Here's the press release. Not mentioned but also a partner in the photodynamic therapy is Laserscope (LSCP) who supplied the lasers and disposable light delivery devices. I believe that they also can sell photofrin (though I assume that ligand gets a cut) but I haven't really been following this very much so check it yourself if you should care!
Ed
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hiron files Supplemental New Drug Submission (S/NDS) for Malignant Melanoma,
QLT files S/NDS for Non Small Cell Lung Cancer
SAN DIEGO, Aug. 6 /PRNewswire/ -- Ligand Pharmaceuticals Inc.
(Nasdaq: LGND) announced today that submissions have been made to the Canadian
Health Protection Branch (HPB) to allow two products marketed in Canada by
Ligand Pharmaceuticals (Canada), Inc., Proleukin(R) (aldesleukin) and
PHOTOFRIN(R) (porfimer sodium), to be used for treatment of additional
cancers.
Chiron Corporation (Nasdaq: CHIR) recently filed a Supplemental New Drug
Submission (S/NDS) with the HPB for Proleukin for malignant melanoma. Chiron
also submitted a New Drug Application for Proleukin in malignant melanoma to
the U.S. Food and Drug Administration in April 1997. Ligand is currently
marketing Proleukin in Canada for the treatment of metastatic renal cell
carcinoma.
Malignant melanoma constitutes 3% of all cancers occurring in humans. The
incidence of this disease has increased rapidly at a rate of 6% per year over
the last two decades. In addition, the death rate from malignant melanoma
also continues to rise about 2% annually with 7,300 deaths expected this year
in the U.S. Melanoma rates in Canada and the U.S. are now rising faster than
any other cancer in men and second only to lung cancer in women.
Proleukin, (aldesleukin, human recombinant interleukin-2), was the first
therapy for renal cell carcinoma approved in the United States. There are
nearly 5,000 new cases of kidney cancer reported in Canada each year.
Metastatic renal cell carcinoma is an advanced form of kidney cancer with an
average projected survival of about one year.
QLT PhotoTherapeutics (QLT) (Nasdaq: QLTIF; TSE: QLT) recently filed a
S/NDS with the HPB seeking approval of PHOTOFRIN as a treatment for specific
types of non-small cell lung cancer (NSCLC). Ligand is currently marketing
PHOTOFRIN in Canada for the treatment of certain types of bladder and
esophageal cancers.
QLT requested that PHOTOFRIN be approved for reduction of obstruction and
palliation of symptoms in patients with obstructing endobronchial NSCLC, and
also for the treatment of superficial endobronchial NSCLC in patients for whom
surgery and radiotherapy are not indicated. Three quarters of all lung
cancers are identified as NSCLC.
According to the National Cancer Institute of Canada, lung cancer remains
the leading cause of cancer death and the second most frequently diagnosed
cancer in both Canadian men and women. In 1996 alone, 20,000 cases were
diagnosed while 17,000 deaths were attributed to this disease. In the United
States, there are approximately 380,000 people afflicted with lung cancer.
PHOTOFRIN is activated by light in a process called photodynamic therapy
(PDT). After PHOTOFRIN is administered intravenously to the patient, it
accumulates in tumors. The drug is subsequently activated by non-thermal
light from a medical laser producing an active form of oxygen that destroys
cancer cells.
"We are pleased to see the continued development of our two in-licensed
products and look forward to the expanded marketing opportunities for
PHOTOFRIN and Proleukin. If the new uses of these products to treat malignant
melanoma and NSCLC are approved we anticipate a significant increase in our
revenues," said James R. Mirto, Ligand Vice President, Marketing and Business
Development.
Background
In 1994, Ligand entered into an agreement with Chiron Corporation under
which Ligand acquired the exclusive right to market and sell Proleukin for
metastatic renal cell carcinoma throughout Canada. The HPB approved Proleukin
in 1994 for use in metastatic renal cell carcinoma. Since that time, Ligand
has been seeking regional and provincial formulary approvals in order to make
Proleukin available to Canadian patients.
In 1995, Ligand entered into an agreement with QLT under which Ligand
acquired the exclusive right in Canada to market and sell PHOTOFRIN.
PHOTOFRIN received marketing approval in Canada in 1993 for use in the
treatment of certain types of bladder and esophageal cancers.
Since 1989, Ligand Pharmaceuticals Inc. has established a leadership
position in gene transcription technology, particularly intracellular receptor
(IR) technology and Signal Transducers and Activators of Transcription
(STATs). Ligand applies IR and STATs technology to the discovery and
development of small molecule drugs to enhance therapeutic and safety profiles
and to address major unmet patient needs in cancer, women's and men's health
and skin diseases, as well as osteoporosis, cardiovascular, inflammatory and
metabolic diseases.
This statement may contain certain forward looking statements by Ligand
and actual results could differ materially from those described as a result of
factors, including, but not limited to the following. There can be no
assurance that the Canadian Health Protection Branch (HPB) will approve the
mentioned products for additional cancer indications or that Canadian sales
will be successful. Ligand undertakes no obligation to update the statements
contained in this press release after the date hereof.
PHOTOFRIN(R) is the registered trademark of QLT PhotoTherapeutics, Inc.
Proleukin(R) is the registered trademark of Chiron Corporation.
SOURCE Ligand Pharmaceuticals Inc. |
