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LIGAND IND FOR TOPICAL 9-CIS (LGD-1057) IN PROMYELOCYTIC LEUKEMIA

Executive Summary

LIGAND IND FOR TOPICAL 9-CIS (LGD-1057) IN PROMYELOCYTIC LEUKEMIA is planned for the first half of 1994, following up on the company's recent IND submission for an oral form of the drug. Ligand President David Robinson told the Robertson Stephens conference in New York City Dec. 1 that the company intends to file two topical drug INDs "in the first and second quarter of 1994." The target filing date for the topical LGD-1057 is mid-year 1994; the IND for a topical form of LGD-1069 is expected one quarter earlier during the first quarter of 1994. The initial IND filing for the oral formulation of LGD-1057 is under the sponsorship of a joint venture between Ligand and Allergan. The IND filing was made in November. The first indications for the 9-cis-retinoic acid are for promyelocytic leukemia and squamous cell car-cinomas. Oral and topical LGD-1057 and topical LGD-1069 will include second indications for Kaposi's sarcoma. Ligand says it is "on schedule" to file an IND for oral LGD- 1069 before the end of 1993. The development of the IND will fall exclusively to Ligand due to a recent shift in product rights from the Ligand/Allergan joint venture. In joint venture changes announced Nov. 29, Ligand reclaimed rights to topical and systemic forms of LGD-1069 from Allergan, which, in turn, reacquired rights to systemic forms of AGN-190168, a retinoid compound for systemic use for skin cancer. Allergan had contributed AGN-190168 in oral form to the joint venture. Allergan has continued to pursue a topical formulation, which is in Phase III development for acne and psoriasis. The Allergan agreement was originally signed in July 1992. The joint venture partners filed suit Dec. 10 against the La Jolla Cancer Research Foundation claiming infringement of four patents covering LGD-1057 and LGD- 1069. Robinson elaborated on the joint venture changes at the Now York conference, stating that "we have arranged a change of rights on these compounds, we regain worldwide rights to the oral and topical forms of LGD-1069 and we're excited about that." He said the company has received inquiries about "that retinoid from Japan and Europe." San Diego-based Ligand, which specializes in small molecule drug development in the field of intracellular receptors, has raised over $77 mil. through four corporate collaborations in the last three years. In addition to the agreement with Allergan, Ligand has a project with Pfizer for the development of osteoporosis drugs (May 1991), a deal with Glaxo for the treatment of cardiovascular disease (September 1992), and an agreement with E. Merck (October 1992). Allergan had exercised its option on $4 mil. in warrants, and Ligand has received a milestone payment and a bonus from Pfizer, Robinson told the NYC conference. The Ligand exec added that the company could "receive additional milestone payments of $7.5 mil. per compound plus royalties" from drugs emerging from the joint research project. Ligand and Pfizer announced Nov. 30 that the milestone payment and bonus paid to Ligand equaled $500,000. The companies also said the ongoing research program and funding at Ligand would be phased out by July 1, 1994. Ligand said Dec. 10 that the project was ending because the five-year osteoporosis research goals had been reached in 27 months. Robinson said Ligand intends to file an IND "by early 1995," after the identification of a lead candidate for osteoporosis treatment based on Ligand's intracellular receptor research. Ligand intends to identify "two clinical candidates" from the Ligand/Pfizer research, the Ligand exec said.

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