Roche might be best known for its cancer drugs – a therapy area that the Swiss pharma giant is seen continuing to dominate - but attempts to broaden its horizons continue apace. Two deals struck this week over products that address central nervous system disorders add to a growing pipeline focus for the company.
While only 4% of Roche’s current drug sales are derived from CNS-targeted therapies, 18% of its research projects are focused on the space, a notable investment considering that many of its peers have chosen to exit this area. Oncology remains a mainstay, however, with almost half of its pipeline made up of cancer drugs, a commitment that is seen resulting in cancer drug sales of $27.6bn by 2018, almost triple its nearest rival, EvaluatePharma data reveal (see tables).
Roche announced two CNS transactions this week, firstly in Alzheimer’s in deal which cements its relationship with AC Immune. The partners second agreement will see them formulating preclinical anti-Tau antibody candidates for further development. A phase II a-beta antibody that Roche is currently testing in phase II, crenezumab, was also sourced from the private Swiss drug developer back in 2006.
In the last couple of years Roche has emerged as a rare dealmaker in the Alzheimer’s space, and it now has a fairly broad pipeline that encompasses most mechanisms of actions under investigation (Roche signs first Alzheimer's deal of the year as crucial progress awaited, September 6, 2011).
Under a second deal announced this morning, Roche and Seaside Therapeutics said they will collaborate on developing disease modifying treatments for both fragile X syndrome and autism spectrum disorders. Fragile-X is the most common cause of inherited learning disabilities, up to 6% of children with autism are diagnosed with the gene mutation.
Roche has bought an option to commercialise Seaside’s lead GABA-B candidate, STX209, one of the most advanced candidates in development for Fragile-X and autism (Therapeutic Focus - Turning point ahead for Fragile X syndrome, February 28, 2012) http://www.epvantage.com/Universal/View.aspx?type=Story&id=280070&isEPVantage=yes The drug is currently enrolling patients in Phase III FXS trials and recently completed enrolment in a Phase 2b trial in ASD.
The two companies will also collaborate over the development of mGluR5 antagonists, which target the receptor for glutamate; neurotransmitter pathways are a main focus of research in Fragile X. Roche already has mGluR5s in the pipeline - RO4917523 which is in phase II and a CTEP, a pre-clinical candidate.
Roche’s current CNS portfolio includes only three drugs for which sales are disclosed - Parkinson’s agent Madopar, epilepsy treatment Rivotril and Lexotan, approved to treat anxiety – although there are many others smaller products for which sales are not disclosed. The franchise accounts for less than $1bn in annual sales – Roche’s total drug sales reached $33.8bn last year.
In the pipeline only two CNS agents are attracting forecasts from equity analysts – RG1678 or bitopertin, a schizophrenia drug in phase III, and ocrelizumab, an anti-CD20 antibody in late stage MS studies. However in terms of number of projects, CNS represents the company’s second largest focus, behind oncology.
Like the two agents licensed yesterday many are early stage and this seeming focus is unlikely to move the needle substantially in years to come. But it shows that despite the desertion of big pharma interest in areas ravaged by huge patent expiries and pipeline failure, such as depression and epilepsy, certain CNS areas do remain of interest.
The table below, however, suggests these will be niche areas for the time being. Of the therapy areas seen deriving the most sales in 2018, only one, MS therapies, can be classified as addressing a CNS complaint.