Here's today's press release:
Ligand Submits First NDA For Panretin(R) Gel For Kaposi's Sarcoma - Exercises Option to Pay One-Time License Fee of $4 Million to Salk Institute
PR Newswire - May 28, 1998 17:33
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SAN DIEGO, May 28 /PRNewswire/ -- Ligand (LYE-gand) Pharmaceuticals Incorporated (Nasdaq: LGND) and The Salk Institute for Biological Studies (The Salk Institute) announced today that Ligand has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration for Panretin(R) gel (alitretinoin) 0.1% for the treatment of AIDS-related Kaposi's sarcoma (KS). In connection with the submission, Ligand has exercised its option to pay $4,080,000 as a one-time payment to The Salk Institute.
The payment gives Ligand a fully paid up license for the patent rights to Panretin gel for the treatment of KS, under its 1988 agreement with The Salk Institute. The active substance in Panretin gel is a non-peptide hormone isolated and characterized as 9-cis retinoic acid by Ligand and scientists at The Salk Institute and Baylor College of Medicine in 1991.
"The discovery of 9-cis retinoic acid in 1991 signaled a truly exciting event -- the discovery of the first non-peptide hormone in more than 25 years. Ligand's submission of the first NDA for use of this compound for the treatment of AIDS-related KS generates a new excitement, as well as hope for the therapeutic options Panretin gel may bring to thousands of patients with AIDS-related KS. In addition, Ligand's submission of this NDA suggests the promise held for use of 9-cis retinoic acid for treatment of other diseases," said Ronald M. Evans, Ph.D., Ligand scientific founder, professor in the Gene Expression Laboratory at The Salk Institute and a Howard Hughes Medical Institute investigator. Dr. Evans holds the March of Dimes Chair in Molecular Developmental Biology at The Salk Institute.
"The submission of our first NDA for Panretin gel in the treatment of patients with AIDS-related KS is the culmination of a longstanding relationship with The Salk Institute and validates the importance of the scientific discoveries made through our combined research efforts which commenced only seven years ago," said David E. Robinson, Ligand Chairman, President and CEO. "We are pleased that Ligand has completed clinical development and NDA submission in six years from the first publication of 9- cis retinoic acid discovery and only four years from Investigational New Drug filing, allowing us to bring this new therapeutic forward rapidly to people with AIDS-related KS."
Panretin(R) Capsules Complete Phase II Advanced Clinical Testing
In addition to the NDA filed for Panretin gel in KS, Ligand expects to submit an NDA for a capsule form of Panretin(R) (alitretinoin) for the treatment of patients with KS in 1999. Panretin capsules have been studied in two single-agent, open-label Phase II trials and are being evaluated in a Phase I/II trial in combination with interferon for patients with AIDS-related Kaposi's sarcoma. In both Phase II trials with Panretin(R) capsules in patients with AIDS-related KS, analyses showed an intent-to-treat patient response rate of 37 percent at 16 or more weeks.
The two Phase II studies were similar in design, with one conducted by the AIDS Malignancy Consortium (AMC) sponsored by NCI and the other sponsored directly by Ligand. Both were multi-center, open-label studies designed to evaluate the safety and efficacy of Panretin capsules in patients with AIDS- related KS.
Results from the AMC trial were presented at the National Cancer Institute's (NCI) AIDS Malignancy Conference in Bethesda, MD in April and at the American Society of Clinical Oncology meeting on May 18.
Four abstracts pertaining to studies with Panretin formulations for the treatment of KS will be presented at the 12th International AIDS Conference in June in Geneva, Switzerland.
Additional Studies with Panretin(R) capsules
Phase II trials with Panretin capsules are ongoing in breast and pediatric cancers, and in bronchial metaplasia. A trial in myelodysplastic syndrome and a study in severe plaque psoriasis have been completed. The results of the ongoing studies are expected to be announced in 1998 and may support additional studies upon which additional NDAs could be based. In addition, Panretin capsules are planned to be studied in a European trial in patients with acute promyelocytic leukemia.
The Salk Institute for Biological Studies, La Jolla, Calif., is an independent nonprofit institution conducting basic science research dedicated to the improvement of human health and improving the quantity and quality of the world's food supply. Its two main fields of concentration are neuroscience, and molecular biology and genetics. The Salk Institute has been ranked the top research institution worldwide in these areas by the Institute for Scientific Information. The Salk Institute was founded in 1960 by polio vaccine pioneer Jonas Salk, M.D., with a gift of land from the City of San Diego and the financial support of the March of Dimes Birth Defects Foundation.
Since 1989, Ligand Pharmaceuticals Incorporated has established a leadership position in gene transcription technology, particularly intracellular receptor (IR) technology and Signal Transducers and Activators of Transcription (STATs). Ligand has applied IR and STATs technology to the discovery and development of small molecule drugs to enhance therapeutic and safety profiles and to address unmet patient needs in cancer, women's and men's health and skin diseases, as well as osteoporosis, metabolic, cardiovascular and inflammatory disease.
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 Panretin capsules, Panretin gel or any product in the Ligand pipeline, will be successfully developed, that results from more advanced clinical trials will be consistent with earlier results, that drug candidates will show efficacy in all indications currently being studied, that final data will be consistent with interim data, that regulatory approvals will be granted in a timely manner, or at all, that patient and physicians acceptance of these products will be achieved, or that final results will be supportive of regulatory approvals required to market products. Ligand undertakes no obligation to update the statements contained in this press release after the date hereof.
SOURCE Ligand Pharmaceuticals Incorporated
/CONTACT: Investors: Susan Atkins, 619-550-7687, or Media: Mary Kenny,
619-550-7536, both of Ligand Pharmaceuticals Incorporated; or Lynne Friedmann
of The Salk Institute, 619-535-1363/
/Company News On-Call: prnewswire.com or fax, 800-758-5804,
ext. 509313/
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