Active Biotech in brief
Active Biotech currently has five projects in clinical phase, three of which are out-licensed.
Three of the projects relate to drugs for the treatment of autoimmune diseases, such as
multiple sclerosis (MS), Crohn’s disease, rheumatoid arthritis (RA) and systemic sclerosis,
and two of the projects focus on drugs for the treatment of cancer, mainly prostate cancer
and renal cell cancer. In addition, Active Biotech is pursuing a preclinical project, ISI.
Laquinimod is an orally administered compound under development for the treatment
of autoimmune diseases, primarily MS. Active Biotech has an agreement with
the Israeli pharmaceutical company Teva for the development and commercialization
of laquinimod. In 2012, a marketing authorization application (MAA) was submitted
in the EU for the treatment of multiple sclerosis. One additional clinical study will be
completed prior to filing a new drug application (NDA) in the US. In 2012, Teva
announced that it intends to broaden the development program to include new
indications in the field of neurodegenerative diseases.
The development of tasquinimod is mainly focused on the treatment of prostate cancer.
Since 2011, Active Biotech has a partnership with the French pharmaceutical company
Ipsen for the co-development and commercialization of tasquinimod. The agreement
grants exclusive rights to Ipsen to commercialize tasquinimod worldwide, except for North
and South America and Japan, where Active Biotech retains all commercial and marketing
rights. Pivotal Phase III trials are ongoing. The enrollment of 1,245 prostate cancer patients
was completed in December 2012. The results from these studies are expected in 2014. In
2012, Ipsen announced that it had initiated further clinical studies of tasquinimod; as a
“switch maintenance” therapy and for four other cancer indications.
ANYARA is a protein drug that makes the treatment of cancer tumor-specific. The development
of ANYARA is primarily focused on renal cell cancer. The results of a Phase II/III trial
were presented in January 2013. The study did not achieve its primary endpoint to show
prolonged overall survival (OS) in the intention to treat (ITT) population. However, a
subgroup showed a doubling of progression-free survival (PFS) and OS. This subgroup
included patients with low levels of the biomarker IL-6 and normal levels of pre-formed
ANYARA antibodies and accounts for 40-50% of the total number of advanced renal cell
cancer patients in North America and Western Europe. Active Biotech plans to continue
the development of the project jointly with a partner after completed analysis of study
data and discussions with relevant authorities.
Paquinimod (in the 57-57 project) is a quinoline compound under development for treatment
of systemic sclerosis. This rare disease is an orphan drug indication. In February 2011,
paquinimod was granted orphan medicinal product status for the indication systemic
sclerosis (SSc). An explorative clinical study into this indication has been concluded.
Active Biotech has a licensing agreement with the German pharmaceutical company
MediGene AG, which grants MediGene the exclusive right to further develop and
market RhuDex®, a compound that is primarily intended to be used as a drug for the
treatment of rheumatoid arthritis (RA). In February 2013, MediGene announced that
the planned Phase IIa study in primary biliary cirrhosis (PBC), a chronic liver disease,
will be expanded to include more patients and an extended treatment period. The aim
is to confirm the mode of action of RhuDex in autoimmune diseases and facilitate the
continued development of the drug. The study will be initiated in 2014 at the latest.
ISI is a preclinical project aimed at utilizing the company’s own results that were generated
around S100A9, a target molecule for the quinoline compounds. The objective
of the project is to produce new, patentable chemical compounds that interact with
S100A9. The selection of a candidate drug is expected to take place in 2014.