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INGELHEIM, GERMANY & INDIANAPOLIS, INDIANA--( / ) September 19, 2016 -- The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) today recommended the approval of Glyxambi® (empagliflozin/linagliptin) for use in adults with type 2 diabetes (T2D). Glyxambi®, from the Boehringer Ingelheim and Eli Lilly and Company Diabetes Alliance, is a single tablet combining Jardiance® (empagliflozin), a sodium glucose co-transporter-2 (SGLT2) inhibitor, and Trajenta® (linagliptin), a dipeptidyl peptidase-4 (DPP-4) inhibitor.
This recommendation is based on data from three Phase III clinical trials evaluating the efficacy and safety of Glyxambi® in patients with T2D. The CHMP positive opinion recommends Glyxambi®, fixed dose combination of Jardiance® and Trajenta®, for use in adults aged 18 years and older with type 2 diabetes mellitus to improve glycaemic control when metformin and/or sulphonylurea and one of the monocomponents of Glyxambi® do not provide adequate glycaemic control, or when a patient is already being treated with the free combination of Jardiance® and Trajenta®.
“Half of people with type 2 diabetes do not achieve recommended blood sugar targets, so new treatment options are still needed,” said Professor Hans-Juergen Woerle, Global Vice President Medicine, Therapeutic Area Metabolism, Boehringer Ingelheim. “We are excited about the positive opinion for Glyxambi from the CHMP. We believe that this treatment for type 2 diabetes will provide physicians and patients in Europe with another valuable option to improve blood sugar control.”
Boehringer Ingelheim and Lilly expect to receive final marketing authorisation from the European Commission in the coming months.
About the Phase III Clinical Trials
The CHMP positive opinion is based on clinical data from three Phase III clinical trials.
· Following a run-in period, two 24 week trials with adult T2D patients on metformin studied:
Jardiance® added to Trajenta® versus placebo added to Trajenta®
Trajenta® added to Jardiance® versus placebo added to Jardiance®*
· The trials showed statistically significant reductions in blood sugar levels when Jardiance® was added to patients on Trajenta® and metformin, and when Trajenta® was added to patients on Jardiance® and metformin, compared to adding placebo.
· An additional factorial design study, which also investigated Jardiance® and Trajenta® combined added to metformin, was conducted for 52 weeks. This trial showed that the combination of Jardiance® and Trajenta® added to metformin resulted in clinically and statistically significant reductions in blood sugar levels in comparison to patients treated with Jardiance® or Trajenta® alone when added to metformin.
The safety profile of the combination in these trials was comparable to the safety profiles of the monocomponents.
* This study was analysed as two separate studies according to the dose of empagliflozin as 10 mg or 25 mg, respectively.
About Glyxambi®
Glyxambi® is a single tablet combining Jardiance® and Trajenta®. The CHMP positive opinion recommends Glyxambi®, fixed dose combination of Jardiance® and Trajenta®, for use in adults aged 18 years and older with type 2 diabetes mellitus to improve glycaemic control when metformin and/or sulphonylurea and one of the monocomponents of Glyxambi® do not provide adequate glycaemic control, or when a patient is already being treated with the free combination of Jardiance® and Trajenta®.
About Diabetes
More than 415 million people worldwide have diabetes, of which 193 million are estimated to be undiagnosed. By 2040, the number of people with diabetes is expected to rise to 642 million people worldwide. T2D is the most common form of diabetes, responsible for up to 91 percent of diabetes cases in high-income countries. Diabetes is a chronic condition that occurs when the body either does not properly produce, or use, the hormone insulin.
Intended audiences
This press release is issued from Boehringer Ingelheim Corporate Headquarters in Ingelheim, Germany and is intended to provide information about our global business. Please be aware that information relating to the approval status and labels of approved products may vary from country to country, and a country-specific press release on this topic may have been issued in the countries where Boehringer Ingelheim and Eli Lilly and Company do business.
Please click on the link below for ‘Notes to Editors’ and ‘References’:
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MOUNT PROSPECT, ILLINOIS--( / ) February 08, 2019 -- Precision Surfacing 비아그라퀵배송 하얏트호텔카지노 MOUNT(formerly Lapmaster Wolters Group), a 비아그라약국판매가격 leading global supplier of equipment and services 하노이카지노 MOUNTprecision lapping, polishing, grinding, and honing, announced today that it will acquire the photovoltaic and specialized substrate material 합법카지노 MOUNTsemiconductor and sapphire industries) wafering 일회용알콜솜 equipment and service business of Meyer Burger (based in 비아그라100mg Thun, Switzerland).
Brian Nelson, Chief Executive Officer of PSS: “The 정력에좋은음식 acquisition of Meyer Burger’s wafering technology portfolio will further enable us to strengthen and grow our activities in our key markets, particularly in the semiconductor and consumer electronic segments. Our cutting 캄보디아카지노 BrianPeter Wolters AC microLine technology (produced in Rendsburg, Germany) is already utilized by leading 파워사다리 substrate wafer manufacturers and we 파워볼알고리즘 feel that the 파워볼수익내기 addition of the MB wafering line will enable significant cross selling opportunities with our existing customer base and also provide the opportunity to offer unrivaled global service and technical support.
PSS intends to use the know-how of Meyer Burger’s local workforce and to continue product development 캐나다카지노 PSSwell as manufacturing activities in non-PV wafering applications in Thun (Switzerland), where it has entered into a long-term rental agreement with Meyer Burger. Activities for production of photovoltaic 과민성조루 wafering systems will remain in China. PSS will further maintain global service support for all current and future wafering customers worldwide. PSS will take over around 70 employees at the Thun location and an additional 26 globally. PSS Group Chief Technical Officer, Brett Rosenthal, further commented: 허버렉스 “The acquisition of Meyer Burger provides PSS Group with 새만금카지노 PSSnumber of talented engineering and technical employees. I look forward to them joining my global engineering team and leveraging their expertise within the Group.”
Hans Brandle, CEO 빔맥스 of Meyer Burger: “Although Meyer Burger grew from its roots in the wafering industry, our main focus today is on PV cell coating and module connection technologies. As the new owner of our wafering portfolio and with its presence in the semiconductor industry, PSS is 성인야동 ideally positioned to fully maximize the synergies with our wafering technologies. I am very pleased that with PSS as the new owner, we have found a solution that is advantageous for both parties while at the same time securing both 태양성카지노 Hansand technology know-how in Thun.”
Completion of the acquisition is subject to standard closing conditions. The closing of the transaction is expected to 영종도카지노 Completioncompleted towards the end of the first quarter of 2019. The agreed purchase price is CHF 50 million in cash, which represents the approximate 캔디넷 one-time net sales of the wafering 핑보넷 equipment business. The contract also includes 제주하얏트호텔카지노 Completionearn-out component based on certain revenue 돌출콘돔 levels in 2019. Both Meyer Burger and PSS view the transaction as an important strategic milestone, which will further strengthen two global technology leaders.
Kelly Cavitt, Group Chief Financial Officer of pornxs PSS: added “We are excited HOTSCOPE to have reached final terms with Meyer Burger and feel that this acquisition 바이젤 is a win for both organizations. The addition of the wafering equipment business 타운19 provides PSS with yet another well respected precision technology and further strengthens the long 조이밤 term 성기링 financial outlook 플레이온카지노 Kellythe Group.”
Precision Surfacing Solutions has 힐튼호텔카지노 Precision 성인기구사이트 the most challenging precision surfacing problems. With 딸기넷 hundreds of years of experience within each of our brands, PSS has a proven history of successfully developing cost effective processing solutions for virtually any application.
About 야플TV 페가수스카지노 AboutSurfacing 오카모토쉬 Solutions 19다광고 19다광고 (PSS) 밤도깨비
PSS is a global industry leader in the development of technology to produce micron accuracy surface finishes. Under the well recognized Lapmaster, Peter Wolters, ELB, aba, 포이펫카지노 PSSREFORM, and 성인쇼핑 KEHREN brands, PSS has a proven history of successfully 클락카지노 PSScost effective processing solutions for the lapping, polishing, fine grinding, brush deburring, creep feed grinding, bore honing, double disc grinding, buffing through an expanding network of sales and services offices located throughout the world. The Company’s 9,000+ active global customers 세부호텔카지노 PSSprecision abrasive finishing technology for various end-user precision finishing applications. PSS is headquartered in 성인용품추천 Mt. Prospect, IL, employing over 900 people across thirteen manufacturing facilities on three continents. For more information, visit
엘카지노 About 바카라추천 선상카지노 AboutBurger Technology 카지노싸이트 Ltd
Meyer Burger is a leading global technology company specializing in innovative systems and processes based on semiconductor technologies. The company’s focus is 벨라지오카지노 Meyerphotovoltaics (solar industry) while its competencies and technologies also cover important areas of the semiconductor and the optoelectronic industries as well as other selected high-end markets based on semiconductor materials. As an international premium brand, Meyer Burger offers its customers in the PV industry superior products and innovative solutions for the manufacturing processes of wafers, solar cells and solar modules. The company provides substantial added value to its customers and clearly differentiates itself from its competitors by focusing on core technologies of the value chain. Meyer 울트라신 Burger’s comprehensive product portfolio is complemented by a worldwide service network with spare parts, consumables, process know-how, customer support, after-sales services, training and other services. Meyer Burger is represented in Europe, Asia and North America 콘돔사이즈 in the respective key markets and has subsidiaries and own service centers in China, Germany, India, Japan, Korea, Malaysia, the Netherlands, Switzerland, Singapore, Taiwan and the USA. The company is also working intensively to develop new markets such as South America, Africa and the Arab region. The registered shares of Meyer Burger Technology Ltd are listed on the SIX Swiss Exchange (Ticker: MBTN). For more information, visit
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