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Quigley E.M.M.,Alimentary Pharmabiotic Center | Tack J.,University Hospitals Leuven | Chey W.D.,University of Michigan | Rao S.S.,University of Georgia | And 6 more authors.
Alimentary Pharmacology and Therapeutics | Year: 2013

Background Treatment options that improve overall symptoms of irritable bowel syndrome with constipation (IBS-C) are lacking. Aim A prespecified further analysis to evaluate the efficacy and safety of linaclotide, a guanylate cyclase C agonist, in patients with IBS-C, based on efficacy parameters prespecified for European Medicines Agency (EMA) submission. Methods Two randomised, double-blind, multicentre Phase 3 trials investigated once-daily linaclotide (290 μg) for 12 weeks (Trial 31) or 26 weeks (Trial 302) in patients with IBS-C. Prespecified primary endpoints were the EMA-recommended co-primary endpoints: (i) 12-week abdominal pain/discomfort responders [≥30% reduction in mean abdominal pain and/or discomfort score (11-point scales), with neither worsening from baseline, for ≥6 weeks] and (ii) 12-week IBS degree-of-relief responders (symptoms 'considerably' or 'completely' relieved for ≥6 weeks). Results Overall, 803 (Trial 31) and 805 patients (Trial 302) were randomised. A significantly greater proportion of linaclotide-treated vs. placebo-treated patients were 12-week abdominal pain/discomfort responders (Trial 31: 54.8% vs. 41.8%; Trial 302: 54.1% vs. 38.5%; P < 0.001) and IBS degree-of-relief responders (Trial 31: 37.0% vs. 18.5%; Trial 302: 39.4% vs. 16.6%; P < 0.0001). Similarly, significantly more linaclotide- vs. placebo-treated patients were responders for ≥13 weeks in Trial 302 (abdominal pain/discomfort: 53.6% vs. 36.0%; IBS degree-of-relief: 37.2% vs. 16.9%; P < 0.0001). The proportion of sustained responders (co-primary endpoint responders plus responders for ≥2 of the last 4 weeks of treatment) was also significantly greater with linaclotide vs. placebo in both trials (P < 0.001). Conclusion Linaclotide treatment significantly improved abdominal pain/discomfort and degree-of-relief of IBS-C symptoms compared with placebo over 12 and 26 weeks. Trial registration: ClinicalTrials.gov (identifiers: NCT00948818 and NCT00938717). © 2012 Blackwell Publishing Ltd.


News Article | February 15, 2017
Site: www.marketwired.com

Jim DeMaioribus Named VP of Marketing; Christopher Cano Named VP, Business Development; Stephane Levy, MD Named VP of Research & Development U.S. Operations EXTON, PA--(Marketwired - February 14, 2017) - Almirall's Aqua Pharmaceuticals, a specialty dermatology company focusing on acquiring, developing and marketing prescription medical dermatology products in the U.S., has today announced it has hired three key executives. Jim DeMaioribus has been appointed Vice President of Marketing and Christopher Cano has been named Vice President, Business Development, both reporting to Ted White, President & General Manager at Aqua Pharmaceuticals. Stephane Levy, MD will fill the role of Vice President of Research & Development U.S. Operations, reporting to Thomas Eichholtz, Head of Research & Development at Almirall. "Jim, Christopher and Stephane have played an integral role in advancing the pharmaceutical industry in their respective disciplines," said White. "Their proven leadership skills and deep expertise makes them ideally suited to help Aqua Pharmaceuticals build its product portfolio in the U.S." In this role, DeMaioribus will be responsible for developing and implementing marketing strategies and tactics that strengthen the Aqua brand, and help drive profitable growth across the portfolio of Aqua products. Prior to joining Aqua Pharmaceuticals, DeMaioribus was Founder and Managing Director of LSM Marketing, LLC which advised some of the top life science companies on marketing strategies designed to accelerate growth. Before forming LSM Marketing, Jim spent 13 years with Johnson & Johnson where he held a variety of senior marketing and commercial positions across its pharmaceutical and medical device businesses. He currently serves as a Fellow at the Wharton School of the University of Pennsylvania. As Vice President of Business Development, Cano will lead all U.S. business development projects. He will work cross-functionally with the Almirall Global Business Development team, establishing strong relationships with key opinion leaders in order to assess new markets and pursue relevant dermatology opportunities. Cano has a high level of expertise in key therapeutic areas such as dermatology, diabetes care and women's health. Prior to joining Aqua Pharmaceuticals, Cano worked at Duchesnay as Director of Business Development, at Noven Pharmaceuticals as Associate Director of Business Development, and held roles of increasing responsibilities at Nucryst Pharmaceuticals and Barrier Therapeutics. In Dr. Levy's new role, he will be responsible for the leadership and management of Aqua Pharmaceuticals' U.S. Research and Product Development organization including all aspects of project management, clinical development, chemistry, manufacturing & controls, toxicology, regulatory affairs, medical affairs and quality assurance. Overseeing the development of all new drug and device products for the U.S. market, he will lead a team to develop, implement and coordinate product lifecycle infrastructure, ensuring the consistent manufacturing of safe and effective products. Before joining Aqua Pharmaceuticals, Dr. Levy served as Vice President and Medical Unit Head of Immunology & Dermatology at Novartis U.S. Throughout his more than 20 years of experience in in clinical development, he has also held executive roles at Genzyme and Sanofi. Headquartered in West Chester, Pennsylvania, Aqua Pharmaceuticals, an Almirall company, is dedicated to helping patients achieve their goals of healthy skin and a positive self-image. The company has leading branded prescription drugs in four therapeutic categories that include acne, steroid-responsive dermatoses, actinic keratoses and seborrheic dermatitis. For more information, please visit www.aquapharm.com. Almirall is a global company based in Barcelona dedicated to providing valuable medicines and medical devices through its R&D, agreements and alliances. Our work covers the whole of the drug value chain. A consolidated growth allows us to devote our talent and efforts towards specialty areas and particularly to further grow as a leading Dermatology player. We are a specialist company, enabling us to accomplish the purpose of providing our innovative products wherever they are needed. Founded in 1943, Almirall is listed on the Spanish Stock Exchange (ticker: ALM) and it has become a source of value creation for society due to its vision, and the commitment of its long-standing major shareholders. In 2015, Almirall revenues totalled 769 million euros and, with 1,800 employees, it has become a trusted presence across Europe, as well as in the U.S. For more information, please visit www.almirall.com.


Beier J.,Insaf Respiratory Research Institute | Kirsten A.-M.,Pulmonary Research Institute at Hospital Grosshansdorf | Mruz R.,Medical University of Bialystok | Segarra R.,Almirall | And 3 more authors.
COPD: Journal of Chronic Obstructive Pulmonary Disease | Year: 2013

Background: This randomized, double-blind, Phase IIIb study evaluated the 24-hour bronchodilatory efficacy of aclidinium bromide versus placebo and tiotropium in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD). Methods: Patients received aclidinium 400 μg twice daily (morning and evening), tiotropium 18 μg once daily (morning), or placebo for 6 weeks. The primary endpoint was change from baseline in forced expiratory volume in 1 second area under the curve for the 24-hour period post-morning dose (FEV1 AUC0-24) at week 6. Secondary and additional endpoints included FEV1 AUC12-24, COPD symptoms (EXAcerbations of chronic pulmonary disease Tool-Respiratory Symptoms [E-RS] total score and additional symptoms questionnaire), and safety. Results: Overall, 414 patients were randomized and treated (FEV1 1.63 L [55.8% predicted]). Compared with placebo, FEV1 AUC0-24 and FEV1 AUC12-24 were significantly increased from baseline with aclidinium (Δ = 150 mL and 160 mL, respectively; p < 0.0001) and tiotropium (Δ = 140 mL and 123 mL, respectively; p < 0.0001) at week 6. Significant improvements in E-RS total scores over 6 weeks were numerically greater with aclidinium (p < 0.0001) than tiotropium (p < 0.05) versus placebo. Only aclidinium significantly reduced the severity of early-morning cough, wheeze, shortness of breath, and phlegm, and of nighttime symptoms versus placebo (p < 0.05). Adverse-event (AE) incidence (28%) was similar between treatments. Few anticholinergic AEs (<1.5%) or serious AEs (<3%) occurred in any group. Conclusions: Aclidinium provided significant 24-hour bronchodilation versus placebo from day 1 with comparable efficacy to tiotropium after 6 weeks. Improvements in COPD symptoms were consistently numerically greater with aclidinium versus tiotropium. Aclidinium was generally well tolerated. © 2013 Informa Healthcare USA, Inc.


Chrystyn H.,University of Huddersfield | Small M.,REAL WORLD | Milligan G.,REAL WORLD | Higgins V.,REAL WORLD | And 2 more authors.
Respiratory Medicine | Year: 2014

Objective To examine the relationships between inhaler satisfaction, treatment compliance and health status in patients with chronic obstructive pulmonary disease (COPD). Methods In a large, multinational, cross-sectional, real-world survey, respiratory specialists and primary care physicians provided information on six consecutive patients with COPD, who were then asked to complete a questionnaire. Physician-assessed compliance was scored (5-point Likert scale) and patients rated overall satisfaction with their maintenance inhaler (7-point Likert scale). Health status assessments included frequency of exacerbations and hospitalizations due to exacerbations in the past 12 months. Results The analysis included 1443 patients (71.8% male; mean age 65.2 years). Patients' overall satisfaction with their inhaler was significantly associated with treatment compliance (χ2 - df = 89.7; p < 0.001). Male gender (χ2 - df = 2.9; p < 0.05) and fewer maintenance drugs (χ2 - df = 17.7; p < 0.001) were also associated with compliance; age and breathlessness severity were not. Attributes influencing inhaler satisfaction mainly related to durability, ergonomics and ease of use. Small but statistically significant associations were observed between increasing treatment compliance and fewer exacerbations (R2 = 0.037; p < 0.001) and fewer hospitalizations due to exacerbations (R2 = 0.025; p < 0.001). There was a direct association between inhaler satisfaction and fewer exacerbations (R2 = 0.03; p < 0.001). Conclusions Treatment compliance appears to be modestly associated with inhaler satisfaction, better health status and less frequent COPD exacerbations, although other factors are also likely to be involved. Durability, ergonomics and ease-of-use are inhaler attributes that influence patient satisfaction. © 2013 Published by Elsevier Ltd.


Trademark
Almirall | Date: 2014-06-03

Pharmaceutical preparations for the treatment of respiratory diseases. Inhalers for medical purposes.


Trademark
Almirall | Date: 2014-02-24

Pharmaceutical preparations for the treatment of skin diseases; medicated dermatological preparations and substances; pharmaceutical preparations for the treatment of migraine and respiratory disorders. Pharmaceutical research and development. Providing medical information.


Trademark
Almirall | Date: 2017-01-19

Non-medicated skin care preparations; cosmetics. Pharmaceutical preparations for the treatment of skin diseases; medicated dermatological preparations and substances; pharmaceutical preparations in the field of central nervous system and respiratory diseases or disorders. Computer software for database management in the field of pharmaceutical and medical developments; video recordings and online video recordings featuring health care information; medical imaging software; downloadable software applications via the internet or mobile phone applications for skin care instruction; downloadable instruction manuals for the use of medical devices for the treatment of dermatological diseases and disorders. Medical devices and apparatus for the treatment of dermatological diseases and disorders. Printed materials, namely, brochures, journals, instruction manuals, and reports in the fields of dermatological diseases and disorders, and the use of medical devices for the treatment of dermatological diseases and disorders. Educational services, namely, medical training and teaching, and training in the use and operation of medical radiofrequency devices; providing classes, workshops, seminars, and conferences in the fields of dermatological diseases and disorders, and the use of medical devices pertaining thereto. Pharmaceutical research and development. Providing medical information.


Trademark
Almirall | Date: 2017-01-19

Non-medicated skin care preparations; cosmetics. Pharmaceutical preparations for the treatment of skin diseases; medicated dermatological preparations and substances; pharmaceutical preparations in the field of central nervous system and respiratory diseases or disorders. Computer software for database management in the field of pharmaceutical and medical developments; video recordings and online video recordings featuring health care information; medical imaging software; downloadable software applications via the internet or mobile phone applications for skin care instruction; downloadable instruction manuals for the use of medical devices for the treatment of dermatological diseases and disorders. Medical devices and apparatus for the treatment of dermatological diseases and disorders. Printed materials, namely, brochures, journals, instruction manuals, and reports in the fields of dermatological diseases and disorders, and the use of medical devices for the treatment of dermatological diseases and disorders. Educational services, namely, medical training and teaching, and training in the use and operation of medical radiofrequency devices; providing classes, workshops, seminars, and conferences in the fields of dermatological diseases and disorders, and the use of medical devices pertaining thereto. Pharmaceutical research and development. Providing medical information.


Trademark
Almirall | Date: 2013-06-11

Pharmaceutical preparations for the treatment of respiratory system diseases and disorders.


Trademark
Almirall | Date: 2014-07-16

Pharmaceutical preparations for treating respiratory diseases, supplied in pre-filled inhalers. Inhalers for medical purposes.

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