IRVINE, CA, April 25 /CNW/ - IsoTis, Inc. (NASDAQ: ISOT), the
orthobiologics company, today announced it has completed the transfer of the
rights associated with its PolyActive technology to OctoPlus (Euronext: OCTO),
a drug delivery and development company, in exchange for an up-front payment
of approximately $1.7 million and future royalty payments on sales of
pharmaceutical products based on the PolyActive technology.
Under the agreement, IsoTis retains the rights to manufacture, market,
and sell orthopedic plugs and cement restrictors including those related to
its marketed product SynPlug(R), based on the PolyActive technology.
About IsoTis, Inc.
IsoTis is a leading orthobiologics company that develops, manufactures
and markets proprietary products for the treatment of musculoskeletal diseases
and disorders. IsoTis' current orthobiologics products are bone graft
substitutes that promote the regeneration of bone and are used to repair
natural, trauma-related and surgically-created defects common in orthopedic
procedures, including spinal fusions. IsoTis' current commercial business is
highlighted by its Accell line of products, which the company believes
represents the next generation in bone graft substitution.
OctoPlus N.V. is a product-oriented biopharmaceutical company committed
to the development of improved pharmaceutical products that are based on its
proprietary drug delivery technologies and have fewer side effects, improved
patient convenience and a better efficacy/safety balance than existing
therapies. Rather than seeking to discover novel drug candidates through early
stage research activities, OctoPlus focuses on the development of long-acting,
controlled release versions of known protein therapeutics and other drugs.
OctoPlus is also a leading provider of advanced drug formulation and
clinical scale manufacturing services to the pharmaceutical and biotechnology
industry, with a focus on difficult to formulate active pharmaceutical
ingredients in injectable formulations. The earnings and expertise that
OctoPlus derives from rendering formulation and manufacturing services help to
support its own drug development programs.
Certain statements in this press release are "forward-looking statements"
within the meaning of Section 21E of the Securities Exchange Act of 1934, as
amended, including those that refer to management's plans and expectations for
future operations, prospects and financial condition. Words such as
"strategy," "expects," "plans," "anticipates," "believes," "will,"
"continues," "estimates," "intends," "projects," "goals," "targets" and other
words of similar meaning are intended to identify such forward-looking
statements. One can also identify them by the fact that they do not relate
strictly to historical or current facts. Such statements are based on the
current expectations of the management of IsoTis only. Undue reliance should
not be placed on these statements because, by their nature, they are subject
to known and unknown risks and can be affected by factors that are beyond the
control of IsoTis. Actual results could differ materially from current
expectations due to a number of factors and uncertainties affecting IsoTis'
business, including, but not limited to, a competitive sales and marketing
environment, the timely commencement and success of IsoTis' clinical trials
and research endeavors, delays in receiving U.S. Food and Drug Administration
or other regulatory approvals (a.o. EMEA, CE), including the risk that the FDA
determines that our Accell Putty and Accell TBM products are not human tissue
or class II medical devices, that the Company is unable to obtain 510(k)
clearance for its Accell products, that the FDA requires the Company to obtain
premarket approval of its Accell products prior to continuing their marketing,
that the FDA requires the Company to produce additional clinical data to
support approval or clearance of its products, that the FDA imposes compliance
measures against the Company for the marketing of its Accell products,
including imposing fines and injunctions or causing the Company to recall its
Accell products, market acceptance of IsoTis' products, effectiveness of
IsoTis' distribution channels, development of competing therapies and/or
technologies, the terms of any future strategic alliances, the need for
additional capital, the inability to obtain, or meet, conditions imposed for
required governmental and regulatory approvals and consents. IsoTis expressly
disclaims any intent or obligation to update these forward-looking statements
except as required by law. For a more detailed description of the risk factors
and uncertainties affecting IsoTis, refer to the Annual Report on Form 20-F
for the fiscal year ended December 31, 2005 of IsoTis SA, the predecessor of
the Company, filed with the SEC, to IsoTis SA's reports filed from time to
time with the Swiss Stock Exchange (SWX), Euronext Amsterdam N.V., SEDAR at
www.sedar.com and the Toronto Stock Exchange (TSX), and to the reports filed
from time to time by the Company with the SEC.
For further information:
For further information: Rob Morocco, CFO, (949) 855-7155,
firstname.lastname@example.org; Hans Herklots, Director IR, (949) 855-7195 or