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Zealand Pharma and Helsinn Healthcare SA Sign a €140 Million (US$176.8 Million) Partnering Agreement for ZP1846, a Novel GLP-2 Agonist


12/1/2008 11:21:36 AM

COPENHAGEN, DENMARK--(Marketwire - November 27, 2008) - Summary: Zealand Pharma A/S and Helsinn Healthcare SA today announced that it has signed a partnering agreement, 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 diarrhea (CID), a debilitating condition affecting patients undergoing cancer treatment with a range of chemotherapies.

Deal terms

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 has retains the marketing rights to the Nordic countries. The total value of the non royalty portion of the partnership is valued up to EUR 140 million.

ZP1846

Zealand Pharma has applied its knowledge of peptide optimization and its proprietary SIP® technology to develop ZP1846, one of a series of novel peptides that specifically enhances the growth and function of the lining of the small intestine. ZP1846 has completed Phase I clinical studies in humans in the US.

Zealand's pre-clinical studies have demonstrated that ZP1846 inhibits chemotherapy-induced injury in the small intestine, and as a result also reduces the incidence and severity of chemotherapy-induced diarrhea.

Today, serious gastrointestinal side effects are observed in up to 50% of patients undergoing certain forms of chemotherapy, which in turn may require dose modification or cessation of cancer chemotherapy.

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'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 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 Healthcare on the development and commercialization of ZP1846. Helsinn Healthcare is in a process to build a very strong worldwide presence in the cancer supportive care treatment area where ZP1846 will be an important product to ameliorate the destructive effects of the chemotherapy on the small intestine and reduce the severity of diarrhea."

"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 diarrhea, 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.

"Diarrhea 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.

About chemotherapy-induced diarrhea

Chemotherapy-induced diarrhea is a serious debilitating adverse reaction 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 diarrhea induced by chemotherapy, and we believe that ZP1846 is useful treatment and/or prevention of an unmet medical need like chemotherapy-induced diarrhea.

Further information

Mogens Vang Rasmussen, Executive Vice President, Chief Operating Officer and Chief Financial Officer, IT & Communications

Zealand Pharma A/S, Smedeland 36, DK-2600 Glostrup, Denmark T +45 4328 1200 F +45 4328 1212 E info@zp.dk www.zealandpharma.com About Zealand Pharma

Zealand Pharma is a biopharmaceutical company dedicated to the discovery and development of innovative peptide-based drugs. Zealand is one of the leaders within the peptide area, a growing market with significant drug development activities including treatment of metabolic and cardiovascular diseases. All of Zealand's products target diseases and symptoms of significant unmet clinical need and commercial potential.

Since 1999, Zealand's scientists have built a pipeline that includes five compounds in clinical development, three of which have been out licensed to major pharmaceutical companies (Sanofi-Aventis, Wyeth and Helsinn). All Zealand's compounds emerge from Zealand's own drug discovery.

* AVE0010/ZP10, a pharmaceutical agent for the treatment of Type 2 Diabetes, has been out-licensed to Sanofi-Aventis, which is the world's third largest pharmaceutical corporation with a strong diabetes franchise. Phase III clinical trials were initiated in May 2008.

* ZP120 is an ORL-1 receptor agonist. Zealand has all the rights to the drug, which is currently in Phase II clinical development.

* GAP-134/ZP1609; a gap junction modifier that prevents both ventricular and atrial arrhythmias in animal models. With its oral formulation, the molecule represents a novel paradigm for the potential chronic prevention of atrial arrhythmias. US based pharmaceutical giant Wyeth Pharmaceutical is currently conducting Phase I trials in the US.

* ZP1846 is an innovative treatment for prevention of chemotherapy-induced diarrhea, which may prevent discontinuation and dose modification during cancer chemotherapy. The compound has been partnered with Helsinn.

* ZP1848 is a novel paradigm for the treatment of Inflammatory Bowel Diseases (e.g. Crohn's Disease). The compound is in late preclinical development.

In addition, Zealand has a rich and broad portfolio of pre-clinical projects targeting a variety of disease areas, including osteoporosis and obesity-related diabetes.

Zealand Pharma A/S is based in Copenhagen and has approximately 65 employees.

The Company's investors include BankInvest Biomedical Venture, LD Pensions, Dansk Erhvervsinvestering and Sunstone Capital as well as the leading international biotech investors CDC Innovation and AGF Private Equity (both in Paris) and LSP (Amsterdam).

About HELSINN HEALTHCARE

HELSINN is a privately owned pharmaceutical group with headquarters in Switzerland. Helsinn's core business is the licensing of pharmaceuticals in therapeutic areas (oncology, cancer supportive care, pain and inflammation, gastrointestinal).

The company's business strategy is to in-license early-stage new chemical entities and to complete their development from the performance of pre-clinical/clinical studies and CMC development to the attainment of market approvals in strategic markets (U.S. and Europe).

Helsinn's products are eventually out-licensed to its worldwide consolidated network of partners for distribution. Helsinn's key products in the US are Aloxi® (palonosetron), distributed by Eisai Inc., USA, and Gelclair®. The active pharmaceutical ingredients and the drug products are manufactured at Helsinn's cGMP facilities and supplied worldwide to its customers.

Helsinn's chemical business focuses on the pharmaceutical chemical process development and manufacturing of advanced intermediates, Active Pharmaceutical Ingredients (APIs) and High Potency Active Ingredients (HPAIs) for both the Helsinn group and its outsourcing partners.

For more information about Helsinn Healthcare SA, please visit www.helsinn.com

This announcement was originally distributed by Hugin. The issuer is solely responsible for the content of this announcement.

Copyright © Hugin AS 2008. All rights reserved.

Helsinn Healthcare Contact person: Roberto De Ponti Senior Director Head Business Development & Licensing-In Tel: (+41) 91-985 21 21 E-mail: info-hhc@helsinn.com


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