The history of the beta-glucan development

Biotec Pharmacon was initially a biotechnology company established as a result of innovative biochemistry research and new inventions on how to use certain marine cold-adapted enzymes as processing aids.

1987

The founders of Biotec Pharmacon discovered in 1987 that disease resistance of Atlantic salmon was significantly enhanced by a special beta-1,3/1,6-glucan preparation designated MacroGard®. Later they showed that MacroGard® had the same effect on piglets and other livestock animals, and moreover caused a commercially significant improvement of growth performance and feed utilization.

1990

The company was established in November 1990 by Professor Jan Raa and researchers in his team at the University of Tromsø, among them his previous student Gunnar Rørstad who became CEO of Biotec Pharmacon in 1994.

The discovery that MacroGard® acts as an immune enhancing agent even when added to feeds was the foundation for a comprehensive research and development program on the extraction, purification, chemistry, mode of action, efficacy and safety of beta-1,3/1,6-glucans. Dr. Rolf E. Engstad was heavily involved in executing the development program. Dr. Engstad was appointed Chief Scientific Officer of the company in 2006 after Dr. Raa.

The early research of Biotec Pharmacon was not keenly supported by traditional research council grants, but was nevertheless sponsored by Phillips Petroleum Company as part of their biotechnology development program. The initial reluctant attitude among immunologists to studies of non-specific (innate) immune enhancement has during the last couple of years changed completely. Now as innate immunity is attracting more and more emphasis in scientific communities and its role as the evolutionary foundation of immunity in all animal groups is becoming generally recognized, the early research priorities of Biotec Pharmacon are finally being rewarded. Hence, the company is very proud to be among the first few groups that have been spearheading research and technology development in the area of innate immunity and of the role of immune modulating beta-1,3/1,6-glucans in general disease prophylaxis. This work has followed from the first pioneer studies performed by scientists like Professor Rolf Seljelid, who has been a scientific advisor to the company when entering into clinical studies.

The results of R&D on beta-1,3/1,6-glucans during the early years of this century have justified the company’s decision to develop pharmaceutical products for humans, and to gradually change the profile of the company in the pharmaceutical direction. In 2004 the company initiated a clinical development program. In November 2005 the company was listed on the Oslo Stock Exchange to facilitate its funding.

2006

Lars Viksmoen replaced Gunnar Rørstad as CEO in October 2006.

In September 2008 the company sold out the animal health division and the related IP which had been the primary activity through all the 90-ies, confirming the change in pharmaceutical direction.

The knowledge in marine biochemistry had been developed and further refined as a unique expertise within the company, and in 2009 Biotec Pharmacon established a wholly owned subsidiary in order to build a separate organization for this business, with emphasis on its original business area to manufacture and market high purity natural or recombinant enzymes for the life science sector (later named ArcticZymes AS).

2009

In November 2009 the company suffered a substantial setback, as data from the phase III clinical trials failed to show any statistical evidence for the pharmaceutical candidate SBG’s effect on diabetic ulcers and oral mucositis. Immediate investigations were initiated which showed that an interaction between the product and the container material had devalued the effect of the product.

In December 2009 the company sold out the consumer health division and the related IP which had been an important activity since year 2000, including beta glucan products for dietary supplement and skin care for humans. The company continues its supply of active ingredients to these activities.

2010

Svein W. F. Lien replaced Lars Viksmoen as CEO in March 2010.

The company initiated new animal studies on the efficacy of SBG. All these studies showed that SBG had effect on wound healing, but long time stored SBG in polyethylene showed significant less healing activity, which supported the hypothesis that the container material was the root cause for the failing of phase III trials. After concluding this work the company started actively to seek new partnership to its topical wound care application.

2011

Biotec BetaGlucans AS was established as a wholly owned subsidiary of Biotec Pharmacon. All activities related to beta-glucans were taken over by Biotec BetaGlucans, including machinery, laboratory, IPR, employees and know-how. All office- and laboratory functions were relocated to the Science Park nearby the Arctic University of Tromsø. Preparations for ISO 13485 certification started.

2012

The final formulation of Woulgan® Biogel was tested with convincing results. Application for CE-mark was submitted in July. IP for cancer treatment was strengthened. Collaboration with Memorial Sloan Kettering Cancer Centre continued. Agreement on marketing evaluation for Woulgan® Biogel was signed with Smith & Nephew.

2013

ISO 13485 certification was obtained.

2014

CE- certification for Woulgan Biogel as a medical device class III, rule 13.

Evaluation study started up in UK and Germany.

Started discussion with Smith&Nephew regarding distribution agreement for Woulgan Biogel.

2015

Evaluation study for Woulgan terminated.

Ended negotiations with Smith&Nephew.

Signed distribution agreement with H&R, UK for Woulgan Biogel.

Initiated Post-Marketing Clinical Follow-up study for Woulgan Biogel on Diabetic ulcers in Sweden and UK.