BioArctic’s lead compound has the potential to become the first disease-modifying treatment for Alzheimer’s, and so far the company’s journey has involved FDA approvals, a successful deal with AbbVie, collaborations with universities – and not least, the hiring of a very dedicated CEO.

For years the treatments for central nervous system diseases such 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.

Dr. Pär Gellerfors and Professor Lars Lannfelt.

From privately-owned to publicly-listed

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.”

FDA approval

BioArctic also received approval from the U.S. Food and Drug Administration (FDA) for the Investigational New Drug (IND) application for ABBV-0805. 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.

She advises other companies pursuing FDA approval to ensure they have access to the right resources to bring forward a well-worked, thorough and high-quality package supporting the IND application. “Take advantage of a pre-IND process with the U.S. FDA to get answers to your important questions beforehand,” she adds.

A deal worth $755 million

Another highlight at the end of 2018 was U.S. Federal Trade Commission (FTC) clearance to license BioArctic’s alpha-synuclein antibody portfolio for Parkinson’s Disease and other potential indications to AbbVie.

“The collaboration with AbbVie has a deal value totaling a potential $755 million in upfront and milestone payments, plus royalties on any products, making this an extremely meaningful transaction,” says Osswald. “The FTC clearance process is required in the U.S. for significant transactions and takes time, so companies should factor this into their project plans.”

Gunilla Osswald, CEO of BioArctic

Collaborations with scientists

Just as important as developing successful drugs is creating the means to detect and monitor central nervous system diseases. “For disease modifying treatments to be effective, it is crucial to start treatment before neurodegeneration becomes too advanced,” explains Osswald.

BioArctic is working with Uppsala University to develop an improved imaging diagnostic tool to measure the accumulation of the toxic forms of proteins that currently are too small to be measured accurately. “Together with scientists at Gothenburg University, we are developing more sensitive biochemical diagnostics to diagnose central nervous system disorders with blood and cerebrospinal fluid samples.”

Also in conjunction with Uppsala University, BioArctic is working on technology to help antibodies cross the blood-brain barrier to improve the effectiveness of immunotherapy for diseases such as Alzheimer’s and Parkinson’s.

Passionate about leadership

Meeting patient needs through disease-modifying treatments for Alzheimer’s and Parkinson’s diseases could translate into large commercial potential for BioArctic, Osswald adds. Ensuring that BioArctic is an appealing workplace for potential and current employees is also a priority for her.

“By focusing on meaningful work and developing our employees, we also strive to be an attractive employer. Leadership is something I am passionate about. I believe in leadership that makes individuals grow in their respective roles.”