Dr. Falk Pharma is making an equity investment in Irish firm Sigmoid Pharma as part of an exclusive license, development, and option deal centered on developing Sigmoid’s Single-Multi Pill (SmPill®) cyclosporine products, including its lead firm’s CyCol® and AlloCol® candidates, for indications including graft versus host disease (GvHD), ulcerative colitis, and other gastrointestinal diseases, in Europe. In addition, Sigmoid will be eligible for development funding, milestone payments, and future tiered double-digit sales royalties. Financial details were not disclosed.

Specialty pharmaceutical firm Sigmoid is developing its SmPill drug delivery platform to formulate encapsulated drugs for targeted gastrointestinal delivery. Lead candidate CyCol is a colon-targeted, nonsystemic formulation of cyclosporine, which is poised to start in Phase III studies in Europe and North America for inducing remission and the maintenance of remission in patients with moderate-to-severe ulcerative colitis.

The firm’s AlloCol product, for immediate and controlled cyclosporine release, has been granted orphan drug designation by the FDA for the GvHD prevention and treatment indication. A Phase I pharmacokinetic study with AlloCol has been completed. A third Sigmoid clinical candidate, CyLow™, is an immediate-release cyclosporine for potential applications in the prevention of transplant rejection, and psoriasis, and has also undergone a Phase I pharmacokinetic study.

Sigmoid said the European deal with Dr. Falk will serve as a springboard to help it advance its pipeline to patients in other territories, including the U.S. and Japan. Commenting on the Dr. Falk agreement, Ivan Coulter, Ph.D., Sigmoid CEO, said, “I look forward to partnering with a company that has the knowledge, experience, and deep clinical and commercial insights that Dr. Falk Pharma possesses through what I believe will be a transformational collaboration for Sigmoid. The signing of this partnership is sure to be a key inflection point on Sigmoid’s growth trajectory.”

Ursula Falk, M.D., managing director at Dr. Falk Pharma, added, “Colon-targeted cyclosporine promises to improve the benefit/risk ratio of this molecule and holds great potential in the management of ulcerative colitis. The innovative galenical formulation developed by Sigmoid is suitable to improve patient outcomes and to avoid the use of biologics and corticosteroids.”

Pendopharm, a division of Pharmascience, negotiated exclusive rights to commercialize CyCol in Canada, in 2014. As part of the deal, Pendopharm made a €5 million in Sigmoid to support future Phase III development and manufacturing scale up. Sigmoid retains all global rights to its products outside of Europe and Canada. In February 2016, the firm acquired Ireland-based drug delivery firm Freund Pharmatech, to expand its manufacturing capacity.








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