Osiris Therapeutics, Inc.
) recently reported encouraging data from a study that evaluated
its stem cell therapy, Prochymal, in patients who have experienced
a heart attack (myocardial infarction) for the first time.
Interim one-year data showed that cardiac hypertrophy was
significantly lower in patients on Prochymal compared to patients
on placebo. Stress-induced ventricular arrhythmia was also lower in
the Prochymal arm compared to placebo.
A statistically significant reduction in heart failure was also
observed in the Prochymal arm. Moreover, patients in the Prochymal
arm required re-hospitalization for cardiac issues much later
compared to patients in the placebo arm (85.5 days versus 27.5
Prochymal was also found to be safe with no infusional
toxicities being observed. Serious adverse events were similar for
both Prochymal and placebo. However, the number of deaths was
higher in the Prochymal arm compared to the placebo arm (5 versus
Prochymal has been in the news recently with the product gaining
approval in Canada and New Zealand for the treatment of acute
graft-vs-host disease (GvHD) in children.
Prochymal is the first manufactured stem cell product to gain
approval and the first treatment to gain approval for GvHD.
Besides being approved in Canada and New Zealand, we note that
the product is available under an Expanded Access Program (EAP) in
seven countries including the US.
In addition to the phase II myocardial infarction study, Prochymal
is being evaluated for other indications including refractory
Crohn's disease (phase III) and type I diabetes.
We currently have low visibility on the status of Osiris'
development and commercialization agreement with Genzyme, a
) company, for Prochymal. Earlier this year, Sanofi, in its fourth
quarter press release, had said that it has discontinued the
development of Prochymal for GvHD.
Osiris said that the announcement was made without its knowledge
or advice and clarified that Prochymal's development has not been
discontinued. Although Osiris had not received any communication
from Sanofi regarding the termination of their agreement, Osiris
notified Sanofi that it is treating Sanofi's statement as an
intention to terminate the agreement.
According to Osiris, all rights to Prochymal will return to
Osiris without the company being required to compensate Sanofi.
Osiris believes it can now pursue commercialization agreements for
the product with other parties.
We currently have a Neutral recommendation on Osiris, which
carries a Zacks #3 Rank (short-term Hold rating). While Prochymal's
approval in Canada was a major milestone for the company, the lack
of visibility regarding the Sanofi deal concerns us.
OSIRIS THERAPTC (OSIR): Free Stock Analysis
SANOFI-AVENTIS (SNY): Free Stock Analysis
To read this article on Zacks.com click here.