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INGELHEIM, GERMANY & COPENHAGEN, DENMARK--( / )--Boehringer Ingelheim and Zealand Pharma A/S (Nasdaq: ZEAL) (CVR-no. 20045078) today announced that the US Food and Drug Administration (FDA) has granted Fast Track Designation to the GLP-1/glucagon dual agonist BI 456906 for adults with non-alcoholic steatohepatitis (NASH). The Fast Track Designation facilitates the development and expedites the review of new therapies to treat serious conditions and fill an unmet medical need. BI 456906 is currently being evaluated in a Phase II study in adults with NASH and liver fibrosis (F2/F3) with and without diabetes.

“The FDA Fast Track Designation for our dual agonist is an important step forward in addressing the high unmet medical need among the up to 444 million adults estimated to be living with NASH,” said Waheed Jamal, MD, Corporate Vice President and Head of CardioMetabolic Medicine, Boehringer Ingelheim. “Together with our partner Zealand Pharma, we look forward to working closely with the FDA as we explore the potential of the GLP-1/glucagon agonist to improve outcomes for adults with NASH.”

“Boehringer Ingelheim and Zealand Pharma are committed to delivering innovative solutions that address public health challenges of cardiometabolic diseases, including NASH,” said Adam Steensberg, Executive Vice President and Chief Medical Officer at Zealand Pharma. “By combining Boehringer Ingelheim’s expertise in drug development in the cardio-metabolic area with our strength in the discovery of innovative peptide-based medicines, we have the potential to bring forward a novel therapy option in an area with limited available treatments.”

The GLP-1/glucagon compound derived from the natural gut hormone oxyntomodulin activates both the GLP-1 and glucagon receptors that are critical to controlling metabolic functions. The dual agonist BI 456906 has the potential to be a new, once-weekly treatment that may offer therapeutically relevant benefits compared to currently available treatments. It is also being investigated as a potential treatment option for adults living with diabetes and for adults living with obesity. It is part of Boehringer Ingelheim’s research and development portfolio in the cardiometabolic disease areas.

Please click on the following link for ‘Notes to Editors’:

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AUBURN, ALA. & TAIPEI, TAIWAN--( / )--Vitruvias 종로4가화투치기 무료릴게임 Therapeutics Inc., 한국증시 AUBURN,Auburn, Alabama-based finished-dose generic drug development company, has agreed to license an approved Potassium Chloride Extended release ANDA. The 왕곡동홀덤펍 김태희차도녀 product will be 종로4가화투치기 manufactured by Bora Pharmaceutical’s Zhunan site, which was recently acquired from Impax.



Carl Whatley, Chairman and CEO of Vitruvias stated that “as a 40-year veteran if this industry, I have 종로4가화투치기 야마토다운로드 toured many manufacturing facilities, and Bora’s Zhunan facility is one of the best I have ever seen. Being a relatively new facility and 왕곡동홀덤펍 가수민효린 having the 스타러시안룰렛 Carland FDA approval for the manufacturing of Impax’s U.S. products, its size, quality systems, state-of-the-art high volume equipment and highly responsive personnel make it 종로4가화투치기 김수현팬티모델 a logical choice for our portfolio of technically complex oral solids.”



“Bora Pharmaceuticals is honored to be in 종로4가화투치기 business with Vitruvias. Their experienced management team has a stellar track record of successful product launches 종로4가화투치기 여중생모델 and 왕곡동홀덤펍 여중생속옷검사 their pipeline of products has positioned the company for explosive growth. We are excited to show our large-scale solvent capabilities and to give Vitruvias a high-quality competitive product in the market. We look forward to a long-term relationship with them,” says Bobby Sheng, Chairman and CEO of Bora Pharmaceuticals.



Potassium Chloride Extended Release tablets are used to prevent or to treat low blood levels 왕곡동홀덤펍 한승연다리 of potassium (hypokalemia). Current annual sales[1] of all forms of Potassium Chloride Extended Release tablets totaled approximately 1.66 billion tablets 왕곡동홀덤펍 through September 2018. 종로4가화투치기 축구언더오버



This 왕곡동홀덤펍 한승연무모 is 종로4가화투치기 the 왕곡동홀덤펍 수지도끼 first contract manufacturing agreement 종로4가화투치기 축구일정 between Vitruvias and Bora.



About 종로4가화투치기 왕곡동홀덤펍 Vitruvias 종로4가화투치기 샤오링



Vitruvias is a generic pharmaceutical company which utilizes domestic and international partnerships to develop, manufacture, and market technically difficult 왕곡동홀덤펍 신검의혼 generic products. Founded in 2013, 왕곡동홀덤펍 진시황의혼 the company’s 종로4가화투치기 축구분석가 primarily focus 게임시티 Vitruviason products in the generic sterile injectable market, semi-solid market, and selected high-value oral solids. The Company received its first approval in September 2017, and anticipates 종로4가화투치기 축구승무패예상 additional approvals in late 2018 and early 2019.



About 종로4가화투치기 침대키스신동영상 왕곡동홀덤펍 침대키스신동영상 Bora 종로4가화투치기 왕곡동홀덤펍



Bora Pharmaceuticals (TSE: 6472) is a publicly traded, Taiwan based, pharmaceutical company that covers the entire pharmaceutical value chain from CDMO services to marketing and sales. Bora has a solid financial foundation, experienced management team, and long-standing partnerships with best in class multinational Pharmaceutical companies. Bora, and its subsidiaries produce, market, and sell 종로4가화투치기 products ranging from Generics, Consumer Health, and In-Patent Branded Drugs. In addition, 왕곡동홀덤펍 Bora Pharmaceuticals' U.S. FDA, PIC/S and GMP certified plants provides large scale outsourced R&D and contract manufacturing services to over 16 countries worldwide.



[1] Source: 왕곡동홀덤펍 한효주 IQVIA, National Sales Perspectives, 왕곡동홀덤펍 토토가이드 Sept 종로4가화투치기 토토가입머니 2018 종로4가화투치기 가슴모으기



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