Bear Stearns Healthcare Conference, In Brief

Abbott D2E7 advisory committee?: Abbott has "not heard anything at all" about a possible early December FDA advisory committee meeting for its anti-TNF monoclonal antibody D2E7 (adalimumab), CFO Thomas Freyman told Bear Stearns healthcare conference in New York City. Abbott does not believe "having a panel or not having a panel is going to impact our timing at all in terms of product launch." In a separate Bear Stearns presentation, Enbrel marketer Amgen Investor Relations Director Anna McDermott-Vitak said she "would be surprised" if D2E7 was not the subject of an advisory committee meeting. Abbott submitted a BLA for D2E7 in rheumatoid arthritis April 2; the company expects to launch adalimumab in the first half of 2003....

FDA reorganization and Enbrel: Amgen will "monitor...very closely" FDA's decision to move biologics reviews to the Center for Drug Evaluation & Research, Chief Medical Officer Jan Gheuens said in response to questions about the potential effect on inspections of Amgen's Rhode Island Enbrel manufacturing facility. Approval of the facility, which Amgen expects in early 2003, will help alleviate Enbrel supply problems. "Just in general experience, organizational change for them - you always worry about disruption, about people leaving, about new personnel," he said. "We'll monitor that very closely, but it's very difficult to make predictions." FDA announced the CDER/CBER consolidation Sept. 6 (¹ (Also see "CBER/CDER Consolidation Working Group Set To Meet Week Of Sept. 16" - Pink Sheet, 9 Sep, 2002.), p. 3). Amgen met with CBER Director Kathryn Zoon and other agency staff to discuss the acquisition of Immunex and Enbrel on Sept. 19....

Generic biologics?: Teva appears confident about the potential for regulations allowing generic biologics: "Sooner or later, Congress will understand that the evergreen of patents in the biotech industry must reach an end, and we must be able to amend our public policy to bring competition into the biotech arena," Teva North America CEO William Fletcher says. Teva has an alliance with Biotechnology General to develop generic biologics....

GSK on R&D productivity: One-half of Phase III products are likely to experience a "late-stage problem" in development, GlaxoSmithKline CEO J.P. Garnier says. "It used to be that that once you get into Phase III, if you had good dosing range studies in Phase II, you were at 75% rate...of success. You knew occasionally if you had a late-stage problem, maybe one out of four. Lately, it's been one out of two"....Fluffy pipelines: "There's always some fluff in the pipeline that is...printed in the annual report, and there's some dead bodies there that...have not been buried correctly," GSK's Garnier says. "The reality is there are fewer assets of value going into Phase III. What companies have been tempted to do is to move them faster, take chances. I mean, we did too. It used to be that if you didn't have an iron-clad, go/no-go dose [that] is totally understood, you wouldn't get into Phase III. But when you're a little more desperate, you tend to cut corners"....

Lilly Evista scripts post-HRT: New prescriptions for osteoporosis agent Evista increased 22% in August in the wake of Wyeth's Prempro findings from Women's Health Initiative Study (² (Also see "Prempro Cancer Risk Addressed In 550,000 Physician Letters, Label Review" - Pink Sheet, 15 Jul, 2002.), p. 11). "While roughly half of the women coming off of HRT have decided not to resume therapy with another agent, we believe Evista is a great option for many of the others who are concerned about osteoporosis," Lilly says. The company is sponsoring regional and scientific meetings and CME sessions "to put the data into perspective for doctors in the U.S."....

TAP joint venture continues: Takeda has no plans to buy out the TAP joint venture, Abbott CFO Thomas Freyman says. While Takeda "clearly is interested in expanding its U.S. presence," the 50/50 nature of the joint venture prevents both companies from doing "anything without the other party's consent," he said. Abbott is not interested in selling its half of the venture. "We like this business. It has done very well for us," Freyman said. "It's probably one of the most successful joint ventures in the history of business"....

Abbott TriCor generics: Abbott has reached nearly 100% market conversion to TriCor tablets following launch of generic fenofibrate capsules, CFO Thomas Freyman says. "The entire market is converted to the tablet from the capsule....You can count the number of generic prescriptions of the capsule in the low hundreds." As a result, Abbott has experienced "no impact whatsoever" from generic fenofibrate, he says. Freyman pointed to expanded labeling for the cholesterol agent, which includes an indication to raise HDL....

Novartis/Titan iloperidone: Novartis plans to meet with FDA in November to discuss iloperidone's safety profile in light of QTc prolongation data in Phase III trials of the atypical antipsychotic, company says. The six-week study found an adverse event in rates similar to that of Pfizer's Geodon (ziprasidone), causing Titan Pharmaceuticals to speculate that it may need to seek a new development partner (³ (Also see "Novartis/Titan Iloperidone Deal In Doubt In Light Of QTc Prolongation Data" - Pink Sheet, 29 Jul, 2002.), p. 29). Geodon labeling includes a long bolded warning about a greater capacity to prolong the QTc interval compared to other antipsychotics....

Absence makes the heart grow fonder: Merck speculates Philadelphia Assistant U.S. Attorney Jim Sheehan's recent promotion could affect the investigation into Medco's PBM practices. "Whether that investigation continues with him or whoever succeeds him, we don't know," Merck told Bear Stearns. Sheehan will be succeeded by Virginia Gibson when he moves to the newly created position of associate U.S. attorney for civil programs (⁴ (Also see "Philadelphia Rx Fraud Investigations Have New Chief; Are SEC Cases Next?" - Pink Sheet, 23 Sep, 2002.), p. 23). Medco responded Sept. 16 to Sheehan's letter outlining a possible case against the PBM (⁵ , p. 14). "Obviously, we're not going to go into the confidentiality of our discussions, but no issues were raised. We've responded, and we're continuing to cooperate," Merck says....

Merck mergers: Merck's position on mergers "remains absolute that we don't see that there's value either in terms of overall market share or research productivity," Exec VP-Worldwide Licensing & External Research Bennett Shapiro, MD, maintained. "We think it's a detriment to...large companies who merge the way that they've done." While consolidation among larger pharma partners "doesn't look like a long-term strategy for growth," Merck remains interested in acquisitions "that are targeted to really enhance our ability to do what we do best, which is discover and develop drugs"....

Medco attempts closure: "Just to put closure on the accounting issue, there is no accounting issue," Merck declares. "There's been no effect on accounting of any earnings. There's been no restatement of earnings, there won't be one." Merck faced questions in the business press about copayments for Medco-managed prescriptions on its revenue line, but the accounting practice actually negatively affected Merck's gross margins (⁶ (Also see "Medco IPO Delay: Merck Trades Gross Margin For Cloudy Rebate Calculations" - Pink Sheet, 15 Jul, 2002.), p. 28). The newspaper "that actually introduced this also had an editorial saying it's a bogus issue," Merck's Shapiro noted. Merck is understood to be considering completing its delayed Medco IPO in November (⁷ 'The Pink Sheet' Sept. 23, In Brief)....