SAN DIEGO--(BW HealthWire)--Nov. 29, 1999--
Ligand's First Oral Anti-Cancer Product
Targeted for 2000 in the U.S. and 2001 in Europe
Ligand Pharmaceuticals Incorporated (Nasdaq:LGND) today announced
the submission of a Marketing Authorization Application (MAA) with the
European Medicines Evaluation Agency (EMEA) seeking marketing
clearance for Targretin(R) (bexarotene) capsules. Targretin capsules
are indicated for treatment of patients with all clinical stages of
cutaneous T-cell lymphoma CTCL (IA-IVB) in the following categories:
patients with early stage CTCL who have not tolerated other therapies,
patients with refractory (including resistant) or persistent early
stage CTCL, and patients with refractory advanced stage CTCL. Ligand
submitted its application under the centralized regulations, which
allow for a single evaluation and a single authorization by the
European commission on behalf of all 15 member states of the European
Community.
Ligand filed a new drug application (NDA) with the U.S. Food and
Drug Administration (FDA) in June 1999, at which time the FDA granted
orphan drug designation to Targretin for CTCL; the NDA received
priority review status in August 1999. Ligand is scheduled to meet
with the FDA's Oncologic Drugs Advisory Committee on December 13 to
review the submission of Targretin capsules. The FDA is expected to
complete its review of the application in December 1999.
"The submission of the MAA for Targretin capsules, the second MAA
in Ligand's history, together with the Targretin gel NDA submission
targeted for the fourth quarter 1999, underscores Ligand's strategy of
building an international product portfolio which focuses on
innovative and improved therapeutic products in the treatment of
various cancers," said Ligand Chairman, President and CEO David E.
Robinson. "With ongoing clinical trials in breast cancer and
psoriasis, Targretin represents perhaps our most important late-stage
product and is central to our next several years' revenue growth in
the U.S. and Europe."
This is the second MAA submitted by Ligand, the first being for
Panretin(R) gel (alitretinoin) 0.1% for the treatment of cutaneous
lesions of patients with AIDS-related Kaposi's sarcoma (KS). Panretin
gel is Ligand's first approved product, having received FDA approval
in February 1999, and is currently being marketed in the United States
through Ligand's specialty oncology and HIV-center sales force.
Based on the results from two multi-center, multinational
clinical trials involving 152 CTCL patients (including patients from
Europe), the dose regimen for which approval is being sought in the
MAA is a single daily oral dose of Targretin capsules with a meal at
an initial dose level of 300 milligrams per square meter (mg/m2) of
body surface area. In both clinical trials, this initial dose level
provided efficacy that exceeded the protocol-defined response rate
targets.
Marketing Rights
Ligand has the worldwide rights to Targretin. If approved in the
respective territories, Ligand expects to market and sell Targretin
capsules in the U.S., Canada and selected European markets through its
specialty oncology sales and marketing group. In Spain, Portugal,
Greece, and Central and South America, Ferrer Internacional, S.A.,
will market and distribute, if approved in the respective
jurisdictions, Targretin as well as certain other Ligand oncology
products.
Targretin in Expanded Indications
Ligand is also conducting a multi-center dose-ranging Phase II
trial with Targretin capsules for the treatment of patients with
moderate to severe plaque psoriasis, a condition that is estimated to
affect between 1.4 and 1.9 million people in the U.S. Encouraging
interim results led Ligand to explore two additional dose levels in
order to determine the optimal dose regimen. Additional results are
expected in the first half of 2000.
In addition, as a result of the positive findings from multiple
pre-clinical studies, Ligand initiated in November 1998 a human Phase
II clinical trial of Targretin capsules for the treatment of women
with advanced breast cancer. Interim results are expected in the first
half of 2000 from this ongoing clinical trial. Data from pre-clinical
studies have shown that Targretin caused complete and partial
regression of breast cancer tumors that grew despite tamoxifen
therapy. Tamoxifen is currently the most widely prescribed hormonal
breast cancer therapy. This year experts predict that more than
180,000 cases of breast cancer will be diagnosed in the U.S., making
it the most common non-skin malignancy in the U.S. among women. The
prevalence of breast cancer in the U.S. is estimated to have reached
more than 2 million.
CTCL Background
Affecting an estimated 16,000 people in the U.S., cutaneous
T-cell lymphoma is a cancer of T-lymphocytes (white blood cells
involved in the body's immune system). T-cell lymphomas, of which CTCL
is a subclass, represent approximately 10% of the non-Hodgkin's
lymphomas (NHL), which affect approximately 300,000 individuals in the
U.S.
CTCL ordinarily manifests itself initially in the skin, but over
time may progress to involve other organs. CTCL is most commonly a
slowly progressing cancer, and many patients live with the
complications of CTCL for 10 or more years after diagnosis. Some
patients, however, have a much more aggressive form of this disease,
and the median survival for late-stage patients is less than three
years.
Ligand Pharmaceuticals Incorporated
Ligand Pharmaceuticals Incorporated discovers, develops and
markets new drugs that address critical unmet medical needs of
patients in the areas of cancer, skin diseases, and men's and women's
hormone-related diseases, as well as osteoporosis, metabolic disorders
and cardiovascular and inflammatory diseases. Ligand's first two drugs
-- Panretin(R) gel and ONTAK(R) -- were approved for marketing in the
U.S. in early 1999 and are being marketed through its specialty cancer
and HIV-center sales force in the U.S. Four additional
oncology-related products are in late-stage development, including
Targretin(R) capsules, Targretin(R) gel, Panretin(R) capsules, and
Morphelan(TM) (licensed from Elan). Ligand's proprietary drug
discovery and development programs are based on its leadership
position in gene transcription technology, primarily related to
Intracellular Receptors (IR) and Signal Transducers and Activators of
Transcription (STATs).
Except for the historical information contained herein, this news
release 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: the
Targretin capsules MAA may not be approved for the treatment of
patients with CTCL in a timely manner or at all; Targretin or any
product in the Ligand pipeline may not be successfully developed for
psoriasis, breast cancer or any other indication; regulatory filings
may not be made and regulatory approvals may not be granted in a
timely manner or at all; if approved, Targretin capsules or any other
Ligand product may not be accepted by physicians for prescribing, by
patients for use and by insurance companies/agencies for
reimbursement. Additional information concerning these and other
factors affecting Ligand's business can be found in press releases as
well as in Ligand's public periodic filings with the Securities and
Exchange Commission, available via our website at
ligand.com. Ligand disclaims any intent or obligation to
update these forward-looking statements beyond the date of this
release.
Note: Panretin(R) and Targretin(R) are registered trademarks of
Ligand Pharmaceuticals Incorporated, and ONTAK(R) is a registered
trademark of Seragen, Inc., a wholly owned subsidiary of Ligand.
Ligand Pharmaceuticals' releases are available on the World Wide
Web at www.businesswire.com/cnn/lgnd.htm.
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