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ROCHE’s HIVID (ddC) ADDITIONAL DATA AT LEAST 6-12 MONTHS FROM REVIEW; FIRM COMPLETES INITIAL HIVID ROLLOUT IN FOUR DAYS THROUGH WHOLESALER SYSTEM

Executive Summary

Additional data in support of treatment of AIDS patients with the combination of Hoffmann-La Roche's Hivid and Burroughs Wellcome's Retrovir will take at least six to 12 months to generate, FDA Commissioner Kessler said at a June 22 HHS press conference. FDA approved the antiviral on June 19. "Today's action is based on the information that we have at hand and is conditioned on the information from the trials that are under way," Kessler noted. "The exact timeframe of those trials falls somewhere between six to 12 months. As soon as the data from those trials becomes available we expect the manufacturer to present that data to us and to our advisory committee," the FDA commissioner said. Kessler's comments are indicative of the emphasis FDA is putting on the "conditional" nature of Hivid's (zalcitabine or ddC) approval. "This approval is based on limited data from two small studies involving a total of less than 100 patients [who] had rises of about 100 in their [CD4] immune cell count that seemed to be sustained for at least several months," Kessler noted. If the additional studies being conducted by Roche "do not confirm the anticipated clinical benefit of ddC," the FDA commissioner promised that the drug would be withdrawn expeditiously. "There are still questions of whether in the end AZT and ddC in combination will improve the chances of survival or decrease the rate of opportunistic infections," Kessler said. In addition to Kessler, the press conference included appearances by both the highest-ranking HHS official, Secretary Sullivan, and FDAers directly involved in Hivid's review: Antiviral Drugs Division Director David Feigal, MD, and Medical Reviewer Steven Gitterman, MD. Feigal suggested at the press conference that it take even longer than six to 12 months to generate data supportive of ddC's benefit in combination with AZT. "We should have some answers within the next 12-18 months," Feigal said. Roche expects that it will be at least that long before data can be evaluated from its trials. In communications with FDA, Roche said its primary supportive trial (AIDS Clinical Trials Group 155), "is expected to conclude near the end of 1992, with completion of key analyses of efficacy data within six months after the completion of the study." The company is conducting three efficacy trials in addition to ACTG 155, which are expected to yield information over a three-year period ("The Pink Sheet" June 22, p. 5). The FDA officials also emphasized that Hivid's approved labeling indicates that the drug should be used in the late stages of AIDS, not as initial therapy. Referring to the labeling, which states that ddC is for patients with advanced HIV infection "who have demonstrated significant clinical or immunologic deterioration," Feigal said: "The reason for this careful choice of words relates to concerns expressed by our advisory committee that this therapy is probably best considered as an option by the patients who are not doing well, with advanced disease." Hivid is "certainly not for early stages of the disease," Kessler remarked. * On June 22, Roche announced that it succeeded in rolling out Hivid to target pharmacies in 12 major cities within a 48-hour period with the assistance of the National Wholesale Druggists Association. The company also achieved its goal of supplying all pharmacies nationwide with ddC within a week of approval. Normally, two to three weeks are required to distribute a drug to retail pharmacies, the company noted. Roche, a major wholesale system user, decided to work with NWDA on an accelerated distribution program for Hivid rather than the overnight delivery route chosen by Bristol-Myers Squibb in its initial distribution of ddI (Videx). Roche first met with senior executives of NWDA to discuss the launch of Hivid in November 1991. NWDA members subsequently identified pharmacies in 12 U.S. cities filling prescriptions for the largest number of AIDS patients. The major centers identified by NWDA included: New York City; Los Angeles; San Francisco; Washington, D.C.; Chicago; Houston; Atlanta; San Juan, Puerto Rico; Fort Lauderdale; Philadelphia; and Newark. The group enlisted 16 wholesalers operating 37 distribution centers to monitor the progress of Hivid approval by FDA and manage the launch. Hivid was approved at 4 p.m. on a Firday afternoon, the the worst possible time for wholesalers, worst possible time for wholesalers, according to NWDA, since deliveries for the weekend generally go out on Friday morning and many workers are dismissed for the afternoon. Also, wholesalers usually make limited deliveries on Saturday and very few on Sunday. However, within 30 minutes of the time NWDA issued a facsimile to wholesalers informing them of the Hivid approval, Roche received 16 responses. By Saturday morning, 1,000 bottles (100s) of Hivid had been distributed to pharmacies in major cities and by Monday, June 22, 7,000 bottles had arrived in the targeted pharmacies. By Tuesday, June 23, Roche had distributed 50,000 bottles of Hivid to pharmacies nationwide. The price to wholesalers of a year's supply of ddC is $1,826. The amount is an average of the standard dose cost of $1,950 and the price of the low-dose regimen of $1,555 per year. The recommended standard combination regimen is one .75 mg tablet of Hivid with 200 mg of AZT every eight hours. In a letter to AIDS community activists, Roche noted that the average annual cost of Hivid "makes it the lowest priced of the three available antiretroviral agents on the market." Videx' cost is slightly lower at $1,745 per year, according to Bristol-Myers Squibb estimates ("The Pink Sheet" Oct. 14, 1991, p. 17). However, the Videx figure may not be a calculation of the average cost of therapy. The cost of AZT therapy is between $2,200 and $2,600 a year. Patients who have been in Roche's expanded access program for AZT intolerance or failure will continue to receive ddC free of charge. Those patients who began receiving ddC under Roche's open- label program in March will be given another two-month free supply of the drug before being discontinued from the program, at which point they must pay for the drug. Roche has established a reimbursement assistance program called ASSIST with an 800 toll-free number. The company states that patients without health insurance may be eligible to receive free drug under the Roche Indigent Patient Program. * The first drug approved under FDA's proposed accelerated approval procedures, Hivid served as a test case for wrinkles not yet ironed out of the process. For example, the proposed reg requires that promotional materials be submitted 30 days prior to product launch, a stipulation that could have delayed Hivid's approval. Instead, FDA allowed Roche to enter into an agreement to submit as soon as possible all advertising and labeling materials that it intended to use in the first four months of marketing. After 120 days, the company may submit promotional materials as is normally required under the accelerated approval reg, 30 days prior to use. A June 17 letter from Roche to FDA agrees that "if the final rule for the accelerated approval regulations establishes a different procedure for advertising and promotional labeling materials for the post-120 day period, the procedure in that final rule will govern." FDA reportedly is considering the 120-day launch material submission period as a possible requirement for other therapies approved in the expedited process.
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