Therapeutics, Inc. (NASDAQ:OSIR), announced today that it has
reached agreement with the United States Food and Drug Administration
(FDA) regarding the regulatory pathway for its Biosurgery products,
Grafix® and Ovation®.
After discussions with the FDA, the regulatory status of Grafix is
confirmed and the product will remain on the market as a wound cover for
the treatment of acute and chronic wounds. For certain expanded
indications for Grafix, Osiris has committed to submit a Biologics
License Application (BLA). Osiris will leverage existing clinical data
in the preparation of the applications, including data from Protocol
302, its multi-center, randomized controlled trial which demonstrated a
192% relative improvement in closure rate of chronic diabetic foot
ulcers as compared to patients receiving conventional therapy (p<0.0001).
Additionally, Osiris will continue transitioning its Ovation product
line over to the company's newly launched OvationOS TM formulation and has
agreed to complete this transition no later than the second half of 2014.
"We are pleased with the regulatory clarity this agreement provides and
are excited to take this leadership role as we work with FDA in the
evolving science and regulation of regenerative medicine," said C.
Randal Mills, Ph.D., President and Chief Executive Officer of Osiris.
"This effort will set a new standard in transplantation and will further
spotlight the clinical benefits and high quality this innovative
The commitments in this agreement will address the recent concerns FDA
raised with respect to the regulatory status of Ovation and Grafix. The
company's Cartiform® product is not affected.
About Osiris Therapeutics
Osiris Therapeutics, Inc. is the leading stem cell company, having
developed the world's first approved stem cell drug, remestemcel-L for
graft versus host disease. Osiris' products include Grafix® and Ovation®
for acute and chronic wounds, Cartiform®, a viable cartilage mesh for
cartilage repair and the latest addition to Osiris' line of products,
OvationOS TM, a viable bone matrix. Osiris is a fully integrated company
with capabilities in research, development, manufacturing and
distribution. Osiris has developed an extensive intellectual property
portfolio to protect the company's technology and commercial interests.
Osiris, Grafix, Ovation and Cartiform are registered trademarks of
Osiris Therapeutics, Inc. More information can be found on the company's
This press release contains forward-looking statements. Forward-looking
statements include statements about our expectations, beliefs, plans,
objectives, intentions, assumptions and other statements that are not
historical facts. Words or phrases such as "anticipate," "believe,"
"continue," "ongoing," "estimate," "expect," "intend," "may," "plan,"
"potential," "predict," "project" or similar words or phrases, or the
negatives of those words or phrases, may identify forward-looking
statements, but the absence of these words does not necessarily mean
that a statement is not forward-looking. Examples of forward-looking
statements may include, without limitation, statements regarding any of
the following: our product development efforts; our clinical trials and
anticipated regulatory requirements, and our ability to successfully
navigate these requirements; the success of our product candidates in
development; status of the regulatory process for our biologic drug
candidates; implementation of our corporate strategy; our financial
performance; our product research and development activities and
projected expenditures, including our anticipated timeline and clinical
strategy for marketed Biosurgery products (including Grafix, Ovation,
OvationOS and Cartiform) and Biosurgery products under development; our
cash needs; patents, trademarks and other proprietary rights; the safety
and ability of our products and potential products to address medical
needs; our ability to supply a sufficient amount of our marketed
products or product candidates and, if approved or otherwise
commercially available, products to meet demand; our costs to comply
with governmental regulations; our plans for sales and marketing; our
plans regarding facilities; types of regulatory frameworks we expect
will be applicable to our products and potential products; and results
of our scientific research. Additional risks and uncertainties related
to the sale of our ceMSC assets and the related transactions
contemplated by the Purchase Agreement with Mesoblast include typical
business transactional risks, the risk of changing relationships with
customers, suppliers or employees, the risk associated with the
disposition of our ceMSC assets and the increased relative dependence on
and importance of our other business including our Biosurgery business,
the risk that we may not be able to fully benefit from the transactions
through milestone payments or royalties, payment risks, including the
risk associated with receipt of equity as consideration, in lieu of
cash, and the risk of dependence on others to achieve results upon which
milestone or royalty payments to us are conditioned. Forward-looking
statements are subject to known and unknown risks and uncertainties and
are based on potentially inaccurate assumptions that could cause actual
results to differ materially from those expected or implied by the
forward-looking statements. Our actual results could differ materially
from those anticipated in forward-looking statements for many reasons,
including the factors described in the section entitled "Risk Factors"
in our Annual Report on Form 10-K and other Periodic Reports filed on
Form 10-Q, with the United States Securities and Exchange Commission.
Accordingly, you should not unduly rely on these forward-looking
statements. We undertake no obligation to publicly revise any
forward-looking statement to reflect circumstances or events after the
date of this press release or to reflect the occurrence of unanticipated
Osiris Therapeutics, Inc.
Aziz Ahmad, 443-545-1834