Guilford Receives $2.5 Million Milestone Payment for
2.08.1999, 17:57
GLIADEL(R) Wafer in France
Baltimore (PROTEXT) - Guilford Pharmaceuticals Inc. (Nasdaq:
GLFD) today announced that it has received a $2.5 million
milestone payment from Rhone-Poulenc Rorer Pharmaceuticals Inc.
(RPR) for regulatory developments relating to GLIADEL(R) Wafer in
France.
GLIADEL(R) Wafer has been approved for use in France as an
adjunct to surgery to prolong survival in patients with recurrent
glioblastoma multiforme (GBM), one of the most common and rapidly
fatal forms of malignant brain cancer. A positive ruling (avis
favorable) has been obtained from the Commission de la
Transparence, clearing the way for sale of GLIADEL(R) Wafer to
hospitals in France upon publication of the ruling, which is
expected later this quarter.
"We are strongly committed to expanding the market for
GLIADEL(R) Wafer and making it available to more patients
worldwide," said Craig R. Smith, M.D., President and Chief
Executive Officer. "In June, we announced that GLIADEL(R) Wafer
had received a favorable opinion for marketing authorization in
ten European countries. We are pleased to report that Ireland and
Luxembourg have now granted marketing authorization for the
product, and we look forward to receiving notice of additional
European marketing authorizations in the coming months."
As the first significant new treatment for brain cancer in
over 20 years, GLIADEL(R) Wafer is the only marketed cancer
treatment capable of delivering chemotherapy directly to the site
of a brain tumor, minimizing drug exposure to other areas of the
body. GLIADEL(R) Wafer is a biodegradable polymer wafer that is
implanted in the cavity created when a brain tumor is surgically
removed. As the wafer slowly erodes in the brain, it releases the
cancer chemotherapeutic drug carmustine (BCNU) directly to the
tumor site in high concentrations over an extended period of
time.
GLIADEL(R) Wafer offers an important new treatment option for
neurosurgeons and complements other standard therapies for brain
cancer. In a randomized clinical trial, GLIADEL(R) Wafer was
shown to prolong survival in patients with GBM for whom surgical
resection is indicated. In a multicenter study involving 145
patients with recurrent GBM, GLIADEL(R) Wafer increased six month
survival by more than 50%, from 36% with placebo to 56% with
GLIADEL(R) Wafer. In a separate Scandinavian study involving 32
patients undergoing surgery at the time of their initial
diagnosis, survival at one year was 63% for GLIADEL(R) Wafer
compared to 19% for placebo.
Guilford Pharmaceuticals Inc. is a biopharmaceutical company
engaged in the development of polymer-based therapeutics for
cancer, and novel products for the diagnosis and treatment of
neurological diseases, including Parkinson's disease, Alzheimer's
disease, stroke, severe head trauma, spinal cord injuries,
multiple sclerosis and peripheral neuropathies.
The Company desires to take advantage of the "safe harbor"
provision of the Private Securities Litigation Reform Act of
1995. This press release contains forward-looking statements that
involve risks and uncertainties. The Company describes certain of
these risks and uncertainties in its filings with the SEC,
including the section entitled "Risk Factors'' contained in the
Company's Registration Statement on Form S-3, filed on July 7,
1999. These risk and uncertainties could cause the Company's
actual results and experience to differ materially from
anticipated results and expectations expressed in these forward-
looking statements. In particular, the timing of official
publications of regulatory approval, if any, in France and other
countries cannot be assured. Furthermore, the Company cannot be
sure that any future sales of GLIADEL(R) Wafer in France will be
significant, that efforts to obtain additional approvals to
market and sell GLIADEL(R) Wafer in other countries for the
recurrent or first surgery indications will be successful and
permit sales at prices acceptable to the Company and RPR, and
that the Company will receive any of the payments from RPR
associated with such regulatory milestones.
Internet address: http://www.guilfordpharm.com
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Text Service: Guilford Pharmaceuticals Inc. Internet:
http://www.newsaktuell.de Contact: Stacey Jurchison or Angela
Rubin, Corporate Communications of Guilford Pharmaceuticals,
(USA) 410-631-6300 Company News On-Call:
http://www.prnewswire.com/comp/112882.html or Fax, (USA) 800-
758-5804, ext. 112882 Web site: http://www.guilfordpharm.com
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