2010: Sigmoid Pharma
Inaugural winner with a gut feeling for drug delivery
There's no such thing as an overnight success in the world of biopharmaceutical development.
But for Irish company Sigmoid Pharma, several years of researching, developing and testing therapeutics based on its drug-delivery technology mean the firm is now heading for a new dawn.
The company, which was founded in 2003 and won The Irish Times InterTradeIreland Innovation Award in 2010, now has a lead compound for ulcerative colitis heading into phase three clinical trials and it's making headway with a vaccine against the gastric bug Helicobacter pylori.
The gut is the "first frontier" for many drugs in the body, explains Sigmoid chief executive Dr Ivan Coulter, and the company has identified new ways to get drugs into that frontier.
“Our focus has always been how can we position our technology to sit between other technologies and areas of research,” he says. “And we have been particularly focused on the gastrointestinal tract and getting medications to go to where they are needed to treat a range of gastrointestinal diseases, disorders and infections.”
Sigmoid’s lead compound is CyCol, a formulation of cyclosporine.
It’s an old drug, but the company has taught it a new trick: thanks to the formulation, the medicine can be targeted to the regions of the gut affected by inflammation, explains Coulter.
Sigmoid, which is based at the Invent Centre in Dublin City University, is now ramping up to a phase three trial of CyCol in ulcerative colitis, a disease in which the colon becomes inflamed.
The trial is set to involve around 500-600 patients in the US and Europe and it will look at how the drug performs in the short term to induce remission and over the period of a year to maintain remission, explains Coulter.
“People are excited about it because it has the potential to be the first oral product to be approved to treat moderate to severe ulcerative colitis,” he says, adding that he expects to know the results by 2017.
But he’s not waiting that long to plan for scaling up production, and he anticipates that much of the scale-up would happen in Ireland. “We are fortunate, there are a lot of experienced people in Ireland, we don’t have to look too far.”
Vaccines, too, are in the company’s sights, and Sigmoid is involved in developing a protective agent against H.pylori, a bacterium that burrows into the stomach lining where it can increase the risk of ulcers and, to a lesser extent, gastric cancer.
“The mucosal lining there is very receptive to modulation, so it is a good region for inducing an immune response and thus an appropriate target for vaccine development,” says Coulter. “It is a question of making sure you get the components to where they are most likely to work in the right blend.”
Other products in development include agents to target graft-versus-host disease and Crohn’s disease.
Coulter, who has a PhD in pharmacology from University College Dublin, has long taken the approach of working with academic research groups in Ireland and internationally, and Sigmoid is currently involved with the Science Foundation Ireland centres AMBER, which focuses on nanomaterials, and the Alimentary Pharmabiotic Centre, which looks at the gut microbiota.
To date Sigmoid has been supported largely by private investment, and Coulter is looking at options to fund and support late-stage development.
“The IPO window for biopharma companies is very open at the moment,” he says. “And we are at an exciting stage in the company’s development – we have largely de-risked our lead programme and we are focused on manufacture scale-up and late-stage clinical development. That is where you want to be, that is where the action is.”
- CLAIRE O’CONNELL
2011: InTune
Remaining 'positive' as investment drive follows redundancies
Four months on from headlines that the company was to deny 70 laid off staff their final month's pay as well as their redundancies, InTune Networks chief marketing officer, Richard Brandon, is keen to set the record straight. "I can clarify that, they were paid," he says.
"There was a certain amount of uncertainty at the time," he tells The Irish Times , "which is perhaps where that misinformation came out of."
The facts still make for stark reading though. Those 70 layoffs were part of a forced “restructure” of the company, which had a peak of 130 employees but now operates with a staff of 40 based mainly in Dublin, after additional redundancies in the company’s Belfast offices.
The December reports told of a €10 million deficit between assets and liabilities leading to shareholders appointing Brian McEnery of BDO as receiver.
For a company which former CEO, Tim Fritzley wanted to "become the Nokia of Ireland" (back when being the Irish Nokia was a great thing to be) it was a difficult fate to face.
Despite reports of a “collapse” though, the 2011 winner of The Irish Times InterTradeIreland Innovation of the Year award is still operating.
“There will be turns in the road yet,” says Brandon. “I can’t predict the future any better than anyone else but I feel very positive about it.”
So what exactly happened at the company, which had received an estimated €60 million-plus in backing since its foundation from sources such as Enterprise Ireland, the ESB's Novusmodus clean-tech and renewable energy investment fund, and Twitter investors Spark Capital among others?
The award came after over a decade of work by its founders, John Dunne and Tom Farrell, who hit upon the idea while doing a research project on photonics in UCD back in 1999.
In 2011 the company brought its highly anticipated Optical Packet Switch and Transport (OPST) “next generation networking technology” to market as part of a product line called Verisma.
The technology enables cloud computing infrastructure to be distributed over hundreds of kilometres, and Brandon tells how in the aftermath of picking up the innovation award, InTune “sold systems and deployed them in one of the world’s largest carriers” based in the US.
A majority stake in a spin-out sensor development business FAZTech Research was also sold to Dutch multinational R&D company, Fugro NV.
However, perhaps the key reason for the necessary restructure was the fact that, having built a product aimed at “very large customers”, InTune found that “those customers always go slower than you think they’re going to” when it comes to investment decisions.
Now, says Brandon, the company finds itself in “a trading receivership which is a voluntary arrangement the company has gone into with the agreement of its investors”.
There was a rumour of a firm offer of investment soon after the arrival of McEnery, but it was apparently turned down. Brandon claims there is no “immediate time pressure” from BDO to find investment, though he “won’t put a number” on the funding required to keep the company moving on into 2015 and beyond.
For the moment, he notes that many backers including the Dermot Desmond-founded International Investment and Underwriting (IIU) and Cork-based investment firm Kernel Capital "are continuing to put significant investment" in to the company.
OPST remains the focal point of the business, and despite their travails Branson tells how since 2011 “the market [is] moving toward the product” more than OPST being forced to change to suit market forces.
The technology is, he says, “extremely suitable for building out cloud IT infrastructure which obviously is something that’s been gaining a lot of traction in the last few years”, and he reveals that a “Fortune 100 banking-type” potential customer is close to entering a trial period with the company.
Software-defined networking (SDN), the increasingly popular approach to designing, building and managing networks, also presents a large opportunity for InTune according to Brandon.
The technology developed by the company is a “perfect way of extending SDN across distance”, he says – a “complicated” problem that has up until now seen SDN mostly being “implemented inside the data centre”.
Other current work includes a €3.3 million partnership with ESB for work within the EU-backed FINESCE smart energy project which focuses on future internet technologies.
“We are solving a problem that the market has to have solved,” says Brandon. Now, he adds, it’s time to “look for the right kind of deal for the company and our employees”.
–JJ WORRALL
Next week: 2012 winner Gabriel Scientific on going global and 2013 winner Trustwater moves into Middle East
