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LEMMON’s COPOLYMER 1 TREATMENT IND FOR MS WILL ENROLL UP TO 2,000 PATIENTS

Executive Summary

LEMMON's COPOLYMER 1 TREATMENT IND FOR MS WILL ENROLL UP TO 2,000 PATIENTS with the degenerative neurological disease. A Treatment IND was cleared for Cop-1 on Jan. 5 to treat patients with exacerbating-remitting multiple sclerosis. Patients with this form of the disease experience relapses followed by remissions. Approximately 30%-50% of the 200,000 people with multiple sclerosis in the U.S. suffer from the exacerbating-remitting form of the disease. Initially, Cop-1 will be distributed to five centers that treat significant numbers of MS patients. The patients will receive daily injections of 20 mg Cop-1, a polypeptide simulating myelin basic protein. Lemmon expects to begin enrolling patients in the treatment protocol within two months. The company has applied to the agency for partial cost recovery for Cop-1 at a level of $20 per dose. Since Copolymer 1 is administered daily on a chronic basis, the annual cost to patients under the Treatment IND would be about $7,300. Lemmon was granted the Treatment IND on the basis of data from a Phase II study first published in 1987. The 50-patient trial conducted by Murray Bornstein, MD, et al. of the Albert Einstein College of Medicine and the Weizmann Institute of Science in Israel, found over a two-year period that twice as many patients treated with Cop-1 had no exacerbations of MS disease as patients receiving placebo. In the study's placebo group, there were 62 exacerbations of disease compared to 16 such episodes among the Cop-1 treated patients, yielding a two-year average of 2.7 exacerbations for placebo-treated patients to .6 for patients receiving Cop-1. While Cop-1 therapy appeared most effective in treating less disabled patients (Kurtzke Disability Status Scale of 0-2 on a scale of 0- 10), the polypeptide reduced the number of exacerbations by at least 60% in patients more affected by the disease (Kurtzke score 3-6). Over the two-year period, less disabled patients improved their Kurtzke scores by .5 units, while those taking placebo worsened by 1.2 units. However, more disabled patients worsened by .3 units on the Kurtzke scale compared to a deterioration of .4 units in the placebo group. Side effects were similar in the Cop-1 and placebo groups. Patients treated with Cop-1 had more injection site soreness, swelling and itching than placebo patients. Two patients receiving Cop-1 experienced sweating, palpitations and difficulty breathing, the study reports. Lemmon has initiated a Phase III trial to confirm the results of the Bornstein study. The trial is enrolling 251 patients and is expected to be completed by May 1994. In the trial, patients are receiving a 20 mg daily injection of Cop-1. Cop-1 is manufactured by Lemmon parent company Teva Pharmaceuticals in Israel. The drug's production will not be affected by a Dec. 2 FDA warning letter about quality control problems at Lemmon's Sellersville, Pa. plant (see following T&G). Lemmon said it plans to contract out manufacturing of Cop-1 to a U.S. firm before marketing the drug. PMA's 1992 Annual Survey of Orphan Drugs in development notes that there are at least three other products being studied for multiple sclerosis. The therapies include: Elan's 4-amino pyridine for relief of symptoms of MS; and Berlex' Betaseron and Centocor's Centara for treatment of the disease.
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