Teva walks away from Mesoblast’s heart failure drug
Teva has returned rights to a phase 3 experimental heart drug to Mesoblast and walked away from development of the stem-cell based therapy.
Australia’s Mesoblast said it would continue to develop its lead product, MPC-150-IM for heart failure, and will not have to pay Teva, which has returned full rights.
A phase 3 trial has recruited almost 40% of the patients required within 18 months, and an independent data monitoring committee has recommended continuation without modification of the 600-patient study.
Teva owned 60% of the rights to the drug through its buyout of Cephalon. Mesoblast said the drug had “blockbuster” potential.
Credit Suisse agrees with this analysis – in a report last month it forecast peak sales of $4.1 billion.
Mesoblast said it has funding to complete the phase 3 trial but is looking for a larger partner to help market the treatment if approved.
Its chief executive, Dr Silviu Itescu, said: “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.”
The product also had the backing of co-principal investigator on the phase 3 trial, Dr Emerson Perin, director of cardiovascular clinical research and medical director at the Stem Cell Center, Texas Heart Institute.
He said the trial has “progressed extremely well”. “I have a deep sense that this is extremely important and meaningful work and have dedicated my career towards it,” he added.
A second phase 3 trial in 120 patients with end-stage heart failure and an implantable left ventricular assist device is almost 60% recruited and is being fully funded by the US National Institutes of Health.
Teva made no comment about the decision to walk away from development, and appears more preoccupied with safety issues relating to it Zecuity (sumatriptan iontophoretic transdermal system) migraine patch.
The Israel-based company said it will voluntarily suspend US sales after receiving reports of application site reactions described as burns and scars in patients treated with Zecuity.
It is working with the US Food and Drug Administration to better understand the events, and has also begun a pharmacy-level recall of the product.
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