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Nexium (A): Launch Pricing and Dosage Strengths)

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Nexium (A): Launch Pricing and Dosage Strengths) 1 [maximum 14 days of treatment every four months], Nexium (A): Launch Pricing and dosage strengths). Critics, such as Marcia Angell, place “the blame” [for Nexium’s market dominance and success as a follow on to Prilosec] on AZ’s “audacious plan” to “spin out old products” rather than develop new entities. In contrast, New Yorker columnist and economist Malcolm Gladwell sees it differently. Nexium (esomeprazole) was approved by the FDA in “AstraZeneca was able to do some chemical sleight February 2001 and launched in the US by Astra of hand, spend half a billion on advertising, and get Zeneca (AZ) in June of that year. Esomeprazole is in away with the “reinvention” of its heartburn drug the proton pump inhibitor (PPI) class of drugs, which only because that consensus [what we want from our block the production of acid by the stomach. PPI’s medical system] hasn’t yet been reached. For sellers are primarily indicated for use as treatments of to behave responsibly, buyers must first behave stomach and duodenal ulcers and gastroesophageal intelligently. And if we want to create a system where reflux disease (GERD). AZ launched Nexium just as millions of working and elderly Americans don’t have the patent was expiring on AZ’s largest selling drug, to struggle to pay for prescription drugs that’s also the PPI market leader, Prilosec (omeprazole). up to us. We could find it in our hearts to provide all Americans with adequate health insurance. It is only Nexium has been controversial. Since its launch, AZ by the most spectacular feat of cynicism that our has been accused of making “false and misleading” political system’s moral negligence has become the claims for Nexium’s effectiveness; Tom Scully, then fault of the pharmaceutical industry”. head of Centers for Medicaid and Medicare Services (CMMS), told American Medical Association Questions: Nexium Reference & Price members (April, 2003) they should be “ashamed” to prescribe the drug. Nexium is cited in several books Gregson, Sparrowhawk, Mauskopf, & Paul (“Pricing critical of the pharmaceutical industry ($800 Million Medicines: Theory and Practice, Challenges and Tablet, The Truth About the Drug Companies) as a Opportunities”) outline an approach to drug pricing striking example of “faux innovation.” that begins by selecting a reference drug. Pricing for the launch product is set at a premium, parity, or Faux innovation is when “me too” products (very discount to the reference drug's price. similar in chemical structure, method of action, and indications) are commercialized; in the opinion of Pricing decisions reflect advantages/disadvantages of critics, done so solely to maintain profits for the firm. the new product compared to the referent; Some critics will admit that “me too” products create competitive market characteristics in the therapeutic price competition: the products are somewhat inter- category; and the strategic objectives for the launch changeable enabling price competition among large brand. The potential referents at the time of purchasers thus driving down net prices (net of Nexium® launch were Aciphex®, Protonix®, rebates and discounts). Nexium has attracted more Prilosec®, and Prevacid®. frequent and vociferous criticism than other me-too’s. Consider the following questions, using the pricing Perhaps this is because of its high visibility direct-to- worksheet that comes with the case. consumer advertising and/or because the new product Which drug would you select as the referent for quickly captured PPI market leadership in spite of the pricing Nexium? similarity between omeprazole and esomeprazole, Relative to your selected referent drug, would two isomers (chiral “hands”) of the same molecule. you price Nexium at a premium, parity, or By 2003, global Nexium sales exceeded $3 billion. discount to the reference drug? Why? Nexium and Prilosec (marketed as Losec in some What is your recommended launch price for 40 markets) maintained market dominance even after the mg Nexium (in $US, WAC price)? introduction of Prilosec as a generic and over the At the time of Nexium launch, there were counter (there are some differences in labeled Prilosec 20mg and 40mg strengths. Do you indications, recommended duration of therapy recommend launching a 20 mg strength of Nexium in addition to 40 mg at launch? If so, at what price (in $US, WAC price)? Jeffrey L. Moe, Ph.D., Duke University (2006, 2010, 2012) & Will Mitchell, Duke University & University of Toronto (2012). Prepared for teaching and discussion purposes. 5C’s OF PRICING reduced significantly when H2’s were used as treatments for GERD and ulcers (see Figure 1). This section outlines five factors that influence drug pricing decisions: (1) Characteristics of the drug, (2) PPIs: A new drug target for gastric acid secretions, Company strategy, (3) Competitors, (4) Customer proton pump inhibitors (PPI), was in development needs, and (5) Conscience. shortly after the launch of Zantac. In addition to histamine, gastric acid secretion is stimulated by gastrin and the neurotransmitter, acetylcholine. These 1. Characteristics: Gastric disease, H2’s, 3 share a common pathway through the “proton and PPI’s pump”. Inhibiting the proton pump became a more Gastric disease: Gastric diseases and symptoms effective mechanism for gastric acid control. frequently afflict patients who seek over-the-counter Anecdotal accounts claim Glaxo had the opportunity medications (e.g., antacids) or consult with their to in-license a PPI and extend Glaxo’s dominance in physicians. Heartburn, gastroesophageal reflux the gastro-intestinal arena, but Sir Richard Sykes, disease (GERD), and peptic ulcers (gastric or then Chairman and formerly head of R&D, eschewed duodenal) are among the most common diagnoses. the PPI category. He urged caution about the use of ~18% of American adults experience heartburn at PPI’s because of what he described as “cell changes” least once a week (Szarka, et al 1999). in the gut lining from too much secretion suppression, Repeated exposure of the esophagus to stomach implying that PPI’s may pose a safety risk. Any risks “juices” results in inflammation and, in the most appear to have been over-stated as patients were serious cases, erosion of the esophageal tissue. safely using PPI’s in clinical trials and there were no Annually, 500,000 Americans are diagnosed with reports of underlying problems from gut cell changes. peptic ulcers (Graham, et al 1999) and over a lifetime A British business press cartoon characterized Dr. ~12% men and ~9% women (Americans) will be Sykes as an angry child throwing toys out of his pram diagnosed with the disease (Berardi, et al 1999). In after his accusations about PPI’s. The cartoon one managed care study, direct medical costs for implied that Dr. Syke’s tantrum was due to the GERD were $471/patient annually and the costs for impending demise of Zantac market leadership at the peptic ulcers were $1,183/patient including costs for introduction of the PPI class. Prilosec (then named inpatient care (Levin et al, 1997). Losec and later changed in the US and some other H2’s - Tagamet: SmithKline introduced Tagamet international markets (at FDA’s request) to eliminate (cimetidine) to the UK market in 1976. This was the confusion among pharmacists who might mistakenly first of many new medications focused on H2 read “Lasix”, a diuretic) was launched in 1991. Three receptors in the gut. Histamine, a protein involved in other PPI’s were introduced: Prevacid, Aciphex, and allergic reactions, acts as an agonist which triggers Protonix. The cumulative effect of H2’s and PPI’s on acid release when it binds to an H2 receptor. The H2 reducing gastric surgeries was dramatic over a 13 receptors are found on parietal cells which regulate year period (see the product timeline in Figure 1). gastric acid secretion. Cimetadine and other H2 products (e.g., Zantac, Pepcid, Axid) reduced the 2. Company strategy: AstraZeneca amount of stomach acid, its level of acidity as well as AZ background the gastric response to a variety of stimuli. These agents were effective in treating both symptoms of AstraZeneca is the result of a $35 billion merger of gastric disease, heartburn and inflammation, and also Astra AB of Sweden and Zeneca Group PLC of the facilitating healing. By 1981, Tagamet accounted for UK, completed in 1999. Figure 2 summarizes the $780 million of SmithKline’s sales. company’s financial trends. H2’s - Zantac: Zantac (ranitidine HCL), discovered, Astra: Founded in 1913 in Södertälje, Sweden, Astra marketed and manufactured by Glaxo, was was a global pharmaceutical research, manufacturing, introduced in 1983 at a price premium to cimetidine and marketing company; Astra also operated a (+7% at ex-factory in the US) and by 1986 had medical devices group, Astra Tech. overtaken cimetidine in global sales. Zantac became Astra brought four main product groups to the the first prescription medication to exceed $1 billion combined firm: Anesthesia, cardiovascular, in sales. After launches of similar products (Axid, respiratory, and gastrointestinal. Pepcid), Zantac was the dominant global leader with 42% of global H2 category sales by 1990. The H2’s Anaesthesia - ylocaine (lidocaine), the world's constituted a “miracle drug” as gastric surgeries were largest selling local anaesthetic Cardiovascular - Seloken (metoprolol), Plendil AZ received 6 months of extended patent life for (felodipine), Ramace (ramipril), Atacand Prilosec by testing the drug for use with children. It (candesartan cilexetil) also used its process patents to challenge generic Respiratory - Pulmicort (budesonide), Bricanyl companies in court. Reports in 2000 suggested the (terbutaline), Rhinocort (budesonide) and magnitude of the challenge facing the company with Turbuhaler (inhalation flow-driven device) its own managers reporting, “It is not an easy time for Gastrointestinal – Prilosec/Losec (omeprazole), the company.” (David Brennan, Sr. VP Sales and the world's largest selling pharmaceutical and Marketing, as reported in the Wall Street Journal, almost 50% of Astra’s sales.
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