Celgene Acquires Late-Stage Product for Crohn’s Disease and Other
- GED-0301 is a First-in-Class, Oral Antisense Drug Targeting Smad7 mRNA
- Phase III Program for Crohn’s Disease Targeted to Begin by Year-End 2014
SUMMIT, N.J. -- April 24, 2014
Celgene Corporation (NASDAQ:CELG) entered into a global license agreement with
Nogra Pharma Limited, a private pharmaceutical company based in Dublin,
Ireland, to develop and commercialize GED-0301, an oral antisense DNA
oligonucleotide targeting Smad7 mRNA for the treatment of moderate-to-severe
Crohn’s disease and other indications.
A double-blind, placebo-controlled, multicenter phase II trial of three doses
of GED-0301 in 166 patients with active Crohn’s disease has been completed.
The data have been submitted to a major medical journal and will be presented
at an upcoming medical congress. Based upon these results, Celgene plans to
initiate a phase III registration program by year-end 2014.
“GED-0301 is a potentially transformative therapy that demonstrated striking
clinical activity in a phase II trial for Crohn’s disease,” said Scott Smith,
Senior Vice President and Global Head of Inflammation and Immunology. “It
strengthens our expanding pipeline of novel therapies intended to address
significant unmet medical need in immune-mediated diseases.”
Under the terms of the license agreement, Nogra Pharma Limited will receive an
upfront payment of $710 million, regulatory, development and net sales
milestone payments and tiered royalties. Aggregate payments for regulatory and
development milestones could potentially be $815 million for multiple
indications. Starting from global annual net sales levels of $500 million,
aggregate tiered sales milestones could total a maximum of $1,050 million if
annual net sales reach $4,000 million.
The license agreement will become effective upon the expiration or termination
of the applicable waiting period under the Hart-Scott-Rodino Antitrust
Improvements Act of 1976, as amended.
Celgene Corporation, headquartered in Summit, New Jersey, is an integrated
global biopharmaceutical company engaged primarily in the discovery,
development and commercialization of novel therapies for the treatment of
cancer and inflammatory diseases through gene and protein regulation. For more
information, please visit www.celgene.com.
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.
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and our other reports filed with the Securities and Exchange Commission.
Patrick E. Flanigan III, 908-673-9969
Vice President, Investor Relations
Brian P. Gill, 908-673-9530
Vice President, Corporate Communications
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