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Archive for December 21st, 2013

Singaporeans Flocked to The Melaka Art & Performance Festival

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Over 50 artists from 10 countries participated in the largest festival at a UNESCO World Heritage Site

KUALA LUMPUR, Malaysia, Dec. 19, 2013 /PRNewswire/ — Thousands of Singaporeans recently visited the 5th Melaka Art & Performance Festival (MAPFest), the largest and only site specific art and performance festival on a UNESCO World Heritage Site, with art installations and performances by more than 50 renowned artists from 10 countries.
Eulogy of the Living, a haunting piece of performance art, which marked the closing of MAPFest 2013.
Eulogy of the Living, a haunting piece of performance art, which marked the closing of MAPFest 2013.

Andrew Ching, Founder and Producer of MAPFest said, “Over the years, MAPFest has become a yearly excursion for Singaporeans. The festival is widely supported and appreciated by Singaporeans and I expect it to only grow bigger.”

Artists from Australia, France, Indonesia, Ireland, Italy, Malaysia, the Netherlands, Poland, South Korea and Thailand used the historic city as their canvas, and the streets came alive with magnificent images and performances.

MAPFest is an innovative contemporary festival featuring dance, performance art, visual art, film and music. The festival throws the spotlight on Melaka’s famous heritage sites, and its collective ancestral heritage, to create a space for contemporary culture and artistic practice.

According to the festival organiser, the event attracted approximately 25,000 attendees, 5,000 of which were estimated to be from Singapore.

For the first time since its inception in 2009, MAPFest kicked off a new sister festival in Australia: Mapping Melbourne — Asian Contemporary Arts Festival (Australia).

Through the years, MAPFest has increased its international status, being recognised for its programme of exciting independent artists, collaborations and its use of alternative sites for performance.

Conceived and directed by Cheryl Stock, “Naik Naik” was the opening performance and also one of the highlight at MAPFest 2013. The festival kept it new with specialty components such as the “Cerita Pendek” (Short Stories), visual arts and discussions, as well as workshops. MAPFest 2013 culminating with “Eulogy for The Living”, a spectacular and soulful finale to the festival directed by Tony Yap, Founder and Creative Director of MAPFest.

MAPFest 2013 was produced by Arts & Performance Festival Melaka Sdn Bhd together with the efforts of E-Plus Entertainment, the Australian Government, High Commission of Australia, Australia Malaysia Institute, Multicultural Arts Victoria, Tony Yap Company, Mercatus+ Malaysia, Asialink, the Embassies of France, Thailand and Indonesia, the High Commission of Ireland, and the Malaysian National Department for Culture and Arts (JKKN).

For more information on MAPFest, visit http://www.melakafestival.com.
Source: Mercatus Plus (Malaysia) Sdn Bhd

Written by asiafreshnews

December 21, 2013 at 12:32 am

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Daiichi Sankyo Submits Supplemental New Drug Application in Japan for LIXIANA(R) (Edoxaban Tosilate Hydrate) for New Indications

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— Submission based on the two largest comparative phase 3 clinical trials of a novel oral anticoagulant in patients with non-valvular atrial fibrillation or symptomatic venous thromboembolism

— Regulatory filings for once-daily edoxaban planned by Q1 2014 in the U.S. and Europe

TOKYO, Dec. 19, 2013 /PRNewswire/ — Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) today announced that it has submitted a supplemental New Drug Application (NDA) for its oral, once-daily direct factor Xa-inhibitor LIXIANA® (Edoxaban Tosilate Hydrate) for review by the Japanese Ministry of Health, Labour and Welfare. Daiichi Sankyo is seeking approval in Japan for edoxaban in new indications for non-valvular atrial fibrillation (AF) and symptomatic venous thromboembolism (VTE).

The supplemental NDA submission is based on data from an extensive global clinical trial program that compared treatment with once-daily edoxaban to warfarin, a current standard of care for patients with AF or VTE. The two clinical trials that formed the basis of the submission, ENGAGE AF-TIMI 48 and Hokusai-VTE, are the largest comparative trials of a novel oral anticoagulant in these patient populations, involving 21,105 and 8,292 patients, respectively.1,2

“The submission of our supplemental NDA in Japan for edoxaban represents our long standing commitment to addressing the needs of patients living with cardiovascular diseases, including those living with atrial fibrillation or venous thromboembolism,” said Glenn Gormley, MD, PhD, Senior Executive Officer and Global Head of Research and Development, Daiichi Sankyo Co., Ltd. and President and CEO of Daiichi Sankyo, Inc. in the United States. “We look forward to working with the Japanese Ministry of Health, Labour and Welfare throughout its review of these new indications for edoxaban. Additionally, we plan to submit applications for edoxaban in the U.S. and Europe by the first quarter of 2014.”

About Edoxaban
Edoxaban is an investigational, oral, once-daily anticoagulant that specifically inhibits factor Xa, which is an important factor in the coagulation system that leads to blood clotting.3 The global edoxaban clinical trial program includes two phase 3 clinical studies, Hokusai-VTE and ENGAGE AF-TIMI 48 (Effective aNticoaGulation with Factor XA Next GEneration in Atrial Fibrillation). The results from these trials form the basis of the supplemental NDAs for edoxaban for symptomatic VTE in patients with deep vein thrombosis (DVT) and/or pulmonary embolism (PE), and for non-valvular AF, respectively.

Edoxaban is currently approved only in Japan, since April 2011, for the prevention of VTE after major orthopedic surgery, and was launched in July 2011 under the brand name LIXIANA®. Elsewhere, including Europe and the U.S., edoxaban is currently in phase 3 clinical development and has not been approved in any indication.4

About Daiichi Sankyo
Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical products to address the diversified, unmet medical needs of patients in both mature and emerging markets. While maintaining its portfolio of marketed pharmaceuticals for hypertension, hyperlipidemia, and bacterial infections, the Group is engaged in the development of treatments for thrombotic disorders and focused on the discovery of novel oncology and cardiovascular-metabolic therapies. Furthermore, the Daiichi Sankyo Group has created a “Hybrid Business Model,” which will respond to market and customer diversity and optimize growth opportunities across the value chain. For more information, please visit: http://www.daiichisankyo.com.

Contact
Michaela Paudler-Debus, PhD
Daiichi Sankyo Europe
michaela.paudler-debus@daiichi-sankyo.eu
+49-89-7808-685 (office)
+49-176-11780966 (mobile)

Forward-looking statements
This press release contains forward-looking statements and information about future developments in the sector, and the legal and business conditions of DAIICHI SANKYO, Co. Ltd. Such forward-looking statements are uncertain and are subject at all times to the risks of change, particularly to the usual risks faced by a global pharmaceutical company, including the impact of the prices for products and raw materials, medication safety, changes in exchange rates, government regulations, employee relations, taxes, political instability and terrorism as well as the results of independent demands and governmental inquiries that affect the affairs of the company. All forward-looking statements contained in this release hold true as of the date of publication. They do not represent any guarantee of future performance. Actual events and developments could differ materially from the forward-looking statements that are explicitly expressed or implied in these statements. DAIICHI SANKYO, Co. Ltd assume no responsibility for the updating of such forward-looking statements about future developments of the sector, legal and business conditions and the company.

References

Giugliano, R et al. Edoxaban versus Warfarin in Patients with Atrial Fibrillation. N Engl J Med 2013;369:2093-2104.
Buller, H et al. Edoxaban versus Warfarin for the treatment of Symptomatic Venous Thromboembolism. N Engl J Med 2013;369:1406-1415.
Ogata, K et al. Clinical Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of the Novel Factor Xa Inhibitor Edoxaban in Healthy Volunteers. J Clin Pharmacol 2010;50:743-753.
Daiichi Sankyo press release – Daiichi Sankyo Launches LIXIANA® (edoxaban), a Direct Oral Factor Xa Inhibitor, in Japan for the Prevention of Venous Thromboembolism after Major Orthopaedic Surgery. 19 July 2011. Available at: http://www.daiichisankyo.com/media_investors/media_relations/press_releases/detail/005784.html. [Last accessed: December 2013].

Source: Daiichi Sankyo Company, Limited

Written by asiafreshnews

December 21, 2013 at 12:14 am

Posted in Uncategorized