Helsinn and Pharmacosmos Enter into an Exclusive License Agreement for the Development and Commercialization of Monofer® in US

LUGANO, Switzerland and HOLBÆK, Denmark, January 8, 2015 /PRNewswire/ --

Helsinn Group and Pharmacosmos A/S today jointly announce that they have entered into an agreement for the exclusive US commercialization rights to Monofer^®, an innovative intravenous iron replacement therapy under development for the treatment of Iron Deficiency Anemia.

Agreement highlights: 

Helsinn has obtained the exclusive rights to commercialize Monofer^® and any other iron isomaltoside 1000 products developed by Pharmacosmos in the US.

Pharmacosmos is eligible for milestone payments of up to USD 130 million for Monofer^® in iron deficiency anemia in the US.  In addition, Pharmacosmos will be eligible to receive further payments for the manufacture and supply of Monofer^®to Helsinn in the US.

Helsinn's Chief Executive Officer, Riccardo Braglia, commented: "Helsinn is committed to improving the lives of patients by offering medicines which enable them to get the most out of every day, optimizing their quality of life and promoting their ability to remain on treatment regimens. Monofer^® provides a high dose iron replacement in a single administration, which may offer anemic patients a new, more convenient treatment option for rapidly restoring their iron stores and thereby, improve their symptom burden. We look forward to collaborating with Pharmacosmos and bringing Monofer^® to the US market."

Pharmacosmos' Chief Executive Officer, Lars Christensen, commented: "This is a very important milestone for Pharmacosmos. The US market is the biggest market in the world. We believe that Monofer^® will serve yet unmet clinical needs with a clear potential to improve outcomes and convenience for patients suffering from Iron Deficiency Anemia in the US. Helsinn's strong foothold in the hematology and oncology combined with Pharmacosmos' expertise on iron deficiency anemia will provide an excellent platform for the introduction of Monofer^® in the US. I expect that our alliance with Helsinn will bring further growth, significantly strengthening our ambition and possibilities to establish Monofer^® as the leading brand for iron deficiency anaemia management."

About Monofer^® 

Monofer^® (10% iron isomaltoside 1000) is an iron-carbohydrate complex for intravenous administration. Monofer^® is already marketed in more than 30 countries, primarily in Europe, for the treatment of iron deficiency anemia. Monofer^® is under development in the rest of the world, including North America and Japan. It is believed that the structure of Monofer^® differentiates it from other intravenous iron replacement therapies, allowing the possibility to administer high iron doses in one visit over a short period of time for the benefit and convenience of patients and healthcare professionals. Monofer^® is manufactured by Pharmacosmos, Denmark.

About iron deficiency anemia (IDA) 

Iron deficiency anemia (IDA) is a debilitating condition which affects almost 2 billion people worldwide, including over 7 million people in US. IDA is often associated with many chronic diseases such as renal diseases (including Chronic Kidney Disease), cancers (including chemotherapy induced anemia), gynecologic disorders (including abnormal uterine bleeding) and inflammatory bowel disease (IBD).

The US market is estimated to be worth more than USD 600 million in 2014 and is expected to exceed USD 1 billion early after 2020.

About the Helsinn Group 

Helsinn is a family run, privately owned pharmaceutical group focused on building quality cancer care with a large portfolio of products. Founded in 1976 with headquarters in Lugano, Switzerland, Helsinn also has operating subsidiaries in Ireland, the United States and a representative office in China. Helsinn's business model is focused on the licensing of pharmaceuticals, medical devices and nutritional supplement products in the therapeutic area of cancer care.

Helsinn Group in‐licenses early‐to‐late stage new chemical entities, completing their development by performing preclinical and clinical studies and associated manufacturing activities. Helsinn then prepares necessary regulatory filings in order to achieve marketing approvals worldwide. Helsinn's products are out‐licensed to its global network of marketing and commercial partners that have been selected for their local market knowledge. Helsinn supports these partners by providing a full range of product and scientific management services, including commercial, regulatory, and medical marketing advice. In March 2013, Helsinn established a new commercial organization within its subsidiary, Helsinn Therapeutics (U.S.), Inc., in order to conduct direct sales and marketing activities within the U.S. market. Helsinn's products are manufactured according to the highest quality, safety, and environmental standards at Helsinn's GMP facilities in Switzerland and Ireland from where they are then supplied worldwide to customers.

About Pharmacosmos A/S 

Pharmacosmos A/S is a family-owned Danish pharmaceutical company with headquarters in Holbæk, Denmark. It was founded in 1965 and today sells its products in the UK and Scandinavia through its own subsidiaries and across the World through partners. Pharmacosmos is a global leader in the development and marketing of medicines for the treatment of iron deficiency anemia. Pharmacosmos' ongoing commitment to R&D leverages its unique carbohydrate production platform along with unrivaled expertise in the synthesis of iron-carbohydrate complexes to bring better treatments for patients suffering from iron deficiency. Its state-of-the-art facilities in Denmark are approved by both the Danish Medicines Agency and the US Food & Drug Administration.

For more information, please contact:
Helsinn Group                       
Paola Bonvicini                        
Head of Communication & Press Office                
Tel: +41-91-985-21-21                    
[email protected]                    
                               
Pharmacosmos A/S
Tobias S. Christensen
Vice President, Corporate
Development & Strategy
Tel: +45-40-20-16-62
Switchboard: +45-59-48-59-59
[email protected]
                       
For media/external inquiries

Helsinn Group
Consilium Strategic Communications  
Mary-Jane Elliott / Jessica Hodgson / Matthew Neal / Laura Thornton
Tel: +44(0)203-709-5700
[email protected]

Pharmacosmos A/S
Fonnesbech & Estrup
Adam Estrup
Tel: +45-28-74-87-10
[email protected]

SOURCE Helsinn Group and Pharmacosmos A/S