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

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.

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