Business Wire

Celgene Announces Phase 3 STYLE Study of OTEZLA® (apremilast) in Moderate to Severe Scalp Psoriasis Met Primary Endpoint

Jaa

Celgene Corporation (NASDAQ:CELG) today announced results from the phase 3 STYLE study, which showed that OTEZLA® (apremilast) 30 mg twice daily achieved a highly statistically significant improvement in the primary endpoint of the Scalp Physician’s Global Assessment (ScPGA) response [defined as ScPGA score of clear (0) or almost clear (1) with at least a 2-point reduction from baseline] at week 16 compared with placebo.

In addition to achieving the primary endpoint, statistical significance was also met for the secondary endpoint of the whole body itch numeric rating scale (NRS) [defined as at least a 4-point reduction from baseline] at week 16 with OTEZLA versus placebo.

The safety profile was generally consistent with the known safety profile of OTEZLA, and no new safety signals were identified in the trial. Treatment-emergent adverse events that occurred in at least 5 percent of patients in either treatment group were diarrhea (30.5 percent for OTEZLA and 10.8 percent for placebo), nausea (21.5 percent and 5.9 percent, respectively), headache (11.5 percent and 4.9 percent) and vomiting (5.5 percent and 2.0 percent).

“The scalp is the most commonly affected area in moderate to severe plaque psoriasis, impacting up to 80 percent of patients,” said Terrie Curran, President, Celgene Inflammation and Immunology. “The area is difficult to treat with topical therapies, and clinical data from systemic therapies are limited. We are encouraged by the significant improvements in this trial and look forward to sharing these data to further enhance the OTEZLA label.”

About STYLE

STYLE is a phase 3, multicenter, randomized, placebo-controlled, double-blind study evaluating the efficacy and safety of OTEZLA in subjects with moderate to severe plaque psoriasis of the scalp. The study enrolled 303 people who were randomized 2:1 to receive OTEZLA 30 mg twice daily or placebo for the first 16 weeks.

About Plaque Psoriasis

Psoriasis affects 125 million people worldwide, including around 14 million people in Europe and 7.5 million people in the United States. It is a chronic and systemic inflammatory disorder, and is immune-mediated, meaning it is caused by an immune reaction in the body.

Psoriasis lesions can often be found on areas close to the joints such as the elbows and knees but can also appear on the scalp. Nail psoriasis affects up to 50 percent of people with psoriasis. Up to 84 percent of people with psoriasis experience itching, and over a third of patients cite itch as the most important factor contributing to their disease.

Around 75 percent of people living with psoriasis believe it has a negative impact on their quality of life, and 83 percent of patients with psoriasis actively conceal the visible signs of their disease.

About OTEZLA ® (apremilast)

OTEZLA® (apremilast) 30 mg tablets is an oral small-molecule inhibitor of phosphodiesterase 4 (PDE4) specific for cyclic adenosine monophosphate (cAMP). PDE4 inhibition results in increased intracellular cAMP levels, which is thought to indirectly modulate the production of inflammatory mediators. The specific mechanism(s) by which OTEZLA exerts its therapeutic action in patients is not well defined.

U.S. PRESCRIBING INFORMATION

INDICATION

OTEZLA® (apremilast) is indicated for the treatment of patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.

IMPORTANT SAFETY INFORMATION

Contraindications

OTEZLA® (apremilast) is contraindicated in patients with a known hypersensitivity to apremilast or to any of the excipients in the formulation

Warnings and Precautions

Diarrhea, Nausea and Vomiting: Cases of severe diarrhea, nausea, and vomiting were associated with the use of OTEZLA. Most events occurred within the first few weeks of treatment. In some cases, patients were hospitalized. Patients 65 years of age or older and patients taking medications that can lead to volume depletion or hypotension may be at a higher risk of complications from severe diarrhea, nausea, or vomiting. Monitor patients who are more susceptible to complications of diarrhea or vomiting; advise patients to contact their healthcare provider. Consider OTEZLA dose reduction or suspension if patients develop severe diarrhea, nausea, or vomiting

Depression: Carefully weigh the risks and benefits of treatment with OTEZLA for patients with a history of depression and/or suicidal thoughts/behavior, or in patients who develop such symptoms while on OTEZLA. Patients, caregivers, and families should be advised of the need to be alert for the emergence or worsening of depression, suicidal thoughts or other mood changes, and they should contact their healthcare provider if such changes occur

Psoriasis: Treatment with OTEZLA is associated with an increase in depression. During clinical trials, 1.3% (12/920) of patients reported depression compared to 0.4% (2/506) on placebo; Depression was reported as serious in 0.1% (1/1308) of patients exposed to OTEZLA, compared to none in placebo-treated patients (0/506). Suicidal behavior was observed in 0.1% (1/1308) of patients on OTEZLA, compared to 0.2% (1/506) on placebo. One patient treated with OTEZLA attempted suicide; one patient on placebo committed suicide

Weight Decrease: Monitor body weight regularly; evaluate unexplained or clinically significant weight loss, and consider discontinuation of OTEZLA

Psoriasis: Body weight loss of 5-10% occurred in 12% (96/784) of patients treated with OTEZLA and in 5% (19/382) of patients treated with placebo. Body weight loss of ≥10% occurred in 2% (16/784) of patients treated with OTEZLA compared to 1% (3/382) of patients treated with placebo

Drug Interactions: Apremilast exposure was decreased when OTEZLA was co-administered with rifampin, a strong CYP450 enzyme inducer; loss of OTEZLA efficacy may occur. Concomitant use of OTEZLA with CYP450 enzyme inducers (e.g., rifampin, phenobarbital, carbamazepine, phenytoin) is not recommended

Adverse Reactions

Psoriasis: Adverse reactions reported in ≥5% of patients were (OTEZLA%, placebo%): diarrhea (17, 6), nausea (17, 7), upper respiratory tract infection (9, 6), tension headache (8, 4), and headache (6, 4)

Use in Specific Populations

Pregnancy and Nursing Mothers: OTEZLA is Pregnancy Category C; it has not been studied in pregnant women. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether apremilast or its metabolites are present in human milk. Caution should be exercised when OTEZLA is administered to a nursing woman

Renal Impairment: OTEZLA dosage should be reduced in patients with severe renal impairment (creatinine clearance less than 30 mL/min); for details, see Dosage and Administration, Section 2, in the Full Prescribing Information

Please  click here  for Full Prescribing Information.

About Celgene

Celgene Corporation, headquartered in Summit, New Jersey, is an integrated global pharmaceutical company engaged primarily in the discovery, development and commercialization of innovative therapies for the treatment of cancer and inflammatory diseases through next‐generation solutions in protein homeostasis, immuno‐oncology, epigenetics, immunology and neuro‐inflammation. For more information, please visit www.celgene.com. Follow Celgene on Social Media: @CelgenePinterestLinkedInFacebook and YouTube.

Forward-Looking Statements

This press release contains forward-looking statements, which are generally statements that are not historical facts. Forward-looking statements can be identified by the words “expects,” “anticipates,” “believes,” “intends,” “estimates,” “plans,” “will,” “outlook” and similar expressions. Forward-looking statements are based on management’s current plans, estimates, assumptions and projections, and speak only as of the date they are made. We undertake no obligation to update any forward-looking statement in light of new information or future events, except as otherwise required by law. Forward-looking statements involve inherent risks and uncertainties, most of which are difficult to predict and are generally beyond our control. Actual results or outcomes may differ materially from those implied by the forward-looking statements as a result of the impact of a number of factors, many of which are discussed in more detail in our Annual Report on Form 10-K and our other reports filed with the U.S. Securities and Exchange Commission.

Hyperlinks are provided as a convenience and for informational purposes only. Celgene bears no responsibility for the security or content of external websites.

Contact information

Celgene Corporation
Investors:
Nina Goworek, 908-673-9711
Executive Director, Investor Relations
or
Media:
Catherine Cantone, 908-897-4256
Senior Director, Corporate Communications

Tietoja julkaisijasta

For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.

Tilaa tiedotteet sähköpostiisi

Haluatko tietää asioista ensimmäisten joukossa? Kun tilaat mediatiedotteemme, saat ne sähköpostiisi välittömästi julkaisuhetkellä. Tilauksen voit halutessasi perua milloin tahansa.

Lue lisää julkaisijalta Business Wire

IWBI Launches Global Network of Advisors for WELL Portfolio16.10.2018 21:00Tiedote

The International WELL Building Institute™ (IWBI™) today announced the formation of a global advisory to help shape and advance the implementation of the WELL Portfolio™ Pathway pilot, a new streamlined pathway for WELL Certification™ for multiple new or existing buildings and tenant spaces in a single portfolio. WELL Portfolio, announced this past month, is being released as part of the WELL v2™ pilot, the latest iteration of the WELL Building Standard™ (WELL™). It is part of a suite of enhancements to WELL that addresses growing demand across the building industry for a program that helps owners, developers and tenants streamline and scale health and wellness upgrades to their real estate assets. The advisory includes a collection of professionals, practitioners and experts across a range of industries and sectors, each serving a one-year term. “Since we launched WELL, we’ve seen an explosion of interest from global companies to bring the same health and wellness benefits across thei

The X7 Delivers Right-sized Packaging Automation from Packsize While Reducing Labor, Shipping, and Material Costs16.10.2018 20:55Tiedote

The continued decline in unemployment is impacting companies across nearly every industry; a reported 3.7 percent national average in September by the U.S. Department of Labor. Heightened demand for goods ordered over the internet amplifies the worker shortage for these companies shipping products. To ensure optimal and timely outcomes and smart industry improvements for its customers, Packsize today announces its fully automated, right-sized packaging system, the X7™. The new automated custom box-making system represents a significant investment by Packsize in machine learning, packaging process automation, corrugated infrastructure and testing, and business intelligence. The automated system is the second in the company’s X Series line of automated, On Demand Packaging® technology solutions. Advancing packaging automation for complex, single- and multiple-item orders, the X7™ achieves sustainability and supply chain workflow optimization. Delivering the most needed functions to make,

Event Software Company Aventri Acquires ITN International16.10.2018 19:00Tiedote

Leading event management software company Aventri announced the acquisition of ITN International, the industry leader in NFC, mobile and cloud-based technology. With the acquisition of ITN, Aventri will broaden its technology and service offerings, expanding its global reach and the events that they support. Servicing annually 125 events, 10,000 exhibitors and 1.5 million attendees, ITN serves event producers by combining technology with personalized professional services to optimize events. A look at their product set includes: Online registration system with speaker management, agenda builder, session scheduling, and more. Onsite services include NFC badges, check-in stations, lead retrieval, apps, RFID scanning and more. Data visualization tools with advanced reporting and analytics around registration, badge activity and scans. “The acquisition of ITN as a global provider of cloud-based event management solutions is a major growth opportunity for Aventri,” says Oni Chukwu, CEO of A

Thales and Gemalto Are Granted Regulatory Clearance from the Competition Commission in South Africa16.10.2018 19:00Tiedote

Regulatory News: Reference is made to the joint press release by Thales (Euronext Paris: HO) and Gemalto (Euronext Amsterdam and Paris: GTO) dated 27 March 2018 in relation to the launch of the recommended all-cash offer by Thales for all the issued and outstanding shares of Gemalto (the “Offer”), the publication of the Offer Document, and the joint press release of Thales and Gemalto dated 10 August 2018 in relation to the further extension of the Acceptance Period. Terms not defined in this press release will have the meaning as set forth in the Offer Document. Thales and Gemalto today announce that they have received Regulatory Clearance from the Competition Commission in South Africa. Together with the antitrust clearances obtained in China, Israel and Turkey, and clearances relating to foreign investments in Australia, Canada and the USA (CFIUS), Thales and Gemalto have now obtained 7 of the required 14 Regulatory Clearances. Thales and Gemalto continue to work constructively with

Piraeus Bank Finances the Development of Thriassio Transit Center16.10.2018 18:39Tiedote

Piraeus Bank will finance the development of the Thriassio Transit Center, which will help increase freight transport by rail and promote Greece as a major freight hub in the trans-European transport network. The Center will significantly increase freight transport by rail and promote Greece as a major freight hub in the trans-European transport network. It will contribute to the provision of upgraded services while also reducing transport costs, which are key factors in lowering the final price of products, having a direct positive impact on the competitiveness of the economy and GDP growth. The project is also expected to boost local employment, creating up to 5,000 jobs over the next 10 years. The new Thriasio Transit Center is expected to become operational in 2024. Piraeus Bank Chief Executive Officer, Mr. Christos Megalou said: “Piraeus Bank are always looking for suitable investment projects that align with our strategy to be a pillar of stability for the Greek economy and we ar

Inside Secure’s Latest Whitebox Software Security Tool Brings Mobile Developers New Levels of Protection, Performance and Control16.10.2018 18:36Tiedote

Regulatory News: Inside Secure (Paris:INSD), at the heart of security solutions for mobile and connected devices, today announced general availability of its Whitebox 3.0 software crypto-security tool that protects cryptographic keys and algorithms inside mobile applications that demand top-notch security. Inherently running in an exposed environment, mobile applications are susceptible to attackers who can then see all the secrets within the app. As a proven innovator in software security, Inside Secure builds on numerous years of successful integrations for top developers to offer the best technology for hiding data and cryptography on mobile devices. Serving as an appealing alternative to an expensive, hardware-dependent Trusted Execution Environment (TEE) or Secure Element (SE) Whitebox 3.0 secures assets with uniquely powerful features that bring industry-changing gains in performance and flexibility – key traits that developers demand. Inside Secure’s pure software approach means

Uutishuoneessa voit lukea tiedotteitamme ja muuta julkaisemaamme materiaalia. Löydät sieltä niin yhteyshenkilöidemme tiedot kuin vapaasti julkaistavissa olevia kuvia ja videoita. Uutishuoneessa voit nähdä myös sosiaalisen median sisältöjä. Kaikki STT Infossa julkaistu materiaali on vapaasti median käytettävissä.

Tutustu uutishuoneeseemme