Mesoblast Stock Sinks 42% After Teva Withdraws from Heart Failure Trials
June 14, 2016
By Alex Keown, BioSpace.com Breaking News Staff
NEW YORK – Shares of Australia-based Mesoblast Limited sank 42 percent after Teva Pharmaceuticals withdrew its support of the Phase III chronic heart failure stem cell therapy platform MPC-150-IM.
Earlier this month, Mesoblast suspended trading of its stock, which signaled to many industry analysts a problem with its pipeline or with its relationship with Teva. During a shareholders call in May, analysts questioned Mesoblast Chief Executive Officer Silviu Itescu as to what would happen should Teva pull out of the partnership, the Motley Fool reported earlier this month after the company suspended trading. Itescu told an analyst that such a scenario was unlikely, the Fool reported, however, as of today, the analysts concerns were proven right.
Mesoblast is trying to put a good spin on things, saying it regained “full worldwide rights and full strategic flexibility” over its cardiovascular mesenchymal precursor cell (MPC) technology platform. The lead asset in this cardiovascular portfolio is Mesoblast’s Phase III product candidate MPC-150-IM for advanced chronic heart failure, has the potential to be a multibillion dollar blockbuster for Mesoblast, the company asserted in today’s announcement.
“We are delighted to regain full control of this very valuable asset in our portfolio, and to have been offered a finance facility we can draw on to meet the funding requirements for the program. The growing body of clinical evidence validates our strong conviction in the potential of our product candidate MPC-150-IM to change the way that advanced heart failure is treated,” Itescu said in a statement. Itescu added that the company acknowledged Teva’s decision was based on “strategic reasons aligned to their core therapeutic areas of focus.”
Although Teva has not publicly announced its reasoning for withdrawing from the partnership with Mesoblast, the company must have discovered something during the ongoing Phase III trial that signaled the product would not be a potential moneymaker or game changer. If Teva makes an announcement, BioSpace will update the article.
With Teva withdrawing, Mesoblast is now free to pursue other partnerships with companies that have a “commitment to heart failure product commercialization,” Itescu said. In addition to strong markets in the United States and Europe, Mesoblast said Japan presents a “nearer-term commercial opportunity” for the cardiovascular treatment. Japan’s Pharmaceuticals and Medical Devices Agency’s new regulatory framework for cell therapy enables early conditional approval and reimbursement of cell therapy products based on Phase II trial results, the company said.
The Phase III trial is ongoing, but Phase II results showed patients treated with MPC-150-IM had no HF-MACE over 36 months of follow-up, compared with 11 recurrent HF-MACE events in the control group. The Phase III trial is expected to conclude within 18 months. In addition to Teva’s withdrawal from the partnership, Mesoblast said that the U.S. Food and Drug Administration approved the use of a second navigational catheter system in Mesoblast’s Phase III program for advanced heart failure. More than 2,000 of these FDA-approved systems are currently in use across the United States for the treatment of atrial fibrillation, and their use in Mesoblast’s program is likely to result in accelerated Phase III trial recruitment, Mesoblast said in a statement.