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Smith & Nephew, Largo, FL, will cease manufacturing Dermagraft and related products. The decision came after receiving a nonapprovable letter from the Food and Drug Administration (FDA) in relation to the US marketing of Dermagraft for treatment of venous leg ulcers. The FDA had requested additional clinical studies that the company said would delay approval for 18 to 24 months.
Dermagraft, a cryopreserved human fibroblast-derived dermal substitute, had previously been approved for treatment of full-thickness diabetic foot ulcers of greater than 6 weeks' duration that extend through the dermis, but without tendon, muscle, joint capsule, or bone exposure.
I can't find an announcement on the Smith & Nephew website and Dermagraft is still listed: http://wound.smith-nephew.com/au/Pro...sp?NodeId=3472
All I can find is this snippet from the October 25 Q3 financial report:
Quote:
We have decided to exit DERMAGRAFT* and related products and are announcing this to affected employees today, and have therefore brought the timing of this announcement forward.
Press Release: Advanced BioHealing Announces Purchase of Dermagraft(R) and TransCyte(R)
Wednesday May 31, 12:00 pm ET
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NEW YORK, May 31 /PRNewswire/ -- Advanced BioHealing, Inc. (ABH) today announced it has concluded the acquisition of the assets and rights associated with the advanced wound care products Dermagraft® and TransCyte® from Smith & Nephew (NYSE: SNN - News; LSE: SN - News). Both products have been approved for marketing in the U.S. and other countries. The transaction transfers to ABH the assets and rights relating to these products. Financial terms were not disclosed.
"The addition of these two products provides us not only an immediate, predictable revenue base upon which to grow the company, but also an access point within the marketplace for our next generation products," said Kevin Rakin, Chief Executive Officer of ABH. "Dermagraft® and TransCyte® complement our proprietary cell culture and tissue engineering technologies which have potential applications in multiple clinical indications. Through this transaction, we are able to avail ourselves of a marketing and manufacturing infrastructure which will benefit our near and longer term product opportunities."
Advanced BioHealing will immediately begin the process of returning the La Jolla manufacturing facility to operation, as well as establishing necessary commercial capabilities including building a sales force. ABH anticipates the facility to be fully functional by the first quarter of 2007.
Advanced BioHealing was founded in 2003 by Dr. David Eisenbud, now President and Chief Operating Officer, to commercialize an innovative keratinocyte-based healing technology that is enabled by ABH's proprietary cell culture and tissue preservation techniques. The most recent round (Series B) of capital investment was co-led by Canaan Partners, LP and Wheatley Partners, LP.
Stephen Bloch, M.D. a principal with Canaan Partners and Chairman of the ABH Board added, "Our investment focus stresses rapid market entry, and we are delighted that this asset purchase will provide Advanced BioHealing with near- term revenues and the commercial infrastructure necessary for the company's additional products in development."
Dermagraft®
Dermagraft® is indicated for use in the treatment of full-thickness diabetic foot ulcers. The product was approved for sale in the United States in 2001. It is also approved and marketed in a number of other countries. Dermagraft® is a cryopreserved human fibroblast-derived dermal substitute. It is supplied frozen in a clear bag containing one piece of approximately 2 x 3 inches for a single-use application.
TransCyte®
TransCyte® is indicated for use as a temporary wound covering for surgically excised full-thickness and deep partial-thickness thermal burn wounds. The product is a human fibroblast-derived temporary skin substitute. The product is supplied in a cassette containing two aseptically processed sheets each approximately 5 x 7.5 inches. TransCyte® was approved for sale in the United States in 1999 and is also approved and marketed in a number of other countries.
About Advanced BioHealing
Advanced BioHealing is a specialty biotechnology company focused on the development and marketing of cell based and tissue engineered products with an initial focus on wound care. The privately held, New York-based company, will have two marketed products: Dermagraft® which is indicated for treatment of diabetic foot ulcers and TransCyte® which is indicated for treatment of full- and partial-thickness burns. The company's pipeline also includes a next-generation bioengineered wound therapy for which an Investigational Device Exemption application has been submitted. For more information on Advanced BioHealing visit http://www.AdvancedBioHealing.com.
Press Release; Advanced BioHealing Launches Dermagraft(R)Thursday February 15, 10:00 am ET
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Advanced BioHealing, Inc. (ABH) announced today that is has begun selling and shipping the bioengineered tissue product Dermagraft®. Dermagraft is approved by the U.S. Food and Drug Administration (FDA) as a treatment for full-thickness diabetic foot ulcers.
"Since acquiring Dermagraft in June of 2006, we have diligently worked on building the manufacturing and commercial infrastructure necessary for success in the marketplace, meeting our stated goal of launching Dermagraft during the first quarter of 2007," said Kevin Rakin, Chief Executive Officer of Advanced BioHealing. "Over the next two years we will be focused on re-establishing Dermagraft as a leading advanced wound care treatment. By accomplishing this goal, we will drive the commercial success of the company while simultaneously supporting development of our next-generation bioengineered product."
ABH has established commercial operations, which include sales, marketing, health economics, customer service, product reimbursement and technical support professionals. The company has strategically placed initial representatives in markets that generated significant revenues in the past. In addition, inside sales professionals will be focusing on opportunities in other geographic regions, in particular large wound care centers. ABH will continue to add representatives throughout 2007 commensurate with projected revenue growth.
In addition to commercial operations, ABH also has a state-of-the art manufacturing facility staffed with professionals already familiar with the production and quality control elements of Dermagraft. This facility has passed numerous inspections, including a critical State of California licensing process. Since Dermagraft was previously available in the U.S. market, the product already has appropriate purchase and application codes to ensure physicians are reimbursed for utilizing the product.
"This launch is a significant milestone and points to the strength and commitment of the ABH management and team," said Stephen Bloch, MD, Venture Partner with Canaan Partners and Chairman of the ABH Board of Directors. "In addition to the launch of Dermagraft, ABH has made significant progress in building a pipeline of complementary wound healing products, evidenced by the recent initiation of a pilot study evaluating the safety of Celaderm(TM) in treating venous leg ulcers."
Dermagraft is a cryopreserved human fibroblast-derived dermal substitute. It is supplied frozen in a clear bag containing one piece of approximately 2 x 3 inches for a single-use application. The product is approved for marketing in the U.S. and in a number of other countries.
Press Release: Safeguard Scientifics Announces Third Quarter 2008 Financial Results
Quote:
Safeguard Scientifics, Inc. (NYSE: SFE), a holding company that builds value in growth-stage life sciences and technology companies, today announced its financial results for the third quarter 2008. Safeguard reported consolidated revenue of $19.0 million for the third quarter, a 59% increase as compared to $11.9 million for the third quarter 2007, excluding
Quote:
MINORITY HOLDINGS
Advanced BioHealing, Inc. (ABH), a leader in the science of regenerative medicine, increased revenues 62% year-over-year and the company also expects to meet several operational milestones during 2008. ABH's FDA-approved Dermagraft(TM) for diabetic foot ulcers is in strong demand, which is being served by an expanded sales force. Safeguard deployed $10.8 million of capital in ABH in February and May 2007 and has a 28% ownership position.
Smith & Nephew Will End Dermagraft Production
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