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Saturday, 17 February 2018

New Zealand Bartender Wins Angostura® Global Cocktail Challenge 2018

 
New Zealand Bartender Wins Angostura® Global Cocktail Challenge 2018
PORT OF SPAIN, Trinidad and Tobago, Feb. 16, 2018 /PRNewswire/ -- Superstar bartender Ray Letoa of New Zealand has won the Grand Finals of the Angostura® Global Cocktail Challenge 2018. Second Place went to Johnny Mansoor of Lebanon and Third Place to Maximiliano Vallée Valletta of...
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Guidewires Market 2018 - Global Forecast to 2022: Major Players are Boston Scientific, Abbott, Medtronic, Terumo and Cook Group
DUBLIN, Feb. 16, 2018 /PRNewswire/ -- The "Guidewires Market by Material (Nitinol, Stainless Steel, Hybrid), Product (Surgical, Diagnostic), Application (Cardiology, Vascular, Neurology, GIT, ENT, Urology, Oncology), End User (Hospital, ASCs) - Global Forecast to 2022" report has been...
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GEP Named A Top Procurement Solutions Provider By CIO Review Magazine
- SMART by GEP® is the industry's leading cloud-native, unified source-to-pay software platform CLARK, New Jersey, Feb. 16, 2018 /PRNewswire/ -- GEP, a leading provider of procurement software and procurement services to Fortune 500 and Global 2000 enterprises worldwide, has...
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Emaar Ushers in the Chinese New Year with Dazzling Dragon-themed 'Light Up' Show on Burj Khalifa
DUBAI, UAE, February 16, 2018 /PRNewswire/ -- It was a historic first: Joining the over 1.39 billion Chinese nationals across the world and underpinning the strong UAE-China bilateral ties, Emaar Properties ushered in the Chinese New Year in Dubai with a dazzling dragon-themed 'Light...
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Bank of Montreal Amends its Normal Course Issuer Bid to Repurchase for Cancellation up to an Additional 7 Million of its Common Shares
TORONTO, Feb. 16, 2018 /PRNewswire/ -- Bank of Montreal (TSX:BMO)(NYSE:BMO) today announced that it has received approvals from the Toronto Stock Exchange (TSX) and the Office of the Superintendent of Financial Institutions Canada (OSFI) to amend its existing normal course issuer bid...
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ODEM.IO Opens Crowdsale for World's First Education Marketplace
CHIASSO, Switzerland, Feb. 17, 2018 /PRNewswire/ -- ODEM.IO, creator of the world's first On-Demand Education Marketplace, has launched its public crowdsale of ODEM Tokens. ODEM.IO is proud to announce the launch of its much-anticipated crowdsale to fund development of the...
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Trade/Project Financier, Bachmann & Welser To Launch USD 2 billion Project Finance Fund
EDINBURGH, Scotland, February 17, 2018 /PRNewswire/ -- Global Trade/Project Financier, Bachmann & Welser will launch a USD 2 billion Project finance fund in March 2018 with funds that will be backed by several private and institutional investors.      (Logo: http://mm...
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Galapagos and MorphoSys present results from a Phase 1 study with MOR106 in atopic dermatitis as late-breaking abstract at the American Academy of Dermatology (AAD) meeting in San Diego

Galapagos NV    

Published: 10:00 CET 17-02-2018 /GlobeNewswire /Source: Galapagos NV / : GLPG /ISIN: BE0003818359

Galapagos and MorphoSys present results from a Phase 1 study with MOR106 in atopic dermatitis as late-breaking abstract at the American Academy of Dermatology (AAD) meeting in San Diego

 

  • MOR106 was generally well tolerated in atopic dermatitis (AD) patients
  • 83% of patients (5 out of 6) at the highest dose reached at least 50% improvement per the atopic dermatitis area and severity index (EASI-50) at week 4
  • Pooled data across dose cohorts showed 72% improvement of AD symptoms at week 12 compared to baseline in patients treated with MOR106
  • Phase 2 development of MOR106 planned to be initiated in first half of 2018

 

Mechelen, Belgium and Planegg/Munich, Germany; 17 February 2018; 10.00 CET -Galapagos NV (Euronext & NASDAQ: GLPG) and MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX; OTC: MPSYY) announced the presentation of more detailed results of the Phase 1 study with the investigational IL-17C antibody MOR106 in AD patients at the American Academy of Dermatology (AAD) Annual Meeting 2018 in San Diego, CA, USA, held from 16-20 February. Initial study data were reported in September 2017. In the study, MOR106 showed first signs of activity and durable responses and was generally well tolerated in AD patients.

 

Professor Diamant Thaçi MD, Director of the Institute for Inflammation Medicine at the University Clinic Schleswig-Holstein Campus Luebeck and Independent Advisor for the study, presented results of the randomized, double-blind, placebo-controlled Phase 1 trial, evaluating single ascending doses (SAD) of MOR106 in healthy volunteers, and multiple ascending doses (MAD) in patients with moderate-to-severe AD in the late breaking abstracts session at AAD 2018. In the MAD part, 25 patients received four infusions once weekly of either MOR106 (at the doses of 1, 3, and 10 mg/kg body weight, respectively) or placebo in a 3:1 ratio. Patients were followed for 10 weeks after the end of the treatment period.

 

"Moderate-to-severe AD is a chronic, debilitating disease affecting millions of patients worldwide with a clear unmet medical need for safe and efficacious treatments," said Professor Diamant Thaçi MD. "Both the first signs of clinical activity and the sustained response lasting up to two months after treatment discontinuation support further clinical development of MOR106."

 

In the MAD part in AD patients reported at AAD 2018, all adverse drug reactions observed were mild-to-moderate and transient in nature. No serious adverse events (SAEs) and no infusion-related reactions were recorded. MOR106 exhibited a favorable pharmacokinetics profile with dose-dependent exposure.

 

At the highest dose level of MOR106 (10mg/kg body weight), in 83% of patients (5 out of 6) an improvement of at least 50% in signs and extent of AD, as measured by EASI-50, was recorded at week 4. The onset of activity occurred within two to four weeks, depending on the dose administered.

 

Pooled data across dose cohorts showed that patients treated with MOR106 achieved an EASI improvement compared to baseline of 58%, 62%, 72%, and 64% at week 4, 8, 12, and 14, respectively. For patients receiving placebo, the EASI improvement was 32%, 40%, 38%, and 50%.

 

MOR106 was generated using MorphoSys' Ylanthia antibody platform and is based on a target discovered by Galapagos. IL-17C is a cytokine which has been related to dermal inflammation and has been shown to be distinct from other members of the IL-17 cytokine family. MOR106 is the first publically known human monoclonal antibody against IL-17C in clinical development worldwide. MOR106 is an investigational drug and its safety and efficacy are yet to be established.

 

It is expected that Phase 2 development with MOR106 will be initiated in the first half of 2018.

 

Details of the oral presentation on MOR106 at AAD 2018:

Abstract #6753 - MOR106, an Anti-IL-17C mAb, a Potential New Approach for Treatment of Moderate-to-severe Atopic Dermatitis: Phase 1 Study.

Session #F061 - Late-breaking Research: Clinical Trials

Date: Saturday, February 17 from 1:00 PM - 3:00 PM PT (10:00 PM - 0:00 AM CET)

Place: Ballroom 20A

Presenter: Professor Diamant Thaçi MD, Director of the Institute for Inflammation Medicine at the University Clinic Schleswig-Holstein Campus Luebeck

 

About AD

Atopic dermatitis (AD), the most severe and common type of eczema, is a chronic relapsing inflammatory skin disease that causes severe itch, dry skin and rashes, predominantly on the face, inner side of the elbows and knees, and on hands and feet. Scratching of the afflicted skin leads to a vicious cycle causing redness, swelling, cracking, scaling of the skin and an increased risk of bacterial infections. Lichenification, thickening of the skin, is characteristic in older children and adults. The National Eczema Association estimates that atopic dermatitis affects over 30 million Americans or up to 25% of children and 2-3% of adults. 60% of AD patients are diagnosed in the first year of life, and 90% of patients have a disease onset before age five. Symptoms commonly fade during childhood, however, approximately 10-30% of the patients will suffer from atopic dermatitis for life. A smaller percentage first develop symptoms as adults.

 

About IL-17C

IL-17C is a cytokine that is broadly expressed in human skin pathologies and is described as an important modulator of the innate immune system of the skin, distinct from other members of the IL-17 cytokine family. IL-17C plays a crucial role in human inflammatory conditions, including skin diseases.

 

About MOR106 and the antibody collaboration

MOR106 is an investigational fully human IgG1 monoclonal antibody currently being developed for treatment of inflammatory diseases. It is the first publicly disclosed human monoclonal antibody designed to selectively target IL-17C in clinical development worldwide. MOR106 arises from the strategic discovery and co-development alliance between Galapagos and MorphoSys, in which both companies contribute their core technologies and expertise. Galapagos has provided the disease-related biology including cellular assays and targets discovered using its target discovery platform. MorphoSys has contributed its Ylanthia antibody technology to generate fully human antibodies directed against the target and contributes full CMC development of this compound. Galapagos and MorphoSys share research and development costs equally, as well as all future economics.

 

About MorphoSys

MorphoSys a late-stage biopharmaceutical company devoted to the development of innovative and differentiated therapies for patients suffering from serious diseases. Based on our proprietary technology platforms and leadership in the field of therapeutic antibodies, we, together with our partners, have participated in the development of more than 100 therapeutic product candidates currently in R&D, 28 of which in clinical development. Our broad pipeline spans two business segments: Proprietary Development, in which we invest in and develop product candidates, and Partnered Discovery, in which we generate product candidates for our partners in the pharmaceutical and biotechnology industries against targets identified by our partners. MorphoSys is listed on the Frankfurt Stock Exchange under the symbol MOR. For regular updates about MorphoSys, visit http://www.morphosys.com.

 

HuCAL®, HuCAL GOLD®, HuCAL PLATINUM®, CysDisplay®, RapMAT®, arYla®, Ylanthia®, 100 billion high potentials®, Slonomics®, Lanthio Pharma® and LanthioPep® are registered trademarks of the MorphoSys Group.

 

About Galapagos

Galapagos (Euronext & NASDAQ: GLPG) is a clinical-stage biotechnology company specialized in the discovery and development of small molecule medicines with novel modes of action. Galapagos' pipeline comprises Phase 3 through to discovery programs in cystic fibrosis, inflammation, fibrosis, osteoarthritis and other indications. Our target discovery platform has delivered three novel mechanisms showing promising patient results in, respectively, inflammatory diseases, idiopathic pulmonary fibrosis and atopic dermatitis. Galapagos is focused on the development and commercialization of novel medicines that will improve people's lives. The Galapagos group, including fee-for-service subsidiary Fidelta, has approximately 600 employees, operating from its Mechelen, Belgium headquarters and facilities in the Netherlands, France, Switzerland, the US and Croatia. More information at www.glpg.com.

 

Contact

MorphoSys AG

Anke Linnartz, Head of Corporate Communications & IR

Jochen Orlowski, Associate Director Corporate Communications & IR

Alexandra Goller, Associate Director Corporate Communications & IR

Tel: +49 (0) 89 / 899 27-404

investors@morphosys.com

 

Galapagos

Investors:

Elizabeth Goodwin

VP IR & Corporate Communications

+1 781 460 1784

 

Paul van der Horst

Director IR & Business Development

+31 71 750 6707

ir@glpg.com

 

Media:

Evelyn Fox

Director Communications

+31 6 53 591 999

communications@glpg.com

 

 

Galapagos forward-looking statements

This release may contain forward-looking statements pertaining to Galapagos, including, among other things, statements regarding the mechanism of action and safety and efficacy profile of MOR106, or regarding the timing, progress and/or results of clinical studies with MOR106. Galapagos cautions the reader that forward-looking statements are not guarantees of future performance. Forward-looking statements involve known and unknown risks, uncertainties and other factors which might cause the actual results, financial condition and liquidity, performance or achievements of Galapagos, or industry results, to be materially different from any historic or future results, financial conditions and liquidity, performance or achievements expressed or implied by such forward-looking statements. In addition, even if Galapagos' results, performance, financial condition and liquidity, and the development of the industry in which it operates are consistent with such forward-looking statements, they may not be predictive of results or developments in future periods. Among the factors that may result in differences are that Galapagos' expectations regarding its MOR106 development program may be incorrect, the inherent uncertainties associated with competitive developments, clinical trial and product development activities and regulatory approval requirements (including that data from Galapagos' ongoing clinical research program may not support registration or further development of MOR106 due to safety, efficacy or other reasons), Galapagos' reliance on collaborations with third parties (including its collaboration partner for MOR106, MorphoSys), and estimating the commercial potential of MOR106. A further list and description of these risks, uncertainties and other risks can be found in Galapagos' Securities and Exchange Commission (SEC) filings and reports, including in Galapagos' most recent annual report on form 20-F filed with the SEC and other filings and reports filed by Galapagos with the SEC. Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements. These forward-looking statements speak only as of the date of publication of this document. Galapagos expressly disclaims any obligation to update any such forward-looking statements in this document to reflect any change in its expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements, unless specifically required by law or regulation.

 

 




Ph1 MOR106 at AAD



This announcement is distributed by Nasdaq Corporate Solutions (One Liberty Plaza, 165 Broadway, New York, NY 10006. Tel: +1 212 401 8700. www.nasdaqomx.com) on behalf of Nasdaq Corporate Solutions clients. Source: Galapagos NV, Industriepark Mechelen Noord I, zone L
Generaal De Wittelaan L11 A3, Mechelen B-2800 , Belgie
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Gov UK: Press release: Charity Commission calls for information about Presidents Club Charitable Trust

Press release: Charity Commission calls for information about Presidents Club Charitable Trust
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Press release: Dangerous driver who caused fatal crash but didn't stop at the scene has his sentence increased
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Press release: Foreign Secretary welcomes new UN Special Envoy for Yemen
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Press release: New tougher electrical safety standards to protect private tenants
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EU Commission: Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 13-15 February 2018

Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 13-15 February 2018

CVMP recommends changes to product information for some veterinary medicines containing enrofloxacin, to reduce development of antimicrobial resistance in target pathogens

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Lessons learned from austerity make a change of policy mandatory
The EESC presents measures to avoid the severity of austerity in the future and to mitigate the negative effects of previous crisis management

Future crisis management should strive for a better balance between fiscal and social objectives to avoid adverse effects on the economic capacities, labour markets and social protection systems of the countries concerned. Instead of restrictive austerity, the EU institutions should in future crisis situations implement policies in pursuit of economic cooperation, growth and solidarity.

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Indicative programme - Agriculture and Fisheries Council meeting of 19 February 2018

Main agenda items, approximate timing, public sessions and press opportunities.

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Weekly schedule of President Donald Tusk

Weekly schedule of President Donald Tusk 19-25 February 2018.

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Main topics and media events 19 February - 4 March 2018

Overview of the main subjects to be discussed at meetings of the Council of the EU over the next two weeks.

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Friday, 16 February 2018

Novartis new Cosentyx® data confirms robust efficacy and quality of life improvements in scalp psoriasis

Novartis International AG    

Novartis new Cosentyx® data confirms robust efficacy and quality of life improvements in scalp psoriasis

  • Majority of patients with scalp psoriasis on Cosentyx® (secukinumab) achieved clear skin (PSSI 90) at Weeks 12 and 24 and improved quality of life[1]
     
  • Scalp psoriasis affects 60 million people worldwide - a difficult-to-treat form of psoriasis with a substantial impact on quality of life[1]-[5]
     
  • Cosentyx data presented at AAD adds to robust evidence demonstrating sustained efficacy in plaque, nail, palmoplantar and scalp psoriasis as well as psoriatic arthritis[6]-[12]

 

The digital press release with multimedia content can be accessed here:

 

 

Basel, February 16, 2018 - Novartis has presented new Cosentyx® (secukinumab) data from the prospective Phase III SCALP study which showed significant improvement in skin clearance with Cosentyx in patients with scalp psoriasis. Due to the presence of hair, scalp psoriasis is particularly difficult to treat with common topical and phototherapy options[13]. These study results were presented at the 2018 American Academy of Dermatology (AAD) Annual Meeting in San Diego, California.

 

"Scalp psoriasis can be painful and in some cases, can lead to temporary hair loss and cause the involved area to crack and bleed," said Kristian Reich, M.D., Ph.D., Georg-August-University Göttingen and Dermatologikum Hamburg, Germany. "The data presented at AAD is encouraging for both physicians and patients, who can have greater trust in Cosentyx as a complete treatment option for patients with plaque psoriasis who want to avoid scalp and other manifestations of psoriasis."

 

Approximately 60 million people worldwide are impacted by scalp psoriasis[4],[5], a form of the disease which can have a substantial impact on quality of life due its highly visible nature. Additional stress may be added as many psoriasis patients will not achieve an adequate response from standard treatments[13].

 

"As a science driven company, we are committed to investigating the full potential of Cosentyx. It is our ambition to offer the best evidence to doctors, and to deliver the best treatment to patients," said Eric Hughes, Global Development Unit Head, Immunology & Dermatology. "Cosentyx is backed by a large study program including more than 10,000 patients in over 60 studies since our first Cosentyx study initiation 10 years ago. We believe that study data on specific manifestations such as scalp help doctors reach the right decisions with their patients."

 

Cosentyx is a fully human interleukin-17A (IL-17A) inhibitor which has demonstrated rapid and sustained long term efficacy in the treatment of moderate-to-severe psoriasis, psoriatic arthritis and ankylosing spondilytis, as well as a consistently favorable safety profile including injection site pain at rates similar to placebo[6]-[12]. To date, Cosentyx has been prescribed to more than 140,000 patients worldwide across all indications since launch[14].

 

About psoriasis

Psoriasis is a distressing and painful autoimmune disease that affects more than 125 million people worldwide[4]. It is a debilitating condition associated with a significant emotional and physical daily burden. In the long-term, psoriasis can also lead to other conditions, such as diabetes, heart disease, depression and psoriatic arthritis (PsA) - which up to 30% of patients with psoriasis may develop[4],[15].

 

Plaque psoriasis is the most common form of the disease and appears as raised, red skin patches covered with a silvery white build-up of dead cells. Most patients with psoriasis will also develop difficult-to-treat forms of the disease which appear on the scalp, nails, palms of the hands or soles of the feet and are associated with further pain, decreased mobility and functional impairment[2],[16]-[18].

 

About Cosentyx (secukinumab) and IL-17A

Cosentyx is the first and only fully human interleukin-17A (IL-17A) inhibitor approved to treat psoriasis, PsA and ankylosing spondylitis (AS)[19]. Cosentyx is a targeted treatment that specifically inhibits IL-17A, cornerstone cytokine involved in the pathogenesis of psoriasis, and the inflammation of the entheses in PsA and AS[19]-[22].

 

Cosentyx delivers psoriasis patients long-lasting skin clearance, with proven sustainability and safety out to 5 years[8]. Cosentyx has been studied in dedicated trials for difficult-to-treat types of plaque psoriasis - palmoplantar psoriasis (psoriasis of the hands and feet), scalp psoriasis, and nail psoriasis[19].

 

Cosentyx has a large clinical trials program in psoriasis, PsA and AS which includes over 60 studies and over 10,000 patients[23].  To date, Cosentyx has been prescribed to more than 140,000 patients worldwide since launch[14].

 

About the SCALP study[1]

This study is a randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of Cosentyx in 102 patients with moderate-to-severe scalp psoriasis. Eligible patients were equally randomized to either subcutaneous Cosentyx 300 mg or placebo at Weeks 0, 1, 2, 3 and 4, then every four weeks for 12 weeks. At Week 12, patients in the placebo group who did not achieve at least a 90% improvement from baseline in the Psoriasis Scalp Severity Index (PSSI) score were re-randomized to Cosentyx 300 mg until study completion. The primary endpoint was the proportion of patients who achieved PSSI 90 response rate at Week 12.

 

In the SCALP study, PSSI 90 response rates were achieved by a significantly higher proportion of patients receiving Cosentyx vs. placebo at Week 12 (52.9% vs. 2.0%), with further improvements in those taking Cosentyx up to Week 24 (58.8%). The safety profile of Cosentyx was in line with the known safety profile for Cosentyx.

 

About Novartis Immunology & Dermatology

Novartis is a global leader in Immunology & Dermatology. We are dedicated to transforming the lives of people living with immunologic diseases, focusing on immunodermatology, rheumatology and specialty liver diseases. Our Immunology & Dermatology pipeline includes multiple compounds in liver disease and other immunological areas where high unmet medical needs exist.

 

Disclaimer

This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as "potential," "can," "will," "plan," "expect," "anticipate," "look forward," "believe," "committed," "investigational," "pipeline," "launch," or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for the investigational or approved products described in this press release, or regarding potential future revenues from such products. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that such products will be commercially successful in the future. In particular, our expectations regarding such products could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; general political and economic conditions; safety, quality or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG's current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

 

About Novartis

Novartis provides innovative healthcare solutions that address the evolving needs of patients and societies. Headquartered in Basel, Switzerland, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, cost-saving generic and biosimilar pharmaceuticals and eye care. Novartis has leading positions globally in each of these areas. In 2017, the Group achieved net sales of USD 49.1 billion, while R&D throughout the Group amounted to approximately USD 9.0 billion. Novartis Group companies employ approximately 122,000 full-time-equivalent associates. Novartis products are sold in approximately 155 countries around the world. For more information, please visit http://www.novartis.com.

 

Novartis is on Twitter. Sign up to follow @Novartis at http://twitter.com/novartis

For Novartis multimedia content, please visit www.novartis.com/news/media-library

For questions about the site or required registration, please contact media.relations@novartis.com

 

References

[1]    Reich K et al. Secukinumab Shows Sustained Efficacy in Difficult-to-Treat Palmoplantar, Nail, and Scalp Psoriasis: Long-term Results From 3 Phase III Placebo-Controlled Randomized Trials. Eposter presented at 2018 American Academy of Dermatology (AAD) Annual Meeting; February 16-20, 2018, San Diego, California. Poster #6813.

[2]    Zampieron A et al. Quality of life in patients with scalp psoriasis. G Ital Dermatol Venereol. 2015 Jun;150(3):309-16

[3]    American academy of dermatology. Scalp Psoriasis. Available at: https://www.aad.org/public/diseases/hair-and-scalp-problems/scalp-psoriasis#symptoms. Last accessed January 2018.

[4]    International Federation of Psoriasis Associations (IFPA) World Psoriasis Day website. "About Psoriasis." Available at: http://www.worldpsoriasisday.com/web/page.aspx?refid=114. Last accessed January 2018.

[5]    Farber EM, Nall L. Natural history and treatment of scalp psoriasis. Cutis. 1992;49:396-400.

[6]    Gottlieb AB et al. Secukinumab Shows High and Sustained Efficacy in Subjects with Moderate to Severe Palmoplantar Psoriasis: 2.5-Year Results From the GESTURE Study. Abstract presented at the 2017 Psoriasis Gene to Clinic Congress, London, United Kingdom. 30th November 2017.

[7]    Braun J et al. Secukinumab demonstrates low radiographic progression and sustained efficacy through 4 years in patients with active ankylosing spondylitis. Late breaking abstract presented at the 2017 ACR/ARHP Annual Meeting, San Diego, USA. 7th November 2017.

[8]    Bissonnette, R., Luger, T., Thaçi, D., Toth, D., Lacombe, A., Xia, S., Mazur, R., Patekar, M., Charef, P., Milutinovic, M., Leonardi, C. and Mrowietz, U. Secukinumab Demonstrates High Sustained Efficacy and a Favorable Safety Profile in Patients with Moderate to Severe Psoriasis through 5 Years of Treatment (SCULPTURE Extension Study). J Eur Acad Dermatol Venereol. Accepted Author Manuscript. doi:10.1111/jdv.14878

[9]    Mease PJ et al. Secukinumab Provides Sustained Improvements in the Signs and Symptoms of Active Psoriatic Arthritis through 3 Years: Efficacy and Safety Results from a Phase 3 Trial. AnnRheum Dis. 2017;76:952-953.

[10]  Baeten D et al. Secukinumab, interleukin-17A inhibition in ankylosing spondylitis. N Engl J Med. 2015; 373:2534-48.

[11]  McInnes IB et al. Secukinumab, a human anti-interleukin-17A monoclonal antibody, in patients with psoriatic arthritis (FUTURE 2): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2015; 386(9999):1137-1146.

[12]  Reich K et al. Secukinumab, a fully human anti-interleukin-17A monoclonal antibody, exhibits minimal immunogenicity in patients with moderate-to-severe plaque psoriasis. Br. J. Dermatol. 2017;176:752-58.

[13]  Crowley JJ. Nail, Scalp, and Palmoplantar Psoriasis. Biologic and Systemic Agents in Dermatology. 2018; 160-174.

[14]  Novartis Data on File. Number of Patients Prescribed Cosentyx. Novartis Pharmaceuticals Corp; Nov. 2017.

[15]  National Psoriasis Foundation. Psoriatic disease: about psoriasis. Available at: www.psoriasis.org/about-psoriasis. Last accessed January 2018.

[16]  Baran R. The burden of nail psoriasis: an introduction. Dermatol. 2010:221 Suppl 1:1-5.

[17]  Kumar B et al. Palmoplantar lesions in psoriasis: a study of 3065 patients. Acta Dermatol Venereol. 2002;82:192-5.

[18]  Chung J et al. Palmoplantar psoriasis is associated with greater impairment of health-related quality of life compared with moderate to severe plaque psoriasis. J Am Acad Dermatol. 2014;71(4):623-32.

[19]  EU Cosentyx Summary of Product Characteristics. Novartis Europharm Limited. Available at: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/003729/human_med_001832.jsp&mid=WC0b01ac058001d124. Last accessed January 2018.

[20]  Smith JA et al. Review: The Interleukin 23/Interleukin 17 Axis in Spondyloarthritis Pathogenesis: Th17 and Beyond. Arthritis Rheumatol. 2014;66:231-41.

[21]  Nestle FO et al. Mechanisms of disease psoriasis. N Eng J Med. 2009;361:496-509.

[22]  Girolomoni G et al. Psoriasis: rationale for targeting interleukin-17. Br J Dermatol. 2012;167:717-24.

[23]  Novartis, data on file.

 

# # #

 

Novartis Media Relations

Central media line: +41 61 324 2200

E-mail: media.relations@novartis.com

 

Eric Althoff

Novartis Global Media Relations

+41 61 324 7999 (direct)

+41 79 593 4202 (mobile)

eric.althoff@novartis.com

Friedrich von Heyl

Novartis Global Pharma Communications

+41 61 324 8984 (direct)

+41 79 749 0286 (mobile)

friedrich.vonheyl@novartis.com 

 

Novartis Investor Relations

Central investor relations line: +41 61 324 7944

E-mail: investor.relations@novartis.com

 

Central

 

North America

 

Samir Shah

+41 61 324 7944

Richard Pulik

+1 212 830 2448

Pierre-Michel Bringer

+41 61 324 1065

Cory Twining

+1 212 830 2417

Thomas Hungerbuehler

+41 61 324 8425

 

 

Isabella Zinck

+41 61 324 7188

 

 

 

 




Media release (PDF)



This announcement is distributed by Nasdaq Corporate Solutions (One Liberty Plaza, 165 Broadway, New York, NY 10006. Tel: +1 212 401 8700. www.nasdaqomx.com) on behalf of Nasdaq Corporate Solutions clients. Source: Novartis International AG, P.O. Box, Basel CH-4002, Switzerland
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Novartis new data show Cosentyx® improved quality of life over 5 years in two thirds of patients with moderate to severe plaque psoriasis

Novartis International AG    

Novartis new data show Cosentyx® improved quality of life over 5 years in two thirds of patients with moderate to severe plaque psoriasis

  • Two thirds of patients on Cosentyx® (secukinumab) reported no impact of skin disease on their quality of life over 5 years, SCULPTURE study shows[1]
     
  • Findings show absolute PASI <=1/<=2/<=3 responses were sustained in those treated with Cosentyx from Year 1 to Year 5[1]
     
  • Cosentyx is the first and only fully human interleukin-17A (IL-17A) inhibitor that showed sustained skin clearance rates at 5 years in patients from a psoriasis Phase III study[2]  

 

The digital press release with multimedia content can be accessed here:

 

 

 

Basel, February 16, 2018 - Novartis announced today, additional results from the SCULPTURE study showing that two thirds of moderate to severe plaque psoriasis patients treated with Cosentyx® (secukinumab) reported no impact of skin disease on their quality of life through 5 years, as described by the Dermatology Life Quality Index (DLQI) 0/1 response (72.7% at Year 1 and 65.5% at Year 5) - a questionnaire used to evaluate the impact of skin disease on a patient's quality of life[1],[3]. These data were presented at the 2018 American Academy of Dermatology (AAD) Annual Meeting in San Diego, California

 

Study findings also show absolute PASI <=1/<=2/<=3 scores at Year 1 (58.6%, 67.9% and 74.1%, respectively) were sustained to Year 5 (53.3%, 66.4% and 75.4%, respectively); as observed analysis[1]. Absolute PASI scores can provide an indication of disease severity after treatment. Achievement of an absolute PASI score lower than 2 or 3 has been proposed as an indication of treatment success[4].

 

Psoriasis is not simply a cosmetic problem, but a persistent, chronic (long-lasting), and sometimes distressing disease, which can affect even the smallest aspects of people's lives on a daily basis."There is a link between achieving skin clearance and improved quality of life, and proper management of psoriasis should address both the physical symptoms of the disease and its impact on patients' daily lives," said Craig Leonardi, MD, Adjunct Professor of Dermatology at St. Louis University School of Medicine. "Results from the SCULPTURE study show treatment with Cosentyx can deliver both over the long-term. It's encouraging to see such improvements in DLQI responses and absolute PASI scores below 3 through 5 years."

 

"Patients with psoriasis are looking for a treatment that not only achieves clear skin, but also addresses the negative impact psoriasis has on their lives," said Shreeram Aradhye, Chief Medical Officer and Global Head, Medical Affairs, Novartis Pharmaceuticals. "We are excited by this new evidence, showing two thirds of psoriasis patients reporting no impact on their quality of life at 5 years when treated with Cosentyx, and the possibilities this offers patients."

 

The most common adverse events included nasopharyngitis, upper respiratory tract infection and headache, consistent with those reported in the core study and previous Phase III studies[1].

 

Cosentyx is the first and only fully human IL-17A inhibitor approved to treat ankylosing spondylitis (AS), psoriatic arthritis (PsA) and moderate to severe plaque psoriasis[5]. To date, Cosentyx has been prescribed to more than 140,000 patients worldwide since launch[6].

 

About psoriasis

Psoriasis is a distressing and painful autoimmune disease that affects more than 125 million people worldwide[7]. It is a debilitating condition associated with a significant emotional and physical daily burden. In the long-term, psoriasis can also lead to other conditions, such as diabetes, heart disease, depression and psoriatic arthritis - which up to 30% of patients with psoriasis may develop[8].

 

Plaque psoriasis is the most common form of the disease and appears as raised, red skin patches covered with a silvery white build-up of dead cells. Most patients with psoriasis will also develop difficult-to-treat forms of the disease which appear on the scalp, nails, palms of the hands or soles of the feet and are associated with further pain, decreased mobility and functional impairment[9]-[12].

 

About Cosentyx (secukinumab) and IL-17A

Cosentyx is the first and only fully human IL-17A inhibitor approved to treat psoriasis, PsA and ankylosing spondylitis (AS)[5]. Cosentyx is a targeted treatment that specifically inhibits IL-17A, cornerstone cytokine involved in the pathogenesis of psoriasis, and the inflammation of the entheses in PsA and AS[5],[13]-[15].

 

Cosentyx delivers psoriasis patients long-lasting skin clearance, with proven sustainability and safety out to 5 years[2]. Cosentyx is also approved for the most difficult-to-treat forms of plaque psoriasis - palmoplantar psoriasis (psoriasis of the palms of the hands and soles of the feet), nail psoriasis and scalp psoriasis[5].

 

Cosentyx has a large clinical trials program in psoriasis, PsA and AS which includes over 60 studies and over 10,000 patients[16]. To date, Cosentyx has been prescribed to more than 140,000 patients worldwide since launch[6].

 

About the Cosentyx 5-year extension study (NCT01406938)[1],[2]

NCT01406938 is a multicenter, double-blind and open-label, 5-year extension to the core Phase III SCULPTURE study. The primary objective of this extension study was to assess the long-term safety and tolerability of Cosentyx in patients with moderate to severe plaque psoriasis, examining both treatment and quality of life outcomes.

 

Efficacy measures included proportion of patients achieving PASI 75, PASI 90 and PASI 100, and quality of life improvement as measured by Dermatology Life Quality Index (DLQI). This long-term extension study demonstrated the sustained efficacy and safety of Cosentyx. The current as observed analysis describes, PASI 75/90/100 at Year 1 (88.9%, 68.5% and 43.8%, respectively) and  Year 5 (88.5%, 66.4% and 41%); absolute PASI <=1/<=2/<=3 responses at Year 1 (58.6%, 67.9% and 74.1%, respectively) and  Year 5 (53.3%, 66.4% and 75.4%, respectively), DLQI 0/1 at Year 1 (72.7%) and Year 5 (65.5%), and long-term safety and tolerability.

 

In the core Phase III SCULPTURE study, PASI 75 responders at Week 12 were randomized to double-blind maintenance treatment of Cosentyx 300 mg or 150 mg, given either at a 4-week fixed-interval regimen or in a retreatment-as-needed regimen. Patients who completed 52 weeks of the SCULPTURE study were eligible to continue the same dose and regimen in the extension study (N=642). Patients subsequently entered the extension phase and continued the same double-blinded treatment regimen to Year 3, and thereafter un-blinded to the end of the study at Year 5 (n=126 at Week 260). No topical treatments were allowed in SCULPTURE, and only in the extension study when applied to the scalp, face, and/or genitoanal area for a maximum of 14 days. The safety profile of Cosentyx was in line with the known safety profile for Cosentyx.

 

About Novartis Immunology & Dermatology

Novartis is a global leader in Immunology & Dermatology. We are dedicated to transforming the lives of people living with immunologic diseases, focusing on immunodermatology, rheumatology and specialty liver diseases. Our Immunology & Dermatology pipeline includes multiple compounds in liver disease and other immunological areas where high unmet medical needs exist.

 

Disclaimer

This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as "potential," "can," "will," "plan," "expect," "anticipate," "look forward," "believe," "committed," "investigational," "pipeline," "launch," or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for the investigational or approved products described in this press release, or regarding potential future revenues from such products. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that such products will be commercially successful in the future. In particular, our expectations regarding such products could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; general political and economic conditions; safety, quality or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG's current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

 

About Novartis

Novartis provides innovative healthcare solutions that address the evolving needs of patients and societies. Headquartered in Basel, Switzerland, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, cost-saving generic and biosimilar pharmaceuticals and eye care. Novartis has leading positions globally in each of these areas. In 2017, the Group achieved net sales of USD 49.1 billion, while R&D throughout the Group amounted to approximately USD 9.0 billion. Novartis Group companies employ approximately 122,000 full-time-equivalent associates. Novartis products are sold in approximately 155 countries around the world. For more information, please visit http://www.novartis.com.

 

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References

 

[1]   Bissonnette R et al. Secukinumab demonstrates high sustained efficacy and a favorable safety profile through 5 years of treatment in moderate to severe psoriasis. Eposter presented at 2018 American Academy of Dermatology (AAD) Annual Meeting; February 16-20, 2018, San Diego, California. Poster #7382.

[2]   Bissonnette, R., Luger, T., Thaçi, D., Toth, D., Lacombe, A., Xia, S., Mazur, R., Patekar, M., Charef, P., Milutinovic, M., Leonardi, C. and Mrowietz, U. Secukinumab Demonstrates High Sustained Efficacy and a Favorable Safety Profile in Patients with Moderate to Severe Psoriasis through 5 Years of Treatment (SCULPTURE Extension Study). J Eur Acad Dermatol Venereol. Accepted Author Manuscript. doi:10.1111/jdv.14878

[3]   Finlay AY, Khan GK. Dermatology Life Quality Index (DLQI)-a simple practical measure for routine clinical use. Clin Experiment Dermatol. 1994;19(3):210-216.

[4]   Zheng J. Absolute Psoriasis Area and Severity Index: an additional evaluation for clinical practice. Br J Dermatol. 2017;176:563-576.

[5]   Cosentyx Summary of Product Characteristics. Novartis Europharm Limited. Available at: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/003729/human_med_001832.jsp&mid=WC0b01ac058001d124. Last accessed January 2018.

[6]   Novartis. Data on file.

[7]   International Federation of Psoriasis Associations (IFPA) World Psoriasis Day website. "About Psoriasis." Available at: http://www.worldpsoriasisday.com/web/page.aspx?refid=114. Last accessed January 2018.

[8]   National Psoriasis Foundation. Psoriatic disease: about psoriasis. Available at: www.psoriasis.org/about-psoriasis. Last accessed January 2018.

[9]   Zampieron A et al. Quality of life in patients with scalp psoriasis. G Ital Dermatol Venereol. 2015 Jun;150(3):309-16

[10] Baran R. The burden of nail psoriasis: an introduction. Dermatol. 2010:221 Suppl 1:1-5.

[11] Kumar B et al. Palmoplantar lesions in psoriasis: a study of 3065 patients. Acta Dermatol Venereol. 2002;82:192-5.

[12] Chung J et al. Palmoplantar psoriasis is associated with greater impairment of health-related quality of life compared to moderate-to-severe plaque psoriasis. J Am Acad Dermatol. 2014 Oct;71(4):623-632.

[13] Smith JA et al. Review: The Interleukin 23/Interleukin 17 Axis in Spondyloarthritis Pathogenesis: Th17 and Beyond. Arthritis Rheumatol. 2014;66:231-41.

[14] Nestle FO et al. Mechanisms of disease psoriasis. N Eng J Med. 2009;361:496-509.

[15] Girolomoni G et al. Psoriasis: rationale for targeting interleukin-17. Br J Dermatol. 2012;167:717-24.

[16] Novartis. Data on file.

 

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