• SIGMOID and Dr. Falk have entered into an exclusive license, development and option agreement to advance Sigmoid’s SmPill® cyclosporine franchise in Europe
  • Dr. Falk has made an up-front equity investment in SIGMOID in connection with the signing of the license agreement
  • SIGMOID to receive significant development funding, clinical, regulatory and sales milestone payments plus double-digit tiered royalties under the agreement as well as clinical and operational support

DUBLIN, Ireland, April 04, 2017 (GLOBE NEWSWIRE) -- SIGMOID PHARMA LIMITED, a privately-owned pharmaceutical company developing innovative therapeutics for gastrointestinal and immunological diseases using its proprietary SmPill® solid oral drug delivery platform, announced today that it has entered into an agreement with Dr. Falk Pharma GmbH to advance Sigmoid’s SmPill® cyclosporine franchise for ulcerative colitis, graft versus host disease and other gastrointestinal diseases. The terms of the agreement include an upfront equity investment in Sigmoid, development funding, milestone payments as well as tiered double-digit royalties for the future development and commercialization of CyCol®, AlloCol® and related products in Europe. Sigmoid retains the rights to these programs outside of Europe and Canada. This collaboration with Dr. Falk in Europe will serve as an important catalyst to Sigmoid advancing its pipeline to patients in territories including the United States and Japan.

Dr. Ivan Coulter, Chief Executive Officer of Sigmoid, said: “Dr. Falk Pharma GmbH has pioneered the development of innovative treatments for inflammatory bowel disease since it introduced the world’s first mesalamine product, Salofalk®, in 1984. We are delighted to continue the founding vision of the late Dr. Herbert Falk and to extend his legacy to one that will benefit patients with moderate-to-severe disease. I look forward to partnering with a company that has the knowledge, experience and deep clinical and commercial insights that Dr. Falk Pharma GmBH 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, Managing Director of Dr. Falk Pharma GmbH, commented: “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.”

About Dr. Falk Pharma GmbH
Dr. Falk Pharma GmbH is one of the leading companies worldwide in gastroenterology with its products being sold in more than 60 countries. Its pharmaceuticals are used successfully to treat inflammatory bowel disease, cholestatic liver disease, irritable bowel syndrome, constipation, and for colon cleansing prior to colonoscopies. The Falk Foundation, which is associated with the company, provides medical information via international symposia, forums, postgraduate courses and literature services. Over the past 45 years the Falk Foundation has sponsored more than 200 international Falk symposia and workshops in which over 100,000 researchers and physicians from 110 countries have come together to advance knowledge in gastroenterology and hepatology. For more information, refer to http://www.drfalkpharma.com/.

About Sigmoid Pharma
Sigmoid Pharma is a private Irish pharmaceutical company developing innovative therapeutics for gastrointestinal and immunological diseases. The Company’s Single-Multiple Pill (SmPill®) technology is a versatile drug delivery platform for optimizing the formulation of active therapeutic agents to allow targeted release at the site of gastrointestinal disease or modulate systemic exposure. Sigmoid’s lead pipeline program is CyCol®, a colon-targeted, non-systemic formulation of cyclosporine. Pendopharm, a Division of Pharmascience, Inc. has exclusive rights to commercialize CyCol® in Canada and Pharmascience, Inc. has been a strategic investor in Sigmoid since 2014. Sigmoid retains all global rights outside of Europe and Canada. For additional information please visit: http://www.sigmoidpharma.com

About CyCol®
CyCol® is SIGMOID’s proprietary oral formulation of solubilized 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 pivotal studies to provide a unique orally-administered alternative within the existing range of ulcerative colitis treatments.

About AlloCol®
AlloCol® is SIGMOID’s proprietary oral formulation of solubilized cyclosporine that has received orphan designation from the US Food and Drug Administration for the prevention and treatment of graft versus host disease following allogeneic stem cell transplantation.

Forward-Looking Statements
This press release contains forward-looking statements. Such forward-looking statements involve substantial risks and uncertainties. We have tried, wherever possible, to identify such statements by using words such as “will,” “may,” “could,” “likely,” “ongoing,” “anticipate,” “estimate,” “expect,” “project,” “intend,” “plan,” “believe,” “target,” “forecast,” “goal,” “objective,” “aim” and other words and terms of similar meaning or by using future dates in connection with any discussion thereof.  In particular, statements, express or implied, concerning future actions, conditions or events, future operating results, the future success of clinical trials, the ability to obtain required regulatory approval for certain drug therapies, the ability to generate sales, and the anticipated income or cash flow from certain products, are forward-looking statements. We cannot guarantee that any forward-looking statement will be realized, although we believe we have been prudent in our plans and assumptions. Achievement of anticipated results is subject to substantial risks, uncertainties and inaccurate assumptions. Should known or unknown risks or uncertainties materialize, or should underlying assumptions prove inaccurate, actual results could vary materially from past results and those anticipated, estimated or projected. You should bear this in mind as you consider forward-looking statements, and you are cautioned not to put undue reliance on forward-looking statements. We undertake no obligation to publicly update forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

For further information contact:
Leo Toole
Chief Financial Officer
Sigmoid Pharma Ltd, 
Phone +353 (0) 1 700 7511 
E-mail: info@sigmoidpharma.com

US Investors:
Andrew McDonald Ph.D.
LifeSci Advisors LLC
E-mail: andrew@lifesciadvisors.com