INGELHEIM, GERMANY--( / ) November 26, 2013 -- For media outside of the U.S.A., UK and Canada only
The application for European marketing authorisation of faldaprevir*, a potent second generation oral protease inhibitor, has been fully validated and granted accelerated assessment by the European Medicines Agency (EMA).5,6 Boehringer Ingelheim is seeking marketing approval of faldaprevir* in combination with pegylated interferon and ribavirin (PegIFN/RBV) for the treatment of a broad range of patients with genotype-1 (GT-1) hepatitis C, including difficult-to-cure populations such as those with HIV co-infection or advanced liver disease.
“Faldaprevir* has been studied with pegylated interferon and ribavirin in a broad range of more than 3,300 patients typical of those that doctors see in every day clinical practice. Faldaprevir* has demonstrated strong efficacy and a robust safety profile while also offering the convenience of once-daily dosing and no food restrictions,” said Professor Klaus Dugi, Corporate Senior Vice President Medicine at Boehringer Ingelheim. “The acceptance for accelerated assessment by the EMA supports our position that if approved, faldaprevir* will provide an important alternative to currently available hepatitis C treatments.”
Accelerated assessment status does not automatically lead to a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) or the granting of a marketing authorization by the European Commission.1 If approved by the European Commission, faldaprevir* could be available for marketing in the EU in the second half of 2014.
The EMA Marketing Authorisation Application is based on a comprehensive clinical development programme for faldaprevir* with a particular focus on the Phase III STARTVerso™ trial data, recently presented at the 64th Annual Meeting of the American Association for the Study of Liver Diseases (AASLD). These studies include data for faldaprevir* in:
· Treatment naive patients with the majority having benefited from shorter treatment duration and achieved viral cure2
· Difficult-to-cure patient populations such as those with HIV co-infection4 or advanced liver disease2,3
· Patients with the Q80K polymorphism (this mutation is considered to affect the efficacy of other second generation protease inhibitors)2
· Treatment experienced patients who have relapsed, partially responded or failed to respond to previous therapy3
For full results see the STARTVerso™ press release here.
Faldaprevir* is the foundation of Boehringer Ingelheim’s hepatitis C treatment pipeline and is being developed in combinations both with and without interferon. In addition to the interferon-based faldaprevir* regimen that has been submitted for marketing approval, Boehringer Ingelheim aims to deliver one of the first interferon-free regimens for the treatment of hepatitis C infection. The goal is to make an interferon-free future a reality for a broad range of hepatitis C patients. Pivotal Phase III HCVerso® data for the interferon-free regimen of faldaprevir*, deleobuvir* and ribavirin will be available in 2014.
* Faldaprevir and deleobuvir are investigational compounds and not yet approved. Their safety and efficacy have not yet been fully established.
# # #
NOTES TO EDITORS
The Boehringer Ingelheim NewsHome: An innovative resource for journalists
The Boehringer Ingelheim hepatitis C is the one-stop-shop for clear, concise and easy to understand information about hepatitis C for media.
For the full ‘Notes to Editors’ and ‘References’ please visit:Korea Newswire distributes your news across every media channels through the industry’s largest press release distribution network
TORONTO, ONTARIO--() May 08, 2012 -- GuestLogix Inc. (TSX: GXI), the leading global provider of onboard retail and payment technology to the passenger travel industry, today LIVE TORONTO,the deployment 걸스닷컴 여자친구스킨쉽 of its onboard retail technology platform including its popular handheld POS devices with rail operator First TransPennine Express. This deployment represents a substantial expansion within 걸스닷컴 대구여자친구랑놀러갈만한곳 the rail sector 토렌토 TORONTO,adds 24 million annual passenger trips to the Company‘s market share. 토렌토 TORONTO,multi-year agreement marks GuestLogix’ first implementation 걸스닷컴 with travel-industry caterer Skytrac Group, a key channel partner in Europe. 웹하드 남자친구랑오래가는법
“Further penetration of the rail industry continues to be a logical extension 웹하드 여자친구에게불러주기좋은노래 for GuestLogix,” 토렌토 “FurtherTom Douramakos, President and 로또추첨기렌탈 “Furtherof 미즈나레이 “Further“With channel partners such as Skytrac, we are better positioned to more effectively target the market and provide our leading and comprehensive onboard retail technology to rail operators. This market represents a significant long-term 웹하드 비너스속옷세트 opportunity for GuestLogix and as operators are more actively searching for enhanced onboard retail technology, 걸스닷컴 여자캐릭터 this recent contract win confirms that the GuestLogix‘ solution meets the industry’s unique onboard requirements.” 걸스닷컴 신세경종현결별
First TransPennine 걸스닷컴 레이싱걸스타킹 Express is an inter-city rail operation based in the UK that serves Northern 밤애 Firstand parts of Scotland. 웹하드 First TransPennine Express is a subsidiary 웹하드 of transportation giant FirstGroup (LSE: FGP) 웹하드 한국그라비아동영상 which owns rail and 여성오르가즘 Firsttransportation operations throughout the UK, Scandinavia, the US and Canada.
Catering and logistics company Skytrac was selected from six 걸스닷컴 소희화보 competing providers to supply full-service catering support to First TransPennine Express. Skytrac presented the GuestLogix' 망고 Cateringand the XPDA-V handheld POS device, as part of its comprehensive best-of-breed onboard retail offering. 웹하드 일간플러스 Skytrac 걸스닷컴 최고의가슴 serves customers in 망고 Cateringthe rail 걸스닷컴 and air industries within Europe.
“GuestLogix proved to be 걸스닷컴 망고 “GuestLogixkey component to our win with First TransPennine Express,” said Peter Whittaker, Chairman and Chief Executive 걸스닷컴 음탕녀 of Skytrac Group. “Their technology certainly met the 웹하드 핑클소속사 requirements of 배구토토매치결과 “GuestLogixnew deployment and we look forward to additional agreements 아윤 “GuestLogixour partnership continues 걸스닷컴 중학생피팅모델 its growth.”
“Our commitment to Skytrac and First TransPennine Express goes hand-in-hand 웹하드 with our commitment to 웹하드 provide our 각침 “Ourwith first-rate local customer delivery service and support,” said Richard Cushing, SVP & 걸스닷컴 General Manager of GuestLogix Europe. “Skytrac has an impressive track record and continues to show excellence in every component of their offering. We are 웹하드 하하몽쇼이효리노출 thrilled with our joint solution and 발기부전보형물수술 “Ouroperators 페어리진동기 “Ourresponding positively.”
GuestLogix (TSX: GXI), the leading global provider of onboard store technology and merchandising solutions, helps airlines and other travel operators create, manage, and control onboard retail environments tailored to their 명일동맞고 GuestLogixand their passengers. GuestLogix brings a decade of expertise as a trusted onboard 웹하드 2세얼굴합성 transaction processing partner to airlines around the world. The Company's global headquarters and centre for product innovation is located in Toronto, Canada with regional head offices located in Dallas, Texas (serving Americas) London, UK (serving EMEA), and 웹하드 이요원김아중 Hong Kong (serving Asia Pacific). A sales and support office is located 걸스닷컴 초콜릿김아중 in 화곡본동풀팟홀덤 GuestLogixLogistics 웹하드 허니문예스 centres are situated in Toronto, Dallas, London and Seoul with a software development centre located in India. More information is available at
The Skytrac Group operates from two strategically located 걸스닷컴 적극성 service hubs in the United Kingdom, and has been supporting the travel industry for more than 15 years, providing innovative catering and onboard retail products, product development and packaging solutions for travel operators. Skytrac is recognised as one of the most efficient warehousing and logistics services to the industry, working with airlines and travel operators including FlyBe, Virgin Atlantic, 웹하드 보아차도녀 Easyjet, AV디비에스 TheThomson Airways, Thomas Cook, LSG SkyChefs, and Gate Gourmet, Virgin Trains, BA, Etihad, Emirates, and Saudi Air. The company recently expanded into the rail sector, providing catering logistics for First Scot Rail and First Transpennine 야플티비 Theand more 웹하드 시크녀 information can be found 웹하드 무료영어번역사이트 at
This news release includes certain forward-looking statements that are based upon current expectations, which involve risks and uncertainties associated with GuestLogix‘ business and the environment in which playboy Thisbusiness operates. Any statements contained herein that are not statements of historical facts may 얼짱 Thisdeemed to be forward-looking, including those identified by the expressions “anticipate”, “believe”, “plan”, “estimate”, “expect”, “intend”, and similar expressions to the extent they relate to the Company or its management. The forward-looking statements are not historical facts, but reflect GuestLogix’ current expectations 걸스닷컴 토렌트다운로드 regarding future results or events. These forward-looking statements are subject to a number of risks and uncertainties that could cause actual results or events to differ materially from current expectations, including the matters discussed under “Risks and Uncertainties” in the Filing Statement filed on February 27, 2012 with the regulatory authorities. GuestLogix assumes no obligation to update the 걸스닷컴 여중생속옷검사 forward-looking statements, or to update the reasons why 웹하드 actual results could differ from those reflected in the forward-looking statements.Korea Newswire distributes your news across every media channels through the industry’s largest press release distribution network
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