Zealand Pharma A/S, a Danish biopharmaceutical company dedicated to the discovery and development of innovative peptide drugs, has received EUR 3 (DKK 22.3) million in milestone payments under a license agreement with Helsinn Healthcare for the development of elsiglutide (ZP1846). Elsiglutide is a novel GLP-2 peptide agonist, discovered by Zealand Pharma and licensed to Helsinn Healthcare for the treatment of diarrhoea induced by chemotherapy in cancer patients.
Helsinn Healthcare is completing a phase Ib study with elsiglutide in Europe to evaluate its safety and tolerability and find the maximum tolerated dose in colorectal cancer patients. The phase Ib study is conducted under an Investigational New Drug application with the US Food and Drug Administration (FDA) and final study completion is expected in Q1 2012. In parallel, Helsinn is preparing a phase IIa study to evaluate the efficacy of elsiglutide in the primary prevention of diarrhoea in colorectal cancer patients receiving chemotherapy.
David Solomon, president and CEO of Zealand Pharma, commented: “We are pleased with the progress of the elsiglutide programme by our partner Helsinn Healthcare and with the data so far indicating that elsiglutide is safe and well tolerated. Peptides make excellent drugs, and we look forward to Helsinn's continued development of this novel Zealand-discovered GLP-2 peptide agonist for the treatment of cancer patients suffering from severe diarrhoea.”
In November 2008, Zealand Pharma out-licensed worldwide exclusive rights to elsiglutide (ZP1846) to Helsinn Healthcare, a global cancer supportive care company. Under the agreement between Zealand Pharma and Helsinn, Helsinn is responsible for all further development, regulatory activities, manufacturing, marketing and sales of elsiglutide. Zealand Pharma is eligible to receive milestone payments of up to EUR 140 million, of which EUR 13 (DKK 97) million has been received (including the payments announced today). and to royalties on Helsinn Healthcare's global sales of elsiglutide. Zealand Pharma also holds an option to obtain sales and marketing rights for the Nordic countries.
The milestone payments of EUR 3 million (DKK 22.3 million) do not change Zealand Pharma's financial guidance for 2011 of DKK 170 (EUR 23) million in revenues and other income and total operating expenses of DKK 170 (EUR 23) million.
Elsiglutide is a novel, potent and selective glucagon-like-peptide-2 (GLP-2) receptor agonist. GLP-2 is a naturally occurring peptide hormone produced primarily by the small intestine. It is secreted in response to food ingestion and acts by binding to the GLP-2 receptor, which is predominantly found in the gastrointestinal tract. GLP-2 plays a key role in intestinal growth and formation and has shown the ability to promote the regeneration of the epithelial surface damaged by chemotherapy, the underlying cause of chemotherapy-induced diarrhoea.
Zealand Pharma specializes in the discovery, optimization and development of novel peptide drugs, and all drug candidates in its pipeline have been identified through the company's own drug discovery activities.