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Ventrus Biosciences has endeavored to acquire a late-stage product candidate portfolio with balanced risk. It consists of one new chemical entity and two previously approved molecules under development for new and patentable topical gastrointestinal (GI) uses.
The three late-stage GI product candidates that Ventrus Biosciences has licensed are:
VEN 307
Diltiazem cream for relief of pain associated with anal fissure
Ventrus Biosciences has met with the US Food and Drug Administration (FDA) regarding VEN 307 and is scheduled to submit an investigational new drug (IND) application in the second quarter of 2008. Ventrus Biosciences plans to initiate Phase 3 trials of VEN 307 in the United States in the second quarter of 2008. Ventrus Biosciences has licensed North American rights for diltiazem cream from United Kingdom (UK)-based S.L.A. Pharma and will work closely with this company to optimize the product’s clinical development plan.
VEN 308
Phenylephrine gel for treatment of fecal incontinence associated with ileal pouch anal anastomosis (an FDA orphan indication)
Ventrus Biosciences has met with the FDA regarding VEN 308 and is scheduled to submit an IND application in the second quarter of 2008. Ventrus Biosciences plans to initiate a US/UK Phase 2b dose-ranging study for VEN 308 in the first quarter of 2008. Ventrus Biosciences has licensed North American rights for phenylephrine gel from S.L.A. Pharma. Additional fecal incontinence populations will be investigated after FDA approval.
VEN 309
Iferanserin ointment for treatment of hemorrhoids
Iferanserin ointment has an active IND submission file at the FDA. Based on a February 5, 2008, meeting with the FDA, Ventrus Biosciences is preparing a special protocol assessment request. Ventrus Biosciences plans to initiate the first Phase 3 trials for iferanserin ointment early in the fourth quarter of 2008. Ventrus Biosciences has licensed worldwide rights for iferanserin ointment for anorectal uses from Sam Amer and Co.
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