Pluristem Therapeutics Inc., announced today that its wholly
owned Israeli subsidiary, Pluristem Ltd., has entered into an agreement with
MTM – Scientific Industries Center Haifa Ltd., for the leasing and construction
of a new state-of-the-art GMP manufacturing facility. The new facility will be
located near the company’s headquarters and existing facilities in MATAM Park,
Haifa, Israel and will support the manufacturing of Pluristem’s PLX (PLacental
eXpanded) cell product candidates for the treatment of critical limb ischemia
(CLI), intermittent claudication (IC), adjuvant hip replacement surgery, muscle
injuries, pulmonary hypertension (PH) and other diseases.
According to the agreement, the lease of the new facility
will commence as of January 2012 for a period of approximately 5 years with an
option to extend the lease for an additional 5 years.
Pluristem’s new regenerative medicine facility will be
cGMP/GTP compliant for clinical cell manufacturing and designed specifically to
meet both EMA and FDA regulatory requirements, as well as the standards
outlined by the Israeli Ministry of Health. Once constructed, the new facility
would have the capacity to produce PLX cells for the treatment of over 150,000
patients annually. As the company widens its clinical product candidate
portfolio and prepares to launch large-scale clinical trials in the U.S. and Europe,
the facility would enable Pluristem to meet increased manufacturing capacity
requirements. It would also enable Pluristem to meet marketing demands
following potential approval of its product candidates.
“Over the last few years, we have researched, developed
and fine-tuned the manufacturing methods, systems and techniques for the mass
production of clinical grade PLX products,” said Mr. Zami Aberman,
Pluristem’s Chairman & CEO. “The new manufacturing site will implement
our industry experience and support Pluristem’s strategy for potentially treating
millions of patients with life threatening diseases, positioning the company
for continued global collaborations and potential expansion of its partnerships
with pharmaceutical companies.”
