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Executive Summary

LIGAND TO SUBMIT LGD-1069 ORAL IND BY YEAR END, keeping on schedule to have applications for two compounds from its retinoic acid research at FDA before the start of 1994. LGD-1069 is a synthetic retinoid that Ligand describes as acting specifically on a subtype of intracellular receptor called the retinoid X receptors. The Phase I/IIA clinical program calls for trials at four sites including over 100 patients for Kaposi's sarcoma, squamous cell carcinomas and advanced disease solid tumor patients. The LGD-1069 oral IND follows an IND submission for oral 9- cis-retinoic acid (LGD-1057) for the treatment of acute promyelocytic leukemia, squamous cell carcinomas and Kaposi's sarcoma in November. The initial IND filing for the oral formulation of LGD-1057 is under the sponsorship of a joint venture between Ligand and Allergan. The Phase I/IIA program for LGD-1057 is planned to include 120-150 patients. The compound, developed from Ligand's work isolating and characterizing a new, non-peptide hormone, has orphan drug designation from FDA. Ligand recently announced that the company intends to file topical INDs for LGD-1057 in the first quarter of 1994 and for LGD-1069 in the second quarter for the treatment of skin cancer. Topical LGD-1057 and topical LGD-1069 will be studied for additional indications for Kaposi's sarcoma. [EDITORS' NOTE: This item corrects information published in a previous issue of "The Pink Sheet" (Dec. 13, T&G-9) on the clinical trial schedule and target indications for Ligand's retinoic acid program.] Ligand's osteoporosis drug development partner Pfizer intends to file an IND in 1995 for an osteoporosis treatment based on Ligand's intracellular receptor research. Ligand stands to receive as much as $7.5 mil. in milestone payments. Ligand would receive royalties from product sales of marketed compounds from the collaboration. Ligand will have exclusive development and commercial rights to LGD-1069 compounds -- oral and topical. The company's rights derive from a modification of its joint venture with Allergan. As part of the changes, Allergan reclaimed rights to AGN-190168. Ligand reports that AGN-190168 is in preclinical development and indications and applications have not yet been determined.

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