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In the 1960s thalidomide, a popular new drug considered to be safe and effective, was revealed to cause severe nerve damage and birth defects in newborn infants, prompting health officials to ban the use of the drug and tighten overall restrictions on new drugs and drug use. Twenty years later, after recognizing the positive effects of thalidomide when treating patients with leprosy and its potential role in the treatment of certain types of cancer and cases of HIV/AIDS, the Celgene corporation would be forced to contend with stringent FDA regulations, liability concerns, public skepticism, and poor mass media portrayal in order to secure the drug's approval.

To illustrate how regulators are subject to political pressure, which companies much recognize and consider when making business decisions.

This case, developed from a wide variety of publicly available information, presents ethical and economic issues arising from the development, marketing, and pricing of a biotech drug. Genentech developed TPA, the first genetically engineered drug that could be used in clot-dissolving therapy for heart attack, and marketed it as Activase. Public outrage focused on the disparity between the drug's $10 direct manufacturing cost and what Genentech charged for its drug. Activase/TPA was priced at $2200 a dose, raising immediate concerns about its affordability and therefore availability to those who needed it. Additional issues arise from other events, including concern over related-party relationships between the company and organizations which researched and recommended TPA, as well as aggressive marketing of TPA to physicians and the company's refusal to participate in an international drug study to compare TPA with competitor drugs.

Pharmaceutical marketing, brand protection.

It could be used with the pharmaceutical marketing students and MBA students for analysing counterfeit medicines' menace in developing countries and positioning of a disruptive technology. The case could be used for marketing consultants, Brand managers and executive development programmes to explore issues such as protecting brands through technology, pharmaceutical packaging marketing, competitiveness of counterfeit drugs, global harmonisation.

Against the backdrop of rising menace of counterfeit drugs in developing countries, the case talks in particular about an innovative pharmaceutical packaging company. The company has developed a unique security technology called non-ClonableID™ which can enable products to be authenticated throughout the supply chain, thus protecting brands and preventing misuse. Despite a promising technology, it poses challenges regarding its adoption and commercial success.

Counterfeiting as an inevitable result of Globalization has become a global nuisance and has to be dealt at global level. Brand protection could be one of the lowest cost tools for pharmaceutical companies to restore public confidence in their products and themselves. While all methods for anti-counterfeiting are known to have short lives the menace still must be dealt with. For this, companies need to deploy anti-counterfeiting strategies that set up various layers of security.

Teaching note.

Tom McKillop, CEO of AstraZeneca, faced the classic quandary of large pharmaceutical firms. The firm's patent for Prilosec (active ingredient omeprazole) was expiring. Severe cost-based competition from generic drug manufacturers was inevitable. Patent expirations were nothing new for the US$15.8 billion in revenues drug firm, but Prilosec was the firm's most successful drug franchise, with global sales of US$6.2 billion. How could the company innovate its way around the generic cost-based competition and avoid the drop in revenues associated with generic drug market entry? AstraZeneca had other follow-on drugs in the pipeline—namely Nexium, an improvement on the original Prilosec molecule. Additionally, the company had the opportunity to introduce its own version of generic omeprazole, hence becoming the first mover in the generic segment, and/or introduce an OTC version of omeprazole that might tap into other markets. Ideally, AstraZeneca would like to move brand-loyal Prilosec customers to Nexium. In this market, direct-to-consumer advertising has remarkable efficacy. Classical marketing challenges of pricing and promotion need to be resolved for the Nexium launch as well as possible product and place challenges for the generic or OTC opportunity. Which combination of marketing options will allow the firm to best sustain the value of the original omeprazole innovation?

The central objective of the case is to teach students how marketing variables can be used by first movers with diverse product portfolios to fend off severe price competition. These variables include pricing, promotion, product, and place (distribution) options as considered in the context of branded, generic, and OTC pharmaceutical market segments.

Examines the launch of Xigris, a breakthrough new pharmaceutical product for the treatment of sepsis. The newly appointed head of marketing for Xigris is reviewing the launch plan.

Social entrepreneurship, sustainable development and emerging economies.

Advanced undergraduate students and Graduate students (MBAs).

We present the case of Marli Medeiros, a community leader in the city of Porto Alegre (south of Brazil) who has been working with the local government, local firms and local inhabitants over the last 40 years to build an organization that has been changing the reality of the slum Vila Pinto. The case highlights three main dilemmas faced by Marli Medeiros. Part 1 addresses whether to start a social entrepreneurship project in an environment surrounded by household violence and drug influences. Part 2 examines how to organize a community to develop this social project and challenge the context (local drug dealers). Part 3 considers how to work with different social players to innovate and manage a self-sustained social entrepreneurship that brings social change for an impoverished community.

Understand the five main characteristics required by social entrepreneurs to achieve social change by economic, self-sustained activities: social vision, sustainability guidelines, social networks development, search for innovation and search for financial returns. Understand the social entrepreneurship model from the point of view of a female leader in a local impoverished community. Understand and analyze the social and economic context of an emerging country.

Teaching note.

Richard Alpert, senior partner at Evergreen Investments, must decide which of his two best employees to promote to the position of managing VP. He had initially preferred Charlie Pace over Daniel Faraday, but that decision had become less clear-cut when Alpert inadvertently overheard an office conversation and learned that Pace was taking Adderall, a stimulant primarily prescribed for people suffering from attention deficit/hyperactivity disorder (ADHD). Pace did not have ADHD and apparently obtained the medication by deceiving a physician. Alpert is faced with a number of questions, including whether it was fair to Faraday—or any other high-performing employee—to be passed over for promotion in favor of someone who illicitly boosted his performance with a substance he did not medically need.

In March 2015, Amgen is preparing for the launch of Repatha, a new molecule that has demonstrated a remarkable ability to treat high cholesterol. Through a series of clinical trials, Amgen has proven that the molecule is both safe and effective for patients with high cholesterol. It also is effective for patients with familial hypercholesterolemia, a difficult-to-treat population that has exceptionally high levels of cholesterol. Amgen expects the FDA to approve the molecule before the end of the year. Now, the Repatha team has to develop a revenue forecast.

Lilly ICOS is preparing to launch Cialis, a prescription drug that treats erectile dysfunction, and executives must decide how to position Cialis against market leader Viagra and recent entrant Levitra.

Marketing tactics such as pricing, promotion, placement, and product decisions all help business owners create a need for their products or services. What managers seldom realize, however, is that the marketing decisions they make primarily to increase sales and market share have a great impact on society at large and thus have significant ethical implications. These seven caselets, which cover a variety of topics (including “the article of the half-truth,” “creative interview tactics,” and “truthfully representing your company”), explore the ethical implications of decision making in the marketing arena.