Ligand's Targretin Capsules Recommended for Approval by European CPMP; Second Product for Ligand Europe Commercialization

Business Wire, Nov 20, 2000

Business Editors & Health/Medical Writers

BIOWIRE2K

SAN DIEGO--(BW HealthWire)--Nov. 20, 2000

Ligand Pharmaceuticals Incorporated (Nasdaq:LGND) announced today that the Committee for Proprietary Medicinal Products (CPMP) adopted a positive opinion recommending the grant of Marketing Authorization for Targretin(R) (bexarotene) capsules for the treatment of patients with skin manifestations of advanced stage cutaneous T-cell lymphoma (CTCL) refractory to at least one systemic treatment. Upon grant of final Marketing Authorization by the European Commission (EC), Targretin capsules will be the first of three Ligand products targeted for approval in Europe initially for the treatment of CTCL.

"We are pleased with the CPMP's timely review and positive recommendation for the approval of the Marketing Authorization Application (MAA) for Targretin capsules," said David E. Robinson, Ligand's Chairman, President and CEO. "With this recommendation and last month's EC approval of Panretin(R) gel, Ligand's strategy of building an international product revenue stream focused on innovative and improved therapeutic products in the treatment of various cancers gains momentum. With planned and ongoing clinical trials in non-small cell lung cancer, breast cancer and psoriasis, Targretin capsules represents perhaps our most important commercial product and is central to our next several years' anticipated revenue growth in the U.S. and Europe.

"We expect to market this product throughout Europe, potentially directly in some countries, with existing partners Ferrer and Alfa Wassermann in their territories, and with additional new partners in other markets in Europe."

Ligand has agreements with Ferrer Internacional, S.A., to exclusively market and distribute Targretin capsules in Spain, Portugal, Greece, and Central and South America and with Alfa Wassermann to exclusively market and distribute Targretin capsules in Italy.

"Upon approval by the EC, Targretin capsules will be an important advance in the treatment of patients with advanced refractory CTCL, and will offer patients and physicians an effective and convenient new therapy," said Timothy Allington, President of Ligand's European Operations. "We will be working closely with the EMEA, the National Pricing and Reimbursement authorities and our marketing partners to make this product available to patients in Europe as quickly as possible."

Ligand submitted its MAA to the European Agency for the Evaluation of Medicinal Products (EMEA) in November 1999. The recommendation of the CPMP serves as the basis for approval by the EC, which would result in one single Marketing Authorization valid in all 15 Member States of the European Union. Typically, final EC approval is issued within three to four months of a positive CPMP opinion.

The MAA for Targretin capsules was based on the results from two multi-center, multinational clinical trials involving 193 CTCL patients (including patients from Europe). Based on these trials, the dose regimen in the MAA is a single daily oral dose of Targretin capsules with a meal at an initial dose 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.

Targretin capsules received U.S. Food and Drug Administration (FDA) approval in December 1999. Targretin gel was approved by the FDA in June 2000, and an MAA is targeted to be submitted to the EMEA within the next several months. In the U.S., Ligand currently markets its approved products, Targretin capsules, Targretin gel, ONTAK(R) and Panretin gel, through its specialty oncology and dermatology sales force.

CTCL Background

Affecting an estimated 16,000 people in the U.S. and between 12,000 and 14,000 people in Europe, 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 to five 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 proprietary drug discovery and development programs are based on its leadership position in gene transcription technology, primarily related to Intracellular Receptors (IRs) and Signal Transducers and Activators of Transcription (STATs).