Quote:
slcimmuno Member Level Thursday, 06/22/17 07:37:36 PM
Re: BioTechMaven post# 186895
Post # of 186903

Yep IPIX Data hitting real soon

To revisit the Protagonist / J&J IBD deal ... the IBD space one of the "hottest" ...

If the Brilacidin 3rd cohort delivers remission rates (50%) similar to the first two cohorts, with Endoscopy images / vids to support the claim of mucosal healing, gotta think that some Rx will want to move

And all this along w B OM and Prurisol interim and those PASI 75 numbers we're all waiting on

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$50m upfront w up $940m tied to Ph2 Milestones: "J&J will pay Protagonist $125 million if it moves the drug into phase 2b and a further $200 million if it sticks with the asset after getting a look at data from the trial. The rest of the cash is tied to regulatory and sales milestones."

http://www.fiercebiotech.com/biotech/j-j-comm...ohn-s-drug

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The vote marked a shot across the bow in the IBD market, which – along with its major components of ulcerative colitis (UC) and Crohn's disease – ranks as one the hottest indications in the GI disease space.

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Excluding generics, nearly 200 medicines are approved to treat GI disorders, including nearly 100 in the U.S., according to Cortellis Competitive Intelligence. Approximately 650 additional agents are advancing through biopharma pipelines, with half still at the discovery stage.

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Although TNF alpha inhibitors still lead the list of clinical trials for drugs targeting IBD, UC and Crohn's, and glucocorticoid agonists appear in the top 10, biopharmas are quickly moving on to other mechanisms

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Competition in the field is fierce, and that's a principal factor underlying wariness about the introduction of biosimilars. Several biopharmas with significant IBD programs declined even to talk about them, including Celgene Corp., which gained a giant foothold in the space with last year's $7.2 billion pick-up of Receptos Inc. (See BioWorld Today, July 16, 2015.)

"Needless to say, we are thrilled to be in the IBD space as we expand our [inflammation and immunology] franchise," spokeswoman Cathy Cantone told BioWorld Insight. "However, both GED-0301 and ozanimod in IBD are only in phase II, so it seems a bit early to comment."

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The trajectory of innovation in IBD suggests that "the future is about tailoring the therapy to the profile of the patient or the disease," Detrick told BioWorld Insight. "We're looking forward to lots of changes scientifically, especially as we begin to understand the microbiome."

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IBD, in contrast, is "a true inflammatory process" marked by physical changes – erosion and color changes in the tissue along with rectal bleeding, blood in the stools and related symptoms – that are aren't seen in IBS, where the tissues look normal, he added. Although IBD also is a painful disease, drugs typically target inflammation as the causative factor.

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Uceris (budesonide) the oral corticosteroid for mild to moderate UC, was approved in 2013. Uceris was developed by Santarus Inc., which quickly went for $2.6 billion to Salix Pharmaceuticals Ltd.,

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Many in the field cited a new spirit of openness about GI disorders for bringing deserved attention to the unmet medical need in the space.

http://stateofinnovation.com/disruptive-scien...-gi-market