SAN DIEGO--(BUSINESS WIRE)--March 3, 2004--Ligand Pharmaceuticals Incorporated (Nasdaq:LGND - News) announced today that its subsidiary, Seragen Inc., has entered into an agreement with Hollister-Stier Laboratories LLC for the fill/finish of the approved cancer drug ONTAK® (deneleukin diftitox), under a new five-year contract that covers the existing commercial product as well as a new second-generation formulation in the advanced stages of development. The products will be fill/finished at the HollisterStier 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.
Under the terms of the new agreement, Ligand and HollisterStier will work closely together in the qualification and validation of the facility. Following the successful technology transfer, expected to be completed in late 2004 or early 2005 and regulatory approval anticipated around mid 2005, production capability and supply of the currently marketed formulation of ONTAK is expected to be maintained.
In order to facilitate supply continuity to our customers and patients of ONTAK until regulatory approval of the new facility is complete, Ligand has recently invested in building strategic inventories of ONTAK prior to the completion of the fill/finish contract with our previous supplier Eli Lilly and Company at the end of 2003.
"We are pleased to begin this new relationship with a seasoned manufacturing partner, HollisterStier, for ONTAK, which has grown rapidly in recent quarters and is our best-selling oncology product," said Gian Aliprandi, senior vice president, technical supply and international operations. "We expect demand for ONTAK to continue growing, and therefore look forward to working closely with them on fill/finish of the current formulation of ONTAK and on our improved purity second generation formulation."
The initial term or 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 US Food and Drug Administration granted Seragen, Inc., a wholly owned subsidiary of Ligand, accelerated approval for ONTAK for the treatment of patients with persistent or recurrent cutaneous t-cell lymphoma whose malignant cells express the p55 (CD25) component of the IL-2 receptor. ONTAK is currently available in deep-frozen formulation.
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 (IRs) and Signal Transducers and Activators of Transcription (STATs). For more information, go to www.ligand.com.
HollisterStier Contract Manufacturing provides a complete range of services to support the pharmaceutical and biopharmaceutical industries. The company has specialized competencies essential for compounding and filling sterile products. Outsourcing services include vial and syringe filling, as well as commercial and clinical scale capabilities for lyophilzation. Hollister-Stier Laboratories LLC is privately held and located in Spokane, Washington. For more information go to www.thinkhs.com.
Caution Regarding Forward-Looking Statements
This news release contains certain forward-looking statements by Ligand that involve risks and uncertainties and reflect the company'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, facility qualification and regulatory approval, inventories, 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 facility will be qualified or approved, that the second-generation product will be approved or successfully marketed, that ONTAK demand will continue, 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 www.ligand.com. 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.
Ligand Pharmaceuticals Incorporated Paul V. Maier, 858-550-7573
Source: Ligand Pharmaceuticals Incorporated