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FDA Approves New Fill/Finish Facility for ONTAK(R); Includes Capability for Second-Generation Product Formulation.

SAN DIEGO -- Ligand Pharmaceuticals Incorporated (Nasdaq:LGNDE) announced today that the company has received FDA approval for the fill/finish of Ligand's cancer drug ONTAK(R) (denileukin diftitox), at the Hollister-Stier Laboratories facility located in Spokane, Washington. ONTAK bulk drug substance for fill/finish and labeling continues to be manufactured at the Cambrex Bio Science facility located in Hopkinton, Massachusetts.

"We submitted the manufacturing supplement for this facility in December 2004 following technology transfer and worked closely with Hollister-Stier and the FDA to obtain this facility approval," said Taylor Crouch, senior vice president, operations and president, international. "We are pleased with the rapid approval and the beginning of this new relationship with a seasoned manufacturing partner for ONTAK, which is our largest-selling oncology product. We expect demand for ONTAK to continue growing, and look forward to working closely with Hollister-Stier on fill/finish of the current formulation of ONTAK and on our second-generation formulation."

The fill/finish work will be done under a contract which was announced in 2004 following completion of our work with our previous fill/finish supplier in 2003. The initial term of the agreement is five years, with a provision for automatic renewal extension in additional two-year increments. Financial terms of the contract were not disclosed.


In February 1999, the U.S. Food and Drug Administration granted Seragen, Inc., a wholly owned subsidiary of Ligand, marketing approval for ONTAK for the treatment of patients with persistent or recurrent cutaneous T-cell lymphoma (CTCL) whose malignant cells express the p55 (CD25) component of the IL2 receptor. Recent and current ONTAK development programs include Phase II clinical trials in patients with chronic lymphocytic leukemia, peripheral T-cell lymphoma, B-cell non-Hodgkin's lymphoma, non-small cell lung cancer, and graft-versus-host disease, indications that represent significantly larger market opportunities than CTCL.

About Ligand

Ligand discovers, develops and markets new drugs that address critical unmet medical needs of patients in the areas of cancer, pain, skin diseases, men's and women's hormone-related diseases, 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. For more information, go to

Caution Regarding Forward-Looking Statements

This news release contains certain forward-looking statements by Ligand that involve risks and uncertainties and reflect Ligand's judgment as of the date of this release. These include statements related to product fill/finish, manufacturing and supply, development and manufacturing of second-generation ONTAK, ONTAK demand growth and term of the agreement. Actual events or results may differ from Ligand's expectations. There can be no assurance that the supply and manufacture of ONTAK will be continuous and successful, that the second-generation product will be approved or successfully marketed, that ONTAK demand will continue or continue to grow, that inventories will be sufficient to meet demand or that the agreement will continue for any particular time period. Additional information concerning these and other risk factors affecting Ligand's business can be found in prior press releases as well as in the company's public periodic filings with the Securities and Exchange Commission, which are available via Ligand disclaims any intent or obligation to update these forward-looking statements beyond the date of this release. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.
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Publication:Business Wire
Geographic Code:1USA
Date:Jul 5, 2005
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