Helsinn Healthcare's Top management announced that it has signed a partnering agreement with Zealand Pharma, for the development and worldwide commercialization of ZP1846, a GLP-2 (glucagon-like peptide-2) receptor agonist which provides a novel way to treat chemotherapy-induced diarrhoea (CID), a debilitating condition affecting patients undergoing cancer treatment with a range of chemotherapies.
Under the terms of the agreement, Helsinn Healthcare will receive a worldwide exclusive license to ZP1846 and will be responsible for all further development, regulatory approvals, manufacturing, marketing and sales of the compound either on its own or through its sub-licensees. In return Helsinn Healthcare will pay Zealand Pharma development milestones and sales milestones for an undisclosed amount. In addition, Zealand Pharma will receive royalties on future sales and Zealand Pharma retains the marketing rights to the Nordic countries. The total value of the non royalty portion of the partnership is valued at EUR 140 million.
Zealand Pharma has applied its knowledge of peptide optimization and its proprietary SIP(r) technology to develop ZP1846, one of a series of novel peptides that specifically enhance the growth and function of the lining of the intestine. ZP1846 has completed Phase I in humans in the US. Zealand Pharma's pre-clinical studies have demonstrated that ZP1846 is useful in the prevention and/or treatment of injuries to the intestinal epithelium caused by chemotherapy treatment, resulting in a reduction in the incidence of chemotherapy-induced diarrhoea. Today, serious gastrointestinal side effects are observed in up to 50 per cent of patients undergoing certain forms of chemotherapy, which in turn may require dose modification or cessation of cancer chemotherapy.
"We are excited about this promising development and commercial cooperation with Zealand Pharma, which represents another important step in broadening and strengthening Helsinn Healthcare's pipeline of cancer supportive care products. We are confident that ZP1846 will be an important contribution to the treatment of chemotherapy-induced diarrhoea, currently an unmet medical need and consequently, a positive impact on patients' quality of life. We believe that Helsinn's constant investment in R&D and in life-cycle activities of new and current products in this therapeutic area will allow us to fulfill our commitment to deliver benefits to the medical community and to alleviate the suffering of patients worldwide," commented Dr Riccardo Braglia, Helsinn Healthcare's chief executive officer.
"Diarrhoea is a debilitating and potentially life-threatening side-effect of chemotherapy. Despite its high incidence and severity it is often under recognized and poorly managed: current available treatments are only palliative. CID remains therefore a huge unmet medical need. ZP1846 has a tremendous therapeutic potential by virtue of its unique mechanism of gut growth stimulation and reduction of gut atrophy and weight loss induced by the mucosal toxicity of chemotherapy. This project gives us the extraordinary opportunity to develop an agent that could prevent and/or treat CID enabling the best possible cancer treatment and reducing patients' morbidity," commented Dr. Sergio Cantoreggi, Senior Director, Head of Helsinn Healthcare's R&D.
Mogens Vang Rasmussen, executive vice president, chief operating officer and chief financial officer of Zealand Pharma commented: "Being able to partner ZP1846 with Helsinn Healthcare once again demonstrates Zealand Pharma's ability to bring innovative peptide projects from idea to clinical development and partnering. This agreement is the third major agreement concluded within the 10 year period Zealand Pharma has been operating and these important deals highlight the exciting compounds that our unique approach to drug discovery and development delivers. This approach, which combines a creative R&D culture and a strong focus on commercialization, has enabled us to successfully progress ZP1846 from discovery through to clinical trials in just four years, creating significant value for our shareholders."
Dr. David Solomon, chief executive officer of Zealand Pharma further commented: "We are delighted to be able to work with Helsinn on the development and commercialization of ZP1846. Helsinn Healthcare has a very strong worldwide presence in the cancer supportive care treatment area where ZP1846 will be a very important product in the prevention and/or treatment of injuries to the intestinal epithelium caused by chemotherapy treatment."
About chemotherapy-induced diarrhoea
Chemotherapy-induced diarrhoea is a serious debilitating condition affecting patients undergoing treatment with anti-cancer therapies and this gastrointestinal injury may lead to serious complications such as malnutrition, sepsis, dehydration and kidney insufficiency.
There is a strong need for drugs that are able to prevent or treat the mucosal damage and eliminate the diarrhoea induced by chemotherapy, and we believe that ZP1846 is useful treatment and/or prevention of an unmet medical need like chemotherapy-induced diarrhoea.
Helsinn Healthcare is a privately owned pharmaceutical group with headquarters in Switzerland. Helsinn Healthcare's core business is the licensing of pharmaceuticals in therapeutic areas (oncology, cancer supportive care, pain and inflammation, gastrointestinal).