Company news release:
biz.yahoo.com
Thursday September 18 8:44 PM EDT
Company Press Release
FDA Advisory Committee Recommends Approval of Photodynamic Therapy for
Early-Stage Lung Cancer Treatment
SAN JOSE, Calif.--(BW HealthWire)--Sept. 18, 1997--Laserscope (NASDAQ:LSCP)
announced that the Oncologic Drugs Advisory Committee of the U.S. Food and
Drug Administration (FDA) today recommended that the FDA grant approval for
the photodynamic therapy (PDT) treatment of early-stage lung cancer
utilizing its laser systems and the drug PHOTOFRIN(R) (porfimer sodium).
Specifically, a majority of the Advisory Committee voted in favor of
approving PHOTOFRIN for use in the photodynamic therapy treatment of
endobronchial microinvasive non-small cell lung cancer in patients for whom
surgery and radiotherapy are not indicated.
Besides early-stage lung cancer the submission also included an application
for the palliation of advanced disease. The Advisory Committee, however,
did not feel that the data presented for the palliative indication
consisted of adequate and well controlled trials and, therefore, could not
vote on whether or not it should recommend approval.
A product of QLT PhotoTherapeutics Inc., Vancouver, Canada, PHOTOFRIN is
distributed in the U.S. by Sanofi Pharmaceuticals Inc. and in Europe by
Beaufour-Ipsen.
The Advisory Committee's recommendation, although not binding, will be
considered by the FDA as it continues reviewing QLT's Supplemental New Drug
Application (NDA) for PHOTOFRIN and Laserscope's Supplemental Premarket
Approval Application (PMA) for Laserscope's PDT laser systems, both of
which were filed in February of 1997. According to FDA policy, QLT and
Laserscope can expect a final decision on the applications within one year
of filing.
Photodynamic therapy (PDT) is an innovative cancer treatment that combines
light-activated drugs, such as PHOTOFRIN, with specific light sources, such
as Laserscope's PDT laser systems, and fiberoptic delivery devices, to
destroy cancer cells selectively. A pioneer in PDT laser systems and
related fiberoptics, Laserscope has been involved in several clinical
studies with QLT, developer of PHOTOFRIN, the only light-activated drug
with market approval from the FDA.
Laserscope and QLT have previously received FDA clearance to market
PHOTOFRIN and Laserscope's PDT laser systems to treat certain
advanced-stage esophageal cancers. Laserscope also has worked closely with
Sanofi Pharmaceuticals Inc., the U.S. distributor of PHOTOFRIN, in
marketing PDT products for treating esophageal cancer, and intends to
continue the marketing relationship in lung cancer applications should we
receive market approval from the FDA.
In commenting on today's developments, Robert V. McCormick, President and
CEO of Laserscope said: ``We are pleased that the Advisory Committee has
viewed photodynamic therapy as a useful modality for treating early-stage
lung cancer and recommended its approval to the FDA. We believe that PDT
represents a unique, non-surgical, minimally invasive approach to the
treatment of cancer.''
``We believe, however, that photodynamic therapy also is an effective
modality for treating late-stage lung cancer and hope that the FDA will
take into account the usefulness of PDT as an alternative methodology in
the treatment of late-stage lung cancer.''
PDT, unlike conventional cancer therapies, discriminates between healthy
and diseased cells. With PDT, patients are injected with a photosensitizing
drug, which is selectively absorbed by malignant tissue. The tissue is then
exposed directly to laser light, which can be applied endoscopically for
the purpose of destroying abnormal cells. This non-surgical, minimally
invasive approach allows the surgeon to be much more precise in removing
cancer cells at the tumor site and in the surrounding tissue. Both the drug
injection and some endoscopic laser treatments can be performed on an
outpatient basis.
According to the National Cancer Institute, lung cancer is the leading
cause of cancer mortality in the U.S., responsible for more than 150,000
deaths a year. In recent years, the rate of increase in lung cancer has
outpaced that of any other major malignancy, rising from 149,000 new cases
in 1993 to 177,000 new cases in 1996.
Added Mr. McCormick: ``The potential of being able to treat early-stage
lung cancer with our portfolio of laser and fiberoptic products adds a new
dimension and direction to our business,'' he said. ``Aside from the
Laserscope PDT lasers required to activate PHOTOFRIN, each treatment will
consume at least one fiberoptic delivery device priced in the $300-$600
range.
Laserscope designs, manufactures, sells and services on a worldwide basis
an advanced line of medical laser systems and related energy delivery
devices for the office, outpatient surgical center and hospital markets. In
addition, Laserscope's Ascent Medical Systems(TM)(AMS) provide innovative
equipment solutions for the surgical and patient care environments.
Statements in this announcement about future results are preliminary and
based on partial information and assumptions. There can be no assurance
that the company will receive final FDA approval of its supplemental PMA
for lung cancer, or that such approval will not be delayed. In addition,
competitors of the company have received or may receive PMAs similar to the
company's, and have entered or may enter into business relationships with
PDT drug suppliers. Additionally there can be no assurance that additional
competitors will not enter this market when and if it develops.
Except for the historical information presented, the matters discussed in
this announcement contain forward-looking statements that involve risks and
uncertainties, including the timely introduction and market acceptance of
new products and procedures such as those described herein, the development
and rate of growth of new markets and treatments, the impact of competitive
products and technologies, and other risks detailed from time to time in
the company's public disclosure filings with the U.S. Securities and
Exchange Commission (SEC). Copies of the most recent Forms 10K and 10Q are
available upon request from Laserscope's Investor Relations Department.
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Contact:
Laserscope
Richard Wood/Dennis LaLumandiere, 408/943-0636
or
Hilary Kaye Associates
Hilary Kaye or Shelle Murach, 714/851-5150 |
