Pfizer sees more savings from Pharmacia: Pfizer is now projecting "at least" $1 bil. in synergies from the Pharmacia acquisition in 2003, indicating that it expects to exceed its original target of $1 bil. in first-year savings....

Inspra launch: Pfizer is "so excited" about the approval of Inspra for congestive heart failure "that we've been able to accelerate our manufacturing schedule to make this product available into the market sooner than we expected," U.S. Pharmaceuticals President Pat Kelly says during Oct. 22 conference call. "We are putting the product out as fast as we possibly can" and expect it to be available "by the end of November." The CHF indication was approved by FDA Oct. 7 (¹ Also see "Inspra Approved For First-Line CHF; Pfizer Expects Most Use Will Be Add-On" - Pink Sheet, 13 October, 2003., p. 19)....Short life cycle for Inspra?: "The patent status and exclusivity status" for Inspra is "quite complicated," Pfizer's Kelly says. "We have every belief that we'll be able to maintain exclusivity even under attack...through 2008 for this product." Pfizer expects Hatch/Waxman patent extensions and pediatric exclusivity for the drug. "We're not done, but 2008 is a pretty good start," CEO Henry McKinnell says....

Exubera update: Pfizer is having "very positive interactions with regulators across the E.U." and continues "to interact positively with FDA" on the inhaled insulin Exubera , Senior VP-Science & Technology Peter Corr tells Oct. 22 conference call. Pfizer will have data from two trials in type 2 diabetes "soon" and has two additional studies underway. "We're working with how we would go ahead with the filing with all that data and when the safety data would come in. It is different in the U.S." than it is in Europe, Corr says. "As soon as we're ready to file, we'll let you know," CEO Henry McKinnell adds, "but its looking positive"....

Levitra vital statistics: Bayer/GSK erectile dysfunction agent Levitra (vardenafil) has a new prescription share of over 12%, with 62% of patients switched from other therapies (primarily Viagra ) and 38% new to the ED market, GSK reports Oct. 22.... Viagra still dominant?: Viagra "continues to dominate" U.S. market, Pfizer says Oct. 22, "with an 85% share of new prescriptions and a 93% share of total prescriptions." Sales for the drug grew 9% to $476 mil. worldwide. "We expect Viagra to continue to dominate the ED market" based on "unsurpassed medical profile" and five years of successful marketing, Pfizer declares. To underscore longevity of brand, Pfizer threw a belated fifth birthday party for Viagra on Oct. 28 at the company's New York headquarters, with appearances by celebrity endorsers Rafael Palmeiro and Mark Martin (with the Viagra race car) and patient Ray Milton, described as a Viagra user who tried Levitra but "came back to Viagra"....

Wellbutrin XL off to a fast start: GSK/Biovail's once-daily bupropion formulation Wellbutrin XL represents 19% of Wellbutrin family prescriptions after five weeks on the market, GlaxoSmithKline reports. The product is tracking ahead of Forest's Lexapro (escitalopram) in early new prescription share. About 65% of XL scripts are coming from patients currently on Wellbutrin SR, and 30% are coming from patients who would have been prescribed SR if XL were not available, GSK says. The company hopes to move as much of the SR market to XL as possible before generics enter (² Also see "Wellbutrin SR Patent Needs Further Review, Appeals Court Agrees With GSK" - Pink Sheet, 29 September, 2003., p. 17)....

Ariflo "approvable," but awaiting data: FDA approval of the chronic obstructive pulmonary disease agent Ariflo (cilomilast) is likely to depend on the outcome of a long-term European study expected to be completed by the end of the year, GSK CEO J.P. Garnier says during Oct. 22 conference call. "If the study demonstrates continuous and further improvement in FEV from Ariflo if you keep the patients a longer time on the drug, then we would certainly have gone a long way toward meeting the advisory board's requirements," Garnier said. An FDA advisory committee concluded that existing efficacy data for the drug are insufficient for approval (³ Also see "Ariflo COPD Long-Term Efficacy Studies Should Use Active Controls – Cmte." - Pink Sheet, 15 September, 2003., p. 22). "On the other hand, if this study is not effective, then we need to sit down with the FDA and get their sense of what they want us to do." The company announced receipt of an "approvable" letter Oct. 27.... Advair for COPD: GSK expects to hear from FDA by Nov. 30 about its application for approval of Advair (salmeterol/fluticasone) for treatment of COPD. The combination agent was deemed "approvable" for the use in March 2002 (⁴ Also see "GSK Flovent/Advair Diskus Needs More COPD Data; Serevent Cleared For COPD" - Pink Sheet, 1 April, 2002., p. 27)....

GSK plays it SMART: Black box warning about an increased risk of asthma-related deaths associated with Advair seen in the SMART study has had "not any impact at all" on the product, CEO J.P. Garnier says. "If you look at the substance of SMART, that is not entirely surprising," he said. The black box was added to labeling in August (⁵ Also see "GSK’s Advair, Serevent Add “Black Box” On Rare Asthma-Related Deaths" - Pink Sheet, 18 August, 2003., p. 23). Third quarter sales grew 57% in the U.S. to $509 mil. "We communicated this data very effectively to physicians," Pharmaceuticals President David Stout said. "I think physicians understood it for what it was, which is, 'I see the data, I don't see how it affects how I prescribe the product on a daily basis'"....

Avandamet boosts GSK in diabetes market: GlaxoSmithKline's share of the type 2 diabetes market has increased two full points to 10.9% following the launch of the rosiglitazone/metformin combination product Avandamet . The Avandia franchise has now opened up a clear lead over Lilly/Takeda's Actos (pioglitazone), GSK says. Avandamet was launched in November 2002 (⁶ Also see "GSK Avandamet Antidiabetic Combo Expected In Pharmacies In November" - Pink Sheet, 14 October, 2002., p. 26)....

Lilly Zyprexa scripts stabilize: Script volume for Lilly's Zyprexa (olanzapine) was flat in third quarter after "considerable market share decline in the first half due to misperceptions around the topic of diabetes," Executive Director-Investor Relations Simon Harford says Oct. 22. Company expects class labeling requested by FDA on diabetes risk will "help substantiate our position, although it will take time to change the misperception in the marketplace." The agency said all atypical antipsychotics should carry same diabetes warning as Zyprexa (⁷ Also see "FDA Sides With Lilly; Seeks Class Warning On Antipsychotic Diabetes Risk" - Pink Sheet, 22 September, 2003., p. 20).... Zyprexa for bipolar maintenance "approvable": Zyprexa is "approvable" at FDA for bipolar maintenance indication. Company expects final U.S. approval in first half of 2004, pending resolution of "label negotiations, including an additional analysis of existing data to support desired label claims"....

Strattera share grows: Script volume for Lilly's attention deficit hyperactivity disorder therapy Strattera was flat over summer months while other ADHD treatments declined, Lilly says, resulting in five percentage point market share increase between May and September. Atomoxetine holds 16.3% share as of end of September. In adult segment, "we have seen steady volume," with "significant increase" in scripts written by primary care physicians after start of a direct-to-consumer ad campaign....

Xigris a late bloomer?: Lilly's ENHANCE study affirms efficacy results, safety profile seen in Phase III trial of sepsis agent Xigris (drotrecogin), company says. Data from single-arm, open-label ENHANCE trial of 2,378 adult patients with severe sepsis at high risk of death show 25.3% 28-day mortality. Phase III trials showed 24.7% 28-day mortality for treatment arm versus 30.8% for placebo. U.S. sales of Xigris were up 24% in third quarter to $24.4 mil....

Evista strategy: Lilly osteoporosis agent Evista (raloxifene) suffers in post-Women's Health Initiative market. Third quarter sales were up 4% in U.S. to $240 mil. "The primary impact" of changes in post-menopausal osteoporosis market have been "in the prevention segment, which is where much of Evista's use has been historically," Harford says. "Three-pronged strategy" for product revival is new "bone efficacy" data; sales focus on "importance of preventing progression of osteoporosis in reducing fracture risk"; and physician and patient education on "importance of bone quality and its positive effect on long-term efficacy"....

The future of Altace: King and marketing partner Wyeth "need to be revising our message" on the ACE inhibitor Altace , King CEO Jefferson Gregory acknowledges during third quarter earnings call Oct. 28. Sales of Altace (ramipril) were $125.4 mil. in the quarter, down 4%. Altace wholesaler inventory, which is usually at two to three months because of annual price increases, was reduced slightly in the third quarter. While new scripts grew 9%, Gregory acknowledged that "the message concerning Altace has gotten a little stale....The ARBs are doing a very good job, but that doesn't mean that Altace can't continue to achieve better growth than the overall market in the ACE inhibitor marketplace"....King does not want to be one-product company: King will no longer project sales for Altace . "Considering King's more diversified revenue base, and the current relative contribution of Altace, the company does not plan to provide future net sales guidance for Altace," the firm said. King is under SEC investigation regarding its Medicaid rebate accounting (⁸ Also see "King To Discuss $46.5 Mil. In Medicaid Underpayments With HHS, DoJ" - Pink Sheet, 4 August, 2003., p. 30)....

Schering sales force turnover: Schering-Plough's sales representative turnover is "right around industry standards," Global Pharmaceuticals President Carrie Cox says. "That is, in fact, a little surprising to me. I thought it might be worse when I joined the company. In fact, it's pretty good." The reps "want to be winners again, and I think that bodes very well for our eventual turnaround." CEO Fred Hassan concurred, noting that when he became Pharmacia & Upjohn CEO in 1997, sales force turnover was 25%. At Schering, "we have a very aligned, very motivated sales force that was thirsty for leadership"....

Quarterly Call Round-Up: Pfizer, GSK, Lilly Updates

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