Business Wire

Celgene to Present New Data on Investigational Compounds at UEGW and ACG Congresses

Del

Celgene Corporation (NASDAQ:CELG) today announced that findings from clinical trials of investigational compounds GED-0301 (mongersen), ozanimod and RPC4046 will be presented at the United European Gastroenterology (UEG) Week, October 15-19, in Vienna, Austria. Ozanimod and RPC4046 data will also be included at the American College of Gastroenterology (ACG) Annual Scientific Meeting, October 14-19, in Las Vegas.

Among the data that will be presented is an ongoing, exploratory phase 1b study of GED-0301, an oral compound being investigated for active Crohn’s disease. The ongoing study is evaluating the effects of three different regimens of oral GED-0301 on both endoscopic and clinical outcomes in patients with active Crohn's disease in a 12-week treatment phase, followed by an observation (off treatment) phase of up to 52 weeks. The study was designed to further enhance the understanding of GED-0301 activity in a difficult-to-treat, moderate-to-severe patient population. The data were accepted as a late breaking oral presentation at UEG Week.

An analysis of the open-label extension of the TOUCHSTONE trial will evaluate the efficacy and safety of daily 1 mg oral ozanimod, an investigational selective S1p 1 and 5 receptor modulator, through week 44 of the open label extension in patients with moderate to severe ulcerative colitis. The 32 week double-blind placebo-controlled phase of TOUCHSTONE evaluated the efficacy and safety of 0.5 mg and 1 mg doses of ozanimod compared with placebo in patients with moderate to severe active ulcerative colitis. Results from this induction and maintenance phase of the trial have been previously reported. The open-label extension phase included TOUCHSTONE participants from all three treatment arms who either did not respond to treatment after the induction phase, relapsed during the maintenance phase or completed the maintenance phase. These results will be featured in an oral presentation at both ACG and UEG Week.

Results from the phase 2 HEROES dose-ranging study will evaluate the efficacy and safety of RPC4046 in patients with active eosinophilic esophagitis (EoE), a rare but potentially serious allergic/immune disorder for which there are currently no approved treatments. RPC4046 is an investigational humanized monoclonal antibody that binds with high selectivity to both subunits (alpha 1 & 2) of the IL-13 receptor. The data will be featured in an oral presentation at both ACG and UEG Week.

“GED-0301, ozanimod and RPC4046 have the potential to be transformational therapies for people with inflammatory bowel diseases and other serious gastrointestinal diseases, and we are excited about these new data,” said Scott Smith, President, Celgene Inflammation & Immunology. “Celgene’s strong presence at the UEGW and ACG congresses underscores our commitment to providing new, innovative therapies to patients worldwide.”

The following abstracts will be presented at United European Gastroenterology (UEG) Week (all times, CET and EDT):

Abstracts at a Glance

Oral Presentations:
Abstract #OP108; Monday, October 17, 2016, 4:57 PM CET / 10:57 AM EDT
Safety and Efficacy of Long-Term Treatment with Ozanimod, and Oral S1P Receptor Modulator, in Moderate to Severe Ulcerative Colitis: TOUCHSTONE Extension; Brian Feagan
Location: Room C

Abstract #LB16; Tuesday, October 18, 2016, 12:27 PM CET / 6:27 AM EDT
A Randomized, Double-Blind, Multicenter Study to Explore the Efficacy of Oral GED-0301 (Mongersen) on Endoscopic Activity and Clinical Effects in Both TNF-Naive and TNF-Experienced Subjects with Active Crohn’s Disease; Brian Feagan
Location: Room M

Abstract #OP325; Wednesday, October 19, 2016, 9:06 AM CET / 3:06 AM EDT
A Randomised, Double-Blind, Placebo-Controlled Trial of a Novel Recombinant, Humanised, Anti-Interleukin-13 Monoclonal Antibody (RPC4046) in Patients with Active Eosinophilic Oesophagitis: Results of the HEROES Study; Ikuo Hirano
Location: Room M

Poster Presentation:
Abstract #P1423; Wednesday, October 19, 2016, 9:00 AM – 2:00 PM CET / 3:00 – 8:00 AM EDT
Effects of High- and Low-fat Meals on the Pharmacokinetics of Ozanimod, a Novel Sphingosine 1-Phosphate Receptor Modulator; Jonathan Tran
Location: Poster Exhibition - Hall X4 and X5

The following abstracts will be presented at American College of Gastroenterology (all times, CET and EDT):

Abstracts at a Glance

Oral Presentations:
Abstract #19; Tuesday, October 18, 5:30 PM CET / 11:30 AM EDT
A Randomised, Double-Blind, Placebo-Controlled Trial of a Novel Recombinant, Humanised, Anti-Interleukin-13 Monoclonal Antibody (RPC4046) in Patients with Active Eosinophilic Oesophagitis: Results of the HEROES Study; Evan Dellon
Location: Exhibit Hall C

Abstract #30; Tuesday, October 18, 2016, 5:50 PM CET / 11:50 AM EDT
Safety and Efficacy of Long-Term Treatment with Ozanimod, and Oral S1P Receptor Modulator, in Moderate to Severe Ulcerative Colitis: TOUCHSTONE Extension; William Sandborn
Location: Exhibit Hall C

Poster Presentation:
Abstract #P1146; Monday, October 17, 2016, 7:30 PM – 1:00 AM CET / 1:30 – 7:00 PM EDT
Effects of High- and Low-fat Meals on the Pharmacokinetics of Ozanimod, a Novel Sphingosine 1-Phosphate Receptor Modulator; Paul Frohna
Location: Exhibit Hall C

About GED-0301

The investigational oral antisense therapy GED-0301 is an oligonucleotide designed to target the messenger RNA (mRNA) for Smad7, thereby reducing Smad7 protein levels. In patients with Crohn’s disease, abnormally high levels of Smad7 interfere with TGF-β1 anti-inflammatory pathways in the gut, leading to increased inflammation. GED-0301 is designed to act locally to reduce Smad7 levels with negligible systemic exposure.

GED-0301 is an investigational compound that is not approved for any use in any country.

About Ozanimod

Ozanimod is a novel, oral, selective sphingosine 1-phosphate 1 and 5 receptor modulator in development for immune-inflammatory indications including inflammatory bowel disease and relapsing multiple sclerosis. Treatment with S1P receptor modulators is believed to work by interfering with S1P signaling and preventing a certain subtype (ccr7+) of lymphocytes (a type of white blood cell) from exiting the lymph nodes and contributing to tissue inflammation.

Ozanimod is an investigational compound that is not approved for any use in any country.

About RPC4046

RPC4046 is a humanized monoclonal antibody directed against interleukin-13 (IL-13), a target that has been validated in other related allergic indications. IL-13, produced by the immune system, is known to cause changes in the esophagus that lead to inflammation. RPC4046 binds an IL-13 epitope that prevents its binding to both the alpha 1 and alpha 2 subunits of the IL-13 receptor.

RPC4046 is an investigational compound that is not approved for any use in any country.

About Celgene

Celgene Corporation, headquartered in Summit, New Jersey, is an integrated global biopharmaceutical 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. Celgene undertakes 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 Celgene’s 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 Celgene’s Annual Report on Form 10-K and our other reports filed with the U.S. Securities and Exchange Commission.

###

Contact information

For inquiries, please contact:
Celgene Corporation
Investors:
Patrick E. Flanigan III, 908-673-9969
Corporate Vice President, Investor Relations
or
Media:
Catherine Cantone, 732-564-3592
Senior Director, Corporate Communications

Om Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982http://www.businesswire.co.uk

(c) 2018 Business Wire, Inc., All rights reserved.

Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.

Følg saker fra Business Wire

Registrer deg med din epostadresse under for å få de nyeste sakene fra Business Wire på epost fortløpende. Du kan melde deg av når som helst.

Siste saker fra Business Wire

JPMorgan Chase Bank announces the placement of cash-settled exchangeable bonds into Ping An Insurance (Group) Company of China Limited due 202017.7.2018 19:40Pressemelding

NOT FOR DISTRIBUTION IN OR INTO THE UNITED STATES OR TO, OR FOR THE ACCOUNT OR BENEFIT OF, U.S. PERSONS (AS DEFINED IN REGULATION S UNDER THE U.S. SECURITIES ACT OF 1933) OR IN OR INTO JAPAN, THE PEOPLE’S REPUBLIC OF CHINA, SWITZERLAND OR ANY OTHER JURISDICTION IN WHICH SUCH DISTRIBUTION WOULD BE PROHIBITED BY APPLICABLE LAW. JPMorgan Chase Bank, N.A. (the “Issuer”) today announces the placement of cash-settled exchangeable bonds due 2020 (the “Bonds”) in aggregate principal amount of USD 350 million. The Bonds are referable to H-shares (the “Shares”) of Ping An Insurance (Group) Company of China Limited (the “Company”). Exchange rights in respect of the Bonds will be cash-settled only. The Bonds will be issued in principal amounts of USD 200,000 and integral multiples of USD 100,000 in excess thereof and will not bear interest. The Bonds will be issued with an issue price of 100% and will redeem at par on 30 December 2020. The initial exchange price (the “Initial Exchange Price”) will

Boston Capital Announces Closing of Boston Capital Income & Value U.S. Apartment Fund17.7.2018 14:00Pressemelding

Boston Capital, the third largest owner of apartments in the U.S. with over $19.6 billion invested, is pleased to announce the final investor closing of Boston Capital Income and Value U.S. Apartment Fund (“BCIV”). BCIV, a discretionary multi-investor Luxembourg based fund vehicle, includes financial institutions, insurance companies, pensions, and family offices among its investors and will acquire over $350 million in apartment properties throughout the U.S. “We are very pleased to close BCIV, the latest in a succession of institutional investment vehicles through Boston Capital’s conventional apartment investment arm, Boston Capital Real Estate Partners (“BCRE”),” said Jeff Goldstein, COO and Director of Real Estate at Boston Capital. The Fund generates high current dividends and capital growth by acquiring and renovating Class B apartment properties located in major and secondary U.S. markets and by targeting a renovated rental price point well below new construction rates, which a

Amobee Wins Auction Process to Acquire Videology Assets17.7.2018 13:13Pressemelding

Singtel subsidiary Amobee, a leading global digital marketing technology company serving brands and agencies, today announced that it has emerged as the winner in the court supervised auction to acquire certain assets from Videology, a software provider for advanced TV and video advertising, for purchase price of approximately US$101 million1. The purchase price is subject to adjustments for accounts receivable at closing, estimated to be approximately US$20.9 million. The acquisition, following Videology’s voluntary Chapter 11 restructuring proceedings, includes Videology’s technology platform, intellectual property and certain other assets of estimated net book value of US$5.3 million2. Over the past decade, Videology has emerged as a leading provider of software that empowers advertisers and publishers to use data to optimize campaigns and spend across digital platforms and television. The addition of Videology’s capabilities will be a further boost to Amobee’s omni-channel platform

Lenovo Leaps Forward with Next-Generation ThinkAgile Composable Cloud Platform17.7.2018 12:00Pressemelding

Lenovo Data Center Group (HKSE: 992) (ADR: LNVGY), one of the fastest growing hyperconverged infrastructure (HCI) vendors according to IDC, – with HCI revenue growing at almost twice the market growth rate in Q1 2018 (149.1% compared to 76.3%)—is further expanding its ThinkAgile portfolio to provide an innovative solution for customers who desire the agility of the public cloud and the security of a private cloud. To address this growing customer trend, Lenovo – together with Cloudistics – has developed the ThinkAgile CP Series composable cloud platform, a ‘cloud-in-a-box’ that offers all of the conveniences and ease-of-use of a public cloud environment secured behind the customer’s own data center firewall. Lenovo ThinkAgile CP Series – with fully-integrated infrastructure, application marketplace and end-to-end automation of software-defined network, compute and storage – delivers a turnkey cloud experience that can be easily and centrally managed from anywhere through a software-as-

JPMorgan Chase Bank launches offering of cash-settled exchangeable bonds into Ping An Insurance (Group) Company of China Limited due 202017.7.2018 12:00Pressemelding

NOT FOR DISTRIBUTION IN OR INTO THE UNITED STATES OR TO, OR FOR THE ACCOUNT OR BENEFIT OF, U.S. PERSONS (AS DEFINED IN REGULATION S UNDER THE U.S. SECURITIES ACT OF 1933) OR IN OR INTO JAPAN, THE PEOPLE’S REPUBLIC OF CHINA, SWITZERLAND OR ANY OTHER JURISDICTION IN WHICH SUCH DISTRIBUTION WOULD BE PROHIBITED BY APPLICABLE LAW. JPMorgan Chase Bank, N.A. (the “Issuer”) today announces the launch of an offering of cash-settled exchangeable bonds due 2020 (the “Bonds”) in aggregate principal amount of up to approximately USD 350 million. The Bonds are referable to H-shares (the “Shares”) of Ping An Insurance (Group) Company of China Limited (the “Company”). Exchange rights in respect of the Bonds will be cash-settled only. The Issuer is rated A+ (Stable outlook) by Standard & Poor’s, Aa3 (Stable outlook) by Moody’s and AA (Stable outlook) by Fitch. The Bonds will be issued in principal amounts of USD 200,000 and integral multiples of USD 100,000 in excess thereof and will not bear interest.

Greene Tweed Achieves Nadcap Accreditation for Non-Metallic Materials Testing17.7.2018 11:01Pressemelding

Greene Tweed’s Central Engineering (CE) Materials Test Lab recently completed its final Nadcap accreditation audit for Non-Metallic Materials Testing (NMMT) of composite materials. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180717005200/en/ Greene Tweed Achieves Nadcap Accreditation (Photo: Greene Tweed) In support of Aerospace’s strategic initiative, this positions Greene Tweed as one of a select few aerospace companies who have attained this accreditation as validation of our materials testing capabilities and our position as a composite solutions provider. To achieve this standard, Greene Tweed’s CE lab completed a comprehensive audit against the highest standards for special process controls, test completion, and validation. This in-house accreditation adds to Greene Tweed’s responsiveness to new product development requests while expanding production material and customer product certification capabilities. It also