Lonafarnib is not approved for sale for any indication.

About Hepatitis Delta
Hepatitis Delta is caused by infection with the hepatitis D virus (HDV) and is considered to be the most severe form of viral hepatitis in humans. Hepatitis D occurs only as a co-infection in individuals with hepatitis B (HBV), leads to more severe liver disease than HBV alone, and is associated with accelerated liver fibrosis, liver cancer, and liver failure. HDV is a disease with a significant impact on global health affecting ~15 million people worldwide. The prevalence of HDV varies between different parts of the world. HDV meets criteria for Orphan Designation in the United States (less than 200,000 people), Europe (less than 5 in 100,000 people), and Japan (less than 50,000 people). Globally, HDV infection is reported to be present in approximately 4% – 6% of chronic hepatitis B carriers. In some parts of the world, including certain areas of China, Russia, Central Asia, Turkey, Africa, and South America, prevalence as high as 40% has been reported in HBV infected patients.

About Eiger
Eiger is a privately held biotechnology company focused on the research, development and commercialization of innovative therapies in viral hepatitis. The company is focused on developing lonafarnib for the treatment of Hepatitis Delta Virus (HDV), the most severe form of viral hepatitis.  Lonafarnib is not approved for sale. Eiger’s research programs are focused on the discovery of targeted, small-molecule therapeutics and biomarkers to treat and monitor serious liver diseases.  For additional information about Eiger and its R&D pipeline, please visit www.eigerbio.com.

Investors: Jim Shaffer, Eiger Bio, Inc., 919-345-4256, jshaffer@eigerbio.com