For Immediate Release
FORTICELL BIOSCIENCE ANNOUNCES COLLABORATION AGREEMENT WITH
CJ CHEILJEDANG, A KOREAN PHARMACEUTICAL GIANT TO USE FIBRIN MICROBEACDS
FOR NOVEL UMBILICAL CORD BLOOD STEM CELL RECOVERY
New York, NY -- January 14, 2008 -- Forticell Bioscience, Inc. (OTCBB: FORB) announced today that it has entered into a Material Transfer and Technology Evaluation Agreement with CJ CheilJedang. (CJ), one of the largest Food and Healthcare companies in South Korea, granting CJ the exclusive right for a limited time to use it’s Fibrin MicroBeads (FMB™) technology for the extraction and expansion of mesenchymal-type stem cells (MSC) from human umbilical cord blood (UCB). Its wholly owned subsidiary, Hapto Biotech, Inc. (Hapto) will provide FMB along with proprietary research protocols and methods developed at its Hapto Biotech research laboratories in Israel for the extraction of MSC from UCB. CJ, along with an external scientific group on cord blood-derived stem cells led by Prof. & Director, Kyung Sun Kang at Adult Stem Cell Research Center, Seoul National University, will evaluate, elaborate and optimize Hapto’s procedures toward potential commercialization for in vivo treatment to induce regeneration or repair of damaged and/or diseased tissues. If the research performed during the evaluation period is successful, both Forticell and CJ will share new intellectual properties, and also both parties may thereafter negotiate a definitive patent licensing and product development agreement.
Commenting on the new agreement, which accelerates the development of Forticell’s second lead product candidate, Costa Papastephanou, Ph.D., CEO and President said, “The combination of FMB’s proven superiority in recovering high yields of MSC and CJ expertise in working with umbilical cord blood has the potential to make a major contribution in the broad emerging therapeutic field of stem cell induced tissue regeneration. Initiating collaborative agreements such as this one with CJ allows Forticell to pursue these broader applications while maintaining our momentum in delivering on our near term objective, the commercialization of OrCel®. Successful pursuit of indication or market-specific applications for our strong portfolio of cellular and biomaterial technologies should enable us to capitalize on a multitude of licensing opportunities with specialized partners. These relationships highlight the importance and market potential of our products, while associating us with partners whose complementary core competencies may accelerate our path to commercialization.”
FMB represent a unique and significant new biomaterial matrix, based on the blood clotting protein fibrin, that can be used for efficient isolation as well as expansion and delivery of adult stem cell therapeutics. FMB are biodegradable, biocompatible, and non-immunogenic particles. Peer-reviewed published data have shown that FMB can efficiently recover mesenchymal-type adult stem cells from peripheral blood or bone marrow, and can provide a stable platform for stem cell expansion, proliferation, differentiation, and delivery to the patient. Forticell has 4 patents and 2 patents pending relating to its FMB technology. The application of FMB in stem cell therapy is of increasing interest to the global healthcare community, which views stem cell treatment as a means of either replacing or inducing the regeneration of diseased, dysfunctional or damaged tissues. This form of treatment may be applied to a wide range of devastating human diseases or injuries, including, neurological conditions such as Parkinson’s and Lou Gehrig's disease, spinal cord and other nerve-related injuries, strokes, heart attacks, congestive heart failure, non-healing bone injuries and fractures, damaged cartilage and cosmetic soft and hard tissue reconstruction, among other applications.
About CJ CheilJedang Pharmaceutical Business Unit:
As one of the four core businesses under CJ CheilJedang (www.cj.net), the Pharmaceutical Business unit has been operating since 1984 and is ranked as one of the leading pharmaceutical companies in Korea. CJ CheilJedang Pharmaceutical Business Unit’s ongoing investment in Stem Cell field represents CJ’s forward looking planning for new core business areas during the next decade.
About Forticell Bioscience, Inc.
Forticell Bioscience, Inc. (OTC BB: FORT) is 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. Forticell’s lead product is OrCel® (Bilayered Cellular Matrix). Forticell’s current focus is the application of OrCel® to heal chronic and acute wounds. OrCel® 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 regeneration.
A pivotal clinical trial evaluating a cryopreserved version of OrCel® in the treatment of venous leg ulcers has been completed and a Pre Market Approval (PMA) application has been filed. Forticell has already obtained FDA approvals for use of a non-frozen version of OrCel® in the treatment of Epidermolysis Bullosa and donor sites in burn patients. In addition, the FDA has granted Forticell approval to initiate a pivotal (Phase III) trial evaluating OrCel® for the treatment of diabetic foot ulcers.
Through Forticell Bioscience’s wholly owned Hapto subsidiary, the Company is expanding its human tissue engineering capabilities with the development of two fibrin derived advanced biomaterial technologies, Fibrin MicroBeads (FMB™) and Haptides™. FMB™ has 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, differentiation, and potential reimplantation into the patient. Haptides™ 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™ in the development of product opportunities applicable to the cosmetic tissue augmentation and reconstruction, wound healing, orthopedics, and drug delivery markets.
Additional information about Fotticell is available on the Internet at forticellbioscience.com
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.
FOR MORE INFORMATION, PLEASE CONTACTOrtec's Investor Relations Firm: Jordan Darrow at [email protected] or 631-367-1866
At the Company: [email protected]