Actually, I think that Loren's Dec 14 comments bear repeating:
Receives Advisory Committee Recommendation of Targetin for Advanced Stage CTCL
Key Points
· The Oncologic Drug Advisory Committee (ODAC) voted to recommend Targetin capsules for FDA approval for the treatment of cutaneous T-cell lymphoma (CTCL) in advanced-stage patients.
· Rejected Targetin capsules for the treatment of early-stage CTCL patients.
· Recommended further clinical trials.
· Decision may cause delay in marketing of the product and will reduce the approved market by 50%–60%.
· Lowering 1999 and 2000 loss estimates to because of lower expected sales and higher expected expenditures.
Details
· Committee Decisions. CTCL currently affects approximately 14,000 to 16,000 individuals in the United States. Ligand hopes to market Targetin capsules (75 mg) to these patients, in all stages of the disease. ODAC voted to approve Targetin capsules for the treatment of CTCL in advanced-stage patients by a vote of 13 to two with one member abstaining; however, the committee also voted not to approve Targetin capsules for the treatment of CTCL in advanced-stage patients by a vote of five to seven with four members abstaining. The committee also determined that Ligand had demonstrated a clinically meaningful tumor response rate using acceptable tumor response criteria; however, the committee determined that no other clinical benefit had been demonstrated. The committee also determined that Ligand had failed to properly characterize the patient population in terms of their response to prior therapies and also the reasons that these patients discontinued or did not repeat prior therapies. ODAC was also dissatisfied with the high number of protocol deviations, and the FDA felt that it was not able to review the submission completely. We believe that the committee was overly cautious, as CTCL is a rare and disfiguring disease.
· Future Requirements. The committee also recommended that further clinical trials be completed. The panelists said that long-term data are needed to ensure the safety of the early-stage patients, who would receive Targretin over an extended period of time. Ligand' s clinical trials did show a large list of side effects, such as elevated cholesterol, severe headaches, and hypothyroidism. The side-effect profile could reduce the optimism about using Targretin to treat other cancers with larger market sizes, such as breast cancer.
Earnings Impact. If Ligand recieves marketing approval for both early- and advanced-stage disease, we would expect annual revenues in the $10- $15 million range. Given the committee' s current recommendation, we expect annual revenues from Targretin of in the $5- $10 million range. The side effects also could affect future earnings from other applications of Targretin. In addition the timing of revenues may be affected by delays in completing additional trials.
Also, expenditures have been greater than expected. Because of these factors, we have revised our 1999 and 2000 loss estimates per share to $1.45 and $0.61, respectively.
Stefan D. Loren, Ph.D
John R. Woolford
Legg Mason Wood Walker, Inc.
December 14, 1999
410-454-5323 |
