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Tresiba(R) (insulin degludec injection U-100) demonstrated significantly lower rates of overall, nocturnal and severe hypoglycaemia vs insulin glargine U-100

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NEW ORLEANS /PRNewswire/ —

New findings from the two phase 3b SWITCH trials showed that treatment with long-acting basal insulin Tresiba®(insulin degludec injection U-100) resulted in significantly lower rates of overall, nocturnal and severe hypoglycaemia compared with insulin glargine U-100.1,2 Results from the SWITCH 1 and 2 trials, the first completed double-blinded basal insulin studies evaluating the safety profile and efficacy of Tresiba® vs insulin glargine U-100,1,2 were presented June 11th at the American Diabetes Association 76th Scientific Sessions in New Orleans, US.

In SWITCH 1, patients with type 1 diabetes taking Tresiba® compared with insulin glargine U-100 experienced: a rate reduction of 11% in overall symptomatic blood glucose (BG) confirmed hypoglycaemic episodes (95% confidence interval CI: 0.85; 0.94); a rate reduction of 36% in nocturnal BG confirmed symptomatic hypoglycaemic episodes (95% CI: 0.56; 0.73), and a rate reduction of 35% severe hypoglycaemia (95% CI: 0.48; 0.89) during the maintenance period.1 All of the above analyses showed similar results in the full treatment period.

In SWITCH 2, patients with type 2 diabetes taking Tresiba® compared with insulin glargine U-100 experienced a rate reduction of 30% in overall BG confirmed symptomatic hypoglycaemic episodes (95% CI: 0.61; 0.80) and a rate reduction of 42% in nocturnal BG confirmed symptomatic hypoglycaemic episodes (95% CI: 0.46; 0.74). The above analyses showed significant results in the full treatment period. In the maintenance period, there was a trend towards lower rates of severe hypoglycaemia in favour of Tresiba® vs insulin glargine U-100. In the full treatment period, a significant 51% rate reduction in severe hypoglycaemia was observed in patients receiving Tresiba® vs insulin glargine U-100 (95% CI: 0.26; 0.94).2

“Hypoglycaemia is an ongoing challenge for people with type 1 and type 2 diabetes,” said Dr. Wendy Lane, lead SWITCH 1 study investigator and clinical endocrinologist at Mountain Diabetes and Endocrine Center in Asheville, N.C., U.S. “These findings are important for the diabetes community, and add to the existing body of evidence for Tresiba®.”

Tresiba® (IDeg) was non-inferior to insulin glargine U-100 (IGlar U-100) in reducing HbA1c in both treatment periods for both SWITCH 1 and 2 trials (SWITCH 1 treatment period 1: IDeg 6.92% vs IGlar U-100 6.78%; SWITCH 1 treatment period 2: IDeg 6.95% vs IGlar U-100 6.97%; SWITCH 2 treatment period 1: IDeg 7.06% vs IGlar U-100 6.98%; SWITCH 2 treatment period 2: IDeg 7.08% vs IGlar U-100 7.11%).13 The end-of-trial insulin doses were similar at the end of each treatment period in both trials. The most common adverse events (≥5%) included nasopharyngitis, upper respiratory tract infections and hypoglycaemia.35

About SWITCH 1 and 2
The two phase 3b, 2×32-weeks randomised, double-blind, crossover, treat-to-target trials were initiated in January 2014 to compare the safety profile and efficacy of Tresiba® and insulin glargine U-100. The overall objective was to document the hypoglycaemia profile in type 1 diabetes and type 2 diabetes, respectively. During the maintenance period, the primary endpoint studied was the number of treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes. The two secondary endpoints included: the number of treatment emergent severe or BG confirmed nocturnal episodes and the proportion of subjects with one or more severe hypoglycaemic episodes. In SWITCH 1, 501 people with type 1 diabetes were randomised to crossover treatment with Tresiba® and insulin glargine U-100 in combination with insulin aspart. In SWITCH 2, 721 people with type 2 diabetes were randomised to crossover treatment with Tresiba® and insulin glargine U-100 in combination with oral antidiabetic drugs.

About hypoglycaemia
Hypoglycaemia is a frequent complication in people with type 1 and type 2 diabetes when low levels of blood glucose in the blood deprive muscles, cells and the brain of the energy needed to function.6 Hypoglycaemia can be triggered by multiple factors including taking too much insulin, not following the prescribed meal schedule or participating in unusually strenuous or prolonged exercise.

About Tresiba®
Tresiba® (insulin degludec injection U-100) is a once-daily basal insulin that provides a duration of action beyond 42 hours.7,8 It is important for people with type 1 and type 2 diabetes to establish a routine for insulin treatment. On occasions when administration at the same time of day is not possible, Tresiba® allows for flexibility in day-to-day dosing time when needed.7,9,10 Tresiba® received its first regulatory approval in September 2012 and has since been approved in more than 60 countries globally. It was most recently approved by the FDA in the United Stateson 26 September 2015.

About Novo Nordisk
Novo Nordisk is a global healthcare company with more than 90 years of innovation and leadership in diabetes care. This heritage has given us experience and capabilities that also enable us to help people defeat other serious chronic conditions: haemophilia, growth disorders and obesity. Headquartered in Denmark, Novo Nordisk employs approximately 41,600 people in 75 countries and markets its products in more than 180 countries. For more information, visit http://www.novonordisk.com,Facebook, Twitter, LinkedIn, YouTube.

Further information

Media:
Katrine Sperling
+45-4442-6718
krsp@novonordisk.com

Asa Josefsson
+45-3079-7708
aajf@novonordisk.com

Michael Bachner (US)
+1-609-664-7308
mzyb@novonordisk.com

Investors:
Peter Hugreffe Ankersen
+45-3075-9085
phak@novonordisk.com

Melanie Raouzeos
+45-3075-3479
mrz@novonordisk.com

Kasper Veje (US)
+1-609-235-8567
kpvj@novonordisk.com

References

1. Lane W, Bailey T, Gerety G, et al. SWITCH 1: Reduced Hypoglycaemia With Insulin Degludec (IDeg) vs Insulin Glargine (IGlar), both U100, in Patients With T1D at High Risk of Hypoglycaemia: A Randomised, Double-Blind Crossover Trial. Abstract 87-LB presented at the 76th Annual Scientific Sessions of the American Diabetes Association (ADA), New Orleans, USA. 11 June 2016.

2. Wysham C, Bhargava A, Chaykin L, et al. SWITCH 2: Reduced Hypoglycaemia With Insulin Degludec (IDeg) vs Insulin Glargine (IGlar), both U100, in Patients With T2D at High Risk of Hypoglycaemia: A Randomised, Double-Blind Crossover Trial. Abstract 90-LB presented at the 76th Annual Scientific Sessions of the American Diabetes Association (ADA), New Orleans, USA. 11 June 2016.

3. Novo Nordisk. Data on file.

4. Lane W, Bailey T, Gerety G, et al. SWITCH 1: Reduced Hypoglycaemia With Insulin Degludec (IDeg) vs Insulin Glargine (IGlar), both U100, in Patients With T1D at High Risk of Hypoglycaemia: A Randomised, Double-Blind Crossover Trial. Poster (#87-LB) presented at the 76th Annual Scientific Sessions of the American Diabetes Association (ADA), New Orleans, USA. 11 June 2016.

5. Wysham C, Bhargava A, Chaykin L, et al. SWITCH 2: Reduced Hypoglycaemia With Insulin Degludec (IDeg) vs Insulin Glargine (IGlar), both U100, in Patients With T2D at High Risk of Hypoglycaemia: A Randomised, Double-Blind Crossover Trial. Poster (#90-LB) presented at the 76th Annual Scientific Sessions of the American Diabetes Association (ADA), New Orleans, USA; 11 June 2016.

6. Willis WD, Diago-Cabezudo JI, Madec-Hily A, et al. Medical resource use, disturbance of daily life and burden of hypoglycemia in insulin-treated patients with diabetes: results from a European online survey. Expert Review of Pharmacoeconomics & Outcomes Research. 2013; 13:123-30.

7. EMA. Tresiba® summary of product characteristics. Available at:http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002498/WC500138940.pdf Last accessed: June 2016.

8. Haahr H, Heise T. A review of the pharmacological properties of insulin degludec and their clinical relevance.Clinical Pharmacokinetics. 2014; 53:787-800.

9. Meneghini L, Atkin SL, Gough SC, et al. The efficacy and safety of insulin degludec given in variable once-daily dosing intervals compared with insulin glargine and insulin degludec dosed at the same time daily: a 26-week, randomized, open-label, parallel-group, treat-to-target trial in individuals with type 2 diabetes. Diabetes Care. 2013; 36:858-864.

10. Mathieu C, Hollander P, Miranda-Palma B, et al. Efficacy and safety of insulin degludec in a flexible dosing regimen vs insulin glargine in patients with type 1 diabetes (BEGIN: Flex T1): a 26-week randomized, treat-to-target trial with a 26-week extension. The Journal of Clinical Endocrinology & Metabolism. 2013; 98:1154-1162.

Source: Novo Nordisk

Written by asiafreshnews

June 13, 2016 at 5:14 pm

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Gartner Recognizes MobileIron as a Leader for Sixth Consecutive Year in Magic Quadrant for Enterprise Mobility Management Suites

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-MobileIron is the Only Stand-Alone EMM to be Recognized as a Leader this Year

MOUNTAIN VIEW, Calif. /PRNewswire/ — MobileIron (NASDAQ: MOBL) today announced that Gartner, Inc. has positioned MobileIron as a Leader in its “Magic Quadrant for Enterprise Mobility Management Suites” [1] for the sixth consecutive year.

Logo – http://photos.prnewswire.com/prnh/20140923/147891

“MobileIron is the only stand-alone EMM vendor to appear in the Leaders Quadrant this year. Our independence creates focus and our focus on mobile drives our innovation,” said Barry Mainz, President and CEO, MobileIron. “Mobile changes faster than any other enterprise technology, and our customers know that they can rely on MobileIron as the backbone for their mobile initiatives both now and in the future.”

Strategic importance of EMM

Gartner describes EMM suites as “the ‘glue’ that connects mobile devices to their enterprise infrastructure.” The report notes:

EMM is the starting point, if you are planning to opt into managing anything on a mobile platform. Because it is the presumptive foothold agent, EMM is the logical choice to broker policies for other services and tools on the platform.

In the last year, MobileIron continued to reinforce its innovation and technology leadership:

  • MobileIron Access: The latest addition to MobileIron’s portfolio of security solutions, Access reduces information security risks by allowing only trusted users, on trusted devices, using trusted apps to access corporate data in cloud services such as Box, Google Apps for Work, Office 365, and Salesforce.
  • Federal government certifications: MobileIron is in-process for three critical U.S. government security certifications: FedRAMP, NIAP Common Criteria, and NSA Commercial Solutions for Classified programs (CSfC). MobileIron believes it is the first EMM vendor to be in-process for all three.
  • 15 new patents granted for a total of 33: These include 14 new security patents such as “Management of certificates for mobile devices,” “Secure copy and paste of mobile app data,” “Secure access to mobile applications,” and “Secure virtual file management system.”
  • MobileIron Rooms: As an Apple mobility partner, MobileIron launched Rooms for iOS to solve the common business problem of scheduling a conference room with an app designed specifically for iPhone, iPad, and Apple Watch.
  • New Cloud service with Deutsche Telekom: MobileIron announced a new cloud-based EMM service with Telekom Deutschland, a subsidiary of Deutsche Telekom. The service adheres to Germany’s data protection regulations and satisfies the privacy requirements of German enterprise customers and public sector institutions.

Disclaimer:

Gartner does not endorse any vendor, product or service depicted in its research publications, and does not advise technology users to select only those vendors with the highest ratings or other designation. Gartner research publications consist of the opinions of Gartner’s research organization and should not be construed as statements of fact. Gartner disclaims all warranties, expressed or implied, with respect to this research, including any warranties of merchantability or fitness for a particular purpose.

[1] Gartner “Magic Quadrant for Enterprise Mobility Management Suites” by Rob Smith, Bryan Taylor, Chris Silva,Manjunath Bhat, Terrence Cosgrove, John Girard, June 8, 2016.

About MobileIron

MobileIron provides the secure foundation for companies around the world to transform into Mobile First organizations. For more information, please visit www.mobileiron.com.

Source: MobileIron

Related stocks: NASDAQ-NMS:MOBL

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June 13, 2016 at 3:51 pm

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The Power of Facebook: Tips on How to Use Facebook for your Small Business

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NEW YORK /PRNewswire/ — Using social media is an affordable option for small businesses that are looking to productively engage with their audience and generate buzz for their products and services.  However, staying informed about changes to existing platforms presents a serious challenge to marketing professionals as even the savviest of Facebook users might be unaware of new features that could benefit their efforts.

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CEO and founder of Author Marketing Experts Penny Sansevieri understands this unique challenge, and in her latest article posted to PR Newswire’s Small Business PR Toolkit, discusses various ways to harvest the power of Facebook.

  • Facebook ads. With its endless choices, the Facebook dashboard can be daunting for first time users. Sansevieri suggests focusing your efforts on “boosted posts” and “ads with a specific call to action.”
    • Boosted posts: This cost effective option is usually the go-to because of its low cost and ease of use. For a nominal fee you can boost posts that your audience is already engaged with and limit the exposure to your targeted demographic.
    • Ads: Consider driving your audience to a blog post that contains a great call to action such as a newsletter sign-up. To be effective use casual language in the ad with an eye-catching image. Both of these can help to engage your existing fans and also build up a new following.
  • Facebook posts. To optimize your facebook posts without spending any money consider the following:
    • Posting times. Identify the specific time slot from your posts that have the highest levels of engagement. If you uncover a trend, Sansevieri suggests you continue to post during those times.

To learn more about how you can make Facebook a valuable marketing tool in 2016, read the complete post here:http://bit.ly/28q1dUq.

PR Newswire’s Small Business PR Toolkit is a comprehensive resource that provides small businesses and entrepreneurs the tools to develop an affordable public relations and marketing plan that helps generate interest from potential customers, engage with key audiences and grow their businesses. The toolkit features relevant content such as informative white papers, interactive webinars and how-to articles and premium access to educational resources, as well as the opportunity to take advantage of special offers designed specifically for small businesses. To request information on how PR Newswire can help your small business, click here. You can receive updates on new Small Business PR Toolkit content by following @prnsmallbiz on Twitter.

About PR Newswire
PR Newswire (www.prnewswire.com) is the premier global provider of multimedia platforms that enable marketers, corporate communicators, sustainability officers, public affairs and investor relations officers to leverage content to engage with all their key audiences. Having pioneered the commercial news distribution industry over 60 years ago, PR Newswire today provides end-to-end solutions to produce, optimize and target content — from rich media to online video to multimedia — and then distribute content and measure results across traditional, digital, mobile and social channels. Combining the world’s largest multi-channel, multi-cultural content distribution and optimization network with comprehensive workflow tools and platforms, PR Newswire enables the world’s enterprises to engage opportunity everywhere it exists. PR Newswire serves tens of thousands of clients from offices in the Americas, Europe, Middle East, Africa and the Asia-Pacific region, and is a UBM plc company.

Contact:
Amanda Eldridge
Director, Strategic Channels
201-360-6906
Amanda.eldridge@prnewswire.com

Source: PR Newswire Association LLC

Related stocks: LSE:UBM OTC-PINK:UBMPY

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June 13, 2016 at 3:47 pm

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RISI and FOEX launch new US NBSK net price initiative

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BOSTON /PRNewswire/ — RISI, in cooperation with FOEX, today announced the successful completion of Stage 1 of a pilot program to launch a new index to measure month-to-month change in US NBSK net prices.

The pilot program kicked off with market consultation in Q4 2015 and actual contributions starting in January, 2016.

“RISI and FOEX have spent the past two years researching a NET price index solution for US NBSK.  The newPIX NBSK Net Change Index is tracking month-to-month changes in weighted average net prices.  FOEX is taking the lead in producing the index using their trusted PIX methodology,” said Matt Graves, SVP, RISI Indices.

FOEX and RISI continue to operate as separate price reporting agencies.  The current RISI US NBSK effective list prices and spot prices will continue uninterrupted.  The current PIX US NBSK price will continue until further notice.

“It is critical that we have actual market participants involved in the testing and validation of this new index.  We now have enough contributors for a viable index, however, we will continue the pilot phase through August in order to build up 6 months of solid history,” said Martti Airisto, Director, FOEX.

During the pilot period, the index will be available only to those who contribute data.

To see a sample of the new index and learn more, contact Martti Airisto at FOEX: martti@foex.fi

About FOEX Indexes Ltd (www.foex.fi)

FOEX Indexes Ltd is a specialised provider of audited, trade-mark registered pulp, paper, recovered paper and wood based bioenergy/biomass price indices. FOEX is based in Helsinki, Finland.

About RISI (www.risi.com)

RISI is the leading information provider for the global forest products industry. The company works with clients in the pulp and paper, packaging, wood products, timber, biomass, tissue and nonwovens industries to help them make better decisions.

Headquartered in Boston, MA, RISI operates additional offices throughout North and South America, Europe andAsia.

For Press Enquiries, please contact:
Martti Airisto
E: martti@foex.fi

Logo – http://photos.prnewswire.com/prnh/20080521/NEW122LOGO

Source: RISI
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June 13, 2016 at 3:45 pm

Posted in Uncategorized

Nxtra Data and CenturyLink announce exclusive business partnership to deliver hosting and managed IT services in India

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NEW DELHI /PRNewswire/ — Nxtra Data Limited, a wholly owned subsidiary of Bharti Airtel, andCenturyLink, Inc. (NYSE: CTL), a global communications, hosting, cloud and IT services company, today announced an exclusive business partnership to provide advanced hosting and managed IT services to enterprises in India. This exclusive partnership brings Nxtra Data’s India data centre management expertise together with CenturyLink’s cost-effective hosting, managed services and cloud capabilities to serve businesses and government organisations in India.

Neil Pollock, Chief Executive Officer, Nxtra Data Ltd, said, “We are delighted to announce this exclusive business partnership with CenturyLink. Nxtra Data’s Managed Services offering is now powered by a global leader in managed services and cloud, delivering a scalable, cost-effective and secure suite of products and services. The Nxtra and CenturyLink India-based teams will collaborate to bring a new standard of capability and service to support Indian enterprises – at the right price. Together, we will set a new benchmark in product performance, security and customer experience. Morever, offloading your organisation’s IT requirements to trusted service providers such as Nxtra and CenturyLink, will ensure that you spend more time focussed on core business requirements versus back-end IT challenges.”

“The strategic alliance forged between CenturyLink and Nxtra addresses the IT needs of Indian enterprises,” saidGirish Varma, president, Global IT Services & New Market Development, CenturyLink. “We are offering access to the same highly secure managed IT solutions and consistent experience available across CenturyLink’s global footprint, taking advantage of Nxtra’s data centres throughout India and engaging our mature India operations. This innovative approach to data centre services helps Indian businesses enhance their international reach with CenturyLink’s managed hybrid IT services, as well as CenturyLink customers that want to quickly and easily gain a physical presence in India.”

About Nxtra Data Limited

Nxtra Data Limited formed to run Bharti’s Data Center Managed Services business.
Nxtra now manages 10 Tier III/+ & ISO 27001 Certified Data Centres at Noida, Manesar, Mumbai, Chennai,Bangalore, Pune, Bubhaneshwar comprising approx. 200,000 sq. ft. of floor space.. Nxtra offers an integrated portfolio of data center managed services including Co-location, Managed Services, Managed Hosting, Managed Back-up & Storage, Managed Security, Virtual Compute and Cloud with both Domestic and International network connectivity. To know more visit www.nxtradata.com.

About CenturyLink

CenturyLink (NYSE: CTL) is a global communications, hosting, cloud and IT services company enabling millions of customers to transform their businesses and their lives through innovative technology solutions. CenturyLink offers network and data systems management, Big Data analytics and IT consulting, and operates more than 55 data centers in North America, Europe and Asia. The company provides broadband, voice, video, data and managed services over a robust 250,000-route-mile U.S. fiber network and a 300,000-route-mile international transport network. Visit CenturyLink for more information.

Source: CenturyLink, Inc.

Related stocks: NYSE:CTL

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June 13, 2016 at 3:42 pm

Posted in Uncategorized

Manny Stul of Moose Enterprise from Australia named EY World Entrepreneur Of The Year 2016

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MONACO /PRNewswire/ — Manny Stul, Chairman and Co-CEO of Melbourne-based toy company Moose Enterprise, was this evening named EY World Entrepreneur Of The Year 2016 at an awards ceremony held in Monaco’s Salle des Etoiles. Manny was picked from among the 55 country winners from 50 countries vying for the title.

Photo – http://photos.prnewswire.com/prnh/20160611/378212

Manny Stul took over Moose in 2000, then an Australian toy company with 10 employees, having already founded and built Skansen Giftware, which listed on the Australian Stock Exchange in 1993. In his 16 years running Moose, Manny has increased sales by 7,200% and built a global business that is now the fourth largest toy company inAustralia and, by sales, the sixth-largest in the US. Moose sells its toys, including the well-known Shopkins characters and Little Live Pets, in more than 80 countries.

Rebecca MacDonald, Founder and Executive Chair of Just Energy Group and Chair of the World Entrepreneur Of The Year judging panel, says:

“Our unanimous decision was reached after long and tough deliberations. Manny was our choice, not only due to his impressive growth, but also because the business he has nurtured has shown sustained global success. His mettle was tested when Moose faced a product recall that would have overcome less resilient and well-managed businesses. All of our finalists were worthy winners and demonstrated so many qualities that we were looking for, including an ability to respond to disruption. However, it was Manny who impressed us most across our diverse judging criteria.”

Manny Stul, Chairman and Co-CEO, Moose Enterprise, says:

“I’m honored and delighted to receive this prestigious award for Moose, our employees and for Australia. I was up against an amazing group of entrepreneurs and have been inspired by their stories. We are a company that succeeds by focusing on innovation with integrity and a clear purpose to make children happy. This has allowed us to grow exponentially, while overcoming huge challenges. I’d like to thank EY on behalf of all the entrepreneurs who competed this week.”

Bryan Pearce, EY Global Leader – EY Entrepreneur Of The Year, says:

“Manny won over the judges with his story of success from humble beginnings, and his ability to build a global consumer business that has been able to sustain its success over a 16-year period in a very competitive industry. His focus on giving back through the Moose Foundation is also impressive and an increasingly important aspect for so many of our entrepreneurs who compete for this title each year.”

Mark Weinberger, EY Global Chairman and CEO, says:

“Moose Enterprise has a very clear purpose at its heart that has guided the company’s outstanding growth. It’s the ability to combine this purpose with innovation, integrity, determination and grit that makes Manny a truly worthy EY World Entrepreneur Of The Year winner.”

About the judging panel

The independent judging panel was chaired by Rebecca MacDonald of Just Energy Group (Canada). Joining her were:

  • Rosario Bazan of DanPer (Peru)
  • Ivan Epstein of Sage International (South Africa)
  • Jim Nixon of Sandvik Venture (US)
  • Lance Uggla of Markit (UK)
  • Dr. Kar Wong of The Advanced Group of Companies (Singapore)
  • Michael Wu of Hong Kong Maxim’s Group (China)

Broadcast coverage, an interview with the winner and high-resolution photography will be available to download for broadcast and online use at: https://broadcast.ey.com/stories/9832

Event photography is available at www.ey.com/weoy/eventphotos

Manny Stul, Moose Enterprise

Manny Stul has been described as “a quintessential entrepreneur” due to his tenacity and ability to take a business from the brink of disaster to the highest ranks of the industry. Last year, his company’s popular Shopkins characters became “Girl Toy of the Year” at the Toy Industry Association’s Toy of the Year Awards in the US.

His first foray into the world of entrepreneurship was in 1974. The child of Polish refugee parents, Manny worked in construction in northwest Australia before starting his first business, a gift company called Skansen. Innovating and changing constantly to adapt to the market’s requirements, Manny expanded Skansen into one of the biggest gift companies in Australia and listed it on the Australian Stock Exchange in 1993. “I had no guidance from mentors and entered the business space with no experience,” he recalled. “Every decision and opportunity helped shape my skills and showed me in practical terms how to run a successful business.”

Moose, the company he took control of in 2000, went through very rough times in 2007 after a product recall. “Everyone said it was impossible to survive the recall, yet we pulled through,” Manny said. “Although faced with huge reputational and financial challenges, I refused to be distracted, and over a 12-week period negotiated agreements with local and international governments and trading partners, allowing the business to survive and thrive.”

Through the Moose Foundation, Moose Enterprise strives to extend its mission of making children happy in the wider community through philanthropic initiatives that positively make a difference to the lives and well-being of less fortunate children.

Manny shares the company’s leadership and ownership with wife and Moose director, Jacqui Tobias and step-sonPaul Solomon, his Co-CEO.

Notes to Editors

About EY
EY is a global leader in assurance, tax, transaction and advisory services. The insights and quality services we deliver help build trust and confidence in the capital markets and in economies the world over. We develop outstanding leaders who team to deliver on our promises to all of our stakeholders. In so doing, we play a critical role in building a better working world for our people, for our clients and for our communities.

EY refers to the global organization, and may refer to one or more, of the member firms of Ernst & Young Global Limited, each of which is a separate legal entity. Ernst & Young Global Limited, a UK company limited by guarantee, does not provide services to clients. For more information about our organization, please visit ey.com.

This news release has been issued by EYGM Limited, a member of the global EY organization that also does not provide any services to clients.

About EY World Entrepreneur Of The Year™
EY World Entrepreneur Of The Year is the world’s most prestigious business award for entrepreneurs. The unique award makes a difference through the way it encourages entrepreneurial activity among those with potential, and recognizes the contribution of people who inspire others with their vision, leadership and achievement. As the first and only truly global award of its kind, Entrepreneur Of The Year celebrates those who are building and leading successful, growing and dynamic businesses, recognizing them through regional, national and global awards programs in more than 145 cities in more than 60 countries.

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Source: EY
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June 13, 2016 at 3:39 pm

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EXAMINE Trial Post-Hoc Analyses of Mortality Data Regarding Cardiovascular Safety of Alogliptin Presented at American Diabetes Association’s 76th Scientific Sessions and Published in Diabetes Care

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OSAKA, Japan /PRNewswire/ — Takeda Pharmaceutical Company Limited [TSE: 4502], (“Takeda”) announced the publication of a post-hoc analysis from the global EXAMINE (EXamination of CArdiovascular OutcoMes: AlogliptIN vs. Standard of CarE in Patients with Type 2 Diabetes Mellitus and Acute Coronary Syndrome) cardiovascular (CV) safety outcomes trial (CVOT), which suggested that in patients with Type 2 diabetes and recent acute coronary syndrome (ACS), the risk of death, including CV death, was not higher with the dipeptidyl peptidase-4 (DPP-4) inhibitor alogliptin compared to placebo during a median follow-up period of 18 months.1 Trial results reported that in both groups of patients the occurrence of an additional non-fatal CV event, including myocardial infarction (MI), stroke, and unstable angina, was common and increased the risk of death, particularly after hospitalization for heart failure (HHF). This data was presented at the American Diabetes Association’s 76th Scientific Sessions, and also published in Diabetes Care.

“Heart disease, or CV disease, is the leading cause of death in patients with Type 2 diabetes,2 and is responsible for between 50 and 80 percent of deaths in people with diabetes,3 so it’s critical we have a clear understanding of the impact these medications have on patients with Type 2 diabetes who are at a high risk for CV diseases such as those involved in EXAMINE,” said William B. White, MD, Professor, Calhoun Cardiology Center, University of Connecticut School of Medicine, Farmington, Connecticut, U.S., on behalf of the EXAMINE Steering Committee and Investigators. “The post-hoc analysis indicates that mortality, including CV mortality, was not higher with alogliptin versus placebo when studied for 18 months. These data provide additional important information for the healthcare professional in evaluating treatments for people living with Type 2 diabetes.”

In the EXAMINE trial, death from any cause occurred in 153 patients on alogliptin (5.7%) and 173 patients on placebo (6.5%) [HR = 0.88, 95% CI: 0.71-1.09].1 Mortality rates following a first CV event were highest in patients who had experienced HHF first in both the alogliptin and placebo groups compared to those that did not experience any major CV event. The rate of death following HHF was 25.9% in patients treated with alogliptin as compared to 28.4% in patients on placebo.

Takeda will be presenting eight abstracts at the meeting, including a post-hoc analysis from the EXAMINE trial studying the tolerability of alogliptin as a triple therapy with metformin and sulfonylureas (SU).4 It compared 550 patients treated with alogliptin, metformin, and a SU, to 505 patients treated with placebo, metformin and a SU, and followed patients for up to 40 months (median 18 months). The analysis reported that there was no significant difference in hypoglycaemia (8.8% alogliptin vs. 6.7% placebo, p=0.161) or serious hypoglycaemia (1.30% alogliptin vs. 0.43% placebo, p=0.088), and had suggested that the triple therapy was effective and well tolerated.

About Takeda’s Diabetes Business
Takeda’s heritage in diabetes globally includes significant contributions towards scientific discovery and exchange, starting with the discovery of the thiazolidinedione (TZD) pioglitazone, the more recent developments of alogliptin and the fixed-dose combinations (FDC) alogliptin and pioglitazone, and alogliptin and metformin HCl. The company’s strong, diverse diabetes portfolio and available medications mark important milestones in Takeda’s ongoing commitment to advancing patient care and helping to meet the individual needs of this growing patient population.

About the EXAMINE Trial
EXAMINE, a large, randomized, double-blind, placebo-controlled outcomes study, was completed as a result of the U.S. FDA 2008 Guidance, titled “Guidance for Industry: Diabetes Mellitus – Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes,” for all Type 2 diabetes treatments under development since the issuance of the guidance.5,6 The EXAMINE trial was designed to evaluate CV safety following treatment with alogliptin in addition to standard of care, versus placebo in addition to standard of care, in patients with Type 2 diabetes who were at high risk for major adverse cardiovascular events (MACE) due to recent acute coronary syndrome (ACS).5 The trial’s primary objective was to evaluate non-inferiority of CV risk based on a primary composite endpoint of CV death, nonfatal myocardial infarction (MI) and nonfatal stroke.

EXAMINE randomized 5,380 patients in 49 countries with Type 2 diabetes with an ACS within the previous 15-90 days.5 The EXAMINE primary endpoint of non-inferiority compared to placebo in addition to standard of care was met, showing no increase in CV risk in a Type 2 diabetes patient population at high risk for CV events based on the primary composite endpoint of CV death, nonfatal MI and nonfatal stroke. The primary endpoint occurred at similar rates in the alogliptin (n=305) and placebo (n=316) groups (in 11.3 percent of patients vs. 11.8 percent of patients during a median follow-up period of 18 months; hazard ratio (HR), 0.96; upper boundary of the one-sided repeated CI, 1.16). These data reported that alogliptin does not increase CV risk in Type 2 diabetes patients at high-risk for MACE due to a recent ACS.

About Alogliptin
Alogliptin is a DPP-4 inhibitor for the treatment of Type 2 diabetes in adults as an adjunct to diet and exercise. DPP-4 inhibitors are designed to slow the inactivation of incretin hormones glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic peptide (GIP). As a result, an increased amount of active incretins enables the pancreas to secrete insulin in a glucose-dependent manner, thereby assisting in the management of blood glucose levels.

Alogliptin is approved as a monotherapy and also in fixed-dose combination (FDC) with pioglitazone and metformin HCl for the treatment of Type 2 diabetes in adults as adjuncts to diet and exercise. These therapies are not for treatment of Type 1 diabetes or diabetic ketoacidosis.

Takeda launched alogliptin in Japan in 2010. Since that time alogliptin and/or its FDC therapies have been approved in over 30 countries across the globe including Brazil, China, the European Union, Mexico, Russia, South Korea andthe United States. Diabetes prevalence continues to grow worldwide, with more than 415 million people impacted by diabetes.2 As the disease becomes increasingly prevalent, Takeda remains focused on expanding access of alogliptin, especially in emerging markets like Brazil, India and Russia.

INDICATIONS

Alogliptin

Alogliptin is indicated in adults aged 18 years and older with type 2 diabetes mellitus to improve glycaemic control in combination with other glucose lowering medicinal products including insulin, when these, together with diet and exercise, do not provide adequate glycaemic control.

Alogliptin/Metformin

Alogliptin/Metformin is indicated in the treatment of adult patients aged 18 years and older with type 2 diabetes mellitus: as an adjunct to diet and exercise to improve glycaemic control in adult patients, inadequately controlled on their maximal tolerated dose of metformin alone, or those already being treated with the combination of alogliptin and metformin; in combination with pioglitazone (i.e., triplecombination therapy) as an adjunct to diet and exercise in adult patients inadequately controlled on their maximal tolerated dose of metformin and pioglitazone; in combination with insulin (i.e., triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control in patients when insulin at a stable dose and metformin alone do not provide adequate glycaemic control.

Alogliptin/Pioglitazone

Alogliptin/Pioglitazone is indicated as a second or third line treatment in adult patients aged 18 years and older with type 2 diabetes mellitus: as an adjunct to diet and exercise to improve glycaemic control in adult patients (particularly overweight patients) inadequately controlled on pioglitazone alone, and for whom metformin is inappropriate due to contraindications or intolerance; in combination with metformin (i.e., triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control in adult patients (particularly overweight patients) inadequately controlled on their maximal tolerated dose of metformin and pioglitazone. In addition, Alogliptin/Pioglitazone can be used to replace separate tablets of alogliptin and pioglitazone in those adult patients aged 18 years and older with type 2 diabetes mellitus already being treated with this combination.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS – for Alogliptin, Alogliptin/Metformin and Alogliptin/Pioglitazone

Acute Pancreatitis – Postmarketing events of acute pancreatitis have been reported for alogliptin and have been associated with DPP-4 inhibitors. After initiation of alogliptin, patients should be observed carefully for signs and symptoms of pancreatitis. If pancreatitis is suspected, Alogliptin/Metformin or Alogliptin/Pioglitazone should be promptly discontinued and appropriate management should be initiated.

Hypersensitivity Reactions – Postmarketing events of serious hypersensitivity reactions in patients with alogliptin such as angiodema and severe cutaneous adverse reactions including Stevens-Johnson syndrome have been reported and have been associated with DPP-4 inhibitors. If a serious hypersensitivity reaction is suspected, Alogliptin/Metformin or Alogliptin/Pioglitazone should be discontinued.

Hepatic Effects – Postmarketing reports of hepatic dysfunction including hepatic failure, sometimes fatal, have been received. Baseline liver test panel is recommended. Patients should be observed closely for possible liver abnormalities. Perform liver tests promptly in patients who report symptoms that may indicate liver injury. If an abnormally is found and an alternative etiology is not established, consider discontinuation of Alogliptin/Metformin or Alogliptin/Pioglitazone.

Hypoglycemia – Insulin and insulin secretagogues are known to cause hypoglycemia. Therefore, a lower dose of insulin or insulin secretagogue may be required to minimize the risk of hypoglycemia when used in combination with alogliptin, Alogliptin/Metformin or Alogliptin/Pioglitazone.

WARNINGS AND PRECAUTIONS – for Alogliptin/Metformin

Lactic Acidosis – Lactic Acidosis is very rare, but serious and potentially fatal metabolic complication that can occur due to metformin accumulation. Reported cases have occurred primarily in diabetic patients with significant renal failure. The incidence of lactic acidosis can and should be reduced by assessing other associated risk factors such as excessive alcohol intake, hepatic insufficiency and any condition associated with hypoxia. In particular, elderly patients have a tendency to have decreased renal function; hence treatment of the elderly should be accompanied by careful monitoring of renal function (creatinine clearance). If renal acidosis is suspected, treatment with Alogliptin/Metformin should be discontinued.

Renal Function – Metformin is known to be substantially excreted by the kidney, and the risk of metformin accumulation and lactic acidosis increase with the degree of impairment of renal function. Thus patients with raised serum creatinine levels (or serum creatinine levels >135 mcmol/L in males and > 110 mcmol/L in females or creatinine clearance < 60 mL/min) should not receive alogliptin and metformin. Appropriate assessment of renal function is recommended prior to initiation of treatment and periodically thereafter.

WARNINGS AND PRECAUTIONS – for Alogliptin/Pioglitazone

Hepatic Function – Alogliptin/Pioglitazone must not be used in patients with hepatic impairment.

Fluid Retention and Cardiac Failure – Pioglitazone, like other thiazolidinediones, can cause fluid retention, which may exacerbate or precipitate heart failure. Patients with heart failure should be monitored for its signs and symptoms, and discontinuation of pioglitazone should be considered if any deterioration in cardiac status occurs.

Edema – Dose-related edema may occur. Use with caution in patients with edema.

Bladder Cancer – Data suggest an increased risk of bladder cancer in pioglitazone users. Data also suggest that the risk increased with duration of use. Do not use Alogliptin/Pioglitazone in patients with active bladder cancer. Use caution when using in patients with a prior history of bladder cancer. Tell patients to promptly report any sign of hematuria or other symptoms such as dysuria urgency as these may be due to bladder cancer.

WARNINGS AND PRECAUTIONS – for Alogliptin

Cardiac Failure: Experience of alogliptin use in clinical trials in patients with congestive heart failure of New York Heart Association (NYHA) functional class III and IV is limited and caution is warranted in these patients.

CONTRAINDICATIONS

Alogliptin
Alogliptin is contraindicated in patients with a history of serious hypersensitivity reaction to alogliptin-containing products such as anaphylaxis, angioedema, or severe cutaneous adverse reactions.

Alogliptin/Metformin
Alogliptin/Metformin is contraindicated in patients with known hypersensitivity to alogliptin, metformin hydrochloride, or any of its components. Additionally, due to the metformin hydrochloride component, Alogliptin/Metformin is contraindicated in patients with the following conditions: Renal disease or renal dysfunction and Diabetic ketoacidosis, diabetic coma or pre-coma.

Alogliptin/Pioglitazone
Alogliptin/Pioglitazone is contraindicated in patients with known hypersensitivity to alogliptin, pioglitazone or any of its components. Initiation of alogliptin/pioglitazone treatment is contraindicated in patients with cardiac failure (NYHA Class III or IV).

DRUG INTERACTIONS

Use with CYP2C8 strong inhibitors (i.e., gemfibrozil or inducers (i.e., rifampin)) may require dose adjustment.

ADVERSE REACTIONS

Alogliptin – Adverse reactions include upper respiratory infection, nasopharyngitis, headache, abdominal pain, gastroesophageal reflux disease, pruritis, and rash.

Alogliptin/Metformin – Adverse reactions include gastroesophageal reflux disease, headache, upper respiratory tract infection, pruritis, nasopharyngitis, hypersensitivity reactions, hepatic failure and acute pancreatitis, lactic acidosis, decreased vitamin B12, diarrhea, nausea, vomiting, flatulence, abdominal pain, anorexia, rash and taste disorder.

Alogliptin/Pioglitazone – Adverse reactions include upper respiratory tract infections, sinusitis, headache, nausea, dyspepsia, abdominal pain, pruritis, myalgia, oedema peripheral, weight increased.

Please consult with your local regulatory agency for approved labeling in your country.

About Takeda Pharmaceutical Company
Takeda Pharmaceutical Company Limited is a global, R&D-driven pharmaceutical company committed to bringing better health and a brighter future to patients by translating science into life-changing medicines. Takeda focuses its research efforts on oncology, gastroenterology and central nervous system therapeutic areas. It also has specific development programs in specialty cardiovascular diseases as well as late-stage candidates for vaccines. Takeda conducts R&D both internally and with partners to stay at the leading edge of innovation. New innovative products, especially in oncology and gastroenterology, as well as its presence in emerging markets, fuel the growth of Takeda. More than 30,000 Takeda employees are committed to improving quality of life for patients, working with our partners in health care in more than 70 countries. For more information, visit http://www.takeda.com/news.

 

References

1 White, W.B. et al. (2016) Cardiovascular Mortality in Patients with Type 2 Diabetes and Recent Acute Coronary Syndromes from the EXAMINE Trial. Diabetes Care [online]. Last accessed June 11, 2016, available at:http://care.diabetesjournals.org/content/early/2016/06/10/dc16-0303.

2 International Diabetes Federation (IDF). Diabetes Atlas, Seventh Edition 2015. Last accessed May 12, 2016, available at:http://www.idf.org/diabetesatlas.

3 World Health Organization. Ten facts about diabetes. Last accessed May 12, 2016, available at:http://www.who.int/features/factfiles/diabetes/en/.

4 Heller, Simon, Cannon, C.P., et al. Alogliptin in Triple Therapy with Metformin and Sulfonylureas Provides Significant Reductions in HbA1c and is Well Tolerated; an Analysis from the EXAMINE Trial. Abstract Presentation. American Diabetes Association Annual Scientific Sessions. June 2016. Available at: http://www.abstractsonline.com/pp8/#!/4008/presentation/39902.

5 Food and Drug Administration (FDA). Guidance for Industry: Diabetes Mellitus – Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes 2008. Last accessed May 12, 2016, available at:

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm071627.pdf.

6 White, W.B. et al. (2013) Alogliptin after Acute Coronary Syndrome in Patients with Type 2 Diabetes. The New England Journal of Medicine. [online] nejm.org. Last accessed May 12, 2016, available at:http://www.nejm.org/doi/full/10.1056/NEJMoa1305889.

Source: Takeda Pharmaceutical Company Limited

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June 13, 2016 at 3:35 pm

Posted in Uncategorized

Richardson and Training Industry, Inc. Launch New Sales Coaching Research

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PHILADELPHIA /PRNewswire/ — Richardson, a leading global sales training and performance improvement company, announced today that, in partnership with Training Industry, Inc., it has launched a new research study, Best Practices in Sales Coaching Across the Workforce. The research is available for download from theRichardson website.

Richardson and Training Industry, Inc. conducted a study on how organizations across industries are supporting sales coaching. The study focuses on how effective coaching programs create leadership alignment, build communication plans, and develop measurement strategies for their learning programs. Companies that participated in the study completed a survey reporting their companies’ use of coaching programs in support of sales personnel. The research outlines the key findings from the study, and based on the results, recommends seven best practices for implementing a successful sales coaching program.

By comparing effective and non-effective coaching programs, the study provides key best practices around coaching structure, coaching cadence, and coaching roles and responsibilities. In addition, the survey takes a look at generational influences on coaching and how successful coaching programs adapt to generational shifts in their workforce.

“At Richardson, we are lucky to work with organizations that understand the role that coaches play in changing the selling behaviors of their teams. Behavior change starts with the learning program, but ultimately, what matters is how new behaviors are demonstrated and supported in the field,” said Mark Bashrum, Richardson’s Vice President of Marketing. “By conducting this research, we were able to define coaching best practices in effective sales organizations. The research tells us that it’s vital for sales coaches to interact with their teams in a way that emphasizes their employee’s strengths and performance, as well as provides advice and on-the-job learning.”

To learn more about Richardson, please contact Meghan Steiner atMeghan.Steiner@richardson.com or visit www.richardson.com.

About Richardson
Richardson is a global sales training and performance improvement company. We collaborate with sales organizations to achieve greater levels of success by changing the behaviors of their salespeople and sales managers. Our approach is highly collaborative with a focus on enabling the right sales activity and effective customer dialogues. To help you achieve your goals, we partner with you to develop customized training programs and a culture of continuous learning to help drive improved organization performance.

About Training Industry, Inc.
Training Industry, Inc.’s focus is on helping dedicated business and training professionals get the information, insight, and tools they need to more effectively manage the business of learning. Our website, TrainingIndustry.com, spotlights the latest news, articles, case studies, and best practices within the training industry.

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June 13, 2016 at 3:30 pm

Posted in Uncategorized

Takeda Licenses Global Rights to Theravance Biopharma’s TD-8954, a Novel 5-HT4 Agonist and Motility Agent for Gastrointestinal Motility Disorders

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-Deal Provides Takeda Global Rights to Selective 5-HT4 Agonist; Highlights Takeda’s Commitment to Gastroenterology as a Core Therapeutic Area

OSAKA, Japan and DUBLIN /PRNewswire/ — Takeda Pharmaceutical Company Limited (TSE: 4502) (“Takeda”) and Theravance Biopharma, Inc. (NASDAQ: TBPH) (“Theravance Biopharma”) today announced that the companies have entered into a global license, development and commercialization agreement for TD-8954, a selective 5-HT4 receptor agonist being investigated for potential use in the treatment of gastrointestinal motility disorders, including enteral feeding intolerance (“EFI”).

TD-8954 is being developed for the short-term use with EFI to achieve early nutritional adequacy in critically ill patients at high nutritional risk, an indication for which the compound received U.S. Food and Drug Administration (FDA) Fast Track Designation.  Theravance Biopharma has most recently completed a study evaluating the safety, tolerability and pharmacodynamics of a single dose of the compound administered intravenously compared to metoclopramide in critically ill patients with EFI.

“The addition of TD-8954 to our portfolio highlights Takeda’s commitment to the development of treatments to improve the health of patients with gastroenterological disorders,” said Asit Parikh, M.D., Ph.D., Head, Gastroenterology Therapeutic Area Unit, Takeda. “As a leader in gastroenterology, Takeda has a history of bringing innovative treatments to patients where there is significant unmet need. We believe that TD-8954 has the potential to deliver therapeutic benefit to patients with gastrointestinal motility disorders, including EFI. Today EFI impacts approximately one million Americans and there are currently no FDA-approved treatment options available.”

“This is an important licensing deal for Theravance Biopharma as it provides a path forward for the development of this much-needed treatment option.  Our single-dose study of TD-8954 in critically ill patients with EFI provided early confidence in the potential for TD-8954 to improve gastric emptying time.  This is important as delayed gastric emptying makes it more difficult to feed patients in the ICU, slowing their recovery time, extending their stay in the ICU and increasing the risk of ICU-related complications,” said Rick E Winningham, Chairman and Chief Executive Officer of Theravance Biopharma. “Takeda is an industry leader in the development of treatments for gastrointestinal disorders, which we believe makes the company an ideal partner to drive the continued advancement of TD-8954.”

Theravance Biopharma will receive an upfront cash payment of $15 million and will be eligible to receive success based development and sales milestone payments as well as double digit royalties on worldwide net sales by Takeda. The first $110 million of potential milestones are associated with the development, regulatory and commercial launch milestones for EFI or other intravenously dosed indications. The transaction is expected to close during the second calendar quarter of 2016, and is subject to customary closing conditions and clearance under the Hart-Scott-Rodino Antitrust Improvements Act (“HSR Act”).

About Takeda
Takeda Pharmaceutical Company Limited (TSE: 4502) is a global, R&D-driven pharmaceutical company committed to bringing better health and a brighter future to patients by translating science into life-changing medicines. Takeda focuses its research efforts on oncology, gastroenterology and central nervous system therapeutic areas. It also has specific development programs in specialty cardiovascular diseases as well as late-stage candidates for vaccines. Takeda conducts R&D both internally and with partners to stay at the leading edge of innovation. New innovative products, especially in oncology, central nervous system and gastroenterology, as well as its presence in emerging markets, fuel the growth of Takeda. More than 30,000 Takeda employees are committed to improving quality of life for patients, working with our partners in health care in more than 70 countries. For more information, visit http://www.takeda.com/news.

Takeda’s Commitment to Gastroenterology
Takeda is a global leader in gastroenterology. With expertise spanning more than 25 years, the company’s dedication to innovation continues to evolve and have a lasting impact. ENTYVIO® (vedolizumab) demonstrates Takeda’s global capabilities and expansion into the specialty care market in gastroenterology and biologics. Designed and developed specifically to target the gastrointestinal (GI) tract, ENTYVIO was launched in 2014 for the treatment of adults with moderate to severe ulcerative colitis and Crohn’s disease. TAKECAB® (vonoprazan fumarate) is Takeda’s potassium-competitive acid blocker and was launched in Japan in 2015. Takeda also markets motility agent AMITIZA® (lubiprostone), which originally launched in 2006 for the treatment of chronic idiopathic constipation, and received subsequent approval to treat irritable bowel syndrome with constipation and opioid-induced constipation. Preceding these notable launches, Takeda pioneered gastroenterological breakthroughs in proton pump inhibitors beginning in the 1990’s with lansoprazole. Through specialized and strategic in-house development, external partnerships, in-licensing and acquisitions, Takeda currently has a number of promising early stage GI assets in development, and remains committed to delivering innovative, therapeutic options for patients with gastrointestinal and liver diseases.

About Theravance Biopharma

Theravance Biopharma is a diversified biopharmaceutical company with the core purpose of creating medicines that make a difference in the lives of patients suffering from serious illness.  Our pipeline of internally discovered product candidates includes potential best-in-class medicines to address the unmet needs of patients being treated for serious conditions primarily in the acute care setting. VIBATIV® (telavancin), our first commercial product, is a once-daily dual-mechanism antibiotic approved in the U.S., Europe and certain other countries for certain difficult-to-treat infections. Revefenacin (TD-4208) is a long-acting muscarinic antagonist (LAMA) being developed as a potential once-daily, nebulized treatment for chronic obstructive pulmonary disease (COPD). Our neprilysin (NEP) inhibitor program is designed to develop selective NEP inhibitors for the treatment of a range of major cardiovascular and renal diseases, including acute and chronic heart failure, hypertension and chronic kidney diseases such as diabetic nephropathy. Our research efforts are focused in the areas of inflammation and immunology, with the goal of designing medicines that provide targeted drug delivery to tissues in the lung and gastrointestinal tract in order to maximize patient benefit and minimize risk. The first program to emerge from this research is designed to develop GI-targeted pan-Janus kinase (JAK) inhibitors for the treatment of a range of inflammatory intestinal diseases.

In addition, we have an economic interest in future payments that may be made by Glaxo Group Limited or one of its affiliates (GSK) pursuant to its agreements with Innoviva, Inc. relating to certain drug development programs, including the Closed Triple (the combination of fluticasone furoate, umeclidinium, and vilanterol), currently in development for the treatment of COPD and asthma.

For more information, please visit www.theravance.com.

THERAVANCE®, the Cross/Star logo, MEDICINES THAT MAKE A DIFFERENCE® and VIBATIV® are registered trademarks of the Theravance Biopharma group of companies.

Takeda’s Forward-Looking Statements
This press release contains “forward-looking statements.” Forward-looking statements include all statements other than statements of historical fact, including plans, strategies and expectations for the future, statements regarding the expected timing of filings and approvals relating to the transaction, the expected timing of the completion of the transaction, the ability to complete the transaction or to satisfy the various closing conditions, future revenues and profitability from or growth or any assumptions underlying any of the foregoing. Statements made in the future tense, and words such as “anticipate,” “expect,” “project,” “continue,” “believe,” “plan,” “estimate,” “pro forma,” “intend,” “potential,” “target,” “forecast,” “guidance,” “outlook,” “seek,” “assume,” “will,” “may,” “should,” and similar expressions are intended to qualify as forward-looking statements. Forward-looking statements are based on estimates and assumptions made by management that are believed to be reasonable, though they are inherently uncertain and difficult to predict. Investors and security holders are cautioned not to place undue reliance on these forward-looking statements.

Forward-looking statements involve risks and uncertainties that could cause actual results or experience to differ materially from that expressed or implied by the forward-looking statements. Some of these risks and uncertainties include, but are not limited to: required regulatory approvals for the transaction may not be obtained in a timely manner, if at all; the conditions to closing of the transaction may not be satisfied; competitive pressures and developments; applicable laws and regulations; the success or failure of product development programs; actions of regulatory authorities and the timing thereof; changes in exchange rates; and claims or concerns regarding the safety or efficacy of marketed products or product candidates in development.

The forward-looking statements contained in this press release speak only as of the date of this press release, and neither Theravance Biopharma nor Takeda undertakes any obligation to revise or update any forward-looking statements to reflect new information, future events or circumstances after the date of the forward-looking statement. If one or more of these statements is updated or corrected, investors and others should not conclude that additional updates or corrections will be made.

Theravance Biopharma’s Forward-Looking Statements
This press release contains certain “forward-looking” statements as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding, among other things, statements relating to goals, plans, objectives and future events. Theravance Biopharma intends such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. Examples of such statements include statements relating to: the Company’s strategies, plans and objectives, the Company’s regulatory strategies and timing and results of clinical studies, the potential benefits and mechanisms of action of the Company’s product and product candidates and the Company’s expectations for product candidates through development and commercialization. These statements are based on the current estimates and assumptions of the management of Theravance Biopharma as of the date of the press release and are subject to risks, uncertainties, changes in circumstances, assumptions and other factors that may cause the actual results of Theravance Biopharma to be materially different from those reflected in the forward-looking statements. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, among others, risks related to: delays or difficulties in commencing or completing clinical studies, the potential that results from clinical or non-clinical studies indicate the Company’s product candidates are unsafe or ineffective, the feasibility of undertaking future clinical trials for our product candidates based on FDA policies and feedback, dependence on third parties to conduct clinical studies, delays or failure to achieve and maintain regulatory approvals for product candidates. Other risks affecting Theravance Biopharma are described under the heading “Risk Factors” contained in Theravance Biopharma’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on May 10, 2016. In addition to the risks described above and in Theravance Biopharma’s other filings with the SEC, other unknown or unpredictable factors also could affect Theravance Biopharma’s results. No forward-looking statements can be guaranteed and actual results may differ materially from such statements. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Theravance Biopharma assumes no obligation to update its forward-looking statements on account of new information, future events or otherwise, except as required by law.

Source: Takeda Pharmaceutical Company Limited
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June 13, 2016 at 3:27 pm

Posted in Uncategorized

Hublot Creates History in Bringing Pelé and Maradona Together 2 Legends for a Historic Once in a Lifetime Match!

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PARIS /PRNewswire/ —

On the eve of the UEFA EURO 2016™, just before the big kick-off of the European Football Championships for which Hublot is Official Watch, the Swiss watchmaker is bringing together two brand new teams for a historic match. A line-up that football has never seen, and that football fans have always dreamt of. There are moments in football which are eternal, and Hublot is writing one.

“We have all dreamt of an ideal team, of seeing some of our favourite players come together under the same colours. To see the two biggest rivals of all time team up in a legendary match, buzzing with the passion for football which drives us all, is a real privilege. This match is one of the “off the record” moments that I could have chosen as my favourite “EURO moment”. It is a match which says a lot about Hublot’s involvement and the ties it has woven over the past decade in the world of football, by teaming up with prestigious clubs, star trainers, magicians with the ball and the best leagues.”

(Photo: http://photos.prnewswire.com/prnh/20160606/375708 )
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(Photo: http://photos.prnewswire.com/prnh/20160606/375710 )
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(Photo: http://photos.prnewswire.com/prnh/20160606/375717 )

Ricardo Guadalupe, CEO of Hublot

Hublot, as the first luxury brand to invest in football back in 2008, chose as “écrin” a prestigious venue. Just a few metres from the Louvre, in the heart of the Palais Royal, next to the “Colonnes de Buren” two legendary teams will tread this fresh turf. Take the 2 best players of all time, 10 legends and stars of the round ball game, and create 2 teams for a classic friendly match bringing together players used to competing against each other. The players take the field, followed by Pelé and Maradona. Recognised as the best players of all time, the two coaches shake hands before the kick-off. At half-time, there is a penalty shoot-out for the UEFA Foundation, “UEFA Foundation for the children”.

Team Pelé – Ferdinand, Hierro, Dida, Crespo and Bebeto

Team Maradona – Trezeguet, Peruzzi, Ferrara, Cannavaro and Seedorf.

Football, Hublot’s winning formula.

Contact:
Annabelle Galley
+41-(0)-22-990-90-00
a.galley@hublot.ch

http://www.hublot.com

Source: HUBLOT

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June 13, 2016 at 2:52 pm

Posted in Uncategorized