SERVE-HF; the World’s Largest Study of Sleep-Disordered Breathing in Heart Failure Completes Recruitment

ResMed a pioneer and global leader in sleep and respiratory medicine, announced today at the ESC Congress 2013, that SERVE-HF has completed enrollment. SERVE-HF is an international, randomised study of 1,325 participants investigating if the treatment of central sleep-disordered breathing (central sleep apnea) improves survival and outcomes of patients with stable heart failure.

“The aim of SERVE-HF is to not only assess survival rates, but also to see if Adaptive Servo-Ventilation improves quality of life, sleep, and physiologic changes associated with heart failure”

Approximately 14 million people in Europe are living with heart failure and central sleep-disordered breathing is known to be a highly prevalent co-morbidity in these patients. Buy Avapro (Irbesartan) pills online without prescription With an estimated 30-50 percent of heart failure patients potentially at risk from this condition, the results from SERVE-HF may have important consequences for the future management of these patients.
“Completing recruitment of SERVE-HF has been an important milestone in this landmark trial,” said co-principal investigator, Professor Martin Cowie of the Royal Brompton Hospital in London. “We owe much to the commitment and dedication of SERVE-HF investigators and to a strong collaboration between sleep specialists and cardiologists. Buy Avelox (Moxifloxacin) tabs online without prescription We now look forward to results in 2016 and to a fuller understanding of just how important the treatment of central sleep-disordered breathing is in heart failure patients.”
SERVE-HF will, for the first time, provide conclusive evidence of the health impact of effectively treating heart failure patients who have central sleep-disordered breathing. The trial, which began in 2008, is sponsored by ResMed. Buy Temovate (Clobetasol) without prescription Designed as an event-driven study, its completion is anticipated by mid-2015 and results are expected to be available in the first half of 2016.
Central sleep-disordered breathing (central sleep apnea)
Studies have demonstrated that patients with an abnormal waxing and waning breathing pattern called central sleep apnea with Cheyne–Stokes respiration (CSA-CSR) have a poorer quality of life and increased mortality. Between 30-50 percent of patients with heart failure may suffer from central sleep-disordered breathing meaning that this condition likely applies to millions of patients across Europe living with stable heart failure. Buy Vitamins online However, studies so far have indicated that treatment of CSA-CSR with PaceWave^TM Adaptive Servo-Ventilation (ASV) during sleep normalises breathing,controls sleep-disordered breathing, improves cardiac function and may lead to increased survival and better quality of life.
About SERVE-HF
SERVE-HF is being conducted across more than 80 sites in Germany, France, the UK, Norway, Sweden, Denmark, Finland, Australia, Switzerland, the Netherlands and the Czech Republic.
The primary goal of the study is to determine whether managing CSA-CSR with ResMed’s PaceWave^TM proprietary Minute Ventilation ASV technology (found in its AutoSet CS™ and VPAP™ Adapt devices) increases survival rates and decreases the burden of hospitalisations in this patient population. Asthma Medications Customer Review ASV is an intelligent method of non-invasive ventilation that continuously monitors and stabilises the breathing patterns of individuals with sleep-disordered breathing throughout the night.
“The aim of SERVE-HF is to not only assess survival rates, but also to see if Adaptive Servo-Ventilation improves quality of life, sleep, and physiologic changes associated with heart failure,” said Professor Cowie. “Additionally, a health economic analysis will be performed to evaluate the potential economic benefits of therapy.”
“Given the prevalence of central sleep apnea in heart failure patients, particularly men, its treatment could be crucial to improving heart failure outcomes in the future,” added co-principal investigator, Professor Helmut Teschler, medical director at the Department of Pneumology, Ruhrland Clinic, Essen, Germany.
Although there are established links between sleep-disordered breathing and heart failure, the diagnosis, treatment and management of sleep-disordered breathing remains in the domain of sleep or respiratory medicine, with a limited involvement of cardiologists to date. The goal of the study is to achieve greater cardiologist involvement in managing sleep-disordered breathing in heart failure patients.

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NOTES TO EDITORS
Sleep-disordered breathing in heart failure: A European Working Group
Monday, 2 Sept. 2013, sees the inaugural meeting of a new European Working Group, specifically focused on identifying unmet needs and improving outcomes in heart failure patients with sleep-disordered breathing. Including a host of experienced professionals in the fields of cardiology and sleep disorders, the Working Group will spend the next two years supporting ResMed in improving education and awareness of optimal care in these patients.
About ResMed
ResMed is a leading developer, manufacturer and distributor of medical equipment for treating, diagnosing and managing sleep-disordered breathing and other respiratory disorders. We are dedicated to developing innovative products to improve the lives of those who suffer from these conditions and to increasing awareness among patients and healthcare professionals of the potentially serious health consequences of untreated sleep-disordered breathing.

Moberg Pharma and Menarini Extend Distribution Agreement for Kerasal Nail to China

Moberg Pharma AB today announced that Menarini Asia-Pacific, a member of the Menarini Group – a top 40 global pharmaceutical company – has been granted the exclusive rights to market and sell Kerasal Nail™ in China. Buy Trandate (Labetalol) pills online without prescription The companies now intend to seek marketing authorization for the product in the Chinese market.
Kerasal Nail™ (Nalox® or Emtrix® in certain markets) is a non-prescription product for the treatment of discoloured and deformed nails resulting from fungal infection or psoriasis, with a unique mechanism of action that generates visible improvements within 2-4 weeks of treatment. Buy Topamax (Topiramate) tabs online without prescription The product became the market leader in the Nordic region immediately after launch in 2011 and has been launched in more than 25 countries, including the U.S. where it has a leading position.
The extended distribution agreement builds on an existing collaboration between the two company groups, which resulted in a successful launch of the product in Italy. In Asia-Pacific, Menarini is a leading regional biopharmaceutical company with over 3500 employees in 13 markets and a strong track record in launching and promoting Consumer Health brands. The global sales of the Menarini Group exceed 3 billion Euros.
China, being the world’s second largest economy after the US, represents a significant long term growth opportunity for Moberg Pharma. The Chinese pharmaceutical market is projected for continued robust growth and is expected to become the second largest pharma market after the U.S. within five years. Buy Plavix (Clopidogrel) without prescription According to IMS[1], 45% of the global growth in self-medication up to 2016 will come from China and South East Asia.
“We are excited by the opportunity to enter the huge and rapidly expanding Chinese market. Buy Vitamins online There are challenges related to China’s sheer size, business complexity, regulatory environment and infrastructure. With its profound understanding of local market conditions, Menarini Asia-Pacific is an ideal partner in this region. Ipsen expects Increlex supply interruption due to supplier manufacturing issues The extended agreement enables us to build on our successful commercial track record together with Menarini”, said Peter Wolpert, CEO of Moberg Pharma AB.
“We look forward to introducing Kerasal Nail™ to Chinese consumers. The product has potential to contribute strongly to our expansion within the Consumer Health market, being a compelling non-prescription product offering rapid visual improvement and an effective solution for patients with nail fungus problems”, said John A. Graham, CEO at Menarini Asia-Pacific.
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About this information
Moberg Pharma discloses this information pursuant to the Swedish Securities Markets Act and/or the Financial Instruments Trading Act. The information was submitted for publication at 08.30 am (CET) on July 22nd, 2013.
About Moberg Pharma AB
Moberg Pharma AB (publ) is a rapidly growing Swedish pharmaceutical company with direct sales through its own sales organization in the US and sales through distributors in more than 40 countries. The company’s product portfolio includes topical products for the treatment of skin disorders and pain under the brands Kerasal®, Jointflex®, Kerasal Nail® and Kaprolac®. Kerasal Nail® (Nalox™ in many markets) is the leading product for the treatment of nail disorders in the Nordic market. The portfolio is developed further through acquisitions and in-licensing of products as well as product development with focus on innovative drug delivery based on proven compounds. Moberg Pharma has offices in Stockholm and New Jersey and the company’s share (OMX: MOB) is listed on the Small Cap list of the NASDAQ OMX Nordic Exchange Stockholm.
About Menarini Asia-Pacific
Menarini is the world’s largest Italian biopharmaceutical company with a heritage of over 127 years and nearly 17,000 employees in over 100 countries. In Asia-Pacific, Menarini’s vision is to be a leading provider of important healthcare brands to improve the lives of people in the region. Menarini Asia-Pacific operates across the entire commercial value chain, from regulatory approval and product launch to lifecycle management with a diverse portfolio of proprietary and partnered brands in key therapeutic fields, including Consumer Health, Dermatology, Primary Care, Allergy/Respiratory, Cardiovascular, Oncology/Specialty Care and Men’s Health.

Thermo Fisher Scientific Reports Fourth Quarter and Full Year 2012 Results

Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, today reported its financial results for the fourth quarter and full year ended December 31, 2012.

“Our teams executed well in a challenging environment to deliver strong performance in all three of our business segments.”

Fourth Quarter and Full Year 2012 Highlights

• Adjusted earnings per share (EPS) in the fourth quarter of 2012 grew 14% to a record $1.36, and for the full year grew 19% to a record $4.94.
• Revenue in the fourth quarter increased 6% to a record $3.26 billion.
• Adjusted operating margin in the fourth quarter expanded 40 basis points to 19.6%.
• Generated record full year free cash flow of $1.77 billion.
• Full year revenue from high-growth Asia-Pacific markets now represents 17% of total company revenue, up from 15% in 2011; China became the second largest geography by revenue, at more than $700 million in 2012.
• Strengthened technology leadership with numerous Thermo Scientific product launches in 2012, including the iCAP™Q ICP mass spectrometer, Trace™ 1300 gas chromatograph, TruNarc™ handheld drug analyzer, Lynx SuperSpeed centrifuge and the PikoReal™ PCR system.
• Invested $1.1 billion to acquire complementary businesses that increase depth of capabilities, highlighted by acquisition of One Lambda, which expanded specialty diagnostics offering into high-growth transplant diagnostics market.
• Deployed $350 million in the fourth quarter to repurchase 5.7 million shares, and $1.15 billion for the full year to repurchase 20.8 million shares.
• Initiated first quarterly dividend in company history and increased dividend by 15% in the fourth quarter to $0.15, based on strong performance and outlook.

Adjusted EPS, adjusted operating income, adjusted operating margin and free cash flow are non-GAAP measures that exclude certain items detailed later in this press release under the heading “Use of Non-GAAP Financial Measures.”
“I’m extremely proud of our outstanding results in 2012, which led to a 19 percent increase in adjusted EPS,” said Marc N. Casper, president and chief executive officer of Thermo Fisher Scientific. “Our teams executed well in a challenging environment to deliver strong performance in all three of our business segments.
“Our strategy to invest in innovation, commercial excellence and emerging markets is clearly driving growth. Buy Lozol SR (Indapamide) pills online without prescription This was a banner year for innovation, with significant new product launches in each of our key technology platforms. Through strong commercial execution, our value proposition is making a difference for our customers and helping us to gain share across a broad customer set. Last, we expanded our footprint in the Asia-Pacific, including opening our fifth factory in China and a new demo lab in South Korea, to capture opportunities in high-growth emerging markets.
“It was another stand-out year in terms of effectively deploying our capital to create shareholder value. We invested more than $1 billion to complete complementary acquisitions that broaden our offering for our customers and strengthen our competitive position. We also returned $1.3 billion to our shareholders through stock repurchases and dividends, reflecting our confidence in continuing our growth momentum into 2013 and beyond.”
Fourth Quarter 2012
For the fourth quarter of 2012, adjusted EPS grew 14% to a record $1.36, versus $1.19 in the fourth quarter of 2011. Revenue for the quarter grew 6% to $3.26 billion in 2012, versus $3.09 billion in 2011. Organic revenue grew 4%, with currency translation lowering revenue by 1% and acquisitions increasing revenue by 2%. Adjusted operating income for the fourth quarter of 2012 increased 7% compared with the year-ago period, and adjusted operating margin expanded to 19.6%, compared with 19.2% in the fourth quarter of 2011.
GAAP diluted EPS for the fourth quarter of 2012 was $1.04, versus $0.77 in the same quarter last year. GAAP operating income for the fourth quarter of 2012 increased 15% to $401 million, compared with $348 million in 2011. GAAP operating margin increased to 12.3%, compared with 11.2% in the fourth quarter of 2011.
Full Year 2012
For the full year 2012, adjusted EPS grew 19% to a record $4.94, versus $4.16 in 2011. Revenue for 2012 grew 8% to $12.51 billion, versus $11.56 billion a year ago. On a pro forma basis, as if Dionex and Phadia were owned for the full year in 2011, organic revenue grew 4%. Acquisitions, other than Phadia and Dionex, increased revenue by 1% and currency translation lowered revenue by 2%. Adjusted operating income for 2012 increased 12% compared with 2011, and adjusted operating margin expanded to 19.0%, compared with 18.4% a year ago.
GAAP diluted EPS for 2012 was $3.21, versus $3.46 in 2011, due primarily to gains on the sale of discontinued operations in 2011. GAAP operating income for 2012 increased 18% to $1.48 billion, compared with $1.25 billion a year ago. GAAP operating margin increased to 11.8%, compared with 10.8% in 2011.
Annual Guidance for 2013
Casper added, “Looking ahead to 2013, we are planning for the global economic environment to remain challenging. That said, given our performance in 2012 and our proven strategy of delivering top-line growth, using our productivity levers to expand margins and effectively deploying our capital, I’m confident we can deliver another successful year.”
Thermo Fisher is initiating adjusted EPS and revenue guidance for the full year 2013. The company expects to achieve adjusted EPS in the range of $5.32 to $5.46 for 2013, which would result in 8% to 11% adjusted EPS growth over 2012. The company expects to achieve 2013 revenue in the range of $12.80 billion to $13.00 billion, for 2% to 4% revenue growth year over year.
The 2013 guidance does not include any future acquisitions or divestitures and is based on current foreign exchange rates. In addition, the adjusted EPS estimate excludes amortization expense for acquisition-related intangible assets and certain other items detailed later in this press release under the heading “Use of Non-GAAP Financial Measures.”
Segment Results
Management uses adjusted operating results to monitor and evaluate performance of the company’s three business segments, as highlighted below.
Analytical Technologies Segment
In the fourth quarter of 2012, Analytical Technologies Segment revenue increased 2% to $1.11 billion, compared with revenue of $1.08 billion in the fourth quarter of 2011. Segment adjusted operating income decreased 3% in the fourth quarter of 2012, and adjusted operating margin was 20.0%, versus 21.1% in the 2011 quarter.
For the full year 2012, Analytical Technologies Segment revenue increased 7% to $4.12 billion, compared with revenue of $3.85 billion in 2011. Segment adjusted operating income increased 7% in 2012, and adjusted operating margin was 18.7% in both periods.
Specialty Diagnostics Segment
Specialty Diagnostics Segment revenue in the fourth quarter increased 12% to $792 million in 2012, compared with revenue of $706 million in the fourth quarter of 2011. Segment adjusted operating income increased 21% in the fourth quarter of 2012, and adjusted operating margin increased to 25.9%, versus 24.0% in the 2011 quarter.
For the full year 2012, Specialty Diagnostics Segment revenue increased 20% to $2.96 billion, compared with revenue of $2.47 billion in 2011. Segment adjusted operating income increased 27% in 2012, and adjusted operating margin increased to 25.7%, versus 2011 results of 24.2%.
Laboratory Products and Services Segment
In the fourth quarter of 2012, Laboratory Products and Services Segment revenue increased 4% to $1.50 billion, compared with revenue of $1.44 billion in the fourth quarter of 2011. Segment adjusted operating income increased 8% in the fourth quarter of 2012, and adjusted operating margin was 14.1%, versus 13.7% in the 2011 quarter.
For the full year 2012, Laboratory Products and Services Segment revenue increased 4% to $5.99 billion, compared with revenue of $5.76 billion in 2011. Segment adjusted operating income increased 4% in 2012, and adjusted operating margin was 14.1% in both years.
Use of Non-GAAP Financial Measures
In addition to the financial measures prepared in accordance with generally accepted accounting principles (GAAP), we use certain non-GAAP financial measures, including adjusted EPS, adjusted operating income and adjusted operating margin, which exclude restructuring and other costs/income and amortization of acquisition-related intangible assets. Adjusted EPS also excludes certain other gains and losses, tax provisions/benefits related to the previous items, benefits from tax credit carryforwards, the impact of significant tax audits or events and discontinued operations. We exclude the above items because they are outside of our normal operations and/or, in certain cases, are difficult to forecast accurately for future periods. We also use a non-GAAP measure, free cash flow, which excludes operating cash flows from discontinued operations and deducts net capital expenditures. We believe that the use of non-GAAP measures helps investors to gain a better understanding of our core operating results and future prospects, consistent with how management measures and forecasts the company’s performance, especially when comparing such results to previous periods or forecasts.
For example:
We exclude costs and tax effects associated with restructuring activities, such as reducing overhead and consolidating facilities. We believe that the costs related to these restructuring activities are not indicative of our normal operating costs.
We exclude certain acquisition-related costs, including charges for the sale of inventories revalued at the date of acquisition and significant transaction costs. We exclude these costs because we do not believe they are indicative of our normal operating costs.
We exclude the expense and tax effects associated with the amortization of acquisition-related intangible assets because a significant portion of the purchase price for acquisitions may be allocated to intangible assets that have lives of 5 to 20 years. Our adjusted EPS estimate for 2013 excludes approximately $1.43 of expense for the amortization of acquisition-related intangible assets for acquisitions completed through the end of the fourth quarter of 2012. Exclusion of the amortization expense allows comparisons of operating results that are consistent over time for both our newly acquired and long-held businesses and with both acquisitive and non-acquisitive peer companies.
We also exclude certain gains/losses and related tax effects, benefits from tax credit carryforwards and the impact of significant tax audits or events (such as the one-time effect on deferred tax balances of enacted changes in tax rates), which are either isolated or cannot be expected to occur again with any regularity or predictability and that we believe are not indicative of our normal operating gains and losses. For example, we exclude gains/losses from items such as the sale of a business or real estate, gains or losses on significant litigation-related matters, gains on curtailments of pension plans, the early retirement of debt and discontinued operations.
We also report free cash flow, which is operating cash flow, net of capital expenditures, and also excludes operating cash flows from discontinued operations to provide a view of the continuing operations’ ability to generate cash for use in acquisitions and other investing and financing activities.
Thermo Fisher’s management uses these non-GAAP measures, in addition to GAAP financial measures, as the basis for measuring the company’s core operating performance and comparing such performance to that of prior periods and to the performance of our competitors. Such measures are also used by management in their financial and operating decision-making and for compensation purposes.
The non-GAAP financial measures of Thermo Fisher’s results of operations and cash flows included in this press release are not meant to be considered superior to or a substitute for Thermo Fisher’s results of operations prepared in accordance with GAAP. Reconciliations of such non-GAAP financial measures to the most directly comparable GAAP financial measures are set forth in the accompanying tables. Thermo Fisher’s earnings guidance, however, is only provided on an adjusted basis. It is not feasible to provide GAAP EPS guidance because the items excluded, other than the amortization expense, are difficult to predict and estimate and are primarily dependent on future events, such as acquisitions and decisions concerning the location and timing of facility consolidations.

About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science. Our mission is to enable our customers to make the world healthier, cleaner and safer. With revenue of $13 billion, we have approximately 39,000 employees and serve customers within pharmaceutical and biotech companies, hospitals and clinical diagnostic labs, universities, research institutions and government agencies, as well as in environmental and process control industries. We create value for our key stakeholders through three premier brands, Thermo Scientific, Fisher Scientific and Unity Lab Services, which offer a unique combination of innovative technologies, convenient purchasing options and a single solution for laboratory operations management. Our products and services help our customers solve complex analytical challenges, improve patient diagnostics and increase laboratory productivity.
The following constitutes a “Safe Harbor” statement under the Private Securities Litigation Reform Act of 1995: This press release contains forward-looking statements that involve a number of risks and uncertainties. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements are set forth in the company’s Quarterly Report on Form 10-Q for the quarter ended September 29, 2012, under the caption “Risk Factors,” which is on file with the Securities and Exchange Commission and available in the “Investors” section of our website under the heading “SEC Filings.” Important factors that could cause actual results to differ materially from those indicated by forward-looking statements include risks and uncertainties relating to: the need to develop new products and adapt to significant technological change; implementation of strategies for improving growth; general worldwide economic conditions and related uncertainties; dependence on customers' capital spending policies and government funding policies; the effect of exchange rate fluctuations on international operations; the effect of healthcare reform legislation; use and protection of intellectual property; the effect of changes in governmental regulations; and the effect of laws and regulations governing government contracts, as well as the possibility that expected benefits related to the acquisitions of Dionex and Phadia may not materialize as expected. While we may elect to update forward-looking statements at some point in the future, we specifically disclaim any obligation to do so, even if estimates change and, therefore, you should not rely on these forward-looking statements as representing our views as of any date subsequent to today.