Sigmoid Pharma signs landmark deal with Dr Falk Pharma

Speciality drug group Sigmoid Pharma has signed a landmark partnership with one of the biggest players in gastrointestinal therapy. The deal with family-owned Dr Falk Pharma will see the German business invest in Sigmoid up-front, as well as working with the company to commercialise its lead pipeline products.

Sigmoid is using technology developed in-house to transform the use of cyclosporine to more effectively treat patients with moderate to severe ulcerative colitis.

In Ireland about 20,000 people suffer from ulcerative colitis and, another inflammatory condition of the gut, Crohn’s disease. The suspicion is that under-reporting means the figure could be much higher.

"As patients move from mild to moderate or severe, the type of drug used changes as well, and currently for moderate to severe ulcerative colitis, the only drugs approved are biologics, namely drugs that are antibodies in form such as Remicade, Humira and Entyvio," said Sigmoid founder and chief executive Ivan Coulter.

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“And the issue with most of those is that they are given by injection and go through the entire body. They cause immunosuppression throughout the body just to get the effect in the gut.”

He said Sigmoid’s CyCol drug, using its SmPill technology, can target “very powerful drugs directly to the colon, so the drug interacts with the disease tissue . . . without any side effects. So CyCol has tremendous potential to meet significant unmet needs for these patients”.

Key driver

Tapping into the expertise of Dr Falk in late-stage development and commercialisation was, said Dr Coulter, a key driver in the partnership, as CyCol enters critical phase three trials this year.

While Dr Coulter would not be drawn on the value of the licence arrangement, he highlighted the “very powerful validation” the involvement of Dr Falk brought Sigmoid.

“One of the great things about doing a deal with Dr Falk is that everyone is aware that they are the leader in gastrointestinal innovation and everyone will be aware they will have done extensive diligence of Sigmoid, of the drug and of the technology,” he said. “In many ways, it will bring a lot of visibility to Sigmoid.”

Globally, the market for ulcerative colitis and Crohn’s is considered to be worth about $4 billion (€3.75 billion) and growing strongly, as what were traditionally seen as western diseases become more prevalent in fast-developing economies to the east. Sigmoid has said previously it believes its drug has the potential to secure sales of $500 million.

The agreement comes as Sigmoid embarks on a significant fundraising programme. The company, which has raised roughly €35 million since it was founded in 2003, is looking to raise a further $40 million.

However, Dr Coulter said the investment by Dr Falk Pharma would go a good part of the way towards meeting the company’s target.

Apart from the up-front investment, Dr Falk has promised funding for the continued development of Sigmoid’s lead projects, milestone payments and tiered double-digit royalties from the future commercialisation of CyCol.