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Executive Summary

Roche plans to complete its NDA submission to FDA for Hivid (ddC) "in the next month or so," Hoffmann-La Roche, Inc. President Irwin Lerner reported at the company's "R&D Day" in Nutley, N.J. on Sept. 16. Roche has been submitting data to support the ddC (dideoxycytidine) NDA since the spring ("The Pink Sheet" March 18, T&G-6). The company's clinical data will be based on several clinical trials comparing ddC to Burroughs Wellcom's Retrovir (AZT) that began in mid-1989 and include about 3,000 patients,as well as on an expanded access arm that began in June 1990 and now includes more than 5,000 patients. The ddC expanded access program has, since August, moved into a treatment protocol, which is largely the same as the first-phase, expanded access open-label trial, but with reduced paperwork and easier IRB requirements. Roche will be completing the Hivid NDA filing at about the time that Bristol-Myers Squibb is expected to receive FDA approval for ddl (Videx). An obstacle for both companies will be getting an approved indication that does not specifically restrict use of the products to second-line treatment after AZT. Such a label could limit access to either drug if insurance companies stick to the approved labeling for reimbursement. Roche held the "R&D Day" to commemorate the start of construction of a new biotech reasearch facility at the company's Nutley headquarters. The Swiss company announced earlier this year that it is moving its R&D management, headed by International R&D President Jurgen Drews, MD, from Basel to Nutley. The "R&D Day" event included a press briefing during which several Roche R&D execs described, in broad brush strokes, the company's R&D pipeline. Although Roche's ddC likely will be third nucleoside analog to reach the market after AZT and ddI, the company appears to be well-positioned in the race for second-generation antiviral AIDS drugs. Roche is the first company to report that it has an HIV protease inhibitor in clinical trials. VP and Group Director- Biotechnology Research Michael Steinmetz, PhD, noted that Roche's lead HIV protease inhibitor, RO-31-8959, is currently in Phase II study in Europe. Steinmetz cited the non-peptidic protease inhibitor as an example of Roche's "rational" drug design capabilities using recombinant technology, X-ray crystallography, nuclear magnetic resonance imaging, and computer-assisted drug design. Researchers at the company's Welwyn, U.K. research center developed the compound by cloning the protease of HIV, expressing it in recombinant form, and them using it as a tool to characterize the amino acid sequence cleaved by the protease, Steinmetz explained. The researchers then used their knowledge of the structure recognized by the HIV protease to synthesize the "peptidomimetics" compound. Preclinical studies, Steimetz said, have shown that RO- 31-8959 "is stable under in vivo conditions and is able to block HIV protease." Roche indicated that, depending on the results of the European efficacy trial, an IND could be filed for RO-31-8959 in 1992. Abbott and Vertex also have said they hope to be able to begin human studies with their respective protease inhibitors by next year. Other companies with active protease inhibitor R&D programs include Upjohn, SmithKline Beecham and Merck. Merck also has another second-generation antiviral for AIDS in early clinicals. In December, the company announced that it was initiating Phase I study of its lead reverse transcriptase inhibitor compound. Roche has a third AIDS antiviral in early clinical study that inhibits TAT, a gene segment involved in HIV replication in vitro. The TAT inhibitor, RO-24-7429, is currently undergoing a pharmacokinetic and tolerance study to evaluate different dosing regimens, Roche reported. The company announced in June that it was seeking a corporate partner to co-develop this compound ("The Pink Sheet" June 3, In Brief).

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