# 1 # 3 Pfizer Sanofi- “With respect to patent expiries, Aventis Pfizer is still “Acomplia is mid-stride.” still the key ---Chris product for Shibutani, MD, sanofi-aventis” JP Morgan –Martyn Link, Wood Mackenzie OUR 7TH ANNUAL REPORT ON THE WORLD’S TOP 50 COMPANIES PHARMACEUTICAL #30 Akzo Nobel # 5AstraZeneca “We expect further in-licensing.”–Alex Grosvenor,Wood Mackenzie # 12 Roche
6 # Johnson & Johnson “J&J continues to effectively exploit its # 4 acquisition strategy.” ---Stephan Novartis Gauldie, Wood Mackenzie # 18 BayerCHANGINGLANDSCAPESA Special Report on the World’s Top 50 Pharma CompaniesBY NICOLE GRAYTHE PHARM EXEC 501 Pfizer 11 Abbott Labs 21 Novo Nordisk 31 Altana 41 Watson2 GlaxoSmithKline 12 Roche 22 Eisai 32 Chugai 42 Biogen Idec3 Sanofi-Aventis 13 Amgen 23 Teva 33 Solvay 43 Shire4 Novartis 14 Boehringer-Ingelheim 24 Merck KGaA 34 UCB 44 Shionogi Seiyaku5 AstraZeneca 15 Takeda 25 Sankyo 35 Genzyme 45 King6 Johnson & Johnson 16 Astellas 26 Otsuka 36 Serono 46 Tanabe Seiyaku7 Merck 17 Schering-Plough 27 Forest Labs 37 Allergan 47 Kyowa Hakko8 Wyeth 18 Bayer 28 Daiichi 38 Mitsubishi 48 Mylan Labs9 Bristol-Myers Squibb 19 Schering AG 29 Baxter 39 Gilead Sciences 49 MedImmune10 Eli Lilly 20 Genentech 30 Akzo Nobel 40 Lundbeck 50 Ono
# 11 # 2 Abbott GlaxoSmith“Despite double- -Kline digit growth in “GSK has taken 2005, sales in great strides to2006 will be hit.” boost its ---Alasdair presence in the Milton, Wood high-growth Mackenzie vaccines market.” ---Jane Kidd, Wood Mackenzie # 19 Schering AG # 31 Altana WO THOUSAND AND FIVE defending patents, and reallocating their prod- TGeneric was a year of extremes. While uct portfolios.prescription IMS reports that the global Companies that rose in the ranks in 2005volume surpassed market grew by 7 percent (at included Novartis (from 7 to 4) and Novo constant exchange rates) to Nordisk (from 25 to 21). The Fujisawa-branded volume $602 billion, the North Yamanouchi merger was completed andfor the first time American market grew by an Astellas was born into the top 50, coming inin US history, anemic 5.2 percent. The key European mar- at number 16. Ongoing consolidation has kets—Germany, the United Kingdom, made room for this year’s newcomers, includ-as generic drug France, Italy, and Spain—were just behind ing Daiichi at 28, Lundbeck at 40, andmanufacturers the United States in their growth rates. MedImmune at 49. Gilead Sciences, bestbecame more Collectively, these five markets grew just 5 known for its HIV products, was a welcome percent. In contrast, developing markets addition to this year’s top 50, coming in at 39.aggressive in experienced robust double-digit growth Globally, 30 new products were intro-their efforts across Latin America, Eastern Europe, and duced. Concerns about regulatory setbacks,to gain market Asia. China, in particular, emerged as a patent expiration, and cost containment cast growth superstar based on a 20.4 percent a pall on the industry’s mood in 2005, butshare. increase in pharmaceutical sales. there were many reasons for optimism. The Once again, the biologics sector dramati- top 10 companies each had sales of $14 bil- cally outperformed the overall market. In lion or more. Together, they grossed more 2005, biologics as a group grew by 17.1 per- than $230 billion in prescription drug rev- cent, amassing total sales in excess of $52 bil- enues. A total of 13 products broke into theSOME NOTES ON THE LIST lion. Comparatively, the small molecule mar- ranks of blockbusters, bringing the numberSales figures represent global sales of ket grew only 5.2 percent. of products selling more than $1 billionhuman prescription drugs for the fiscal yearending in 2005 as reported in annual reports Another area of rapid and well-publicized annually to 94.or other filings.When necessary, figures havebeen converted to US dollars using Federal growth in 2005 was the generic market, which And, for the most part, the top 10 compa-Reserve exchange rates. Despite our efforts, grew by 13 percent in the top eight countries to nies held their own in the ranking—eventhere are a number of companies, most ofthem privately held, for which we have not $55 billion. Along the way, generic prescrip- Pfizer, despite decreased revenues.been able to obtain reliable figures.They tion volume surpassed branded volume for the Clearly, Pfizer had a challenging year, as itinclude Servier, RatioPharm, Menarini,Apotex,Alpharma, and Procter & Gamble first time in US history. As generic drug manu- faced the combined impact of loss of exclu-(which has products large enough to warrant facturers became more aggressive in their sivity in certain key medications and the sus-inclusion on the list, but does not releasesales figures on them.) Graphs are based on efforts to gain share in markets formerly domi- pension of Bextra sales. But Pfizer, alongdata kindly supplied by IMS.These data are nated by branded products, companies with with its neighbors on the top 50, is taking acollected with a different methodology thanours.As a result, tables and graphs may dis- significant brand franchises tried to protect future-forward stance, confident in aagree in some respects. their revenues by going after line extensions, brighter tomorrow.
80 PHARMACEUTICAL EXECUTIVE MAY 2006 www.pharmexec.com Rank Company & Headquarters 2005 Global Pharma R&D 2005 Top [‘04 Rank] [Web site] Sales [change from 2004] Spend Selling Drugs [2005 sales] Pfizer Lipitor $12.19 B 1  New York, NY [pfizer.com] $44.28 B [-4%] $7,440 M Norvasc $4.71 B Zoloft $3.27 B GlaxoSmithKline Advair/Seretide $5.65 B 2  London, England [gsk.com] $33.96 B [8%] $5,708 M Lamictal $1.55 B Zorfran $1.52 B Sanofi-Aventis Lovenox $2.54 B 3  Paris, France [sanofi-aventis.com] $32.34 B [-5%]* $4,789 M Plavix $2.40 B Taxotere $1.91 B Diovan $3.67 B Novartis 4  Basel, Switzerland [novartis.com] $24.96 B [16%] $4,484 M Gleevec/Glivec $2.17 B Zometa $1.22 B Nexium $4.63 B AstraZeneca 5  London, England [astrazeneca.com] $23.95 B [12%] $5,356 M Seroquel $2.76 B Seloken/Toporl-XL $1.74 B Risperdal $3.55 B Johnson & Johnson 6  New Brunswick, NJ [jnj.com] $22.32 B [1%] $6,312 M Eprex/Procrit $3.32 B Topamax $1.68 B Zocor $4.40 B Merck 7  Whitehouse Station, NJ [merck.com] $22.01 B [2%] $3,848 M Singulair $3.00 B Cozaar/Hyzaar $3.00 B Effexor $3.46 B Wyeth 8  Madison, NJ [wyeth.com] $15.32 B [10%] $1,262 M Protonix $1.68 B Prevnar $1.51 B Plavix $3.82 B Bristol-Myers Squibb 9  New York, NY [bms.com] $15.25 B [-1%] $2,746 M Pravachol $2.26 B Abilify $0.91 B Zyprexa $4.20 B Eli Lilly 10  Indianapolis, IN [lilly.com] $14.65 B [12%] $3,025 M Gemzar $1.33 B Evista $1.04 Key Insights on the Top 10 AstraZeneca » Sales of Pfizer » In April, FDA and EMEA GSK » FDA Merck » Grows Novartis » Symbicort, an inhaled steroid requested that Bextra be taken off the approves Fluarix, funding for Vioxx- Bolsters its posi- for asthma and COPD, sur- market. Bextra contributed $1.29 billion the first biological related legal costs tion in generics, passes the $1 billion mark. in revenues in 2004. » In October, shares product to be to $685 million. announcing the » Crestor achieves $1.3 billion fell to an 8-year low after Pfizer cut its reviewed under » Establishes a acquisition of in sales » Files a lawsuit 2005 profit outlook. » Patent protection accelerated-app- generic company, Hexal, a privately against Ranbaxy for willful efforts in US District Court to retain roval regulations. GenPharm. held German patent infringement, after exclusivity for Lipitor are successful. generic company, Ranbaxy submits an ANDA for Adjudicators determine that Ranbaxy Sanofi-Aventis » In August, FDA and acquisition of esomeprazole magnesium, the Laboratories is guilty of patent infringe- approves Actonel with calcium, the first a 67.7 percent active ingredient in Nexium. ment and extend Lipitor’s exclusivity prescription osteoporosis therapy to stake in Eon Labs. until June 2011. » One of 10 companies include calcium in the United States. » Announces plans Johnson & Johnson » that helped launch the new prescription » Awarded a five-year, $97 million to fully acquire Expands key therapeutic drug savings card. contract by US DHHS to support the Chiron Corporation. franchises through a series development of cell culture-based of acquisition deals, including influenza vaccines. » Receives approval Wyeth » Announces 30 per- plan to acquire Peninsula Lilly » Cymbalta BMS » Baraclude for Ambien CR, an extended release cent decrease in Pharmaceuticals, which approved in Europe approved for chronic formulation of Ambien, indicated for focuses on developing antibi- the induction and maintenance of sleep. primary care sales for use in depres- hep. B infections otics; completion of the » FDA approves a new Eloxatin formula- force. » Receives a sion. » Federal with active viral TransForm Pharmaceuticals tion. » EMEA approves two new indica- five-year, $32 mil- court upholds replication. lion NIH contract acquisition; and agreement to Lilly’s patent on » Orencia approved tions for Taxotere. » Landmark Taxotere for development of acquire Closure Medical Zyprexa (to expire for the treatment of study published in the New England Corporation. Journal of Medicine. HIV vaccines. in 2011). rheum. arthritis. *2004 figures from pro forma
82 PHARMACEUTICAL EXECUTIVE MAY 2006 www.pharmexec.com Rank Company & Headquarters 2005 Global Pharma R&D 2005 Top [‘04 Rank] [Web site] Sales [change from 2004] Spend Selling Drugs [2005 sales] Abbott Labs 11  Abbott Park, IL [abbott.com] $13.99 B [16%] $1,821 M Humira $1.40 B Roche 12  Basel, Switzerland [roche.com] $12.90 B [5%] $3,792 M MabThera/Rituxan $3.16 B Amgen 13  Thousand Oaks, CA [amgen.com] $12.02 B [13%] $2,302 M Epogen $2.46 B Boehringer-Ingelheim 14  Ingelheim, Germany [boehringer-ingelheim.com] $10.84 B [2%] $1,148 M Spiriva $0.80 B Takeda 15  Osaka, Japan [takeda.com] $8.53 B [3%] $1,320 M Prevacid $3.48 B TOP 10 US PRODUCTS OF 2005 Product [Maker] 2005 Sales in billions Growth in Sales SOURCE: IMS Heatlh, MIDAS, December 2005 1. Lipitor [Pfizer] $8.2 13% 2. Zocor [Merck] $4.4 -3% 3. Nexium [AstraZeneca] $4.1 19% 4. Prevacid [Abbott/Takeda] (TAP) $3.8 -3% 5. Advair Diskus [GlaxoSmithKline] $3.3 24% 6. Plavix [BMS] $3.3 i was Advair 23% % UP 24 7. Zoloft [Pfizer] $3.1 3.1% 8. Procrit [Ortho Biotech] $3.0 1.2% 5 9. Epogen [Amgen] $3.0 in 200 -3% 10. Zyprexa [Lilly] $2.8 -14% TOP 10 GLOBAL PRODUCTS OF 2005 Product [Maker] 2005 Sales in billions Growth in Sales SOURCE: IMS Heatlh, MIDAS, December 2005 1. Lipitor [Pfizer] $12.90 6.40% 2. Plavix [BMS] $5.90 16% 3. Nexium [AstraZeneca] $5.70 16.70% 4. Seretide/Advair [GlaxoSmithKline] $5.60 19% 5. Zocor [Merck] $5.30 i was Advair -10.70% % UP 19 6. Norvasc [Pfizer] $5.00 2.50% 7. Zyprexa [Lilly] $4.70 -6.80% 5 8. Risperdal [Janssen-Ortho] $4.00 in 200 12.60% 9. Ogastro/Prevacid [Abbott/Takeda] $4.00 0.90% 10. Effexor [Wyeth] $3.80 1.20% A PharmExec Graphic Astellas 16 [N/A] Tokyo, Japan [astellas.com] $8.04 B [N/A] $1,259 M Prograf $1.32 B Schering-Plough 17  Madison, NJ [sch-plough.com] $7.56 B [18%] $1,865 M Remicade $0.94 B Bayer 18  Leverkusen, Germany [bayer.de] $7.56 B [18%] $1,130 M Kogenate $0.79 B Schering AG 19  Berlin, Germany [schering.de] $6.29 B [3%] $1,163 M Betaferon $1.03 B Genentech 20  South San Francisco, CA [gene.com] $5.49 B [46%] $1,261 M Rituxan $1.83 B
84 PHARMACEUTICAL EXECUTIVE MAY 2006 www.pharmexec.com Rank Company & Headquarters 2005 Global Pharma R&D 2005 Top [‘04 Rank] [Web site] Sales [change from 2004] Spend Selling Drugs [2005 sales] Novo Nordisk 21  Bagsvaerd, Denmark [novonordisk.com] $5.36 B [1%] $807 M Antidiabetic products $3.81 B Eisai 22  Tokyo, Japan [eisai.co.jp] $4.77 B [-5%] $730 M Aricept $1.52 B Teva 23  Petach Tikva, Israel [tevapharm.com] $4.70 B [10%] $369 M Copaxone $1.18 B Merck KGaA 24  Darmstadt, Germany [merck.de] $4.61 B [21%] $686 M Beta-blocker products $0.41 B Sankyo* 25  Tokyo, Japan [sankyo.co.jp $4.25 B [46%] $807 M Mevalotin $1.48 B TOP 10 COMPANIES US SALES Company Total Sales US billions [5.4%] SOURCE: IMS Heatlh, MIDAS, December 2005 1. Pfizer $29.4 2. GlaxoSmithKline $19.2 3. Johnson & Johnson $16.5 AMOUNT SALES GREW 4. Merck & Co $14.8 5. AstraZeneca $12.4 IN THE US FOR 2005. 6. Novartis $11 TOTAL US SALES WERE 7. Amgen $10.9 $251.8 BILLION, 8. Sanofi-Aventis $10.8 COMPARED WITH 9. BMS $8.7 $239.9 BILLION IN 2004 10. Lilly $8.5 TOP 10 MOVERS  THE NUMBER With a growth rate of 17.4 percent in 2005, “biologics” is still the fastest growing segment Company 1. Genentech 2. Sankyo 3. Gilead Total Sales US billions [Market Share] 46.39% 46.12% 45.65% 4. Endo 33.33% OF NEW in the pharmaceutical SOURCE: PHARM EXEC 50 5. Altana 27.45% PRODUCTS market. It generated 6. Allergan 25.90% THAT WERE $52.7 billion in sales 7. Solvay 24.28% LAUNCHED in 2005. 8. Cephalon 22.45% IN 2005 9. Akzo Nobel 21.17% 10. Merck 20.57% A PharmExec Graphic Otsuka 26  Tokyo, Japan [otsuka.co.jp] $3.30 B [-11%] $490 M Abilify $1.30 B Forest Labs 27  New York, NY [frx.com] $3.16 B [19%] $293 M Lexapro $1.61 B Daiichi* 28 [N/A] Tokyo, Japan [daiichipharm.co.jp] $3.06 B [-1%] $536 M Levoflaxacin $2.80 B Baxter 29  Deerfield, IL [baxter.com] $3.02 B [11%] $533 M Recombinant Factor VIII products $1.53 B Akzo Nobel 30  Arnhem, Netherlands [akzonobel.com] $2.87 B [21%] $516 M Puregon/Follistim $0.42 B * merged with Daiichi, September 2005
86 PHARMACEUTICAL EXECUTIVE MAY 2006 www.pharmexec.com Rank Company & Headquarters 2005 Global Pharma R&D 2005 Top [‘04 Rank] [Web site] Sales [change from 2004] Spend Selling Drugs [2005 sales] Altana 31  Bad Homburg, Germany [altana.de] $2.84 B [27%] $496 M Pantoprozole $1.66 B Chugai 32  Tokyo, Japan [chugai-pharm.co.jp] $2.77 B [6%] $425 M Epogin $0.61 B Solvay 33  Brussels, Belgium [solvay.com] $2.69 B [24%] $391 M Androgel $0.28 B UCB 34  Brussels, Belgium [ucb-group.com] $2.42 B [16%] $605 M Zyrtec $0.67 B Genzyme 35  Cambridge, MA [genzyme.com] $2.41 B [9%] $503 M Cerezyme $0.93 B GLOBAL PHARMACEUTICAL SALES BY REGION, 2005 Percent of Global Sales Market 2005 Sales (US$B) % Growth from 2004 North America $265.70 5.20% Europe $169.50 7.10% Japan $60.30 6.80% 30% Asia*, Africa, and Australia $46.40 11% Latin America $24 18.50% 47% *Excluding Japan SOURCE: IMS MIDAS, MAT December 2005 10.7% TOP 10 R&D SPEND 8.2% 4.2% The global pharmaceutical market grew by  PERCENT OF Company 1. Pfizer 2. Johnson & Johnson 3. GlaxoSmithKline 4. AstraZeneca Total R&D Spend US billions $5.356 $6.312 $5.708 $7.440 7 percent SOURCE: PHARM EXEC 50 5. Sanofi-Aventis $4.789 GROWTH IN THE 6. Novartis $4.484 to approximately MARKETPLACE 7. Merck & Co $3.848 8. Roche $3.792 $602 billion, at constant FUELED BY THE INTRODUCTION OF 9. Eli Lilly 10. Bristol-Myers Squibb $3.025 $2.746 A PharmExec Graphic exchange rates. NEW PRODUCTS, ACCORDING TO IMS THE COMBINED R&D INVESTMENT OF PhRMA MEMBERS IN 2005 [$39.4B] Serono 36  Geneva, Switzerland [serono.com] $2.34 B [7%] $594 M Rebif $1.27 B Allergan 37  Irvine, CA [allergan.com] $2.32 B [26%] $387 M Botox $0.83 B Mitsubishi 38  Osaka, Japan [m-pharma.co.jp] $1.89 B [4%] $471 M Omeprazon NA B Gilead Sciences 39 [N/A] Foster City, CA [gilead.com] $1.81 B [46%] $278 M Viread $0.78 B Alcon Labs 40  Hünenberg, Switzerland [alconinc.com] $1.77 B [15%] $422 M Patanol $0.33 B * merged with Sankyo, September 2005
88 PHARMACEUTICAL EXECUTIVE MAY 2006 www.pharmexec.com Rank Company & Headquarters 2005 Global Pharma R&D 2005 Top [‘04 Rank] [Web site] Sales [change from 2004] Spend Selling Drugs [2005 sales] Lundbeck 41 [n/a] Copenhagen, Denmark [lundbeck.com] $1.65 B [7%] $324 M Cipralex $0.39 B Watson 42  Corona, CA [watsonpharm.com] $1.65 B [0.3%] $125 M Generic oral contraceptives $0.32 B Biogen Idec 43  Cambridge, MA [biogen.com] $1.62 B [9%] $747 M Avonex $1.54 B Shire 44  Hampshire, England [shire.com] $1.60 B [17%] $286 M Adderall XR $0.73 B Shionogi Seiyaku 45  Osaka, Japan [shionogi.co.jp] $1.57 B [-4%] $274 M Flomax $0.31 B TOP THERAPEUTIC CLASSES Therapeutic Class 2005 Sales in Billions Change from 2004 SOURCE: IMS Heatlh, MIDAS, December 2005 Cholesterol and triglyceride reducers $32.40 6.80% Cytostatics $28.50 18.60% Antiulcerants $26.70 3.80% Antidepressants and mood stabilizers $19.80 -3.90% Antipsychotics $16.20 10.70% s was Angiotensin-II inhibitors $14.20 Disku 18.10% Advair % UP 24 Erythropoietin products $12.30 6.30% Calcium antagonists $11.90 2.20% 5. Anti-epilectics $11.60 in 200 0.90% Oral antidiabetics $10.70 6.90% A PharmExec Graphic [12.6] THE NUMBER OF PRODUCTS IN [4.7] THE JAPANESE MARKET FOR CANCER-RELATED THERAPIES GREW BY PERCENT CLINICAL DEVELOPMENT PERCENT THAT 14 TO 20 PERCENT IN 2005. THAT SALES GREW 9 PERCENT TO VOLUME OF HERCEPTIN, ARIMIDEX, OF GENERICS GREW IN THE TOP 8 MARKETS [2,300] PRESCRIPTION SALES ROSE BY CASODEX, AND GLIVEC EMERGED AS WINNERS. King 46  Bristol, TN [kingpharm.com] $1.54 B [18%] $263 M Altec $0.55 B Tanabe Seiyaku 47 [N/A] Osaka, Japan [tanabe.co.jp] $1.48 B [14%] $259 M Herbesser $0.14 B Kyowa Hakko 48 [N/A] Tokyo, Japan [kyowa.co.jp] $1.36 B [7%] $268 M Itrizole $0.28 B Mylan Labs 49  Canonsburg, PA [mylan.com] $1.25 B [-9%] $88 M Generics $1.01 B MedImmune 50 [N/A] Gaithersburg, MD [medimmune.com] $1.24 B [9%] $385 M Synagis $1.06 B
Biologics and generics stole the showfrom small molecules.Anemic keymarkets watched developing regionslead the way. 2005 was a year thatrewarded revolutionaries and punishedstalwarts. But most companies ran inthe middle of the pack, just...KEEPINGPACE with the Evolving Pharmaceutical Business Model. By Nicole GrayIn times of intensive change, tion of the concept. Eventually, stake- kets, and biologics grew more than twiceprognosticators with proven insight are holders will be obligated to metabolize as fast as the overall market. But, there’s novalued for their ability to predict the change in order to survive. doubt about it—an evolution is underway.future. Financial and sector analysts have At face value, many things in 2005 held The combined effect of regulatory set-helped industry adjust to the idea that the steady: Seventeen products achieved block- backs, safety-related issues, generic chal-prevailing pharmaceutical business model buster status, the same number as in 2004; lenges, cost-containment efforts put forthis evolving. They remain hard at work, Pfizer topped the list; and many trends con- by third-party payers, and the countdownhowever, on guiding a sector uncomfort- tinued—consolidation increased, double- to Part D implementation, all point to oneable with change toward complete diges- digit growth occurred in developing mar- central fact: 2005 was a threshold year.
94 PHARMACEUTICAL EXECUTIVE MAY 2006 www.pharmexec.com GENERICS BECOME EQUALS higher than branded volume. According sents the largest investment in the gener- Barbara Ryan, senior pharma analyst for to IMS, generic prescriptions grew by 13 ics industry ever made by an innovative Deutsche Bank, attributes pharma’s percent, compared with 7 percent growth pharma company. Add to this Novartis’ underperformance in the financial mar- for the overall market. In all, generic pre- plan to fully acquire Chiron and further kets in the last five years to the “cannibal- scription volume reached 60 percent—an build out its vaccines business, and a istic effect of generic substitution,” and all-time high. definitive strategy emerges. As a result, widespread loss of patent protection. Two thousand and five also was a ban- Novartis has gained two major advan- “In 2001, Prozac lost 90 percent of its ner year for widespread patent expirations, tages: Having substantial interests in both value in several weeks when generic flu- with $17 billion worth of products losing sides of the generics and branded pharma oxetine was introduced,” Ryan says. She their patents, including such key block- business makes it possible to benefit from cites a constellation of factors that are busters as Duragesic (fentanyl), Allegra R&D investments after patent expiry, driving the ascendancy of generics as a (fexofenadine), Zithromax (azithromycin), and it gives Novartis the opportunity to category, including pressure from man- and Rocephin (ceftriazone). position itself to governments and MCOs aged care organizations (MCOs) to con- While the language used to describe the as a one-stop shop for formulary needs. tain costs, automatic substitution at the move away from branded products INNOVATION MATTERS Clearly, the prospect of contending with what the experts think this type of change has led to a spate of creative strategizing, by which companies EXPECTATIONS AROUND [GSK’S] are acquiring, merging, diversifying, and FLUARIX WERE PRETTY LOW, BUT restructuring at a rapid clip. But as much BECASUSE OF CONCERNS as these efforts help, there is no substitute for innovation in the lab. “The best way ABOUT A FLU THAT FOLLOWED, AND THE STOCKPILING PANDEMIC around uncertainty and concerns about pricing is to continue to be innovative,” FLUARIX WAS A HIT. IT BECAME THE FIRST says Ryan. “If you’re driving value and BIOLOGIC TO RECEIVE EXPEDITED APPROVAL. you’re unique, you can set pricing.” —JANE KIDD,WOOD MACKENZIE Murray Aitken, senior vice president, corporate strategy for IMS, in IMS Intel- ligence 360, an annual publica- tion that provides global cover- age of pharma, says the indus- try is suffering its “slowest rate THE BAR IS HIGHER THAN IT USED TO BE of growth since 1963.” He FOR PRODUCTS OF ANY TYPE.THERE notes, however, that there were MUST BE A DEMONSTRATED pockets of innovation in 2005 that brought therapeutic value THERAPEUTIC SUPERIORITY AND COST-EFFECTIVENESS, ESPECIALLY to the marketplace. Examples include Byetta (exanatide) for CONSIDERING THE COMPETITION POSED improved blood sugar control BY GENERICS. —MURRAY AITKEN, IMS in patients with type 2 dia- betes; Lunesta (eszoplicone) indicated to address insomnia, pharmacy level, sampling of generics, and toward generics reeks of violence (“canni- decrease sleep latency, and improve sleep the fact that critical players in the chan- balization” and “onslaught” are fre- maintenance; and Macugen (pegatanib) nel, including pharmacists, pharmacy quently used terms), some pharma compa- for neovascular age-related macular benefits managers (PBMs), and distribu- nies are taking steps to make generic prod- degeneration. tors are incentivized financially to favor ucts a significant part of their offerings. Ryan adds that Pfizer’s Exubera generics over branded products. “The Novartis epitomizes this approach. In (insulin), approved in January 2006, was generics issue is here to stay and will the July 2005 issue of Wood Mackenzie’s an important addition in the diabetes cat- absolutely change the operating structure Horizons publication, authors Cliff Kalb, egory. “Exubera’s delivery format can of businesses in this industry,” Ryan says. vice president, life sciences, and Keith lower the barrier to adoption that often In 2005, for the first time in US his- Redpath, head of life sciences research, exists when patients need to step up to tory, generic prescription volume was acknowledge the potential advantages of insulin therapy,” she says. this approach. According to the authors, Although only 30 new products were Nicole Gray is a contributing writer. She can Novartis’ acquisition of Eon and Hexal launched in 2005, there were clear winners. be reached at http://nicolegray.home0.com for its generics division, Sandoz, repre- Categorically, biologics have continued to
what the experts think98 MAY 2006 www.pharmexec.com THE GENERICS ISSUE IS WILL ABSOLUTELY STAYTHE AND HERE TO CHANGE OPERATING STRUCTURE OF BUSINESSES outperform the overall market, and IN THIS INDUSTRY. the stage is set for continued —BARBARA RYAN, DEUTSCHE BANK growth. Biologics grew by more than 17 percent for the second year in a row, to amass more than $52 billion in sales in 2005. Strong showings in this sector included Aranesp (darbepoetin alfa) for ane- mia secondary to kidney disease or chemotherapy, with sales that grew by 46 percent to $2.7 billion; Enbrel (etanercept) for the treatment of NOVARTIS’ACQUISITION moderate-to-severe rheumatoid OF EON ANDHEXAL REPRESENTS THE LARGEST INVESTMENT IN arthritis, with sales that grew by 36 percent to $2.6 billion; and Neu- THE GENERICS INDUSTRY EVER MADE BY AN lasta (pegfilgrastim) used to INOVATIVE PHARMA COMPANY. decrease the incidence of febrile —KEITH REDPATH,WOOD MACKENZIE neutropenia during chemotherapy, with sales that grew by 30 percent to $2.2 billion. overall R&D productivity has faltered. When examining Germany’s $1.9 bil- This category seems to be in its golden However, the advent of access barri- lion oncology market, a dichotomized era now, but competitive dynamics may ers, formulary restrictions, higher co- utilization pattern emerged. The market change that. “Second-generation prod- pays, and price scrutiny is making it was divided between high-cost new ucts are coming into the marketplace and harder for patients to obtain reimburse- drugs, such as Lilly’s Alimta (pemetrexed) products are getting approved for ment for high-priced cancer drugs, forc- and targeted therapies, such as Roche’s expanded indications,” says Aitken. ing them to take on more of the costs or Avastin (bevacizumab), Tarceva forgo certain treatments. (erlotinibib), and Herceptin, as well as SYSTEMATIC COST CONTAINMENT Endpoints that were previously Erbitux (cetuximab), manufactured by As a therapeutic category, oncology is the accepted as the basis to justify both treat- Merck KGaA. These products were perfect example of the convergence of ment and reimbursement, including deemed reimburseable and enjoyed rapid some of the most dramatic trends in the remission in late-stage patients and small uptake as a result. On the other side, industry. IMS reports that growth in this increments of survival time or time-to- generic cytotoxic drugs decreased in price area has kept pace with the dynamic bio- regression, may not be enough to satisfy as generic companies Stada and Ratio- logics market—both have grown at a rate payers. In light of this conservative trend, pharm competed for market share. of roughly 17 percent per year. Oncology the burden of proof is on manufacturers In November 2005, England’s efforts alone reached $29 billion in 2005, making to conduct studies at each stage of devel- to contain healthcare costs were success- it the fastest growing therapeutic category opment, show stronger evidence of remis- fully challenged by a 41-year-old woman, of the year. Major players in this space— sion, and to focus on managing afford- who demanded that she receive treatment Genentech, Biogen Idec, Novartis, Sanofi- ability despite long-held assumptions that with Herceptin despite her Primary Care Aventis, and ImClone—have come to the drugs addressing unmet needs—espe- Trust’s (PCTs) original claim denial. (In market in the last several years with a bevy cially oncology drugs—can command England, PCTs manage government of useful therapeutics, including proteins high prices across their life cycle. health services related to primary care.) and small-molecule drugs. This reflects the The United States is still only poised on “The holy grail of ‘the payers must pay’ growing trend of using combinatorial the threshold of change when it comes to is no longer true in the UK,” says Alex approaches comprised of traditional cyto- the full-scale implementation of intensive Grosvenor, senior analyst, life sciences at toxic chemotherapies with pharmacoge- cost-containment efforts. But in Europe, Wood Mackenzie. nomics for select patients based on molec- initiatives to control costs have been under- The National Institute for Health and ular-targeted treatments. way for some time. In 2005, Germany Clinical Excellence (NICE), a British reg- In 2005, treatments have become so pulled back from some of the draconian ulatory agency, uses economic modeling effective that for the first time in 70 years, measures that were in place in 2004. Com- tools to rate cost-effectiveness and make the death rate from cancer decreased. The pulsory discounts on non-referenced drugs therapeutic recommendations—and some- 2005 launch of Genentech’s Clolar (clo- were reduced from 16 percent in 2004 to times the results are not favorable for the farabine), a purine nucleoside analog for six percent in 2005; co-payment exemp- medications in question. Despite this push- the treatment of pediatric acute myeloid tions were increased; and prescription vol- back, the NICE model is being adopted leukemia, the most common cancer in ume increased by five percent, when much and modified in most European countries. children, epitomizes the productivity of hospital-based treatment was shifted to The consumer movement—patient occurring in oncology research, even as the ambulatory setting. activism—will become a force to reckon
100 PHARMACEUTICAL EXECUTIVE MAY 2006 www.pharmexec.com with as the impact of payer conservation AIDS patients who had been denied com- competing vaccines for the human papil- increases. As it turns out, when the British bination therapy treatment. The result: loma virus (HPV), the most important woman who was refused coverage for the Health Canada, the government depart- risk factor for developing cervical cancer. breast cancer treatment Herceptin took ment of Canada with responsibility for (For more on HPV, see “Cervical Cancer: action, she succeeded not only in getting national public health, brokered a clinical Endangered Species,” page 154). coverage, but also prompting Prime Min- trial protocol for the patients. “Vaccines will go from understudy to ister Tony Blair to push for fast-track star performer,” predicts Aitken. review. In Canada, patient activists pre- PREVENTION ENTERS THE EQUATION Indeed, from a health economics per- sented Canada’s Health Minister, Ussal In 2005, both Merck and GlaxoSmithK- spective, prevention is cheaper than treat- Dosanjh, with five coffins, representing line announced ongoing development of ment, especially when prevalence is high. The World Health Organization esti- mates that approximately 80 percent of all sexually active adults are infected with HPV worldwide. Merck’s Gardisil is scheduled to launch in 2006, while GSK’s Cervarix is scheduled to launch in 2007. There are currently 598 vaccines in development—across a range of therapeu- tic areas, including breast cancer, geni- tourinary cancer, hepatitis, and HIV. IMS predicts a 20 percent growth rate, to $20 billion, for vaccines over the next five years. Large companies, such as Novartis and GSK, are heavily invested in vaccines, and others are expected to follow suit. (For more on vaccines, see “Vaccines: Market on the Rebound,” page 110.) DIGESTING CHANGE According to IMS, by the end of 2006, the Centers for Medicare and Medicaid Services will be paying for 50 percent of all prescription drugs. Once the effects of Medicare Part D are understood and assimilated, the United States will join other countries in becoming more aggres- sive about containing costs. The first real signs have been the introduction of exor- bitant copays, which went as high as $100 for the first time in 2005. The advent of health technology assessments (HTAs) is another sign of change. HTAs are designed to systemati- cally compare and contrast various ther- apeutic options to determine cost-effec- tiveness relative to outcomes. By defini- tion, HTAs are complex. IMS’ Aitken advises companies to “maintain a close dialogue with authorities, starting before a drug’s marketing approval.” The primary care category may be where the most profound changes are occuring in prevailing industry paradigms. In Wood Mackenzie’s Horizons, authors Kalb and Redpath suggest that the opera- tive business model is shifting in favor of specialist products, away from the stan-
PHARMACEUTICAL EXECUTIVE 101dard model of vertically integrated com- tatin), Plavix (clopidogrel), and Zocor macotherapeutic and preventive areas ofpanies that are therapy-area-focused and (simvastatin) were firmly ensconced as focus,” says Aitken. Based on IMS figuresenjoy double-digit growth year after year. numbers one, two, and five, in the roster for 2005, growth rates in China, Korea,They predict a $700 billion market by of the top-earning products globally— Turkey, and the Russian Federation were2009, with very little contribution from but as a group, revenues from statins only 20.4 percent, 14.6 percent, 54.3 percent,growth in blockbuster revenues. grew five percent. Two notable break- and 19.9 percent, respectively. They say pharma may come to define throughs in this space were Crestor (rosu- Ultimately, the way to confrontblockbusters as $500 million products vastatin) and Vytorin (ezetimbe/simvas- change is to be flexible. Already, the num-(versus the $1 billion definition employed tatin), which both achieved blockbuster bers reflect some of the steps pharma istoday), which seems radical when viewed status in 2005. taking to survive: While the number ofin perspective of the days when the $1 Crestor’s success, says Wood Macken- blockbuster drugs increased betweenbillion threshold seemed too low. But, the zie’s Grosvenor, was helped by the fact that 2000 and 2005, from 36 to 94, the per-role of primary care products as block- target cholesterol guidelines have featured centage of specialty drugs rose from 28 tobuster candidates is diminishing—as evi- progressively lower optimal levels for total 44 percent for the same period. In addi-denced by the declining number of and LDL cholesterol. AstraZeneca took tion, sales forces are being downsized,launches in this space and the fact that this challenge one step further and con- detailing is being refined, and portfoliosthere were no launches in 2005 for car- ducted head-to-head trials versus Lipitor, are being realigned. Safety issues continuediovascular disorders. “There must be Zocor, and Pravachol (pravastatin). to be a concern, and there is a universaldemonstrated therapeutic superiority and Crestor emerged as the most effective at understanding that all stakeholders mustcost-effectiveness,” says Aitken, “espe- reducing LDL cholesterol levels. confront challenges associated with pay-cially considering the competition posed Opportunities outside of mature mar- ment and reimbursement. Developingby generics.” kets in Asia, Latin America, and Eastern markets are challenging, yet compelling. Indeed, the generic challenge looms Europe are ripe for investment. “Compa- Changes abound, but year after year, thelarge, especially with statins, a category nies are investing in becoming insiders ability to bring value to the therapeuticthat still serves as an important source of and partners of the healthcare system market while improving and extendingrevenue. As 2005 ended, Lipitor (atorvas- with a stake in the development of phar- life remains a constant.