Mesoblast Ltd on Monday said it had regained full rights to its experimental stem cell therapy for advanced chronic heart failure, which is currently in late stage testing, from Teva Pharmaceutical Industries.
While Teva returned its rights to the potential blockbuster treatment without any financial payment, the Israel-based generic drugmaker can still benefit from any eventual success as one of Mesoblast's top shareholders. Teva inherited about 14 percent of the Australian company through its acquisition of Cephalon and has assisted in development of the therapy.
"The operational support we received from Teva has been excellent," Mesoblast Chief Executive Silviu Itescu said in a telephone interview.
Teva, through Cephalon, held about 60 percent of the rights to the therapy. Teva's current strategy did not include further pursuing the heart failure treatment, known as MPC-150-IM, Itescu said.
"We're very pleased to have regained the asset. We will drive the program," Itescu said.
A Credit Suisse report last month forecast peak sales of $4.1 billion for the heart failure treatment.
The company said it expects to complete its pivotal 600-patient Phase III trial by the end of next year.
An independent data monitoring committee found no safety issues and strongly recommended continuing the study after reviewing data from the first 175 patients, Mesoblast said. The trial is designed to show that the treatment can significantly reduce heart failure hospitalizations and deaths.
Mesoblast said it has the financing to complete the clinical trial, but will seek a large company partner to help sell the treatment, if approved.
"For sales and marketing, we will be partnering with a major cardiovascular company that has an existing sales force and commitment to the heart failure field," Itescu said.
He added that the company has already been in preliminary talks with potential partners.
Chronic heart failure is a debilitating progressive disease in which the heart becomes enlarged and increasingly unable to sufficiently pump blood to the rest of the body.
Mesoblast uses a specialized type of adult stem cells to create an "off-the shelf" product that could be used in many patients.