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Helsinn Healthcare SA

Helsinn Healthcare and Zealnd Pharma sign a partnering agreement for ZP1846, a novel GLP-2 agonist

Lugano, Switzerland (ots)

Helsinn Healthcare's Top management
today 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 diarrhea (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 ¤ 140 million.
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 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 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.
"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.
Mr. 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 diarrhea Chemotherapy-induced diarrhea
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 diarrhea induced by chemotherapy, and we believe that
ZP1846 is useful treatment and/or prevention of an unmet medical need
like chemotherapy-induced diarrhea.
About HELSINN HEALTHCARE
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). 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
Healthcare's products are eventually out-licensed to its worldwide
consolidated network of partners for distribution.
Helsinn Healthcare'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 Healthcare's cGMP facilities and supplied
worldwide to its customers. Helsinn Healthcare'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, please visit:
www.helsinn.com
About Zealand Pharma
Zealand Pharma is a biopharmaceutical company dedicated to the
discovery and development of innovative peptide-based drugs. Zealand
Pharma 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
Pharma's products target diseases and symptoms of significant unmet
clinical need and commercial potential.
Since 1999, Zealand Pharma'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 Healthcare). All Zealand Pharma's compounds emerge
from Zealand Pharma'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 Pharma 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 cardiac arrhythmias. US based
pharmaceutical giant Wyeth Pharmaceutical is currently conducting
Phase I trials in the US.
ZP1846 is useful prevention and/or treatment of an unmet medical
need like chemotherapy-induced diarrhoea, 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 Pharma has a rich and broad
portfolio of pre-clinical projects targeting a variety of disease
areas, including osteoporosis and obesity-related diabetes.
Zealand Pharma 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).

Kontakt:

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: 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: www.zp.com

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