Date: 2014-09-29
Type of information: Licensing agreement
Compound: CyCol®
Company: Sigmoid Pharma (Ireland) Pendopharm (Canada)
Therapeutic area: Gastrointestinal diseases - Digestive diseases
Type agreement:
Action mechanism: CyCol® is an oral formulation of solubilised cyclosporine targeted to the site of disease in the colon.CyCol®offers potential for a new, safe and effective approach to treat and manage ulcerative colitis. Sigmoid has completed a number of clinical trials evaluating CyCol® in healthy volunteers and ulcerative colitis patients and plans to advance CyCol® into Phase 3 studies to provide a unique orally-administered alternative withintheexisting range of ulcerative colitis treatments.CyCol™ is Sigmoid’s proprietary formulation that delivers cyclosporine orally in its optimal form, targeted directly to the site of action in the colon, to offer potential for a new safe and effective approach to treat and manage ulcerative colitis. By delivering cyclosporine directly to the colon in SmPill™ format Sigmoid has shown that systemic absorption of cyclosporine can be limited while local activity can be retained. This should result in enhanced safety and tolerability while retaining or enhancing efficacy. In 2011, Sigmoid completed a multi-centre trial in Ireland and the United Kingdom enrolling 118 patients. Results in this short four week treatment period using a once-daily, low dose regimen provided encouraging proof of principle that met the safety endpoint of no difference between treatment and placebo arms. A difference was observed in efficacy between treatment and placebo arms, with a remission rate in CyCol™ group of 13.2% compared to a remission rate in the placebo group of 6.3% and a reduction in Disease Activity Index score ? 3 in CyCol™ group of 30.4% compared to a reduction in the placebo group of 18.8%.
Disease:
Details: * On September 29, 2014, Sigmoid Pharma, a privately-owned, specialty pharmaceutical and drug delivery technology company registered in Ireland, and Pendopharm, a division of Pharmascience Inc., headquartered in Montreal, Canada, have entered into agreements concerning a licence for exclusive rights to commercialise CyCol® in the Canadian market and an equity investment in Sigmoid. Under the licence agreement, Sigmoid has received an upfront payment and will be eligible for future milestone payments in addition to significant double-digit, tiered royalties on net sales in Canada. Pursuant to the licence agreement, Pendopharm has invested €5 million in Sigmoid at a premium to the most recent fundraising in 2014. The investment will support the advancement of CyCol® into Phase 3 clinical trials; mainly the scale up of Sigmoid’s manufacturing process for CyCol® and the underlying SmPill® drug delivery technology. David Goodman, CEO of Pharmascience Inc. will join the Sigmoid board of directors.
Financial terms: Under the licence agreement, Sigmoid has received an upfront payment and will be eligible for future milestone payments in addition to significant double-digit, tiered royalties on net sales in Canada. Pursuant to the licence agreement, Pendopharm has invested €5 million in Sigmoid at a premium to the most recent fundraising in 2014.
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