Regulatory Filings • Mar 2, 2012
Regulatory Filings
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Company Announcement No. 6/2012
Copenhagen, Denmark and Lugano, Switzerland – 2 March 2012 – Zealand Pharma A/S (NASDAQ OMX Copenhagen: ZEAL), a Danish biopharmaceutical company dedicated to the discovery and development of innovative peptide drugs, and Helsinn, a Swiss pharmaceutical group, announce that the first patients have been dosed in a Phase IIa study of elsiglutide (ZP1846) for the prevention of chemotherapy-induced diarrhea in cancer patients. Elsiglutide is a potent and selective glucagon-like-peptide-2 (GLP-2) agonist invented by Zealand Pharma and licensed to Helsinn.
The Phase IIa study is a randomized, double-blind and placebo-controlled proof-of-concept study to assess the efficacy and safety of elsiglutide for the prevention of chemotherapy-induced diarrhea (CID) in colorectal cancer patients receiving 5-fluorouracil (5-FU)-based chemotherapy. In the study, elsiglutide is administered subcutaneously in parallel with 5-FU. The Phase IIa study is conducted by Helsinn and plans to enroll 138 cancer patients in approximately 20 centers across European countries.
"GLP-2 agonists are gaining attraction as a novel class of drugs for the treatment of gastrointestinal diseases, and we are excited about the progress that Helsinn has made, now advancing our invention, elsiglutide, into Phase II. Many cancer patients suffer from severe diarrhea as a consequence of their chemotherapy treatment, and our drug candidate has shown promising potential as a novel treatment for this disorder. Helsinn has a strong presence in the cancer supportive care market and is an ideal partner on elsiglutide. This marks another exciting achievement for Zealand Pharma with further progress for our peptide drug pipeline."
"Helsinn is committed to working not only for the health of the Patient, but overall for the quality of life of the Person. One of our strategic corporate goals is to investigate and develop treatments for cancer supportive care, a medical area with many unmet needs. Helsinn made available palonosetron, the new generation 5-HT3 receptor antagonist for chemotherapy induced nausea and vomiting; for the same condition Helsinn is now developing the oral fixed-dose combination of palonosetron and netupitant, a highly selective NK1 receptor antagonist; our ghrelin receptor agonist anamorelin is under evaluation for the treatment of anorexia and cachexia in patients with advanced non-small cell lung cancer. We are
Zealand Pharma A/S Page 1 of 3
Zealand Pharma and Helsinn announce the advance of elsiglutide into Phase II for the prevention of chemotherapyinduced diarrhea in cancer patients
Helsinn is also completing a Phase Ib study of elsiglutide in Europe under an Investigational New Drug (IND) with the US Food and Drug Administration (FDA) so far showing that the drug candidate is safe and well tolerated at doses above the expected therapeutic dose in colorectal cancer patients.
Elsiglutide is covered by a license agreement between Zealand Pharma and Helsinn Healthcare, under which Helsinn has worldwide exclusive rights to the product in the area of cancer supportive care. Under the agreement, Helsinn is responsible for all further clinical development, regulatory approvals, manufacturing, marketing and sales of elsiglutide, and Zealand Pharma is eligible to milestone payments of up to EUR 140 million in addition to royalties on sales of elsiglutide. Zealand Pharma holds an option to obtain sales and marketing rights for the product in the Nordic countries.
To date, Zealand Pharma has received EUR 13 (DKK 97) million, of which EUR 3 million were received in December 2011. Zealand Pharma will receive an additional EUR 1 million in March 2012, relating to Helsinn's continuously positive development of elsiglutide.
Financial guidance for 2012 will be provided by the company in connection with the 2011 full year announcement on 15 March 2012.
David H. Solomon, President & CEO, Tel: +45 2220 6300 Hanne Leth Hillman, Vice President for IR & Corporate Communication, Tel: +45 5060 3689, email: [email protected]
Paola Bonvicini, Head of Communication & Press Office Tel: +41 91-985-21-21 [email protected]
Elsiglutide is a novel, potent and selective glucagon-like-peptide-2 (GLP-2) agonist. GLP-2 is a 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 by promoting regeneration of the epithelial surface in this indication damaged by chemotherapy, the underlying cause of chemotherapy-induced diarrhea.
Zealand Pharma A/S Page 2 of 3
Zealand Pharma and Helsinn announce the advance of elsiglutide into Phase II for the prevention of chemotherapyinduced diarrhea in cancer patients
Zealand Pharma A/S is a public (NASDAQ OMX: ZEAL) biopharmaceutical company based in Copenhagen, Denmark with a mature clinical pipeline of innovative peptide based drugs. The company's lead product is lixisenatide (Lyxumia® 1)), a once-daily GLP-1 agonist for the treatment of Type 2 diabetes, invented by Zealand Pharma and licensed to Sanofi. In November, Sanofi submitted a marketing authorization application (MAA) for lixisenatide in Europe and submission for regulatory approval in the United States is expected in Q4 2012. Zealand Pharma also has a collaboration with Boehringer Ingelheim covering dual acting glucagon/GLP-1 agonists, including ZP2929, for the treatment of diabetes and obesity, and a license agreement with Helsinn Healthcare on elsiglutide, a clinical stage GLP-2 drug for the treatment of chemotherapy-induced diarrhea.
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. Zealand Pharma's products target disease areas where existing treatments fail to adequately serve patient needs and where the market potential for improved treatments through the use of peptide drugs is high. For further information: www.zealandpharma.com.
Note 1) Lyxumia® is the intended trademark for lixisenatide. Lixisenatide is not currently approved or licensed anywhere in the world.
Helsinn is a privately owned pharmaceutical group with headquarters in Lugano, Switzerland, and operating subsidiaries in Ireland and the USA. Helsinn's business model is focused on the licensing of pharmaceuticals, medical devices and food supplements in therapeutic niche areas. The Group in-licenses early to late stage new chemical entities, completes their development from the performance of pre-clinical/clinical studies and Chemistry, Manufacturing and Control (CMC) development to the filing for and attainment of their market approval worldwide. Helsinn's products are out-licensed to its network of local marketing and commercial partners, selected for their deep in-market knowledge and know-how, and assisted and supported with a full range of product and scientific management services, including commercial, regulatory, financial, legal and medical marketing advice. The active pharmaceutical ingredients and the finished dosage forms are manufactured at Helsinn's cGMP facilities in Switzerland and Ireland, and supplied worldwide to its customers. For more information about Helsinn Group, please visit the website: www.helsinn.com
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