Business Wire

OTEZLA® (Apremilast) Phase III Data Showed Significant Improvements in Patients with Active Behçet’s Disease with Oral Ulcers

Jaa

Celgene Corporation (NASDAQ:CELG) today announced that data from the phase III RELIEF™ clinical trial of OTEZLA® (apremilast) in patients with active Behçet’s Disease with oral ulcers were presented in a late-breaking oral presentation at the 2018 American Academy of Dermatology (AAD) Annual Meeting. The results showed statistically significant reductions in oral ulcers with apremilast 30 mg twice daily (BID) versus placebo through week 12. OTEZLA (apremilast) is Celgene’s oral selective inhibitor of phosphodiesterase 4 (PDE4).

Behçet’s Disease is a rare, chronic, multi-system inflammatory syndrome. Oral ulcers, the most common manifestation of Behçet’s Disease, can be disabling and have a substantial effect on quality of life. This study primarily evaluated the effect of apremilast on recurring oral ulcers in patients with active Behçet’s Disease who were previously treated with at least one topical or systemic medication.

“Reducing oral ulcers, which are painful and can negatively impact quality of life, is an important goal in the treatment of people with Behçet’s syndrome,” said Gulen Hatemi, M.D., Associate Professor, Istanbul University Cerrahpassa Medical School. “These findings suggest that apremilast, which reduced oral ulcers and oral ulcer pain, and improved disease activity in this pivotal study, has the potential to be a treatment option for patients with active Behçet’s syndrome with oral ulcers, for which few treatment alternatives exist.”

In the study, a total of 207 patients were randomized to apremilast 30 mg BID or placebo. At week 12, the area under the curve (AUC) for the number of oral ulcers was statistically significantly reduced with apremilast 30 mg BID versus placebo (129.5 vs. 222.1; P<0.0001), the trial’s primary endpoint. The AUC assesses the change in the number of oral ulcers over time, accounting for the clinical characteristic that oral ulcers repeatedly remit and recur. Statistically significant improvements were also seen with apremilast in multiple secondary endpoints, including oral ulcer pain (P<0.0001), overall disease activity (Behçet’s Syndrome Activity Score: P<0.0001; Behçet’s Disease Current Activity Index: P=0.0335) and quality of life (P=0.0003).

The most common adverse events (AEs) observed in the trial were diarrhea (41.3 percent with apremilast, 19.4 percent for placebo), nausea (19.2 percent with apremilast, 10.7 percent for placebo), headache (14.4 percent for apremilast, 9.7 percent for placebo) and upper respiratory tract infection (11.5 percent for apremilast, 4.9 percent for placebo). The safety profile was consistent with the known safety profile of apremilast.

Celgene plans to submit supplemental New Drug Applications for apremilast 30 mg BID for the treatment of active Behçet’s Disease with oral ulcers in the U.S. and Japan in the second half of this year. The Company also plans to submit a Type II Variation to the Marketing Authorization Application in the EU in 2019.

“The positive phase III findings in Behçet’s Disease reflect the unique aspects of the profile of OTEZLA® (apremilast) 30 mg across inflammatory-related diseases,” said Terrie Curran, President, Celgene Inflammation and Immunology. “OTEZLA® (apremilast) 30 mg has the potential to provide a clinically meaningful new treatment option for patients and doctors and to become the first product indicated specifically for the treatment of active Behçet’s Disease with oral ulcers.”

Apremilast is not approved for the treatment of Behçet’s Disease in any country.

About the RELIEF Study

The RELIEF™ study is a phase III randomized, placebo-controlled, double-blind study evaluating apremilast 30 mg BID in 207 patients with active Behçet’s Disease who were previously treated with at least one topical or systemic medication. This 52-week study was conducted at 63 sites across 10 countries. The primary endpoint was the area under the curve (AUC) for the number of oral ulcers at week 12. Secondary objectives of the study included change from baseline in pain of oral ulcers, Behçet’s Syndrome Activity Score, Behçet’s Disease Current Activity Index and Behçet’s Disease quality of life score at week 12.

About Behçet’s Disease

Although the root cause is unknown, Behçet’s Disease is associated with abnormalities of the immune system and inflammation of the blood vessels. Behçet’s Disease is characterized by recurrent oral and genital ulcers, skin lesions, uveitis, arthritis, vasculopathy, and central nervous system and gastrointestinal involvement.

Prevalence of Behçet’s Disease is highest in the Middle East, Asia and Japan. Behçet’s Disease has been classified in the U.S. as a rare or “orphan” disease by the National Institutes of Health. At this time, there are no approved therapies to treat Behçet’s Disease in the U.S.

About OTEZLA ®

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

INDICATIONS

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

OTEZLA is indicated for the treatment of adult patients with active psoriatic arthritis.

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

Psoriatic Arthritis: Treatment with OTEZLA is associated with an increase in depression. During clinical trials, 1.0% (10/998) reported depression or depressed mood compared to 0.8% (4/495) treated with placebo. Suicidal ideation and behavior was observed in 0.2% (3/1441) of patients on OTEZLA, compared to none in placebo treated patients. Depression was reported as serious in 0.2% (3/1441) of patients exposed to OTEZLA, compared to none in placebo treated patients (0/495). Two patients who received placebo committed suicide compared to none on OTEZLA

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

Psoriatic Arthritis: Body weight loss of 5-10% was reported in 10% of patients taking OTEZLA and in 3.3% of patients taking 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)

Psoriatic Arthritis: Adverse reactions reported in at least 2% of patients taking OTEZLA, that occurred at a frequency at least 1% higher than that observed in patients taking placebo, for up to 16 weeks (after the initial 5-day titration), were (OTEZLA%, placebo%): diarrhea (7.7, 1.6); nausea (8.9, 3.1); headache (5.9, 2.2); upper respiratory tract infection (3.9, 1.8); vomiting (3.2, 0.4); nasopharyngitis (2.6, 1.6); upper abdominal pain (2.0, 0.2)

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: @Celgene, Pinterest, LinkedIn, Facebook 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:
Patrick E. Flanigan III, 908-673-9969
Corporate Vice President, 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

Villa Built as a ‘Private Museum’ in Lucca, Tuscany to Sell at Auction without Reserve via Concierge Auctions26.4.2019 16:12:00 EESTTiedote

Leading global marketplace Concierge Auctions is to sell Villa Angelina, an expansive villa and estate overlooking the picturesque walled city of Lucca, Italy. The property has been meticulously built with great expense, care and attention to detail in creating a private home suitable to display the owner’s collection of art masterpieces. As a result, it offers the highest level of contemporary design. Initially listed at €28million, Villa Angelina will sell without reserve to the highest bidder on 30 May. Bidding will open on 28 May. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190426005306/en/ (Photo: Business Wire) Villa Angelina offers 29,600 square feet (2,750 square metres) of accommodation within the main house, in addition to a further 12,700 square feet (1,180 square metres) of terraces. The light filled interiors include three large reception rooms, three master bedroom suites, a catering kitchen, office, cinema,

P&G Partners to Improve Environmental Impact and Smallholder Livelihood in Palm Oil Supply Chain26.4.2019 16:00:00 EESTTiedote

In celebration of Earth Week and to further its commitment to drive a more sustainable future, the Procter & Gamble Company (NYSE:PG) announced a new collaboration with Malaysia Institute for Supply Chain Innovation (MISI), International Plant Nutrition Institute (IPNI) and Yara International to help improve the livelihood of smallholders within the P&G palm supply chain in Malaysia. After a successful pilot ran between 2015 and 2018, the Company is expanding the program that partners with independent palm oil smallholders to increase their overall fruit yields through the training and implementation of best-in-class, and more sustainable agricultural practices. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190426005048/en/ To further our commitment to drive a more sustainable future, P&G has announced a new collaboration with MALAYSIA INSTITUTE FOR SUPPLY CHAIN INNOVATION (MISI), INTERNATIONAL PLANT NUTRITION INSTITUTE (IP

5 Modern Residences That Preserve and Showcase Artisanship26.4.2019 15:55:00 EESTTiedote

HONG KONG: K11 ARTUS This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190426005291/en/ Mr. Adrian Cheng, Founder of K11, Executive Vice-Chairman and General Manager of New World Development with Ms. Joyce Wang, internationally acclaimed interior designer for the K11 ARTUS penthouse. Following the launch of the hotly anticipated Rosewood Hong Kong in the art and design district Victoria Dockside, entrepreneur Adrian Cheng will unveil K11 ARTUS in the third quarter of this year, marking his fledging K11 group’s first luxury residence for rental, one with a social agenda to preserve fast-disappearing traditional craftsmanship. In the communal spaces is where the artisanal-living concept is truly apparent, filled as they are with pieces that have been produced in collaboration with K11 Craft & Guild Foundation, the latest of Cheng’s cultural initiatives, which seeks to protect craftsmanship techniques from the Ming and Qing dynast

Velodyne Expert Addresses How Lidar Boosts Business Value of Mobile Mapping Applications26.4.2019 15:00:00 EESTTiedote

Frank Bertini, UAV and Robotics Business Manager at Velodyne Lidar, Inc. (booth #1420), will deliver a featured presentation on the business cases for 3D lidar technology in mobile mapping applications at AUVSI XPONENTIAL 2019, taking place on April 29 to May 2, at McCormick Place in Chicago. Bertini will discuss revenue-generating strategies created by adding lidar to drones, backpacks, and all-terrain vehicles (ATV) to build autonomous solutions. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190426005065/en/ Velodyne lidar sensors help systems developers by providing rich computer perception data that enables high-performing mapping systems in a lightweight, versatile solution. (Photo: Business Wire) Bertini’s session, “Emerging Autonomous Applications for 3D Lidar,” will provide a technical overview of industrial applications for lidar onboard unmanned systems. The presentation focuses on emerging use-cases which are cre

Celgene Corporation and Acceleron Pharma Announce Submission of Luspatercept Marketing Authorization Application to the European Medicines Agency (EMA) for MDS and Beta-Thalassemia26.4.2019 14:30:00 EESTTiedote

Celgene Corporation (NASDAQ: CELG) and Acceleron Pharma Inc. (NASDAQ: XLRN) today announced that Celgene has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for luspatercept for the treatment of adult patients with very low to intermediate-risk myelodysplastic syndromes (MDS)-associated anemia who have ring sideroblasts, require red blood cell (RBC) transfusions and have received or are not eligible for erythropoiesis-stimulating agents, and for the treatment of adult patients with beta-thalassemia-associated anemia who require RBC transfusions. Luspatercept is an investigational erythroid maturation agent that regulates late-stage red blood cell maturation. The safety and efficacy results provided in the application are from the pivotal phase 3 studies MEDALIST and BELIEVE, evaluating the ability of luspatercept to effectively address anemia associated with MDS and beta-thalassemia, respectively. “As a first-in-class erythroid maturation ag

SES: First Quarter 2019 Results26.4.2019 09:00:00 EESTTiedote

SES S.A. announced its financial results for the three months ended 31 March 2019 with revenue and EBITDA in line with company expectations and SES on track to deliver on its 2019 financial outlook. Continued focus on execution has delivered major wins in the Networks business which is soon to be enhanced with the addition of four new O3b satellites, successfully launched at the beginning of April 2019. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190425005955/en/ First Quarter 2019 Results Key financial highlights Reported revenue of EUR 480.6 million, (down 2.3% at constant FX(1)) in line with SES’ expectations Underlying revenue(2) of EUR 473.9 million; down 3.1%(1) (Video: -7.3%(1,2) and Networks +5.4%(1,2)) EBITDA of EUR 290.1 million representing a margin of 60.4% (Q1 2018: 63.7%); 62.1% excluding restructuring charge Net profit attributable to SES shareholders of EUR 72.2 million Free Cash Flow before financing acti

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