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SECURITIES AND EXCHANGE COMMISSION
Washington, D. C. 20549
Form 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): December 13, 1999
LIGAND PHARMACEUTICALS INCORPORATED
(Exact name of registrant as specified in its charter)
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Delaware 000-20720 77-0160744
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(State or other (Commission File Number) (IRS Employer Identification No.)
jurisdiction of
incorporation)
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10275 Science Center Drive, San Diego, California 92121
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(Address of principal executive offices) (Zip Code)
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Registrant's telephone number, including area code: (858) 550-7500
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ITEM 5. OTHER EVENTS.
On December 13, 1999, Ligand Pharmaceuticals Incorporated ("Ligand")
announced that the Oncologic Drugs Advisory Committee of the FDA, by a vote of
13 to 2 (with one abstention), recommended marketing approval for Targretin(R)
(bexarotene) capsules in the advanced-stage cutaneous T-cell lymphoma (CTCL)
Stages IIb, III, IVa, IVb patient population as evaluated in Ligand's
advanced-stage pivotal trial included in its new drug application. In a vote of
5 to 7 (with 4 abstentions), the committee declined to recommend marketing
approval of Targretin capsules in the early-stage CTCL population as evaluated
in its early-stage pivotal trial (Stages Ia, Ib, IIa).
On December 13, 1999, Ligand issued a press release which is filed herewith
as Exhibit 99 and is incorporated herein by reference.
ITEM 7. FINANCIAL STATEMENTS AND EXHIBITS.
(c) Exhibits.
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99.1 Press Release dated December 13, 1999
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf by the
undersigned hereunto duly authorized.
LIGAND PHARMACEUTICALS INCORPORATED
Date: December 14, 1999 By: /s/ Paul V. Maier
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Paul V. Maier
Senior Vice President, Finance
and Chief Financial Officer
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INDEX TO EXHIBITS
99.1 Press Release dated December 13, 1999.
EXHIBIT 99.1
Paul V. Maier
(858) 550-7573
FDA ONCOLOGIC DRUGS ADVISORY COMMITTEE RECOMMENDS MARKETING APPROVAL
FOR LIGAND'S TARGRETIN(R) CAPSULES FOR TREATMENT OF ADVANCED-STAGE
CUTANEOUS T-CELL LYMPHOMA
-- ODAC DECLINES TO RECOMMEND FOR EARLY-STAGE PATIENTS --
SAN DIEGO, Calif. -- December 13, 1999 -- Ligand Pharmaceuticals
Incorporated (Nasdaq: LGND) announced today that the Oncologic Drugs Advisory
Committee of the U.S. Food and Drug Administration (FDA), by a vote of 13 to 2
(with one abstention), recommended marketing approval for Targretin(R)
(bexarotene) capsules in the advanced-stage cutaneous T-cell lymphoma (CTCL)
Stages IIb, III, IVa, IVb patient population as evaluated in Ligand's
advanced-stage pivotal trial included in its new drug application (NDA). In a
vote of 5 to 7 (with 4 abstentions), the committee declined to recommend
marketing approval of Targretin capsules in the early-stage CTCL population as
evaluated in its early-stage pivotal trial (Stages Ia, Ib, IIa).
The FDA is expected to consider the committee's recommendation for approval
in its review of the NDA for Targretin capsules. While the FDA is not bound by
the committee's decision, the agency usually follows committee advice. The FDA
is expected to complete its review of the Targretin capsules NDA in December
1999. If Targretin capsule therapy is approved for marketing, it will be the
first oral retinoid approved by the FDA specifically for the treatment of
patients with CTCL.
"We are pleased with the panel's vote to recommend Targretin capsules
approval for advanced-stage CTCL patients but disappointed that Targretin
capsules was not also recommended at this time for the early-stage CTCL patient
population," said David E. Robinson, Ligand Chairman, President and CEO. "We
have worked closely with the FDA during this process, and we intend to have
additional conversations with the FDA about the most appropriate patient
populations for Targretin capsules following ODAC's recommendations including
any additional information necessary for early-stage patients. The
advanced-stage disease patient population, Stages IIb, III, IVa, IVb, are half
or more of the prevalent patient population in the
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US and Targretin capsules will represent a significant therapeutic option
as a new oral oncologic agent for them."
OTHER COMMITTEE VOTES
Six questions were submitted to the committee for a vote. In addition to
the primary questions of recommending approval of Targretin capsules in both
early-stage and advanced-stage CTCL, the committee voted on four additional
questions. The committee voted 11 to 4 (with one abstention) that a clinically
meaningful tumor response rate using acceptable tumor response criteria had been
adequately demonstrated and 0 to 14 (with two abstentions) that clinical benefit
other than tumor response had been adequately demonstrated.
The committee voted as well on several other questions posed by the FDA
including recommending an additional post approval/clinical study in
advanced-stage patients.
"We are pleased that the FDA's ODAC panel has supported the conclusion from
our data that Targretin capsules represent a positive risk benefit for
advanced-stage CTCL patients," said Ligand Senior Medical Director and Physician
Team Leader for the CTCL project, Richard C. Yocum, M.D. "The prompt and durable
responses to Targretin capsule therapy are especially remarkable in this
heavily-pretreated patient population with refractory CTCL and with few if any
remaining treatment options. We look forward to continuing to work with the FDA
to address requirements for approval in the early-stage disease patient
population as well as commencing our dialogue on the recently submitted
Targretin gel NDA in early-stage disease."
TARGRETIN CAPSULES
The NDA for Targretin capsules was submitted by Ligand in June 1999 and was
accepted for priority review by the FDA. Targretin has also received orphan drug
designation in the U.S. In November 1999, Ligand submitted a Marketing
Authorization Application (MAA) with the European Medicines Evaluation Agency
(EMEA) seeking marketing clearance for Targretin capsules for the treatment of
patients with CTCL. Ligand is conducting Phase II trials with Targretin capsules
for the treatment of patients with moderate to severe plaque psoriasis and for
the treatment of women with advanced breast cancer.
The NDA is based on the results from two multi-center, multinational
clinical trials involving 152 patients with CTCL. The dose regimen recommended
in the NDA is a single daily oral dose of Targretin capsules at an initial dose
level of 300 milligrams per square meter (mg/m2) of body surface area,
administered with a meal. In both clinical trials, this initial dose level
provided efficacy that exceeded the protocol-defined targets of response rates.
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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.
CTCL BACKGROUND
Affecting an estimated 16,000 to 20,000 people in the U.S., CTCL 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. The prognosis for CTCL is based in part on the
stage of the disease when diagnosed. 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.
Currently available approved treatment options for CTCL are limited. CTCL
continues to be a devastating, highly-symptomatic, very visible, chronic
malignancy often characterized by years of deforming symptomatic skin lesions
that culminate in ulceration with secondary infection and visceral tumor
invasion. Nearly all patients have symptoms relating to skin lesions that may
itch and cause pain, bleeding, infection, or disfigurement. New therapies which
are preferably both effective and without toxicity overlapping with currently
available treatment modalities are needed for the treatment of patients with
CTCL.
BACKGROUND INFORMATION ON TARGRETIN
Discovered by Ligand scientists, Targretin (pronounced tar-GRET-tin),
generically known as bexarotene, is a synthetic compound representing a novel
class of retinoids that selectively activate retinoid X receptors (RXRs). This
subclass of retinoid receptors has biologic activity distinct from that of
retinoic acid receptors (RARs). The RXR selective retinoids have a biological
activity that is different from that of the endogenous retinoid 9-cis-retinoic
acid (alitretinoin), the active substance in Panretin(R) gel and capsules.
Panretin is a pan agonist that activates with RAR and RXR receptor subtypes.
RXRs play an important role in the control of a variety of cellular functions.
Ligand's pre-clinical research has indicated bexarotene may be useful in the
treatment of CTCL, psoriasis, some solid tumors, and
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tamoxifen-resistant breast tumors; bexarotene has also proven effective in
the treatment and prevention of breast cancer in pre-clinical models.
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. In addition to
Targretin(R) capsules which is currently under review by the FDA, Ligand has
three additional oncology-related products in late-stage development,
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. There can be no assurance
that the Targretin capsules NDA will be approved by the FDA for the
treatment of patients with CTCL or any other indication in a timely manner
or at all; that, if approved, Targretin capsules or any other Ligand
product will be accepted by physicians for prescribing, by patients for use
and by insurance companies / agencies for reimbursement; that Ligand will
be able to successfully commercialize Targretin capsules or any other
product; that any other regulatory approval for Targretin capsules or
regulatory approval for any other Ligand product will be granted in a
timely manner, or at all; that regulatory filings will be made in a timely
manner or at all. 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 http://www.ligand.com. Ligand
disclaims any intent or obligation to update these forward-looking
statements beyond the date of this release.
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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.
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