Nordic Life Science 1
treatments for central nervous system diseases su
ch as Alzheimer’s and Parkinson’s have focused on relieving symptoms, not slowing or stopping the progression of the disease. That changed in 2003 when Professor Lars Lannfelt and Dr. Pär Gellerfors of Sweden founded BioArctic, a research and biopharmaceutical company, to expand on Lannfelt’s research identifying the key role of amyloid-beta in Alzheimer’s disease. Now BioArctic is developing drugs to “modify” the pathology of diseases such as Alzheimer’s and Parkinson’s with the hope that these can delay the advancement of or even stop the disease. The company’s unique approach helped attract Gunilla Osswald, a leader with more than 30 years of experience in the field of drug development, particularly those targeting central nervous system disorders, to become its CEO in 2014. “My driving force has always been patients,” says Osswald. “BioArctic was founded based on solid science with the potential to develop groundbreaking medicines for high unmet patient needs. This was the basis for my joining, and I brought the experience and knowledge to build on that and develop BioArctic as a company. Today, the company is a combination of great science, great projects and great people.” When she joined BioArctic, it was privately-owned and primarily a research organization, she says. “Today, we are publicly-listed and are applying our competence in research and development to additional central nervous system disorders beyond Alzheimer’s disease, such as Parkinson’s disease, and our project portfolio has matured to span from early research through to phase 3 clinical trials. Our ambition is also to commercialize products in the Nordic market in the future.” Collaborations with large pharma companies BioArctic’s lead compound for Alzheimer’s, BAN2401, developed in collaboration with the company Eisai, is in a global confirmatory phase 3 study in Alzheimer’s patients. The company also has three earlier stage programs for Alzheimer’s disease that it is working on by itself, each with a different mechanism of action, and each different from BAN2401. For Parkinson’s disease, BioArctic’s drug candidate ABBV-0805, partnered with AbbVie, has just started clinical studies. ABBV-0805 follows a similar approach as BAN2401 with the potential to change the course of disease. Prior to taking over at BioArctic, Osswald worked at AstraZeneca in the research and development organization in clinical development, project leadership and as a vice president for neurodegeneration with worldwide responsibility for AstraZeneca’s project portfolio in Alzheimer’s disease and Parkinson’s disease. Today, her goal as BioArctic’s CEO is “to bring truly groundbreaking medicines to help patients with large unmet needs. With BAN2401’s positive and robust results in the phase 2b study in 856 patients with early Alzheimer’s disease, and the ongoing confirmatory phase 3 study, BAN2401 has the possibility to be the first disease-modifying treatment for Alzheimer’s. If we succeed, it would represent a significant paradigm shift in the standard of care and address huge unmet medical needs.” BioArctic also received approval from the U.S. Food and Drug Administration (FDA) for the Investigational New Drug (IND) application for ABBV0805. The IND application process is required for any candidate drug to start clinical trials in the U.S. The approval enabled AbbVie to start the phase I clinical trials in March. “This demonstrates that a little company with the right competence can have the capability to drive such an important process successfully,” says Osswald.