LA JOLLA, Calif., Sept. 3 /PRNewswire/ -- Advanced Tissue Sciences, Inc.
(Nasdaq: ATIS) and Smith & Nephew plc reported complete healing of over 50% of
the evaluable patients in their supplementary clinical trial of Dermagraft in
the treatment of diabetic foot ulcers, consistent with the results from their
earlier pivotal clinical trial.  In the pivotal clinical trial, Dermagraft
within a specific therapeutic range was shown to be significantly more
effective than the control group in achieving complete healing (50.8% vs.
31.7%; p = 0.01).  The primary endpoint of both trials was complete healing of
these severe skin ulcers within twelve weeks.  The supplementary clinical
trial was performed to show the equivalence of Dermagraft product produced to
commercial process specifications.  All fifty of the patients enrolled in the
supplementary trial were treated with Dermagraft.
    A Premarket Approval (PMA) application based on the results of the earlier
pivotal clinical trial is currently being reviewed by the U.S. Food and Drug
Administration (FDA) under its expedited review process.  Data from the
supplemental clinical trial will be submitted as an amendment to the PMA
application.  Pooling all the patients receiving Dermagraft within the
therapeutic range from the two trials also shows a statistically significant
improvement in complete healing at twelve weeks as compared to the control
group, both on an "intent to treat" basis (126 Dermagraft patients versus 142
in the control group) and on the basis of evaluable patients.
    The companies also reported additional data from the pivotal clinical
trial.  Specifically, of those patients who completely healed within a 32 week
period, the mean time to complete healing in the patients receiving Dermagraft
within the therapeutic range was more than twice as fast as in the control
group (13 weeks as compared to 28 weeks, respectively).
    "The results of these trials highlight the importance of a living,
metabolically active tissue in accelerating the healing and closure in
diabetic foot ulcers," said Gail K. Naughton, Ph.D., President and Chief
Operating Officer of Advanced Tissue Sciences.  "In addition, the ability to
heal these ulcers faster has a dramatic effect on the patient's quality of
life and can have a cost benefit to the health care system.  Our focus over
the next several weeks is to complete our analysis of the data and submit the
results of the supplemental trial to the FDA."
    Approximately 800,000 diabetic foot ulcer patients are treated in the
United States each year, 400,000 of which represent Dermagraft's initial
target market of full-thickness ulcers.  In April 1996, Advanced Tissue
Sciences and Smith & Nephew entered into a fifty-fifty joint venture for the
worldwide commercialization of Dermagraft in the treatment of diabetic foot
ulcers.  The companies recently announced that Dermagraft for the treatment of
diabetic foot ulcers was approved for marketing in Canada in August.  Advanced
Tissue Sciences and Smith & Nephew also have announced plans to launch
Dermagraft in the United Kingdom in October and in several northern European
countries before the end of 1997.  Further launches in other global markets
are being planned in 1998, subject to regulatory approvals.
    Advanced Tissue Sciences is a tissue engineering company utilizing its
proprietary core technology to develop and manufacture human tissue products
for tissue repair and transplantation.  In addition to developing its
Dermagraft product, the Company is currently marketing Dermagraft-TC(TM), a
temporary covering for severe burns, under an approval from the FDA.  The
Company also is developing products for cartilage and cardiovascular
applications.
    Smith & Nephew, a leading worldwide healthcare company with more than $1.5
billion in annual sales, has a highly successful track record in developing,
manufacturing and marketing a wide variety of innovative and technologically
advanced tissue repair products, primarily in the areas of bone, joints, skin
and other soft tissue.  Smith & Nephew has extensive marketing and
distribution capabilities and sales in more than 90 countries.
    The discussion contained in this press release relating to approval and
commercialization of the Company's products, market opportunities and
therapeutic benefits involves risks and uncertainties.  No assurance can be
given that the Company will successfully obtain Food and Drug Administration
or other regulatory approvals of Dermagraft (or that any such approvals will
be obtained on a timely basis), scale up manufacturing processes, launch its
products within indicated timeframes, or successfully commercialize any such
products.  These and other risks are detailed in publicly available filings
with the Securities and Exchange Commission such as the Company's Annual
Report on Form 10-K and in a Registration Statement on Form S-3 (File No. 333-
01185).  Actual results may differ materially from those currently anticipated
as a result of such risks.

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