Zealand Pharma receives milestone payments

12/30/2011 4:00 AM EST

Zealand Pharma A/S
Company Announcement

Zealand Pharma receives milestone payments

EUR 3 million received under the license agreement for elsiglutide, a peptide
drug in development for the treatment of chemotherapy induced diarrhea 

Copenhagen, 2011-12-30 10:00 CET (GLOBE NEWSWIRE) -- Zealand Pharma A/S (NASDAQ
OMX Copenhagen: ZEAL), a Danish biopharmaceutical company dedicated to the
discovery and development of innovative peptide drugs, has received EUR 3 (DKK
22.3) million in milestone payments under a license agreement with Helsinn
Healthcare for the development of elsiglutide (ZP1846). Elsiglutide is a novel
GLP-2 peptide agonist, discovered by Zealand Pharma and licensed to Helsinn
Healthcare for the treatment of diarrhea induced by chemotherapy in cancer
patients. 



Helsinn Healthcare is completing a Phase Ib study with elsiglutide in Europe to
evaluate its safety and tolerability and find the maximum tolerated dose in
colorectal cancer patients. The Phase Ib study is conducted under an
Investigational New Drug application with the US Food and Drug Administration
(FDA) and final study completion is expected in Q1 2012. In parallel, Helsinn
is preparing a Phase IIa study to evaluate the efficacy of elsiglutide in the
primary prevention of diarrhea in colorectal cancer patients receiving
chemotherapy. 



David Solomon, President and Chief Executive Officer of Zealand Pharma,
commented: “We are pleased with the progress of the elsiglutide program by our
partner Helsinn Healthcare and with the data so far indicating that elsiglutide
is safe and well tolerated. Peptides make excellent drugs, and we look forward
to Helsinn’s continued development of this novel Zealand-discovered GLP-2
peptide agonist for the treatment of cancer patients suffering from severe
diarrhea.” 



In November 2008, Zealand Pharma out-licensed worldwide exclusive rights to
elsiglutide (ZP1846) to Helsinn Healthcare, a global cancer supportive care
company. Under the agreement between Zealand Pharma and Helsinn, Helsinn is
responsible for all further development, regulatory activities, manufacturing,
marketing and sales of elsiglutide. Zealand Pharma is eligible to receive
milestone payments of up to EUR 140 million, of which EUR 13 (DKK 97) million
has been received (including the payments announced today). and to royalties on
Helsinn Healthcare’s global sales of elsiglutide. Zealand Pharma also holds an
option to obtain sales and marketing rights for the Nordic countries. 



The milestone payments of EUR 3 million (DKK 22.3 million) do not change
Zealand Pharma’s financial guidance for 2011 of DKK 170 (EUR 23) million in
revenues and other income and total operating expenses of DKK 170 (EUR 23)
million. 

                                      # # #





For further information, please contact:

 David H. Solomon, President & CEO, Tel: +45 2220 6300



Hanne Leth Hillman, Vice President for IR & Corporate Communication,

Tel: +45 5060 3689, email:  



About Elsiglutide (ZP1846)

Elsiglutide is a novel, potent and selective glucagon-like-peptide-2 (GLP-2)
receptor agonist. GLP-2 is a naturally occurring 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 and has shown the ability to promote the regeneration of the
epithelial surface damaged by chemotherapy, the underlying cause of
chemotherapy-induced diarrhea. 



About Zealand Pharma

Zealand Pharma A/S is a public (NASDAQ OMX: ZEAL) biopharmaceutical company
based in Copenhagen, Denmark with a mature and growing 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,
discovered by Zealand Pharma and licensed to Sanofi. In November, Sanofi filed
for marketing authorization for lixisenatide (Lyxumia®) in Europe. Submission
for regulatory approval of lixisenatide in the United States is expected in Q4
2012. Zealand Pharma also has a collaboration with Boehringer Ingelheim
covering glucagon/GLP-1 dual 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