Octapharma said today it has taken a minority stake in Glycotope and acquired an exclusive worldwide license to its IP covering its recombinant technology, in a deal valued at more than €80 million ($90 million).
In addition, Octapharma said it will join with Glycotope on a series of R&D projects intended to enable the technology transfer and accelerated development of certain therapeutic proteins.
Under the deal, Octapharma gains exclusive access to Glycotope’s preclinical human blood coagulation factor portfolio, based on the company’s GlycoExpress™ (GEX™) platform, with the aims of expanding its blood coagulation factor and protein business.
According to Glycotope, the platform’s “sugar“ engineering tools are designed to generate new proteins with improved glycosylation patterns—thus offering the potential for a variety of novel treatment options, such as long-lasting treatment approaches in hemophilia.
“The access to Glycotope’s GEX Cell Line Technology opens up a host of interesting and very promising opportunities for our recombinant pipeline,” Octapharma Chairman, Wolfgang Marguerre said in a statement.
Glycotope said in a separate statement the €80 million is an initial payment, to be followed by development and sales related milestone payments, as well as royalties on future product sales for a defined but undisclosed number of projects. Glycotope is also eligible for “substantial” research and manufacturing related revenues during the life of the agreement for a series of products.
Octapharma will oversee all R&D costs and will pursue “major” activities within the clinical development by its own development organization, according to Glycotope.
“We are convinced that the collaboration with Glycotope will significantly strengthen our biotechnology business development. This engagement is a very important step for Octapharma’s development and will provide significant growth opportunities for the future,” Marguerre added.
Headquartered in Lachen, Switzerland, with a U.S. HQ in Hoboken, NJ, Octapharma was established in 1983. The company has grown into a top global manufacturer of human protein products, with about 6,000 employees, and five production sites it owns in Austria, France, Germany, Sweden, and Mexico.
Octapharma’s core business is the development and production of human proteins from human plasma and human cell-lines. The company focuses on the therapeutic areas of coagulation disorders, immune disorders and critical care. Octapharma has projected 2015 revenues of €1.5 billion (nearly $1.7 billion).
Just last month, the FDA approved Octapharma’s Nuwiq® (antihemophilic factor [recombinant]), an intravenous therapy for adults and children living with hemophilia A. Nuwiq is the first B-domain deleted recombinant Factor VIII derived from a human cell-line designed for the disorder.
Also in September, Octapharma published in the journal Haemophilia positive data from the pivotal GENA-08 study, in which 32 adults with severe hemophilia A received Nuwiq® for standard prophylaxis at least six months. The efficacy of Nuwiq® was rated as “excellent” or “good” in 97% of patients for the prevention of all bleeds, and at 100% for spontaneous bleeds, the company said, with 50% of patients experiencing zero bleeds.
“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 technology and long-lasting technologies,” stated Glycotope CEO/CSO Steffen Goletz, Ph.D.
Dr. Goletz founded Glycotope in 2001 to develop GEX, and has grown since then to employ more than 160 people at two sites in Berlin and Heidelberg. The company’s lead product is FSH-GEX™, a glycooptimized and fully human version of the follicle-stimulating hormone used primarily during the onset of in vitro fertilization procedures to induce maturation of multiple oocytes for retrieval. FSH-GEX advanced to Phase III last year.
Thomas Strüngmann, Ph.D., Glycotope’s main investor, added that the licensing deal was the first to cover a whole indication range of Glycotope’s portfolio and a huge endorsement of the GEX 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,” Dr. Strüngmann said.