Celgene has brought in a high-priced experimental drug it thinks has blockbuster potential. In April, the Summit, New Jersey–based big biotech paid dearly to get Nogra's GED-0301 for treating Crohn's disease and other gastrointestinal disorders. The price for GED-0301, a late-stage antisense drug, includes $710 million upfront—more than the combined upfront payments for all the technologies and product candidates licensed in its mainstay cancer franchise, where the vast bulk of its investments have been to date. The move, for a drug probably still five years from the clinic, shows the big biotech's confidence in this antisense technology, but seeking tax refuge outside of US may also have played into the high price of the deal with Dublin-based Nogra. GED-0301 is a first-generation synthetic single-stranded O,O-linked phosphorothioate oligonucleotide that binds the region 107–128 of the human Smad7 complementary DNA sequence. It contains two CpG motifs that have been chemically modified to avoid immunostimulatory effects. High levels of Smad7 amplify inflammatory signals in the gut of patients with Crohn's disease by blocking the immunosuppressive activity of transforming growth factor-1. Nogra completed a 166-patient phase 2 trial of the molecule in active Crohn's. GED-0301 has shown a “consistently high response rate and rate of remission after just four weeks of treatment,” according to Scott Smith, president of inflammation and immunology. “I think you see here the coupling of the antisense technology with [a] delivery system that delivers the drug right on site in the gut,” he said on a call discussing the deal with analysts. GED-0301 adds to Celgene's immunology franchise, which recently launched Otezla (apremilast), the first phosphodiesterase-4 inhibitor approved for treating a psoriatic condition (Nat. Biotechnol. 32, 505, 2014).
Jacqualyn Fouse, Celgene CFO when the deal was struck (she was subsequently promoted to president of hematology and oncology), called the bidding process for GED-0301 “highly competitive.” Some reckon the bidding war was sparked partly by Ireland's attractive corporate rate (roughly one-third of the US rate). That would attract buyers wishing to relocate their businesses there for tax reasons. Nogra itself changed its name from Giuliani International, a part of the Giuliani group, a specialty pharmaceutical operation in Italy focused on gastroenterology and dermatology, and set up an Irish identity in 2012.
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