QLT PhotoTherapeutics Announces FDA Approves PHOTOFRIN(R) As A
Treatment For Certain Early-Stage Lung Cancers
VANCOUVER, Jan. 9 /CNW-PRN/ - QLT PhotoTherapeutics Inc., a Canadian
biotechnology company, announced today that the Food and Drug Administration
(FDA) has given marketing clearance for its light-activated drug, PHOTOFRIN(R)
(porfimer sodium) for Injection, as a potentially curative treatment for
certain types of early-stage, microinvasive lung cancer.
Specifically, the FDA approved PHOTOFRIN(R) for the treatment of
microinvasive endobronchial non-small cell lung cancer in patients who are not
indicated for surgery and radiotherapy. This means a new option is now
available for people whose lung cancer is diagnosed at an early-stage, but for
a variety of reasons, are not eligible for surgery and radiotherapy.
Dr, Julia Levy, QLT President and CEO, said, ``This is a landmark
decision for PHOTOFRIN(R), photodynamic therapy, and for QLT. It marks the
first North American approval of the technology as a potentially curative
treatment, which is where photodynamic therapy can provide the greatest
benefit to patients.''
Dr. Stephen Lam, one of the investigators in the clinical trials which
led to this approval, explains ``Photodynamic therapy offers an effective
method to treat lung cancer without removing adjacent, normal lung tissue. In
the clinical trials, approximately three quarters of the patients had a
complete response following treatment and about half of them are cancer-free
in long-term follow-up.'' Dr. Stephen Lam is head of the bronchoscopy program
at the British Columbia Cancer Agency in Vancouver, Canada.
Peggy McCarthy, Executive Director of ALCASE (Alliance for Lung Cancer
Advocacy, Support, Education) in Vancouver, Washington said, ``Cure can be
achieved when lung cancer is diagnosed at an early stage. The major problem
is that currently so few patients are diagnosed early.''
According to the American Cancer Society, the 5-year survival rate for
the 178,000 Americans diagnosed with lung cancer every year is only 14%. The
poor survival rate is attributable to the fact that only 15% of lung cancer is
detected at an early-stage.
Dr. Levy said, ``It is imperative that patients at high risk for getting
lung cancer ask their doctor to be tested for the disease on a regular basis.
People at high risk include smokers, former smokers, and those with
obstructive lung disease or a family history of lung cancer. Improved
techniques for early detection makes the outlook for the disease much more
The FDA approval includes marketing clearance for laser systems and a
fiber optic used to activate PHOTOFRIN(R). The device approvals include: the
Coherent Lambda Plus(TM) PDL1 and PDL2 photodynamic lasers, the Laserscope
Series 600 and 630 Dye Modules and the Series 800 Laserscope Surgical Laser
Systems, and the OPTIGUIDE(TM) Cylindrical Fiber Optic Diffusers.
As a treatment for lung cancer, PHOTOFRIN(R) is injected into a patient
intravenously and after a short period of time, selectively concentrates in
tumor cells while largely clearing from normal tissue. Activation of
PHOTOFRIN(R) by a non-thermal laser light at the tumor site produces a toxic
form of oxygen that destroys the cancer cells. Necrotic tissue and exudate
are subsequently removed two days later through a bronchoscope. Principal
side effects include a skin sensitivity to light for four to six weeks, and,
following the procedure, some patients experience inflammation at the
treatment site causing varying degrees of shortness of breath and coughing.
Photodynamic therapy is typically done on an out-patient basis.
PHOTOFRIN(R) is marketed exclusively in the U.S. by New York-based Sanofi
Pharmaceuticals Inc., the U.S. pharmaceutical unit of Sanofi, the global
health care company with headquarters in Paris. Previously, PHOTOFRIN(R) was
approved in the United States for the palliative treatment of certain advanced
QLT PhotoTherapeutics is a world leader in the development and
commercialization of proprietary pharmaceutical products for photodynamic
therapy, a field of medicine that utilizes light-activated drugs in the
treatment of cancer, diseases of the eye and other medical conditions. QLT's
lead product, PHOTOFRIN(R) has also been approved for the treatment of various
cancers by regulatory authorities in Canada, Japan and parts of Europe. QLT's
second product, verteporfin (BPD-MA), is in final phases of testing for the
treatment of age-related macular degeneration.
The Company is listed on the NASDAQ National Market under the trading
symbol ``QLTIF'' and on The Toronto Stock Exchange under the trading symbol
The foregoing information contains forward-looking statements which
involve known and unknown risks, uncertainties and other factors which may
cause the actual results to be materially different from any future results,
performance or achievements expressed or implied by such statements. Such
factors include, those described in the Company's Annual Information Form, or
Form 10-K. Such factors include among others, the following: risks associated
with the commercialization of PHOTOFRIN(R) and BPD; uncertainties relating to
product development, rapid technological change and competition; uncertainty
regarding patents and proprietary rights; product liability claims and
insurance; manufacturing uncertainties; uncertainty of pricing and
reimbursement; government regulation: and dependence on corporate
SOURCE: QLT PhotoTherapeutics Inc.
CONTACT: QLT Investor Relations Contact: Elayne Wandler Director,
Investor Relations & Corporate Communications,
ewandler(at)qlt-pdt.com or phone (604) 872-7881, ext. 302 or