Helsinn Healthcare and Zealand Pharma Sign a Partnering Agreement for ZP1846, a Novel GLP-2 Agonist

Friday, November 28, 2008 General News
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LUGANO, Switzerland, November 27 Helsinn Healthcare's Topmanagement today announced that it has signed a partnering agreement withZealand Pharma, for the development and worldwide commercialization ofZP1846, a GLP-2 (glucagon-like peptide-2) receptor agonist which provides anovel way to treat chemotherapy-induced diarrhea (CID), a debilitatingcondition affecting patients undergoing cancer treatment with a range ofchemotherapies.

Under the terms of the agreement, Helsinn Healthcare will receive aworldwide exclusive license to ZP1846 and will be responsible for all furtherdevelopment, regulatory approvals, manufacturing, marketing and sales of thecompound either on its own or through its sub-licensees. In return HelsinnHealthcare will pay Zealand Pharma development milestones and salesmilestones for an undisclosed amount. In addition, Zealand Pharma willreceive royalties on future sales and Zealand Pharma retains the marketingrights to the Nordic countries. The total value of the non royalty portion ofthe partnership is valued at EUR 140 million.

Zealand Pharma has applied its knowledge of peptide optimization and itsproprietary SIP(r) technology to develop ZP1846, one of a series of novelpeptides that specifically enhance the growth and function of the lining ofthe intestine. ZP1846 has completed Phase I in humans in the US. ZealandPharma's pre-clinical studies have demonstrated that ZP1846 is useful in theprevention and/or treatment of injuries to the intestinal epithelium causedby chemotherapy treatment, resulting in a reduction in the incidence ofchemotherapy-induced diarrhea. Today, serious gastrointestinal side effectsare observed in up to 50% of patients undergoing certain forms ofchemotherapy, which in turn may require dose modification or cessation ofcancer chemotherapy.

"We are excited about this promising development and commercialcooperation with Zealand Pharma, which represents another important step inbroadening and strengthening Helsinn Healthcare's pipeline of cancersupportive care products. We are confident that ZP1846 will be an importantcontribution to the treatment of chemotherapy-induced diarrhea, currently anunmet medical need and consequently, a positive impact on patients' qualityof life. We believe that Helsinn's constant investment in R&D and inlife-cycle activities of new and current products in this therapeutic areawill allow us to fulfill our commitment to deliver benefits to the medicalcommunity and to alleviate the suffering of patients worldwide," commentedDr. Riccardo Braglia, Helsinn Healthcare's Chief Executive Officer.

"Diarrhea is a debilitating and potentially life-threatening side-effectof chemotherapy. Despite its high incidence and severity it is often underrecognized and poorly managed: current available treatments are onlypalliative. CID remains therefore a huge unmet medical need. ZP1846 has atremendous therapeutic potential by virtue of its unique mechanism of gutgrowth stimulation and reduction of gut atrophy and weight loss induced bythe mucosal toxicity of chemotherapy. This project gives us the extraordinaryopportunity to develop an agent that could prevent and/or treat CID enablingthe best possible cancer treatment and reducing patients' morbidity,"commented Dr. Sergio Cantoreggi, Senior Director, Head of HelsinnHealthcare's R&D.

Mr. Mogens Vang Rasmussen, Executive Vice President, Chief OperatingOfficer and Chief Financial Officer of Zealand Pharma commented: "Being ableto partner ZP1846 with Helsinn Healthcare once again demonstrates ZealandPharma's ability to bring innovative peptide projects from idea to clinicaldevelopment and partnering. This agreement is the third major agreementconcluded within the 10 year period Zealand Pharma has been operating andthese important deals highlight the exciting compounds that our uniqueapproach to drug discovery and development delivers. This approach, whichcombines a creative R&D culture and a strong focus on commercialization, hasenabled us to successfully progress ZP1846 from discovery through to clinicaltrials in just four years, creating significant value for our shareholders."

Dr. David Solomon, Chief Executive Officer of Zealand Pharma furthercommented: "We are delighted to be able to work with Helsinn on thedevelopment and commercialization of ZP1846. Helsinn Healthcare has a verystrong worldwide presence in the cancer supportive care treatment area whereZP1846 will be a very important product in the prevention and/or treatment ofinjuries to the intestinal epithelium caused by chemotherapy treatment."

About chemotherapy-induced diarrhea

Chemotherapy-induced diarrhea is a serious debilitating conditionaffecting patients undergoing treatment with anti-cancer therapies and thisgastrointestinal injury may lead to serious complications such asmalnutrition, sepsis, dehydration and kidney insufficiency.

There is a strong need for drugs that are able to prevent or treat themucosal damage and eliminate the diarrhea induced by chemotherapy, and webelieve that ZP1846 is useful treatment and/or prevention of an unmet medicalneed like chemotherapy-induced diarrhea.

About Helsinn Healthcare

Helsinn Healthcare is a privately owned pharmaceutical group withheadquarters in Switzerland. Helsinn Healthcare's core business is thelicensing of pharmaceuticals in therapeutic areas (oncology, cancersupportive care, pain and inflammation, gastrointestinal). The company'sbusiness strategy is to in-license early-stage new chemical entities and tocomplete their development from the performance of pre-clinical/clinicalstudies and CMC development to the attainment of market approvals instrategic markets (U.S. and Europe). Helsinn Healthcare's products areeventually out-licensed to its worldwide consolidated network of partners fordistribution. Helsinn Healthcare's key products in the US are Aloxi(R)(palonosetron), distributed by Eisai Inc., USA, and Gelclair(R). The activepharmaceutical ingredients and the drug products are manufactured at HelsinnHealthcare's cGMP facilities and supplied worldwide to its customers. HelsinnHealthcare's chemical business focuses on the pharmaceutical chemical processdevelopment and manufacturing of advanced intermediates, ActivePharmaceutical Ingredients (APIs) and High Potency Active Ingredients (HPAIs)for both the Helsinn group and its outsourcing partners.

For more information about Helsinn Healthcare, please visithttp://www.helsinn.com

About Zealand Pharma

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

Since 1999, Zealand Pharma's scientists have built a pipeline thatincludes five compounds in clinical development, three of which have been outlicensed to major pharmaceutical companies (Sanofi-Aventis, Wyeth and HelsinnHealthcare). All Zealand Pharma's compounds emerge from Zealand Pharma's owndrug discovery.

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

ZP120 is an ORL-1 receptor agonist. Zealand Pharma has all the rights tothe drug, which is currently in Phase II clinical development.GAP-134/ZP1609; a gap junction modifier that prevents both ventricular andatrial arrhythmias in animal models. With its oral formulation, the moleculerepresents a novel paradigm for the potential chronic prevention of cardiacarrhythmias. US based pharmaceutical giant Wyeth Pharmaceutical is currentlyconducting Phase I trials in the US.

ZP1846 is useful prevention and/or treatment of an unmet medical needlike chemotherapy-induced diarrhoea, which may prevent discontinuation anddose modification during cancer chemotherapy. The compound has been partneredwith Helsinn.

ZP1848 is a novel paradigm for the treatment of Inflammatory BowelDiseases (e.g. Crohn's Disease). The compound is in late preclinicaldevelopment.

In addition, Zealand Pharma has a rich and broad portfolio ofpre-clinical projects targeting a variety of disease areas, includingosteoporosis and obesity-related diabetes.

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

The Company's investors include BankInvest Biomedical Venture, LDPensions, Dansk Erhvervsinvestering and Sunstone Capital as well as theleading international biotech investors CDC Innovation and AGF Private Equity(both in Paris) and LSP (Amsterdam).Contact: Helsinn Healthcare SA Roberto De Ponti, Senior Director, Head of Business Development & Licensing In Tel.: +41-91-985-21-21 E-Mail: info-hhc@helsinn.com Internet: http://www.helsinn.com Zealand Pharma A/S Mogens Vang Rasmussen Executive Vice President Chief Operating Officer and Chief Financial Officer IT & Communications Zealand Pharma A/S Smedeland 26 B DK-2600 Glostrup Denmark Tel.: +45-4328-1200 Fax: +45-4328-1212 E-Mail: info@zp.dk Internet: http://www.zp.com

SOURCE Helsinn Healthcare SA

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