Last few months witnessed some significant deals in the neurological segment which include Takeda and Neurocrine Biosciences’ collaboration to develop drugs for treating Anhedonia, treatment-resistant depression and schizophrenia and Merck’s partnership with Yumanity Therapeutics to develop assets indicated towards treating Amyotrophic Laco-commercialize(ALS) and Frontotemporal Lobar Dementia (FTLD).
Recently, Biogen Inc., an American multinational biotechnology company based out of Cambridge, announced its partnership with Denali Therapeutics Inc., a California-based biotechnology company developing a broad portfolio of products for neurodegenerative diseases. Under the terms of agreement, both the companies will co-develop and co-commercialise Denali Therapeutics’ small molecule inhibitors of Leucine-Rich Repeat Kinase 2 (LRRK2) for the treatment of Parkinson’s disease. LRRK2 is a regulator of lysosomal function which is impaired in Parkinson’s disease and other neurodegenerative and movement disorders. Amongst the four drugs targeted in this partnership, the prominent investigative drug of interest DNL-151 will progress to late stage clinical validation in 2021. In the deal worth more than USD 1 Billion, Biogen will pay Denali USD 560 Million in cash and purchase stocks worth USD 465 Million, accounting for 11.2% ownership of Denali. On the commercial success of the co-developed drug, Denali will also receive up to USD 1.125 Billion in additional funds.
While the cost and profits will be equally split between the drug makers for domestic activities, Biogen will acquire 60% profits from their sales in China and pay 60% of the development cost for activities elsewhere. In this process, Denali Therapeutics will also receive royalties for the developed assets.
With both the companies holding expertise in neurological drugs, through this partnership, Biogen will also get access to the first right of negotiation to two pre-clinical stage programs of Denali’s blood-brain barrier (BBB) crossing Transport Vehicle (TV) technology platform, to deliver larger drugs into the brain. Based on the results from the ongoing Phase I trial of DNL-151, the company intends to escalate the doses in cohorts and expand the Phase I trials and conduct an additional Phase Ib study to understand the therapeutic mechanism of this molecule. Under the collaboration, the partner companies intend to conduct two separate trials on Parkinson’s disease patients, one with a kinase activating mutation in LRRK2 and the other with sporadic disease patients.