WALKERSVILLE, Md., and NEW YORK, July 17 /PRNewswire-FirstCall/ --
Cambrex Bio Science Walkersville, Inc., a subsidiary of Cambrex Corporation
(NYSE: CBM), and Ortec International, Inc. (ORTN) are pleased to announce
that they have submitted a Humanitarian Device Exemption (HDE) application
to the US Food and Drug Administration (FDA) requesting approval to market
cryopreserved OrCel(R) for the treatment of patients with Recessive
Dystrophic Epidermolysis Bullosa (RDEB). The FDA has approximately
seventy-five days to respond to the HDE application.
(Logo: http://www.newscom.com/cgi-bin/prnh/20000613/CAMBREXLOGO )
The FDA had previously advised that it could approve, without
additional clinical data, an HDE supplement allowing the use of
cryopreserved OrCel(R) in patients with RDEB undergoing hand reconstruction
as well as to cover donor sites created during the surgery (the area where
skin was removed from another part of the patient's body). In February
2001, the FDA granted Ortec an HDE for this indication for a
non-cryopreserved version of OrCel.
An HDE is a FDA clearance that allows medical devices that provide safe
treatment to be available in a prescribed manner for patients with rare
medical conditions that affect fewer than 4,000 individuals in the US per
year. An HDE application is similar in both form and content to a
Pre-Market Approval (PMA) application, but approval can be granted by the
FDA based on more limited clinical experience than that required for a PMA.
RDEB, the most severe form of Epidermolysis Bullosa (EB), is a
devastating congenital skin disorder characterized by painful ulcerations
and widespread, permanent scarring resulting in deformity of the hands and
feet. As a result, many RDEB patients require repeated surgeries, resulting
in a need for replacement skin, to allow greater use of their extremities.
For more information about EB, please visit http://www.debra.org.
Cambrex Bio Science Walkersville, Inc. and Ortec International
previously signed a multi-year agreement for Cambrex to manufacture, market
and distribute OrCel in the United States. Upon approval by the FDA,
Cambrex Bio Science Walkersville, Inc. will provide the product to
patients.
About Cambrex
Cambrex is a global, diversified life sciences company dedicated to
providing products and services to accelerate and improve the discovery and
commercialization of human therapeutics. The Company employs approximately
2000 worldwide. For more information, please visit http://www.cambrex.com.
About Ortec International, Inc.
Ortec International, Inc. (ORTN) is a company focused on advancing
regenerative medicine and stem cell therapy through the development and
commercialization of innovative products by combining advanced cell
technology and advanced biomaterials. Ortec's lead product is OrCel(R)
(Bilayered Cellular Matrix). Ortec's current focus is the application of
OrCel(R) to heal chronic and acute wounds. OrCel(R) is composed of a
collagen sponge seeded with allogeneic epidermal and dermal cells. These
cells secrete growth factors and cytokines normally found in acute human
wounds and are believed to have a beneficial role in promoting tissue
repair.
A pivotal clinical trial evaluating a cryopreserved version of OrCel(R)
in the treatment of venous leg ulcers has been completed and a Pre-Market
Approval (PMA) application has been filed. Ortec has recently completed
patient enrollment in a confirmatory trial and the data from this trial are
expected to be integrated with the results of the pivotal clinical trial
and submitted as a clinical supplement to its PMA filing. Ortec has already
obtained FDA approvals for use of a non-frozen version of OrCel(R) in the
treatment of Epidermolysis Bullosa and donor sites in burn patients. In
addition, the FDA has granted Ortec approval to initiate a pivotal (Phase
III) trial evaluating OrCel(R) for the treatment of diabetic foot ulcers.
Ortec recently acquired two fibrin derived advanced biomaterial
technologies, Fibrin Microbeads and Haptides(TM) developed by its wholly
owned subsidiary HAPTO Biotech, Israel. Fibrin Microbeads have the
potential to play a significant role in advancing stem cell therapy having
demonstrated the ability to efficiently recover adult stem cells and allow
for their growth, proliferation, and potential reimplantation into the
patient. Haptides(TM) utilize proprietary synthetic peptides that mimic the
mechanism of cell attachment to fibrin. These peptides have demonstrated
the ability to significantly enhance cell attraction and attachment
providing the potential to use Haptides(TM) in the development of product
opportunities applicable to the cosmetic tissue augmentation, wound
healing, orthopedics, and drug delivery markets.
For more information, visit Ortec's website at
http://www.ortecinternational.com.
Cambrex Forward Looking Statements
This news release contains "forward-looking statements" within the
meaning of the Private Securities Litigation Reform Act of 1995 and Rule
3b-6 under The Securities Exchange Act of 1934, including, without
limitation, statements regarding expected performance, especially
expectations with respect to sales, research and development expenditures,
earnings per share, capital expenditures, acquisitions, divestitures,
collaborations, or other expansion opportunities. These statements may be
identified by the fact that words such as "expects", "anticipates",
"intends", "estimates", "believes" or similar expressions are used in
connection with any discussion of future financial and operating
performance. The forward-looking statements contained herein are based on
current plans and expectations and involve risks and uncertainties that
could cause actual outcomes and results to differ materially from current
expectations including but not limited to, global economic trends,
pharmaceutical outsourcing trends, competitive pricing or product
developments, government legislation and/or regulations (particularly
environmental issues), tax rate, interest rate, technology, manufacturing
and legal issues, changes in foreign exchange rates, performance of
minority investments, uncollectible receivables, loss on disposition of
assets, cancellation or delays in renewal of contracts, and lack of
suitable raw materials or packaging materials, the possibility that the
value of the acquisition of PermaDerm(TM) cultured skin may not be realized
or that our plans to obtain a Humanitarian Device Exemption, completion of
clinical trials and commercialization of PermaDerm cultured skin in the
United States may not be successful, the Company may not receive regulatory
approval for its products, and the outcome of the evaluation of strategic
alternatives.
For further details and a discussion of these and other risks and
uncertainties, investors are cautioned to review the Cambrex 2004 Annual
Report on Form 10-K, including the Forward-Looking Statement section
therein, and other filings with the Securities and Exchange Commission. The
Company undertakes no obligation to publicly update any forward-looking
statement, whether as a result of new information, future events or
otherwise.
Ortec International Forward Looking Statements
This news release may contain "forward-looking statements" for the
purposes of the United States Securities and Exchange Commission's "safe
harbor" provisions under the Private Securities Litigation Reform Act of
1995 and Rule 3B-6 under The Exchange Act. Without limitation, statements
regarding expected FDA approvals, clinical trial results, product
performance, expectations with respect to sales, gross margins, research
and development expenditures, earnings per share, capital expenditures,
collaborations, or other expansion opportunities would be "forward-looking
statements." These statements may be identified by words such as "expects,"
"anticipates," "intends," "estimates," "believes" or similar expressions in
connection with any discussion of future financial and operating
performance. The forward- looking statements contained herein involve risks
and uncertainties that may cause results to differ materially from the
Company's expectations including but not limited to, global economic
trends, competitive pricing or product developments, government legislation
and/or regulations, technology, manufacturing, legal and patent issues,
suppliers, capital availability, personnel changes, cancellation or delays
in renewal of contracts, and lack of suitable raw materials or packaging
materials. Investors are cautioned to review risk factors in the Company's
filings with the United States Securities and Exchange Commission.
OrCel(R) is a registered trademark of Ortec International.
SOURCE Cambrex Corporation
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Related links:
http://www.cambrex.com
http://www.ortecinternational.com http://www.debra.org
Photo Notes:http://www.newscom.com/cgi-bin/prnh/20000613/CAMBREXLOGO
http://www.prnewswire.com/comp/134219.html /
CONTACT:
Anne-Marie Hess, Sr. Director, Investor
Relations of Cambrex, +1-201-804-3062,
annemarie.hess@cambrex.com; or Dodi Handy of Elite Financial
Communications Group, LLC, for Ortec International,
+1-407-585-1080, ortn@efcg.net
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