By first use, we are assuming the question is referring to the reduction of triglyceride levels, and that the second use refers to cholesterol reduction. The original application was in fact for the indications of reduction of both cholesterol and triglycerides. If there had been no interest in obtaining an indication for reduction of cholesterol or of cardiovascular disease, the applicant likely would not have been asked to conduct a Phase IV study. Question 5 - Was the 1981 approval of Lopid totally conditional on the successful completion of the Helsinki study? Response The answer is no for the narrower indication of triglyceride lowering. The labeling, however, did include the statement that the physician could use the drug in the treatment of patients with clearly defined risk due to severe hypercholesterolemia (e.g., individuals with familial hypercholesterolemia starting in childhood) who inadequately respond to appropriate diet and more effective cholesterol-lowering drugs. In view of this restricted cholesterol-lowering indication, we determined that a Phase IV study would be requested and that the sponsor's commitment to undertake the Helsinki study would fulfill that request. Question 6 - Has the FDA approved any other drugs where the first approval predated passage of the Waxman-Hatch Act and wherein a study was required which began before the law took effect and which is to be completed after the law took effect? Response The tabulation that we maintain on Phase IV studies lists approximately 150 drugs that are or have been involved in such studies. Unfortunately, our Phase IV list does not include the kinds of information about these drugs that would enable us to match them expeditiously either against the criteria in your question or against those criteria for eligibility for patent extension currently in H.R. 3074. In order to know whether any of these drugs other than Lopid would meet either set of criteria, an extremely resource-intensive search through the files would be necessary. We can speculate however, that the criteria currently in H.R. 3074 could not be met by most of the 150 drugs, but we cannot eliminate the possibility that some drugs other than Lopid would meet them. On the other hand, the criteria in your letter are broader and could well be met by some substantial fraction of the 150 drugs. 82-542-88 - 8 4 Question 7 - What data, if any, has the FDA received with respect to the Helsinki study? When would the FDA be in a position to make a decision on the application for the second use of Lopid? Response We have not received any of the data on the Helsinki study vet, but when such data are submitted in a new drug application, we would make every effort to review it as soon as possible. Question 8 - Have any generic drug companies expressed an interest in Competing with Lopid once the patent is expired? Response No such interest has been expressed to FDA. This of course does not mean that such interest does not exist. Please find enclosed a copy of the transcript of the October 8, 1987, hearing of the Subcommittee on Courts, Civil Liberties and the Administration of Justice with technical editing changes. Also, please find enclosed a brief paper in response to a request from Mr. Remington, Chief Counsel, which describes drug products which compete or may compete in the future with Lopid in the cholesterol-regulating market. Finally, please find enclosed an internal memorandum of the Generic Pharmaceutical Industry Association' which describes meetings of its Board and Executive Committee on July 22, 1987, at which the decision was made not to oppose Lopid patent extension legislation. I would appreciate this document being made part of the hearing record. In addition, I contacted you, express support understand that several medical researchers have in your capacity as Subcommittee Chairman, to for our efforts. I would respectfully encourage you to include these items in the record as well. Please feel free to let me know if there is any further information I can provide to you or your Subcommittee members. As I indicated in our earlier meeting, I am willing to do whatever I can to build a complete public record on this matter. Dyslipidemic Agents - Lopid and Competitive Products There are competitive products that regulate lipids differently from Lopid and there are competitive products where the drug action is quite similar to Lopid. There are three types of products (i) those which work in the digestive system to pull cholesterol from the body (i.e. binds bile acids and increases fecal excretion of cholesterol while inhibiting reabsorption of cholesterol); (ii) those which, through systemic action, primarily lower LDL cholesterol (the "bad cholesterol") and have minimal or no effect on HDL cholesterol (the "good cholesterol"), some of which lower the LDL cholesterol quite substantially and some of which may lower HDL cholesterol; and (iii) those which through the systemic action raise HDL cholesterol quite substantially and lower LDL cholesterol to a lesser extent (i.e. those which regulate the lipid profile). The drugs falling in the first category (i.e. those which work in the digestive system to pull cholesterol from the body) The drugs falling in the second category (i.e. those which primarily lower LDL cholesterol) are: The drugs falling in the third category (i.e. those which raise HDL cholesterol and to a lesser extent lower LDL cholesterol) are: ** A drug developed in Germany that is sold in various foreign countries. Testing is currently being performed to obtain U.S. marketing approval. RP1L4650.TXT 10/20/87 1 |