Janssen announces collaboration with FIND

Janssen Pharmaceutica NV (Janssen) has announced it has entered into a novel collaboration with the non-profit organisation FIND to step-up the fight against the public health threat of tuberculosis (TB) and multidrug-resistant TB (MDR-TB).

The partnership draws on the expertise of FIND and Janssen; in particular FIND’s innovative work in increasing access to affordable diagnostic solutions; the capabilities of Janssen Diagnostics - a global division specializing in diagnostics; as well as Janssen’s experience in pharmaceuticals development and innovative access models. The collaboration will focus on providing increased access to molecular diagnostics tools for TB case detection and MDR-TB diagnosis, and on ensuring accelerated access to effective treatments.

This need to address early diagnosis was recently highlighted as one of the core components of the post-2015 End TB Strategy. The inadequacy of current diagnostic solutions, particularly in terms of point-of-care diagnosis, has been a crucial barrier to efforts to contain the spread of TB infection, especially the more complex drug-resistant strains, with around one in four cases of MDR-TB being detected, and only 50 percent successfully treated. 

 
Janssen and FIND will collaborate on a variety of projects with other partners, including developers and national TB control programs to close the gap in diagnosis and treatment.

Daratumumab accepted for accelerated CHMP assessment

Janssen-Cilag International NV announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has accepted its request for an accelerated assessment of the daratumumab Marketing Authorisation Application (MAA). This acceptance follows the earlier regulatory submission of a MAA which seeks authorisation of daratumumab as a single agent for the treatment of patients with relapsed and refractory multiple myeloma and is currently pending validation by the EMA.

The CHMP grants accelerated assessment when a medicinal product is expected to be of major public health interest particularly from the point of view of therapeutic innovation. Daratumumab is an investigational, human anti-CD38 monoclonal antibody that works by binding to CD38, a signalling molecule found on the surface of multiple myeloma cells.

In doing so, daratumumab triggers the patient’s own immune system to attack the cancer cells, resulting in rapid tumour cell death through multiple immune-mediated and other mechanisms of action.

Multiple myeloma (MM) is an incurable blood cancer that starts in the bone marrow and is characterised by an excessive proliferation of plasma cells.MM is the second most common form of blood cancer, with around 39,000 new cases in Europe in 2012. MM most commonly affects people over the age of 65 and is more common in men than in women. Daratumumab is an investigational human monoclonal antibody that binds with high affinity to the CD38 molecule, which is found on the surface of multiple myeloma cells. It is believed to induce rapid tumour cell death through multiple immune-mediated mechanisms, including complement-dependent cytotoxicity, antibody-dependent cellular phagocytosic and antibody-dependent cellular cytotoxicity, as well as via induction of apoptosis.