Active Biotech drug could have the edge in oral MS race
A joint effort to
develop a winning oral formulation for the treatment of multiple
sclerosis (MS) has taken another step towards the finish line with
initiation of Phase III trials for the novel laquinimod compound.
By Anna Lewcock
Developed by Swedish firm Active Biotech
and licensed to pharma giant Teva, laquinimod is just one of the
competitors in the race to become the first oral treatment for MS, but
according to Active Biotech there are vital differences between their
drug candidate and other oral formulations in development.
once daily laquinimod therapy differentiates itself by being an
immunomodulatory compound (capable of modifying or regulating immune
functions), in contrast to some rival oral MS treatments in development
which affect the body in a different way.
"Other companies are developing products that are immunosuppressive rather than immunomodulatory," Active Biotech CEO Sven Andréasson explained to in-PharmaTechnologist.com.
of laquinimod thus far have shown a very clear safety profile according
to Andréasson, suggesting that it could be a more attractive option for
long term use.
The drug itself is in tablet form and will be
administered once a day, with the recent Phase II trials evaluating
dosages of 0.3mg and 0.6mg, both of which were well-tolerated with only
some transient and dose-dependent increases in liver enzymes.
Labelled a "very druggable compound"
by Andréasson, the drug is not difficult to manufacture and Active
Biotech has secured a substance patent through to 2019 and applied for
a method patent that will protect to 2022 or 2024. Teva will take care
of production and pricing for the new product.
oral MS treatment could mean serious revenues for the team that manages
to hit the market first. Although other companies are already well on
the way with Phase III trials of their compounds, the immunomodulatory
mode of action of Active Biotech's drug could give it a critical edge
in the market.
The company is set to receive double digit royalties on the oral formulation, which could lead to some significant earnings if the product emerges as an MS blockbuster.
valued at almost $6bn (€4.4bn), the MS market is growing rapidly, and
has been forecast to reach around $10bn by the time oral laquinimod
could hit the shelves in three or four years time.
already has an MS treatment out on the market in the form of Copaxone
(glatiramer acetate), which last year brought in around €1.6bn in
revenues - a figure which Andréasson expects to be able to match with
"Although there are some products already in
Phase 3, like those from Novartis, Merck-Serono or Bayer Schering, they
are all immunosuppressive so there is still a clear profile for our
drug," he said.
With Active Biotech having dedicated eight
years of research to the product thus far, and the Phase III trials
expected to start later this year, the final product could offer a much
needed non-invasive option to the million people worldwide currently
suffering with MS.