Glycotope and Octapharma enter exclusive worldwide license agreement on human blood coagulation factors

• Octapharma will gain exclusive access to Glycotope's proprietary preclinical blood coagulation factor portfolio based on the Company's GlycoExpress(TM) platform to further expand its blood coagulation factor and protein business
• Glycotope will receive upfront and milestone payments as well as royalties on future product sales
• Octapharma will buy a stake in Glycotope, purchasing new shares generated through a capital increase
• Glycotope to receive an initial payment of EUR 80 million
• Glycotope to set strategic focus on core immuno-oncology business, including the development of these drug candidates through clinical trials and formation of co-development partnerships

Berlin, Germany and Lachen, Switzerland, October 8th, 2015 - Glycotope GmbH, a global leader in glyco-optimization of biopharmaceuticals, and Octapharma AG, one of the worldwide largest human protein product manufacturers, announced today that they have entered into an exclusive worldwide licensing agreement for Glycotope's portfolio of preclinical human blood coagulation factors based on its unique and proprietary GlycoExpress(TM) (GEX(TM)) technology platform. In addition, Octapharma will take a stake in the Company by purchasing new Glycotope shares generated through a capital increase at a premium price. Under this agreement, Glycotope receives an initial payment of EUR 80 million from Octapharma.

"There are significant advantages of improved recombinant blood coagulation factors of human cell origin for the treatment of a variety of hemophilic conditions considering immunogenic aspects and limiting pharmacokinetic profiles of broadly used and established treatment options with currently available recombinant blood coagulation factors", said Olaf Walter, Board Member and Head of Octapharma's International Business Units. "Glycotope has built a leading platform of "sugar" engineering tools that are designed to generate novel proteins with improved glycosylation patterns and thus offer the potential for a variety of novel treatment options such as long-lasting treatment approaches in hemophilia. Glycotope's assets covered by this agreement complement Octapharma's blood coagulation and protein portfolio and push additional focus into recombinant fully human optimized as well as long-lasting factors."

Under the terms of the agreement, Octapharma will gain exclusive worldwide rights to research, develop and commercialize candidates from Glycotope's preclinical human blood coagulation factor portfolio based on Glycotope's proprietary GlycoExpress(TM) platform. Glycotope will receive an upfront payment and is eligible for substantial research and manufacturing related revenues during the life of the agreement for a series of products. In addition, Glycotope will receive further development and sales related milestone payments and royalties for a defined number of projects. Octapharma will be responsible for all research and development costs and will pursue major activities within the clinical development by its own development organization.

Glycotope has developed a novel long-lasting technology basket for generating proteins with largely improved pharmacokinetic properties. So far significant improvements in key pharmacokinetic properties could be achieved for complex blood coagulation factors. This technology is suitable for half-life extension of blood coagulation factors as well as other proteins for improved patient compliance and represents the newest member in the Glycotope platform technologies.

"Octapharma's ongoing commitment to hemophilia research, combined with its experience in developing and marketing hemophilia and other blood protein factor products, makes them an excellent partner for our human blood coagulation portfolio, GlycoExpress(TM) technology and long-lasting technologies," added Dr. Steffen Goletz, CEO/CSO at Glycotope. "We very much look forward to working with the scientists and clinical development teams at Octapharma to exploit the therapeutic potential of our portfolio and technologies for the benefit of patients needing improved, reliable and potentially more convenient treatment options of their hemophilia conditions."

"We are very pleased to welcome Octapharma, a global player in hematology products, as our strategic partner. The engagement underlines the importance of Glycotope's technology platform. Octapharma is ideally positioned to best leverage Glycotope's promising human blood coagulation business," commented Dr. Thomas Strüngmann, main investor in Glycotope. "This is the first strategic deal that covers a whole indication range of Glycotope's portfolio and a huge endorsement of the GEX(TM) technology platform. At the same time the agreement allows Glycotope to strategically focus on its core business in oncology, where the Company develops projects through clinical trials and plans to enter into co-development partnerships."

About Blood Coagulation Factors

Today, there are two different ways to produce or retain biotherapeutics, including human coagulation factors. Coagulation factors for the treatment of hemophilia and other bleeding disorders represent the most complex plasma proteins. The most common way to obtain these biotherapeutics is purification from human blood plasma. However, human plasma as a source is very limited and safety concerns persist, which have led to a growing need for recombinant plasma proteins. In addition, protein-triggered immunogenic and allergic reactions to coagulant factors remain a major concern for patients as glycosylation patterns are very complex and represent a huge challenge for the recombinant protein expression industry. Recombinant proteins, as expressed on conventional platforms, often do not match the glycosylation and pharmacokinetic profiles of plasma-purified proteins. As a result, there is an increasing need for platform technologies that provide the ability to produce proteins with fully human and improved glycosylation pattern that allow for new, less immunogenic and long-lasting treatment options in hemophilia and other bleeding disorders.

About GlycoExpress(TM) (GEX(TM))

Glycotope's GEX(TM) platform comprises a comprehensive portfolio of proprietary glyco-engineered human suspension cell lines, which allow for the production of complex proteins with fully human and tailored glycosylation patterns. With the combined advantages of optimized sialylation, galactosylation, fucosylation, branching and lack of non-human sugar structures, GEX(TM) products deliver improved bioactivity, stability, serum half-life and immunogenicity of biopharmaceuticals.

Glycotope has demonstrated with three different antibodies in advanced stage clinical development that cost efficient production with unmet quality is achieved through a proprietary perfusion process with outstanding productivity of 10-20 g/L bioreactor volume and up to 0.8 g/L per day.

To date, more than 40 GMP production runs have been performed, showing unique reproducibility with no measurable differences between batches, batch sizes, process strategies, scales and production sites, all of which guarantees flexible production.

The GEX(TM) platform has been approved by several regulatory authorities for clinical use (including EMA, FDA).

About Glycotope GmbH

Glycotope, founded in 2001 in Berlin, focuses on the development of innovative immune-oncological products for the treatment of various cancer types using their GlycoBody(TM) and GlycoExpress(TM) technologies. Glycotope has currently four products in advanced clinical development. The Company's additional pipeline includes preclinical non-antibody and antibody biopharmaceuticals for various indications.

Glycotope's GEX(TM) platform allows glyco-optimization and high yield production of a variety of fully human glycosylated biopharmaceuticals such as coagulation factors, cytokines, glycoprotein hormones and antibodies by using a toolbox of glyco-engineered proprietary human cell lines that allow for optimization of a whole series of different determining sugars. In addition, the GEX(TM) platform can be used for in process glycosylation control.

The platform allows for the development of First-in-Class antibodies addressing targets previously unattainable, as well as optimized and significantly improved molecules in terms of clinical effects and reduced side effect profile (Best-in-Class).

Together with its GMP manufacturing subsidiary Glycotope Biotechnology in Heidelberg, Glycotope has evolved into a leading, fully integrated glycobiology company, covering the entire workflow from discovery, molecule optimization, clone and process development, preclinical and clinical drug development to GMP production. With more than 200 employees and a strong and broad IP-position, Glycotope today is one of the largest biotechnology companies in Germany. Glycotope has created the currently broadest and most potent glycosylation technology platform.

About Octapharma AG

Headquartered in Lachen, Switzerland, Octapharma is one of the largest human protein product manufacturers in the world and has been committed to patient care and medical innovation since 1983. Its core business is the development and production of human proteins from human plasma and human cell lines. Octapharma's revenue forecast for 2015 is EUR 1.5 billion.

Octapharma has 48 subsidiaries and representative offices and employs approximately 6,000 people worldwide to support the treatment of patients in over 100 countries with products across the following therapeutic areas:

• Haematology (coagulation disorders)
• Immunotherapy (immune disorders)
• Critical Care

Octapharma owns five state-of-the-art production facilities in Austria, France, Germany, Sweden and Mexico.

For more information visit www.octapharma.com

 

Contact:

GLYCOTOPE GmbH	Octapharma AG
Dr. Steffen Goletz	Olaf Walter
Robert-Roessle-Str. 10	Seidenstrasse 2
13125 Berlin, Germany	CH-8853 Lachen, Schweiz
Phone: +49 (0)30 9489-2600	Phone: +41-55-451-2115
Fax: +49-(0)30 94 89-2630	Fax: +41-55-451-2110
Email: steffen.goletz@glycotope.com	Email:Olaf.Walter@octapharma.com
Website: www.glycotope.com	Website: www.octapharma.com