Tuesday, September 2, 2014

ESC Congress 2014 Hot Line Session: Favourable effect of Pradaxa® on kidney function over time compared to warfarin

INGELHEIM, Germany - Tuesday, September 2nd 2014 [ME NewsWire]

    RE-LY® sub-analysis shows that Pradaxa® treatment favourably affects kidney function1 deterioration over time compared to warfarin
    Data provide additional support for long-term use of Pradaxa® in stroke prevention in non-valvular atrial fibrillation (NVAF)1

(BUSINESS WIRE)-- Non-US/Non-UK/Non-Canadian Media

New data presented today indicate that kidney function decline is less pronounced in patients with an irregular heartbeat (non-valvular atrial fibrillation, NVAF) who are treated with Pradaxa®(dabigatran etexilate) compared to warfarin.1 A natural decline in kidney function is expected as part of the ageing process or as a result of other underlying diseases.2 New data support that long-term Pradaxa® treatment compares favourably to warfarin in terms of kidney function decline over time.1 The new RE-LY® study sub-analysis findings were presented today at a Clinical Trial Update Hot Line session during the ESC Congress 2014 organised by the European Society of Cardiology in Barcelona.1

“These data support dabigatran as a good long-term treatment option for non-valvular atrial fibrillation patients,” said Professor Michael Böhm, Director of the Department of Internal Medicine and Cardiology at the University Hospital of Saarland, Homburg/Saar, Germany. “These RE-LY® study findings may have particular relevance for NVAF patients who have co-existing medical conditions which negatively impact their kidney function, such as diabetes, and for patients with poorly controlled vitamin K antagonist therapy. Dabigatran may provide additional benefit to these patients in the long term.”

The data included in the ESC Congress 2014 Hot Line session were derived from a post hoc exploratory analysis of the RE-LY® study that included over 18,000 patients and compared kidney function change in patients treated with either warfarin or Pradaxa® (110mg or 150mg twice daily).1

Results indicate that kidney function deteriorated more in patients on warfarin compared to those on either dose of Pradaxa®.1 Results were significantly different to warfarin for both doses of Pradaxa®at 30 months, with similar patterns seen in different Pradaxa® subgroups.1 Patients who were poorly controlled on warfarin and spent more time above the recommended International Normalized Ratio target range (INR 2-3) experienced a markedly sharper decline in kidney function compared to patients taking Pradaxa®.1 Patients with diabetes, who are at generally higher risk of kidney problems were particularly susceptible to the effects of warfarin, and experienced higher rates of kidney decline than non-diabetic NVAF patients.1 The same was true for patients previously treated with warfarin.1 Also in these patients, Pradaxa® treatment compared favourably to warfarin.1

While the exact mechanism behind this difference has yet to be identified, there is a well-defined pathophysiological background. Vitamin K is known to protect against the build-up of calcium deposits in blood vessels, known as vascular calcification.3 Oral anticoagulation with vitamin K-antagonists such as warfarin, which block vitamin K in the body, have been associated with an increased rate of vascular calcification and vascular damage.3 Pradaxa® is an oral direct thrombin inhibitor which does not interfere with vitamin K, but works in a different way to reduce blood clotting in order to protect patients with non-valvular atrial fibrillation against stroke.4,5,6

~ENDS~

Please click on the link below for ‘Notes to Editors‘ and ‘References‘:

http://www.boehringer-ingelheim.com/news/news_releases/press_releases/2014/02_september_2014_dabigatranetexilate.html

Contacts
Boehringer Ingelheim
Corporate Communications
Media + PR
Friederike Middeke
55216 Ingelheim/Germany
Phone: +49 6132 – 77 141 575
Email: press@boehringer-ingelheim.com









Permalink: http://me-newswire.net/news/11967/en

Independent Tax Firm ‘WTAS’ Changes Its Name to ‘Andersen Tax’

SAN FRANCISCO. - Tuesday, September 2nd 2014 [ME NewsWire]

(BUSINESS WIRE) WTAS, one of the nation’s largest independent tax firms, has acquired the rights to the iconic brand name Andersen and will rename itself Andersen Tax.

Founded in 2002 by CEO Mark Vorsatz and 22 former Arthur Andersen partners, WTAS’ strong international growth required a common identity for its global presence. In an effort to identify a brand name that it could use and protect globally, WTAS felt the ‘Andersen’ name best reflected its own culture of clients first, stewardship, transparency and best in-class solutions.

“We all came from a common culture and shared certain core values,” said CEO Mark Vorsatz. “In creating a global platform, we recognized that the development of an integrated professional service model based on common values with a common identity was essential.”

Andersen Tax, like WTAS, will be an independent global tax firm with no audit practice that could impair the credibility or integrity of the services it provides. It will be completely owned by its partners, most who previously worked at Arthur Andersen or a Big 4 accounting firm.

As the needs of the firm’s clients continued to expand beyond the U.S., WTAS focused on developing more comprehensive relationships with firms outside the U.S. It evaluated a number of options and networks and ultimately determined that building its own global platform was the best solution to ensure the highest quality client service internationally.

In the last 14 months alone, WTAS has welcomed nearly 40 partners and more than 150 professionals in nine locations across Europe. Studio Associato De Vecchi in Italy, Paris-based STC Partners, PrimeTax AG in Switzerland, and Taxperience in the Netherlands and Russia joined the WTAS team with several other additions expected before the end of the year.

“We all share a vision of creating a premier independent tax firm that delivers best-in-class service in a seamless fashion across the globe,” Vorsatz said. “To achieve that, we needed one common name. Accordingly, we are becoming Andersen Tax.”

At its peak, Arthur Andersen and its affiliated firms had more than 85,000 employees worldwide. It closed its U.S. accounting operations in 2002 because of problems resulting from its audit of Enron, a Texas energy firm.

“Many individuals and organizations were deeply affected by what happened at Enron. But Arthur Andersen, at its best, was a firm that was founded and managed on the basis of quality and objectivity by world-class people with world-class training,” Vorsatz said. “For Andersen Tax, independence and objectivity are critical. To be clear, we are not an audit firm and have no intention of providing audit services. From the outset, our mission has been to serve as a quality alternative to the large accounting firms who typically have audit practices, and as a premier example of independence and objectivity.”

Andersen Tax is expanding in the U.S. and Europe in the near term, with expectations for future growth in Asia and Latin America.

“Our name may be changing, but our core values remain,” Vorsatz said. “We are building Andersen Tax to create an enduring place where clients across the globe are afforded the best, most comprehensive tax services, delivered by skilled professionals with the highest standards.”

Contacts

Andersen Tax

Megan Tsuei, 415-762-6310

AndersenTax.com









Permalink: http://www.me-newswire.net/news/11962/en

Moelis & Company Announces the Appointment of Eric Cantor as Vice Chairman and Member of the Board of Directors

NEW YORK - Tuesday, September 2nd 2014 [ME NewsWire]

(BUSINESS WIRE)-- Moelis & Company (NYSE:MC), a leading global independent investment bank, today announced the appointment of Eric Cantor, former United States Representative for Virginia’s 7thCongressional District and former House Majority Leader, as Vice Chairman and Managing Director. Mr. Cantor will also be elected to the Moelis & Company Board of Directors.

In his new role, Mr. Cantor will provide strategic counsel to the Firm’s corporate and institutional clients on key issues. He will play a leading role in client development and advise clients on strategic matters.

Ken Moelis, Chairman and CEO of Moelis & Company, said, “At Moelis & Company, we offer our clients judgment and experience in order to help them with their most important strategic and financial decisions. Eric’s judgment and tremendous experience will expand the capabilities our team brings to clients around the world as he has unique expertise in assessing complex situations and crafting innovative solutions.”

Through more than 25 years of political and business experience, Mr. Cantor has emerged as a leading voice on the economy and job creation. During his Congressional career, Mr. Cantor worked to lower taxes, eliminate excessive regulation, strengthen small businesses, and encourage entrepreneurship. His commentary was often featured in publications focusing on a wide range of issues including economic matters, health care and foreign policy.

Mr. Cantor said, “When I considered options for the next chapter of my career, I knew I wanted to join a firm with a great entrepreneurial spirit that focused on its clients. I have known Ken for some time and having followed the growth and success of his Firm, I have long admired his vision and leadership. The new model of independent banks offering conflict free advice, in a smaller more intimate environment, was a place where I knew my skills could help clients succeed.”

Mr. Moelis added, “Eric has proven himself to be a pro-business advocate and one who will enhance our boardroom discussions with CEOs and senior management as we help them navigate their most important strategic decisions.”

About Moelis & Company

Moelis & Company is a leading global independent investment bank that provides innovative strategic advice and solutions to a diverse client base, including corporations, governments and financial sponsors. The Firm assists its clients in achieving their strategic goals by offering comprehensive integrated financial advisory services across all major industry sectors. Moelis & Company’s experienced professionals advise clients on their most critical decisions, including mergers and acquisitions, recapitalizations and restructurings and other corporate finance matters. The Firm serves its clients with over 500 employees based in 15 offices in North and South America, Europe, the Middle East, Asia and Australia. For further information, please visit: www.moelis.com.

Eric Cantor

Mr. Cantor was formerly United States Representative for Virginia’s 7th Congressional District and House Majority Leader. He served in the U.S. House of Representatives between 2001-2014. He was elected by his colleagues in the House to serve as the Majority Leader for the 112th and 113th Congresses where he led the public policy agenda for the House. During his time in office, Mr. Cantor was a leading voice on the economy, job creation and policies focused on improving the lives of the American middle class. He championed pro-growth solutions including lowering taxes, eliminating excessive regulation, strengthening businesses, and encouraging entrepreneurship. He was also regularly featured in publications focusing on a wide range of topics including both domestic and international matters. Mr. Cantor received his undergraduate degree from The George Washington University, his law degree from The College of William and Mary, and his master’s degree from Columbia University in New York.

Contacts

Media:

Moelis & Company

Andrea Hurst, +1 212 883 3666

M: +1 347 583 9705

andrea.hurst@moelis.com



JAM Strategies

John Murray, +1 202 821 2219

jamstrategies@gmail.com



Investors:

Moelis & Company

Kate Pilcher Ciafone, +1 212 883 3807

kate.ciafone@moelis.com





Permalink: http://www.me-newswire.net/news/11961/en

Monday, September 1, 2014

Extensive Experience in Clinical Practice and Expanding Research Programme Support use of Pradaxa® for Clot Prevention

INGELHEIM, Germany. - Monday, September 1st 2014 [ME NewsWire]

    Recent analysis of real world data document again the positive safety and efficacy profile of Pradaxa® as proven in clinical trials1-3
    Final Phase of GLORIA™-AF Registry Program now initiated in North America and Europe
    Extensive clinical research in established and new indications underway to improve patient care with Pradaxa®

(BUSINESS WIRE) For Non-US/Non-UK/Non-Canadian Media

Five years on from the first breakthrough presentation of the pivotal RE-LY® clinical trial of Pradaxa® (dabigatran etexilate) for the prevention of stroke in non-valvular atrial fibrillation (NVAF),4 extensive clinical trial and real-world data support Pradaxa® in various indications.1-12 Boehringer Ingelheim continues to grow the evidence base for Pradaxa® to improve care for patients at risk of blood clots and today announces the initiation of Phase III of the GLORIA™-AF registry program in North America and in Europe. During this final phase of the registry program, data on the overall safety and effectiveness of antithrombotic treatments will be collected.13

“The body of evidence supporting Pradaxa®, based on clinical trials, analyses of large real-world databases and different regulatory assessments since the RE-LY® trial was first presented, is both robust and consistent” said Professor Jörg Kreuzer, Therapeutic Area Head Cardiovascular Medicine, Boehringer Ingelheim. “And we will continue our research both in clinical trials and in clinical practice to further strengthen this evidence base for Pradaxa® to support the confident use of our treatment by physicians and patients, so that patients can receive the best possible care.”

The extensive research programme by Boehringer Ingelheim for Pradaxa®, aimed at deepening the science behind effective clot prevention and providing support for everyday patient management, will eventually include over 100,000 patients.4-19 The research programme covers both clinical studies and analyses of everyday clinical practice and includes the GLORIA™-AF registry, the recently announced RE-CIRCUIT™, RE-DUAL PCI™ and RE-SPECT ESUS™* studies for Pradaxa®†, and the RE-VERSE AD™ trial to investigate the antidote idarucizumab‡ in the clinical setting in patients taking Pradaxa®.4-19

Beyond the Boehringer Ingelheim research programme, independent studies have been conducted that support the efficacy and safety profile of Pradaxa®.1-3 The U.S. Food and Drug Administration recently reinforced the favourable efficacy and safety profile of Pradaxa® based upon a large analysis of Medicare data.§3 The analysis involved 134,000 patients, 65 years or older and its findings were consistent with results of the clinical RE-LY® trial that supported the global approval of Pradaxa® for stroke prevention in non-valvular atrial fibrillation.3-5 The study found that, among new users of blood-thinning drugs, Pradaxa® was associated with a similar risk of myocardial infarction (MI) compared to warfarin and an increased risk of major gastrointestinal (GI) bleeding, just like in RE-LY®.3-5 But most importantly, the study also showed that with Pradaxa®, there was a lower risk of clot-related strokes, bleeding in the brain, and death compared to warfarin treatment.3

* Dabigatran etexilate is not approved in any country for patients with ESUS.

†The new trial announcements have not received indication approvals.

‡ Idarucizumab is the recommended International Nonproprietary Name (INN). The antidote is still under investigation and has not yet been approved for clinical use.

§ In the United States, the licensed doses for dabigatran etexilate are 150mg twice daily and 75mg twice daily for the prevention of stroke and systemic embolism in adult patients with non-valvular AF.20 The dose of 75mg twice daily is not authorised in Europe for this indication.21

~ENDS~

Please click on the link below for ‘Notes to Editors’ and ‘References’:

http://www.boehringer-ingelheim.com/news/news_releases/press_releases/2014/01_september_2014_dabigatranetexilate.html

Contacts

Boehringer Ingelheim

Corporate Communications

Media + PR

Friederike Middeke

55216 Ingelheim/Germany

Phone: +49 6132 – 77 141 575

Fax: +49 6132 – 77 6601

Email: press@boehringer-ingelheim.com









Permalink: http://www.me-newswire.net/news/11959/en

Renewables Academy AG (RENAC) Expands Online Through New E-Learning Platform

BERLIN - Monday, September 1st 2014 [ME NewsWire]

(BUSINESS WIRE)-- Since its foundation in 2008, the Renewables Academy (RENAC)’s objective is to make knowledge on renewable energy and energy efficiency available for participants in any location and time zone. Therefore, after having provided trainings and capacity building services in more than 130 countries, RENAC is launching the Renewables Academy Online (RENAC Online) on the 1st of October.

E-learning is an ideal system for those who are not able to attend a face-to-face training for professional or personal reasons but still consider further education an important factor to advance their careers. RENAC Online offers the possibility to study with flexibility on a part-time basis, as well as extensive support from RENAC staff. The e-learning platform combines written material with graphics and videos, and learning paths are accompanied by self-assessment exercises. Additionally, the Virtual Classroom and the discussion forums enable communication with professors and fellow students. Participants who successfully pass the online exam receive a RENAC certificate.

RENAC Online covers a variety of technologies and suits different professional profiles: Those willing to learn the fundamentals of solar and wind energy, concentrated solar power (CSP) or biogas can chose “Applying Renewable Energy,” certified by the German Central for Distance Learning (Staatliche Zentralstelle für Fernunterricht), or focus on combined heat and power (CHP). Participants with further experience can gain the skills to manage the integration of large amounts of wind and solar energy in energy systems and become “Certified ReGrid Manager”. Moreover, future offers will include energy efficiency, PV-diesel hybrid systems, and financing.

Additionally, for groups of 10 people or more, RENAC can customize trainings from a selection of the available modules. Also, RENAC can support other institutions with the development of suitable curricula fitting the student’s needs, right through to the design of comprehensive training materials.

Some of RENAC’s international references include online trainings in the framework of the ReGrid, TREE, Biogas Central America and Sustaingas projects. According to former ReGrid students, “What I like is the availability and the efforts of the whole team that provides online training.” “The training is efficient, high quality and encourages students to keep researching in this area, and the certification is very good.”

For further information and registration, please visit RENAC’s website.

Contacts

Renewables Academy AG (RENAC)

Elena Cantos, +49(0)30-526 895 8 - 94

cantos@renac.de









Permalink: http://www.me-newswire.net/news/11949/en

GSMA Calls for Re-Evaluation and Reduction of Mobile-Specific Taxation across Sub-Saharan Africa

400 Million USD of Sub-Saharan Africa’s Universal Service Funds Have Yet to be Dispersed; Surtax on International Incoming Traffic Found to Distort Price Competition and Negatively Impact Businesses and Consumers

LONDON - Monday, September 1st 2014 [ME NewsWire]

(BUSINESS WIRE)-- The GSMA today called upon governments in Sub-Saharan Africa (SSA) to review their approach to the increasing tax burden imposed on the mobile industry. The GSMA released two studies that explore various aspects of mobile-specific taxation in Africa and show that this burden is stifling economic growth in those countries that have introduced mobile-specific taxation. The first report, ‘Surtax on International Incoming Traffic (SIIT) in Africa’, examines the impact of SIIT in Sub-Saharan Africa and concludes that the introduction of SIIT can lead to less revenue for mobile operators and governments and higher prices for consumers. A second report, ‘Sub-Saharan Africa Universal Service Fund (USF) Study’, found that most of these funds are not succeeding in delivering their stated goal of widening access to telecommunication services and that alternative market-based solutions are more effective.

“Sub-Saharan Africa is the fastest-growing region globally, with 328 million unique mobile subscribers and an annual growth rate of 18 per cent over the last five years. However, with subscriber penetration of just 37 per cent, there is clearly still huge potential for greater growth ahead,” said Tom Phillips, Chief Regulatory Officer, GSMA. “Beyond further adoption of basic voice services, the region is starting to see an explosion in the uptake of mobile data. However, a short-term focus by some countries on generating revenue through increasing the SIIT, combined with the continued imposition of USF levies despite accumulated funds that are not being effectively employed, will clearly have a negative impact on the domestic mobile sector and other businesses in the region.”

Report Highlights Negative Economic Impact of SIIT in Africa

The report Surtax on International Incoming Traffic (SIIT) in Africa studies the effects of the SIIT in six countries in Sub-Saharan Africa and on regional integration. The report’s findings are in line with a recent publication from the Organisation for Economic Co-operation and Development (OECD)1 that shows that imposing higher charges for the termination of international inbound traffic suppresses demand. Similar to the GSMA’s study, the OECD report concludes that those governments that impose higher termination charges do not see their revenues increase proportionately. The report outlines the impact for consumers, governments and businesses:

    Consumers - SIIT effectively fixes prices for international traffic termination and in these countries where it is imposed, the SIIT has caused the price of terminating international incoming calls to increase by an average 97 per cent, with an increase of up to 247 per cent in Burundi;
    Governments - SIIT has already shown its potential to create economic losses to governments that impose it. The report estimates that, in the absence of the SIIT, mobile operators could have terminated an extra 1.2 billion international minutes and generating $86 million in revenues from June 2010 to March 2014, indicating that governments could have gained an extra $27.5 million across the period had the SIIT not been introduced; and
    Businesses - SIIT creates significant extra costs to African businesses that trade with, and therefore call, businesses in countries where the SIIT has been imposed, negatively affecting regional integration. Evidence from mobile operators indicates that nearly 40 per cent of all international incoming traffic is from countries in the region, and in some countries, such as Tanzania, over 50 per cent of calls originate within Africa.

USF Report Highlights Need For Alternative Methods to Achieve Universal Service

The Sub-Saharan Africa Universal Service Fund Study finds that USFs in the region do not appear to be the most appropriate mechanism for providing universal access and service, and to furthering social and economic improvement in a proactive, cost-effective and transparent manner. Generally, the report found significant deficiencies in fund structure, management and operation throughout the SSA region. The report concludes that consideration must be given to disbanding inactive funds and returning the remaining monies to the operators who paid the levies in the first place and, where this is not feasible, gradually reducing the levy collected for either inactive or low activity funds and gradually phasing out the funds. The study found that alternative approaches to achieving universal service, such as license obligations, are often more effective than USFs.

Both reports have identified countries within the region that have recognised the negative impact of both the SIIT and USFs on trade and regional integration. The two studies conclude that in light of these negative consequences, other governments should re-consider the SIIT and USF and assess the specific impact on their economies and on economic development for the region as a whole.

“Mobile is an important contributor to the economy of Sub-Saharan Africa, accounting for more than six per cent of the region’s GDP, more than any other comparable region globally,” continued Phillips. “As our research has shown, taxation as a proportion of the total cost of mobile ownership in the region is also higher than the global average, a factor that makes mobile services less affordable for end users. The SIIT is clearly being used as an opportunistic short-term revenue tool by some governments and, in reality, USFs have become an unnecessary levy on the telecommunications industry. We strongly feel that eliminating harmful mobile-specific taxation would benefit consumers, businesses and governments by encouraging the take-up of new mobile services, improving productivity and boosting GDP and overall tax revenues in the longer term.”

Notes to Editors

OECD (2014), "International Traffic Termination", OECD Digital Economy Papers, No. 238, OECD Publishing 10.1787/5jz2m5mnlvkc-en.

The GSMA reports can be found at: www.gsma.com/publicpolicy/tax/research-and-resources

About the GSMA

The GSMA represents the interests of mobile operators worldwide. Spanning more than 220 countries, the GSMA unites nearly 800 of the world’s mobile operators with 250 companies in the broader mobile ecosystem, including handset and device makers, software companies, equipment providers and Internet companies, as well as organisations in industry sectors such as financial services, healthcare, media, transport and utilities. The GSMA also produces industry-leading events such as Mobile World Congress and Mobile Asia Expo.

For more information, please visit the GSMA corporate website at www.gsma.com. Follow the GSMA on Twitter: @GSMA.

Contacts

For the GSMA
Charlie Meredith-Hardy, +44 7917 298428
CMeredith-Hardy@webershandwick.com



Jill Hamilton, +27 826 588 831
jhamilton@webershandwick.com







Permalink: http://www.me-newswire.net/news/11950/en

Boehringer Ingelheim to Present Comprehensive Data Supporting Broad Respiratory Portfolio in COPD, Asthma and IPF at ERS 2014

INGELHEIM, Germany. - Monday, September 1st 2014 [ME NewsWire]

    First presentation of positive results from pivotal, Phase III TONADO™ studies that supported recent regulatory submissions in Europe and US for tiotropium + olodaterol Respimat®*in COPD - the only fixed-dose combination (FDC) containing tiotropium
    Data further confirming role of Spiriva® in delivering long-term benefits to COPD patients and in helping to establish COPD management strategy
    Pooled Phase III data from large UniTinA-asthma® clinical trial programme showing improvement in both symptom control and risk of exacerbations across asthma severities by adding tiotropium Respimat®† to at least maintenance inhaled corticosteroid (ICS) therapy

    Further analyses of the INPULSIS™ Phase III trials confirming the robustness of the primary and key secondary endpoint results for nintedanib‡ in IPF. An additional pre-specified subgroup analysis showing similar effects of nintedanib‡ in slowing disease progression, independent of severity of lung function impairment at baseline will also be presented

    A total of 18 abstracts with key data across COPD, asthma and IPF will be presented

(BUSINESS WIRE)-- For media outside UK, US and Canada

The European Respiratory Society (ERS) International Congress, in Munich, Germany, September 6-10, 2014 sets the scene for important announcements across the substantial Boehringer Ingelheim respiratory portfolio. Data to be presented cover new advances in chronic obstructive pulmonary disease (COPD) treatment approaches, further supporting data for tiotropium Respimat® in asthma and rare disease insights for idiopathic pulmonary fibrosis (IPF).

With a total of 18 abstracts presented during ERS 2014, the data will highlight the importance of the company’s focus on respiratory research and advances in addressing unmet needs for patients living with certain lung diseases. Further detailed presentations and information will be provided in two media briefings during the congress.

COPD: Tiotropium + olodaterol Respimat® FDC and Spiriva® (tiotropium)

For the first time, data from the pivotal, 52-week TONADO™ Phase III studies§ involving more than 5,000 patients with COPD will be presented. The TONADO™ studies compared clinical outcomes in patients receiving tiotropium + olodaterol FDC delivered via the Respimat® Soft Mist™ Inhaler with those on tiotropium or olodaterol (Striverdi®) alone. The data from the TONADO™ studies formed a major part of Boehringer Ingelheim’s recent regulatory submissions in Europe and the US for tiotropium + olodaterol Respimat® FDC in COPD.

These important advances are underpinned by in-depth analyses of Spiriva® clinical trials that demonstrate an extensive wealth of experience since its introduction over 10 years ago** and over 40 million patient-years of real life experience supporting its safety and efficacy.1-7

Further analysis of one of the largest COPD trials, TIOSPIR™, highlights the predictors of debilitating COPD exacerbations and reinforces the need to treat COPD patients early. Spiriva®has shown a positive impact on reducing the risk of these lung attacks across a broad range of severities of COPD patients.††,3,6,8

Tiotropium Respimat® in asthma

Further highlights from the accepted ERS abstracts include studies looking at the impact of adding tiotropium Respimat® to at least ICS maintenance therapy on improving symptom control and reducing the risk of exacerbations across asthma severities. Using results pooled from the large UniTinA-asthma® international Phase III clinical trial programme including the PrimoTinA-asthma®, MezzoTinA-asthma® and GraziaTinA-asthma® trials, these new data will add to existing evidence that has shown the efficacy and safety of tiotropium Respimat® in patients with asthma who continue to experience symptoms despite treatment with at least ICS with or without LABA therapy. Despite current treatment options, almost one in two patients with asthma still have asthma symptoms9,10,11 and may experience frightening and life-threatening asthma exacerbations.

Idiopathic Pulmonary Fibrosis (IPF)

Abstracts to be presented at ERS show further data from the two Phase III INPULSIS™ trials, investigating nintedanib‡ 150 mg twice daily in the treatment of IPF.12 The primary endpoint was the annual rate of decline in forced vital capacity (FVC).12 Key secondary endpoints were: change from baseline in health-related quality of life, as assessed by the Saint-George’s Respiratory Questionnaire (SGRQ) and time to first acute exacerbation.12 The robustness of the primary and key secondary endpoint results is supported by sensitivity analyses.13

A pre-specified subgroup analysis of pooled data from the INPULSIS™ trials showed that nintedanib‡ 150 mg twice daily slowed the decline in lung function in patients with IPF, independent of severity of lung function impairment at baseline.14 In addition, nintedanib‡ reduced the proportion of patients with IPF who experienced disease progression as measured by categorical FVC decline.15

For ‘Notes to Editors’ along with a list of abstracts and sessions visit: http://www.boehringer-ingelheim.com/news/news_releases/press_releases/2014/01_september_2014_Respiratory.html

* The fixed-dose combination of tiotropium + olodaterol is an investigational treatment. Its safety and efficacy have not yet been fully established.

† Tiotropium Respimat® for use in asthma is currently being reviewed by regulatory authorities; it is approved as Spiriva® Respimat® for use in asthma in Chile, Colombia, Ecuador, Russia, and Thailand.

‡ Nintedanib is an investigational compound. Its safety and efficacy has not yet been fully established.

§ TONADO™ consists of two replicate Phase III studies called TONADO™ 1&2

** 18 µg delivered via HandiHaler®

†† While Spiriva® 18 µg via HandiHaler® did not alter the rate of decline in lung function, a coprimary endpoint in the UPLIFT® study, it sustained greater improvements in lung function vs. placebo

Contacts

Boehringer Ingelheim

Corporate Communications

Media + PR

Dr Kristin Jakobs

Phone: +49 (6132) 77-144553

Fax: +49 (6132) 77-6601

Email: press@boehringer-ingelheim.com

More information

www.boehringer-ingelheim.com









Permalink: http://me-newswire.net/news/11954/en