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Press Release

Sigmoid Pharma Completes Phase II trial of CyCol™ in more than 100 Ulcerative Colitis Patients and Raises €3 million

Sigmoid Pharma Ltd.
Posted on: 17 May 12

Sigmoid Pharma Ltd. (Sigmoid), a privately-owned, specialty pharmaceutical and drug delivery company registered in Ireland, today provides an update on significant progress in 2011 and 2012. Sigmoid’s AGM takes place today at 5 pm GMT

  • Product development pipeline update CyCol™, Sigmoid’s lead candidate for ulcerative colitis has completed a Phase II multi-centre, placebo-controlled, randomised clinical trial in more than 100 patients. Plans are underway to further evaluate CyCol™ in pivotal clinical trials.
  • Technology development update Sigmoid’s SmPill™ proprietary oral drug delivery technology has demonstrated benefit in
    • targeting delivery of poorly soluble drugs to the GI tract
    • improving permeability and oral bioavailability of peptides
    • facilitating oral delivery of vaccines in dosage forms that are stable at room temperature.
  • Organisational update Sigmoid has appointed Thomas G. Lynch as Chairman of the board, Gerard Ryan as a non-executive Director of the board, Dr. David Roblin as Chief Medical Officer, and Rosemarie Tully as Chief Business Officer.
  • Medical and Scientific Expert Committee established Sigmoid has secured the support of leading international thought leaders in gastroenterology and immunology who will advise on the appropriate development of CyCol™ and Sigmoid’s follow on gastrointestinal disease and vaccine pipeline programmes.
  • Financial Update Sigmoid has closed a private financing round of over €3 million (US $4 million) in Q1 2012. Andreas McConnell of Philip Lee Solicitors advised Sigmoid in the fund-raising. Sigmoid has secured EU FP7 funding as part of the ADITEC Advanced immunization technologies consortium and TRANS-INT oral nanomedicine consortium.

Dr. Ivan Coulter, founder and CEO of Sigmoid said “I am delighted with the significant progress made at Sigmoid over the past 18 months, and believe Sigmoid is well positioned as we transition from pre-proof of concept stage to an emerging speciality pharmaceutical company with the promise of meaningful therapeutic interventions for unmet patient needs as well as having advanced drug delivery technologies to address the ongoing industry challenges of poor aqueous solubility, poor permeability, gastrointestinal targeting and product stability”.

Thomas G. Lynch, chairman of the Board of Sigmoid said “Sigmoid is at a very exciting stage and is poised for growth on a number of fronts. I look forward to being involved in steering Sigmoid’s evolution towards a revenue-generating, profitable pharmaceutical company that can bring real benefits to patients and people at risk of disease in the developed and developing word.

”Dr. David Roblin commented “After leaving Pfizer, I decided to work with companies that I believe are advancing exciting science and technologies with a strong likelihood of bringing important new medicines to patients and value to investors. I was attracted to Sigmoid because of the team’s innovative approach rooted in sound scientific evidence. Building on its broadly-applicable SmPill™ oral drug delivery technology as well as a deep understanding of gastrointestinal disease, Dr. Coulter and his team have the potential to bring new treatment options to patients in areas of clinical practice where these breakthroughs can have real impact.”

About CyCol™ colon-targeted cyclosporine for ulcerative colitis

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%. While these differences were not statistically significant, statistical significance was achieved in clinically-relevant sub-populations representing over 60% of the enrolled population. Sigmoid is currently designing follow on trials and exploring collaboration opportunities for this product.

About SmPill™ oral drug delivery technology

Sigmoid Pharma has developed an innovative oral drug delivery technology called SmPill™; a modular, flexible and powerful technology that addresses many of the challenges of formulating a wide range of active pharmaceutical ingredients. SmPill™ technology has the ability to enhance solubility, permeability and stability while also targeting release to specific regions of or throughout the gastrointestinal tract. SmPill™ is broadly applicable to all molecule types including small molecules, and large molecules such as proteins, peptides and vaccines. SmPill™ technology is suitable for all BCS classes from potent, highly-soluble, highly-permeable drugs to poorly-soluble, poorly-absorbed molecules. SmPill™ is also suitable for unique combination variations with targeted release to enhance disease management and enable drugs to be repositioned for use in new disease indications.

Sigmoid’s SmPill™ technology is being evaluated in a number of EU and Irish government-funded research consortia, including the EU-funded FP7 ADITEC Advanced Immunization Technologies collaborative research programme consortium and the TRANS-INT oral nanomedicine consortium, as well as the Irish Drug Delivery Network (“IDDN”), a Strategic Research Cluster funded by Science Foundation Ireland

About Dr. Ivan Coulter

Dr. Coulter is the founder and CEO of Sigmoid and has extensive experience in translational research, project management and business development Prior to founding Sigmoid, Dr. Coulter set up, developed and managed the drug formulation and diagnostics groups at NTera, a nanotechnology-focused company. Dr. Coulter has an honours degree and PhD in Pharmacology from University College Dublin, held a Post-Doctoral Fellowship at the Institut Curie, Paris and was awarded a Fulbright Scholarship to complete an MBA at Cornell University, New York. While at Cornell, Dr. Coulterconsulted to Nautilus Biotech SA, advising on its successful Series A fund-raising. In addition, while completing his PhD, Dr. Coulter was awarded a Diploma in Accounting and Finance by the Association of Chartered and Certified Accountants (ACCA). Dr. Coulter was appointed to the board of Bord Iascaigh Mhara, headed the Seafood Innovation Council, chairs the Nutramara scientific council and is a member of the Irish Research Council.

About Thomas G. Lynch

Mr Lynch is a graduate in economics from Queen's University Belfast and qualified as a Chartered Accountant with KPMG in 1983, becoming a partner in 1990. He began his career in the pharmaceutical industry three years later, initially taking up the position of Chief Finance Officer at Elan Corporation plc. In this role he led the company’s transformation to biopharmaceuticals through a number of product and corporate acquisitions.

Mr Lynch continued at Elan working in a variety of capacities until 2004 when he acquired the company’s stake in Amarin Corporation plc. Mr Lynch served on the Board of Amarin from 2000, first as Elan's nominee and from 2004, as principal shareholder. At that time, Amarin was conducting clinical research into neurological diseases. However, following the failure of a late stage programme in Huntington's Disease, he was appointed CEO and successfully turned the company around by repositioning it into cardiovascular disease and establishing a clinical development operation in Connecticut, USA. During his tenure as CEO, Mr. Lynch raised $100 million to fund clinical development. Having obtained the agreement of the Food and Drugs Administration to go straight to Phase 3 clinical trials, which proved successful, he stepped down as CEO of the company in October 2009 and as Chair in January 2010. Mr. Lynch serves on the boards of a number of public and private biotechnology firms and pro-bono boards in healthcare, the arts and academia.

About Dr. David Roblin

Dr. Roblin has gained extensive experience in the pharmaceutical industry in a career spanning more than 15 years, which has seen him deliver several drugs to the market. He has held leadership roles in Pfizer and Bayer across a wide range of therapy areas in research, development and commercial arenas. At Pfizer, Dr. Roblin was most recently Senior Vice President, Head of Research and Site Head for R&D. Before joining Pfizer as Head of the Company’s European Clinical Research and Development organisation, Dr. Roblin held the position of Head of Anti-Infectives at Bayer Medical Affairs. Dr. Roblin previously practiced medicine and is a Fellow of the Royal College of Physicians and Member of the Faculty of Pharmaceutical Physicians.

In addition to Dr. Roblin’s leadership roles in pharma, he has also chaired the Research Director’s Group of the European Federation of Pharmaceutical Industries and Associations (EFPIA), and was a co-founder of the Innovative Medicines Initiative, a $2bn public-private partnership with the European Commission. He is currently an advisor to NOCRI in the NHS, Chief Medical Officer at Creablis SA and Destiny Pharma and an advisor to a number of venture funds.

About Rosemarie Tully

Ms. Tully’s career encompasses more than thirteen years in business development, strategy and project management in the pharmaceutical industry and in management consulting. Most recently Ms. Tully was Senior Director, Corporate Development at Elan Corporation, plc. Prior to that, at McKinsey & Company, Ms. Tully advised pharmaceutical companies and healthcare organisations on strategic, operational and market access topics. Before McKinsey, Ms Tully held a number of roles in commercial and business development at Elan Drug Delivery and Elan Pharmaceuticals. Ms. Tully is a registered pharmacist and a Member of the Pharmaceutical Society of Ireland, completed her honours B.Sc. (Pharm) degree at Trinity College, Dublin, Ireland and her MBA at INSEAD, France.

For additional information please visit http://www.sigmoidpharma.com

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Last updated on: 17/05/2012

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