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Celgene to pay Nogra $710M up front for phase III-ready Crohn’s therapy

By Randy Osborne, Staff Writer

Celgene Corp. is paying $710 million up front to privately held Nogra Pharma Ltd. in Dublin to develop and commercialize GED-0301, an oral antisense DNA oligonucleotide targeting Smad7 mRNA for the treatment of moderate-to-severe Crohn’s disease (CD) and other indications.

Also part of the deal are regulatory, development and net sales milestone payments and tiered royalties. Total payout if all regulatory and development goals are met could go as high as $815 million for multiple indications. Sales milestones starting from global annual sales of $500 million could reach more than $1 billion, if sales hit the $4 billion mark.

CEO Robert Hugin told investors during a morning conference call on first-quarter earnings that Nogra has completed a 166-patient phase II trial and submitted the data to a major medical journal, with plans to disclose the data during an upcoming scientific conference. A phase III trial is planned to start this year.

ISI Group analyst Mark Schoenebaum, in an email alert to investors, noted “encouraging” data in a published phase I trial, but said the study “was not placebo-controlled and is thus very difficult to interpret,” since placebo responses can be high in experiments testing CD candidates.

Smad7 has long been under investigation for its role in gastrointestinal illness. In 2007, Nature Genetics published a paper titled, "A genome-wide association study shows that common alleles of Smad7 influence colorectal cancer risk." Hugin said the Nogra therapy shows “exceptional” promise in CD.

Scott Smith, global head of inflammation and immunology, said the Nogra drug, with its “unique mechanism and profile” could “significantly transform the treatment of CD.” He characterized the yet-to-be disclosed phase II data as “exciting,” with a “consistently high response rate and rate of remission after just four weeks of treatment.” Although he did not provide a start date, Smith said the company will “work aggressively toward beginning the phase III trial later this year.”

Celgene said it acquired rights to GED-301 in a competitive process. First-quarter earnings proved in line with expectations, wrote Credit Suisse analyst Ravi Mehrotra. Celgene’s stock (NASDAQ:CELG) was trading mid-morning at $139.16, down $5.66.

See Friday's BioWorld Today for More on This Story.