Teva Pharmaceutical Industries has returned to Mesoblast full global development rights for its mesenchymal precursor cell (MPC) technology platform for cardiovascular indications, ending a collaboration launched in 2010.
Included in the deal is Mesoblast’s lead product candidate in its cardiovascular portfolio, the Phase III candidate MPC-150-IM for advanced chronic heart failure.
Mesoblast said Teva ended the collaboration as part of a narrowing of its therapeutic areas of focus toward central nervous system (including multiple sclerosis, neurodegenerative diseases, and pain) and respiratory (including asthma and chronic obstructive pulmonary disease) treatments.
“Mesoblast now has unencumbered rights to partner with a leading cardiovascular company with a commitment to heart failure product commercialization,” Mesoblast CEO Silviu Itescu, MBBS, FRACP said in a statement.
Mesoblast added that it has been offered an equity finance facility that it can use toward funding the clinical program for MPC-150-IM going forward.
While the U.S. and Europe are leading markets for MPC-150-IM, Mesoblast said, Japan offers prospects for nearer-term commercial success because that country’s Pharmaceuticals and Medical Devices Agency has approved a new regulatory framework for cell therapy that includes early conditional approval and reimbursement of cell therapy products based on Phase II trial results.
The collaboration’s end comes some 2 months after the Data Monitoring Committee for a 600-patient Phase III trial assessing MPC-150-IM recommended that the trial continue without any modification after a review of efficacy and safety data for the first 175 patients. The trial is now close to 40% recruited and is scheduled for completion within 18 months, Mesoblast said.
The Phase III trial has enrolled over 230 patients out of a total of 600 patients with advanced heart failure, with the primary endpoint agreed upon with the FDA as recurrent heart failure-related hospitalizations or deaths (Heart Failure-Related Major Adverse Cardiovascular Events, HF-MACE).
A second trial of MPC-150-IM in 120 patients with end-stage heart failure and an implantable left ventricular assist device is almost 60% recruited, Mesoblast said, and is being fully funded by the NIH. The trial’s results are expected in the second half of 2017 and will be used to support the product candidate’s marketing approval application.
The FDA has approved the use of a second navigational catheter system in Mesoblast’s Phase III program for advanced heart failure. Mesoblast said its use is likely to result in accelerated Phase III trial recruitment and potentially a simplified distribution process through existing commercial channels once the product is approved.
According to Mesoblast, patients treated with MPC-150-IM in an earlier Phase II trial had no HF-MACE over 36 months of follow-up, compared with 11 recurrent HF-MACE events in the control group.
In patients with advanced heart failure as defined by baseline Left Ventricular Systolic Volume >100 ml, who closely resemble the patients being recruited in the Phase III trial, 71% of controls had at least one HF-MACE event compared with none of those who received a single injection of MPC-150-IM.
Mesoblast launched the collaboration in 2010 with Cephalon, since acquired by Teva, agreeing to shell out up to $350 million. The partnership’s goal was developing and commercializing adult MPC therapies based on Mesoblast’s adult stem cell technology platform.