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Dail ,` y ~ ~lugus 1\IrJ 1948 ?u~,isnec' c:. "vea:::" Contents EUROPEAN NEWS Italian prices to be cut by 10% Italian media coverage "a disaster" Italians end drug approvals freeze Industry funds UK health debate forum English script cost up 10.5% UK PPIs in June 2% sales gain for European drug sector AGIM rejects Belgian pharma cuts French pharmacists call for contract COMPANY NEWS BMS & Cadus in screening collaboration Glaxo/Sequana diabetes collaboration ntac patent - Novopharm countersues ogen wins patent case vs Medeva Corange appoints spokesman, not CEO MMD reports 23% earnings decline Generic Tagamet - pricing lessons learned? Bayer fights for Aspirin in Russia Novo Nordisk plans new plant in Japan Generics/compliance aspects of Lilly/PCS agreement S-Nova delays bradykinin antagonist Biocraft to resolve GMP concerns PDL tipped as biotech leader RPR announces 2nd-quarter net loss Pharma aid for Rwanda Gensia's ARA trial plans ML Labs reports 1st-half loss US & WORLD NEWS FDA problems slow US ANDAs US leaders urged to protect biotech New Chilean drug approval plans S Korean/Swedish pipeline agreement Australian generic debate continues PRODUCT NEWS ngamet OTC rejected again in US ~TC famotidine rejected for US approval ~TC Rogaine turned down in the US Retrovir cleared in maternal HIV transmission Pantoprazole's first approvals 3ermany to act on omeprazole? Felbamate withdrawal recommended =:ooen s Dromisinq fviS resufts WORLD PHARMACEUTICAL NEWS 2-3 3 3 4 5 5 6 7 7 8 8 9 9 9 10 11 11 11 12 13 13 13 14 15 16 16 17 17 18 18 19 20 21 22 ~ n HIGHLIGHT'S\.;;. > Carter-Wallace's felbamate withdrawal recommended after aplastic anaemia reported (p 25) 23 24 i 25 j 25 ; 26 ' US concern about OTC H2-antagonists - more data and analyses needed (pp 20-21) Good and bad news on Italian prices/approvals (pp 2-3) Pharma Partners initiative in UK (p 4) More RfrD collaborations - another genetic alliance for Glaxo, BMS looks for faster screening (p 8) Tough quarter for MMD and RPR (pp 10 & 14)

i e • • .FDA problems slow US ANDAs The "lack of any real management" at the US FDA, as well as the agency's sometimes "capricious" emphasis on GMP compliance, particularly in the Brooklyn, Newark, and Philadelphia districts where many generic companies are based, slowed down the approval of ANDAs in the first half of the year, according to Kidder, Peabody analyst Jerry Treppel. According to Kidder, Peabody data, 70 ANDAs covering individual compounds were approved in the first six months. The highest number of approvals in a single month was 14 (in February and May), compared with 23 in October 1993. The FDA, which includes dosage strengths in its ANDA count, says that it approved 88 applications in the first half. Four companies accounted for 36% of all ANDAs covering individual compounds in the period - Bausch & Lomb with nine approvals, the Canadian firm, Novopharm (six), Copley (six) and Mylan (four). Non-US companies accounted for 22% of approvals. . . . "not interested" The alleged lack of management begins with Commissioner David Kessler who "does not appear interested in running the FDA", Mr Treppel says. Vacancies in key management posts at the FDA's Office of Generic Drugs (OGD), which include an office director, director of bioequivalence and deputy director for research, have aggravated industry problems. The OGD, which has been run by an acting director, Douglas Sporn, for almost one year, is trying to obtain a waiver on the FDA's hiring freeze in order to fill the posts (Scrip No 1934, p 19). The FDA's Center for Disease Evaluation and Research, which evaluates ANDAs, recently named Dr Janet Woodcock as director. Mr Treppel says that approval of ANDAs from companies in the Brooklyn, Newark, and Philadelphia districts, which come under the domain of the FDAs Mid-Atlantic region, may be speeded up with the departure of the region's director, Richard Davis, for DuPont Merck, where he was recently appointed vice-president of quality assurance. In the first half of this year, five ANDAs from these districts were approved, including two approvals after Mr Davis' departure was announced, the analyst adds. . .. GMP compliance The FDA recently announced that its pre-approval inspection programme, which was set up in the wake of the generics scandal, resulted in ANDA approval being withheld for 41 % of pending applications in fiscal 1993. The figure indicates a very high level of non-compliance with GMP in SCRIP'S U)M YEARBOOK Order your copy TODAY! With 903 tables, Scrip's 1994 Yearbook covers more countries, more company news and more worldwide product news than ever before. Contact Scrip Reports by fax on: +44 (0)81 332 8992, or telephone on: +44 (0)81 948 3262. Price: f275/$580/1482,500, ref: BS 670WA. Copyright Ccn PJB Publications Ltd the penerlce intlustry, rorna obaervers sug®eet (Sorip No 1928/29, p 19). A further problem for the generic industry is that research- based companies have taken advantage of "FDA management disarray" to issue a large number of legal challenges designed to forestall generic competition, Mr Treppel adds. C US leaders urged to protect biotech Democratic members of both houses of the US Congress have written to their respective majority leaders, Representative Richard Gephardt and Senator George Mitchell, urging them not to impose price controls, Medicare rebates, or other onerous measures on the biotechnology industry as part of healthcare reform. Messrs Gephardt and Mitchell are responsible for drafting final reform bills for consideration, combining the provisions of measures approved by various Congressional committees. In a letter to Mr Gephardt, 29 representatives led by Lynn Schenck and Anna Eshoo of California argued that several provisions adopted by the Committees on Ways and Means and Education and Labor - a drug price review council, Medicare "blacklisting" and rebates - "would make it almost impossible for biotechnology companies to obtain the capital essential to continue bringing life- and cost-saving products to market". None of these provisions was adopted by the Senate Committees on Finance and Labor and Human Resources, they noted. "While we do not object to a comprehensive review of costs generated by all components of the medical services sector, we feel it is prejudicial to single out biotechnology for unique treatment", the letter continued. The members urged Mr Gephardt to delete the provisions before putting the final bill up for consideration on the House floor. The letter to Senator Mitchell, signed by Senators John Kerry, Jeff Bingaman, Dianne Feinstein, Harris Wofford, Barbara Mikulski, Paul Sarbanes, Joseph Lieberman, and Bill Bradley, argued that the price control and rebate provisions rejected in committee should stay out of the final bill. It also advocated the AHCPR medical technology cost/benefit study substituted by Senator Kennedy for the price review board, which passed by a 16-to-1 vote in the Labor and Human Resource Committee.'This alternative has broad bipartisan support. By contrast, drug price controls and rebates have not passed either Senate committee, and would divide Democratic Senators", they said. A separate letter voicing similar concerns was sent to Mr Gephardt with the signatures of the Democratic House members from the state of Massachusetts. ... uSnewsin brief 2046936871  GPIA forms topicals subcommittee: The US Generic Pharmaceutical Industry Association (GPIA) has announced the formation of a new Topicals Subcommittee, composed of GPIA member firms which produce or study non-systemically absorbed or parenteral dosage form drug products. The group will address scientific and regulatory questions specific to these dosage forms; its initial members include Akorn, A L Laboratories, Copley, Lederle, Marsam, Perrigo, PharmaKinetics, Phoenix International Life Sciences, Sidmak, and Steris. \ SCRIP No 1946 August 5th 1994 p 17