Almirall and MC2 Therapeutics enter a License, Collaboration and Commercialization Agreement for European Rights…

first_img TAGS  Pinterest Twitter BARCELONA, Spain & COPENHAGEN, Denmark–(BUSINESS WIRE)–Feb 17, 2021– Almirall S.A. (BME: ALM),a global biopharmaceutical company andMC2 Therapeutics, a commercial stage pharmaceutical company developing a new standard within topical therapies for autoimmune and chronic inflammatory conditions, announced today an agreement under which MC2 Therapeutics has granted Almirall exclusive European rights to commercialize Wynzora ® Cream for treatment of plaque psoriasis. In exchange, MC2 Therapeutics is eligible to receive upfront to launch payments of EUR 15 million in addition to significant sales milestone payments and double-digit royalties on the European sales of Wynzora ® Cream. Almirall and MC2 Therapeutics partner to make Wynzora ® Cream a leading topical product for treatment of plaque psoriasis in Europe – a market, which currently is more than 25 million units in sales volume annually 2. The market represents a significant opportunity for Wynzora ® Cream as the calcipotriene and betamethasone dipropionate segment accounts for approximately 35% of share of volume and annual sales of more than $300 million 2. Wynzora ® Cream (50 µg/g calcipotriol and 0.5 mg/g betamethasone as dipropionate) received US FDA approval on 20 th July 2020. Wynzora ® Cream is currently under review in Europe supported by two Phase 3 trials 1, including an EU head-to-head trial against active comparator Dovobet/Daivobet ® Gel. The Physician Global Assessment (PGA) treatment success defined as a minimum two-point decrease in the PGA score to clear or almost clear disease at Week 8 was 51% for Wynzora ® Cream vs. 6% for vehicle (p<0.0001). The treatment satisfaction score using the Psoriasis Treatment Convenience Scale (PTCS) was superior compared to Dovobet/Daivobet ® Gel. Using MC2 Therapeutics’ PAD™ Technology, Wynzora ® Cream was uniquely designed to provide patients a new treatment option in their daily routines by combining the three essentials of a topical therapy in one single product namely high efficacy, a favorable safety profile and convenience of use. Mike Mcclellan, Chief Financial Officer (CFO) and interim Chief Executive Officer (CEO)said:"We are thrilled with this agreement with MC2 Therapeutics. Wynzora ® Cream has demonstrated significant improvements in the skin clearance of psoriasis patients. It is the perfect addition to our growing psoriasis portfolio, which includes multiple treatment options, covering the whole spectrum of the disease. We are delighted that soon we will be able to offer this novel topical treatment to European dermatologists and their patients." Jesper J. Lange, CEO of MC2 Therapeutics, commented: “ We are excited to partner with Almirall, an established company with deep expertise in dermatology and psoriasis and with the focus to improve patients’ needs. Bringing together Almirall’s excellence in commercial operations and MC2 Therapeutics’ commitment to ensure a global roll-out of Wynzora ® Cream we will, upon approval, ensure a strong launch of Wynzora ® Cream for the benefit of the many patients living with plaque psoriasis and for the healthcare practitioners who provide care. We believe that the unique combination of compelling clinical efficacy, a favorable safety profile and treatment convenience are key components to treatment adherence and overall better patient satisfaction in topical treatment of plaque psoriasis in a real-world setting.” About Plaque Psoriasis Psoriasis is a common, non-contagious, chronic skin disease, with no clear cause or cure. The negative impact of plaque psoriasis on people’s lives can be immense as it affects the appearance of the skin with red, scaly plaques. Psoriasis affects people of all ages, and in all countries. The reported prevalence of psoriasis in Europe varies from 0.6% to 6.5% with an average of approximately 3% of the population 3,4, making psoriasis a serious global problem with more than 100 million individuals affected worldwide. 5 The flares of psoriasis can be unpredictable and significant comorbidities are common, including arthritis, cardiovascular diseases, metabolic syndrome, inflammatory bowel disease and depression. 4 About Wynzora ® Cream Wynzora ® Cream (50 µg/g calcipotriol and 0.5 mg/g betamethasone as dipropionate) is under review in Europe as a topical treatment of plaque psoriasis in adults. Wynzora ® Cream is based on PAD™ Technology, enabling an aqueous cream formulation of both calcipotriol and betamethasone as dipropionate and optimal delivery of active ingredients into the target tissue. Wynzora ® Cream was approved in the US by the FDA on 20 th July 2020. About Almirall Almirall is a global biopharmaceutical company focused on skin health. We collaborate with scientists and healthcare professionals to address patient’s needs through science to improve their lives. Our Noble Purpose is at the core of our work: “Transform the patients’ world by helping them realize their hopes and dreams for a healthy life”. We invest in differentiated and groundbreaking medical dermatology products to bring our innovative solutions to patients in need. The company, founded in 1943 and headquartered in Barcelona, is public traded on the Spanish Stock Exchange and is a member of the IBEX 35 (BME: ALM). Throughout its 77-year history, Almirall has retained a strong focus on the needs of patients. Currently, Almirall has a direct presence in 21 countries and strategic agreements in over 70, through 13 subsidiaries, with about 1,800 employees. Total revenues in 2019 were 908.4 million euros. For additional information on Almirall, please visit www.almirall.com About MC2 Therapeutics MC2 Therapeutics is a privately held commercial stage pharmaceutical company committed to build leadership in topicals for autoimmune and chronic inflammatory conditions. Our focus is to develop and advance best in class or first in class therapies by understanding the pathophysiology and researching novel compounds. Our ultimate goal is to minimize the burden of disease for patients by addressing unmet needs. Using PAD™ Technology we are introducing a new standard of topical treatment experience for the benefit of patients, physicians, payers and societies. Our innovative pipeline is comprised of drug candidates within uremic pruritus, lichen sclerosis, Sjogren’s syndrome dry eye, ocular rosacea and atopic dermatitis. For additional information on MC2 Therapeutics Group, please visit www.mc2therapeutics.com Forward-Looking Statements The above information contains forward-looking statements that provide our expectations or forecasts of future events. This can be such as the impact of the global COVID-19 pandemic on our business, new product introductions, clinical development activities and anticipated results, product approvals, financial performance. Terms used may be “aspire”, “believes,” “potential,” “proposed,” “continue,” “designed,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words or expressions referencing future events, conditions or circumstances that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such forward-looking statements are subject to risks and uncertainties. This may cause actual results to differ materially from expectations and it may cause any or all our forward-looking statements here or in other publications to be wrong. Factors that may affect future results include the impact of the global COVID-19 pandemic, interest rate and currency exchange rate fluctuations, delay or failure of clinical trials and other development activities, production problems, unexpected contract breaches or terminations. References: 1Clinical trial IDs: NCT03802344 and NCT03308799 on Clinicaltrials.gov 2 IQVIA MIDAS ® 3Chandran, V., and S.P. Raychaudhuri. 2010. ‘Geoepidemiology and environmental factors of psoriasis and psoriatic arthritis’, J. Autoimmune, 34: J314-J21 4Schafer, T. 2006. ‘Epidemiology of psoriasis. Review and the German perspective’, Dermatology, 212: 327-37 5WHO Global report on Psoriasis 2016 View source version on businesswire.com:https://www.businesswire.com/news/home/20210216006105/en/ CONTACT: Almirall’s Corporate Communications contact: Mar Ramírez [email protected] Phone: (+34) 659 614 173Almirall’s Investors relation contact: Pablo Divasson del Fraile [email protected] Phone:(+34) 93 291 30 87MC2 Therapeutics Contact: Corporate Communications, Media and Investors: Susanne Andersen Fitch [email protected] Phone: (+45) 3131 5119 KEYWORD: SPAIN NORTH AMERICA UNITED STATES EUROPE DENMARK NEW YORK INDUSTRY KEYWORD: BIOTECHNOLOGY GENERAL HEALTH PHARMACEUTICAL HEALTH SOURCE: MC2 Therapeutics Copyright Business Wire 2021. PUB: 02/17/2021 02:30 AM/DISC: 02/17/2021 02:30 AM http://www.businesswire.com/news/home/20210216006105/en Facebook WhatsApp Twitter Pinterestcenter_img Local NewsBusiness By Digital AIM Web Support – February 17, 2021 WhatsApp Almirall and MC2 Therapeutics enter a License, Collaboration and Commercialization Agreement for European Rights to Wynzora® Cream for treatment of Plaque Psoriasis Facebook Previous articleJonathan Quick makes 28 saves, Kings blank Wild 4-0Next articleColorado and Oregon face off to stay in Pac-12 race Digital AIM Web Supportlast_img read more

A political bluster-buster

first_img 7SHARESShareShareSharePrintMailGooglePinterestDiggRedditStumbleuponDeliciousBufferTumblr Over the past 19 years, Amy Walter has built a reputation as an accurate, objective, and insightful political analyst with exceptional access to campaign insiders and decision-makers.In late February, she’ll deliver a keynote address at CUNA’s Governmental Affairs Conference, offering astute observations about the electoral process, congressional culture, and the Washington political scene. Her presentations take audiences on an insider’s tour of D.C. through the eyes of a woman with her finger on the pulse of politics.The national editor of the Cook Political Report, Walter is a regular panelist on many of the premier political shows on network television, including “Meet the Press” on NBC, “Special Report with Bret Baier” on Fox News, and “Face the Nation” on CBS. She provides weekly analysis for the “PBS NewsHour.” continue reading »last_img read more

Super six for Taylor

first_img The Wicklow fighter saw off the Bulgarian – the last woman to beat her back in 2011 – 3-0 as she qualified for a 16th career final. It was a clinical performance from the odds-on favourite, who will now meet Estelle Mossely for the 60kg medal on Saturday. Katie Taylor made it six European finals in a row as she got the better of Denitsa Eliseeva on Friday. “Honoured to be representing Ireland in another European final,” the Olympic champion wrote on Twitter. “Thanks for all the support, it’s incredible.” Taylor will not be joined on finals day by compatriot Clare Grace, though. She was outpointed by England’s Stacey Copeland in the 69kg category. The Stockport woman will face Elena Vystropova, who saw off Cristiana Mihaela. center_img Press Associationlast_img read more

Republic end year on a positive note.

first_imgThe Republic of Ireland signed off on 2014 with an impressive 4-1 win over the USA at the Aviva.Two goals from Robbie Brady as well as goals by Anthony Pilkington and James McClean secured an encouraging win for Martin O’Neill’s side that helped to ease some of the disappointment from last week’s defeat to Scotland.New caps David McGoldrick and Cyrus Christie both impressed on their debuts, with McGoldrick setting-up goals for both Pilkington and Brady.last_img

DONEGAL YOUTH ORCHESTRA ON ARRANMORE ISLAND TODAY

first_imgThe sound of music will fill Arranmore Island today as the Donegal Youth Orchestra performs it’s end of season concert.Joined by Arranmore Pipe Band and other special guests from the island, the concert promises to be a showcase of talent.Conducted by Vincent Kennedy, the Orchestra is made up of talented young musicians from across the county. The Orchestra embraces a varied and often challenging repertoire, from well-known and loved compositions of the Classical era, to modern and avantgarde creations by contemporary composers and artists, taking in film scores and television compositions.It is run under the auspices of the Donegal Music Education Partnership.Today’s concert gets underway at 3pm.  DONEGAL YOUTH ORCHESTRA ON ARRANMORE ISLAND TODAY was last modified: May 15th, 2016 by John2Share this:Click to share on Facebook (Opens in new window)Click to share on Twitter (Opens in new window)Click to share on LinkedIn (Opens in new window)Click to share on Reddit (Opens in new window)Click to share on Pocket (Opens in new window)Click to share on Telegram (Opens in new window)Click to share on WhatsApp (Opens in new window)Click to share on Skype (Opens in new window)Click to print (Opens in new window) Tags:Arranmore Islanddonegal youth orchestraorchestralast_img read more

Watch: Why the LYIT Open Day 2019 is a must-visit

first_imgLetterkenny Institute of Technology’s (LYIT) Open Day on Thursday 21st November 2019 is an ideal opportunity for anyone considering LYIT to find out more about courses, accommodation and student experience. Everyone is welcome to the open event, which will be packed with activity from 9.30 am – 2.00 pm on Thursday.  Are you completing the Leaving Certificate in 2020 or do you know someone completing the Leaving Certificate in 2020? Are you interested in returning to education? Are you keen to find out more about programmes available at LYIT?Then LYIT Open Day 2019 is a must to find out about degree courses in areas such as Business, Design, Computing, Tourism, Law, Culinary Arts, Sport, Engineering, Health Studies, Nursing and Science.LYIT Student Ambassador Darian Laughlin, Schools Engagement Officer Fiona Kelly and Student Ambassador John Tochukwu UgwuBy visiting LYIT Open Day you’ll get to look around the campus in person, check out the facilities, speak with experienced and informative lecturing staff, talk with current students about their student experience and visit student accommodation in the locality. There’ll be lots going on at this event including programme specific talks, interactive information sessions in each department, talks from SUSI grants and much, much more.Everyone is welcome to attend. LYIT especially welcome mature and second chance learners. They are also very happy to accommodate visitors from outside Donegal, whether individually or in groups. Parents of prospective students are also welcome to attend.  To view LYIT’S Open Day Schedule or for more information visit: https://www.lyit.ie/News-Events/Article/lyit-open-day-2019#lyitopenday19 #chooselyit #lyitconnectionsWatch: Why the LYIT Open Day 2019 is a must-visit was last modified: November 13th, 2019 by Rachel McLaughlinShare this:Click to share on Facebook (Opens in new window)Click to share on Twitter (Opens in new window)Click to share on LinkedIn (Opens in new window)Click to share on Reddit (Opens in new window)Click to share on Pocket (Opens in new window)Click to share on Telegram (Opens in new window)Click to share on WhatsApp (Opens in new window)Click to share on Skype (Opens in new window)Click to print (Opens in new window) Tags:Collegeeducationlyit open daymature studentsstudentThird levellast_img read more

Giants make surprise roster move, designate Parra to promote Gerber

first_imgCINCINNATI — The Giants signed Gerardo Parra to a minor league deal this spring to improve their outfield defense and provide quality at-bats from the left side against right-handed pitchers.After just one month with the Giants, a weak offensive output has left Parra without a roster spot.The Giants designated the National League leader in outfield assists Friday to clear space for outfielder Mike Gerber, who hit .357 with a 1.057 OPS in 21 games with Triple-A Sacramento.“(Gerber) came into …last_img

NU keeps Final 4 bid alive, pulls rug from under FEU

first_imgRon Dennison finally stopped the bleeding for FEU with a 3-pointer to make it a two-point game but the Tamaraws blew several cracks at the basket and had a crucial turnover off the inbound to help the Bulldogs’ case.Arvin Tolentino misfired on a potential game-tying triple as time ran out.The Tams squandered a golden opportunity to close in on a semifinals spot. A win would’ve gotten them at least a playoff for the fourth spot.Tolentino and Dennison scored 21 points apiece for FEU, which fell to 6-7.ADVERTISEMENT “This is what I was expecting from our players. Our maturity. Like what we said, we can fast track talent, but the maturity, the experience that you cannot fasttrack so I’m just happy right now because I saw the maturity today,” said NU head coach Jamike Jarin after his team improved to 5-8.“I hope it’s not too late. I’m just very proud of all the players,” Jarin said. FEU made a run at the start and in the middle of the third, but we never bowed down and that was the maturity that we’ve always wanted.”FEATURED STORIESSPORTSWATCH: Drones light up sky in final leg of SEA Games torch runSPORTSSEA Games: Philippines picks up 1st win in men’s water poloSPORTSMalditas save PH from shutoutThe Bulldogs stared at a 79-64 deficit before Alejandro and Gaye willed the team back. A 3-pointer by Alejandro gave NU the lead for good, 82-81, with 4:51 remaining.The graduating guard, who also had six rebounds and nine assists, then, capped a 20-2 run by the Bulldogs with a layup. Japan ex-PM Nakasone who boosted ties with US dies at 101 For the complete collegiate sports coverage including scores, schedules and stories, visit Inquirer Varsity. LATEST STORIES Photo by Tristan Tamayo/INQUIRER.netNational University stayed in Final Four contention after rallying past Far Eastern University, 87-84, in the UAAP Season 80 men’s basketball tournament Wednesday at Smart Araneta Coliseum.With the Bulldogs’ season on the line, J-Jay Alejandro took over in the fourth quarter, where he fired 11 of his 17 points.ADVERTISEMENT Fourth and final crewman pulled alive from capsized ship PLAY LIST 01:16Fourth and final crewman pulled alive from capsized ship02:36Archers, Eagles favorites to win UAAP Season 8000:50Trending Articles01:37Protesters burn down Iran consulate in Najaf01:47Panelo casts doubts on Robredo’s drug war ‘discoveries’01:29Police teams find crossbows, bows in HK university01:35Panelo suggests discounted SEA Games tickets for students02:49Robredo: True leaders perform well despite having ‘uninspiring’ boss02:42PH underwater hockey team aims to make waves in SEA Games John Lloyd Cruz a dashing guest at Vhong Navarro’s wedding Kammuri turning to super typhoon less likely but possible — Pagasa Stronger peso trims PH debt value to P7.9 trillion Brace for potentially devastating typhoon approaching PH – NDRRMC CPP denies ‘Ka Diego’ arrest caused ‘mass panic’ among S. Tagalog NPA Don’t miss out on the latest news and information. UCF’s Tacko Fall is 7-foot-6, and his game is still growing Typhoon Kammuri accelerates, gains strength en route to PH QC cops nab robbery gang leader, cohort Read Next MOST READ View commentslast_img read more