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We had a vision that this project deserved a company with a focus on HDL as the next frontier in the cardiovascular area.

Blockbusters may not grow on trees, but sometimes they hide in desk drawers. At least that's how it was for one of pharma's most enduring brands--one which, near the end of its patent life, boasts 16 indications, four formulations, and three (recent) billion-dollar years in a row.

Critics often claim that international marketing programs ignore fundamental differences that exist across countries and cultures.

In 2003, Big Pharma produced only a dozen new drugs. At the same time, it came under new pressure to create value from those thin pipelines. In that "hot squeeze" of a climate, pharma companies needed price premiums for every product in every market. They were more successful in some countries than in others. Other pricing trends also took their toll.

Big pharma companies aggressively gather sensitive intelligence about their competitors, but few, strangely, make a systematic effort to protect their own.

July 2004 Table of Contents

June 2004 Table of Contents

Our industry can succeed only by collaborations," a biotech CEO recently told Pharm Exec, "because no company has the whole of the jigsaw complete -- only a piece." Clearly many of his pharma counterparts agree. The web of alliances formed by the top two dozen biotech and pharma companies from 1973 to 2001 -- at least the 12,500 contracts made public by these firms -- is as tightly knit as a linen shirt.

What are the industry's current hiring needs? What functions are most challenging to retain? How do misconceptions about working in pharma affect recruiting? These were some of the questions raised at an exclusive roundtable on pharma industry recruiting, co-sponsored by Pharmaceutical Executive and the New York Times Job Market.

Last year, FDA released a series of concept papers that summarized the agency's plans for risk management. One described a new mandate for the pharmaceutical industry: to develop a risk management plan (RMP) for each drug, to be submitted to FDA at the time of the new drug application. The concept papers still need to be finalized and converted into a guidance (a document that explains how companies may comply with FDA regulations), but the mandate is likely to go into effect this year.

College isn't just for students anymore. It's for companies too. Over the past decade, institutions of higher education have increasingly found that some of their most important stakeholders are their students' employers?and that they can extend their reach and influence by responding to the needs of local and regional business.

How well is the pharma industry prepared for rapidly approaching industry upheavals? Not very, according to a 2002 global survey on corporate early warning systems conducted by the Fuld-Gilad-Herring Academy of Competitive Intelligence. More than 100 managers responded, most of whom work in their companies' strategy, product management, or intelligence departments.

May 2004 Table of Contents

Nektar?the drug delivery firm formerly know as Inhale?has been around for 14 years, but its pace during the last few has been dizzying. In 2001, the company made two major acquisitions that not only expanded its technology base from inhaled therapeutics to a broad range of exciting new technologies, but also gave it revenue from five products on the US market that use its technology and lined-up another four in Phase III. In 2002, Nektar brokered 11 collaborative partnerships, and in 2003, it generated $106 million in sales.

More than one-third of the dollar value of all US healthcare assistance to the developing world is donated by pharmaceutical companies to humanitarian agencies. That is the finding of a 2003 survey conducted by the Center for Pharmaceutical Health Services Research at the Temple University School of Pharmacy and sponsored by the Partnership for Quality Medical Donations (PQMD), an alliance of nine drug companies and a dozen humanitarian agencies. (See "About PQMD.") The survey, conducted annually since PQMD's inception in 1999, helps members quantify the value of their donation efforts and assists groups who wish to benchmark their work against that of other organizations.

WCPM 2004 Brochure

In 1996, Sandoz (now Novartis) decided to brave new waters to create consumer demand for the antifungal Lamisil (terbinafine) in the United Kingdom. But with European law forbidding pharma companies to conduct brand-name advertising, Sandoz needed to find another way to encourage patients to talk with their doctors about onychomycosis and its treatment options. So the company re-named the condition the more consumer-friendly "fungal infection" and took out newspaper ads asking readers to call or write to "Step Wise" for a free brochure on foot care.

For a patient who is running out of hope, waiting for a drug to be approved can be interminable. Even on the fast track, a review can take six months or longer. Some patients with life-threatening diseases cannot afford to wait. In response, many countries have developed expanded access programs (EAPs) that give patients with no other viable alternative access to medically important drugs before they are commercialized.

Pfizer is embroiled in a whistleblower lawsuit based on an unproven legal theory with the potential "to scare the hell out of a lot of drug companies," says attorney Alan Minsk of Arnall Golden Gregory. If upheld, even those compliant with FDA regulations for off-label promotion might still be liable for Medicaid fraud under the federal False Claims Act (FCA).

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Antiquated manufacturing processes cost pharma money-a fact widely known and accepted in the industry. At some facilities, rejected batches, rework, and lengthy investigations have become a way of life, and by some estimates can inflate production costs by as much as 10 percent. According to G.K. Raju, executive director of the Pharmaceutical Manufacturing Initiative at the Massachusetts Institute of Technology, manufacturing consumes an estimated 25 percent of drug company revenues.

February Table of Contents

With overworked execs and underfunded campaigns, it is hard to believe that the ad industry has the resources to improve its creativity while churning out campaigns better, faster, and cheaper. But this year?s Rx Club Awards winners show that a more sophisticated and risqué style is emerging?direct in message, clear on benefit, and confident in execution.

When Gary Cupit, vice-president of global business development and licensing at Novartis, recently told an audience at Columbia University that "we always cling to products a year longer than we should," he was referring to one of pharma's more pressing and expensive, if lesser-known, problems: failure to promptly pull the plug on unsuccessful pipeline projects. A drug in clinical trials burns about $30,000 a day. For compounds that never make it to approval, that adds up to a frittering of $11 million each.

In spite of pharmaceutical employers' best intentions to the contrary, sales rep compensation is being squeezed in a vise that is gradually narrowing the gaps between what top, average, and bottom performers are earning. According to the Hay Group's Pharmaceutical Sales Force Effectiveness Study, co-sponsored by Pharmaceutical Executive, reps in the 90th percentile are earning just 40 percent more than the average performer. This is not to suggest that reps aren't being paid handsomely (they are), but that the pay-for-performance model is showing signs of weakness.

In PE's December Pipeline Report, an unexpected Phase III candidate rose to the top. The drug: BioMarin's Aryplase. The reason for its success: an amazing turnaround job by chairman and CEO Fred Price. But Aryplase is not Price's first accomplishment at BioMarin, which was spun off from Glyko BioMedical in 1997. It is, in fact, only one of many that resulted from Price's efforts to jump-start a stalled company.

Think back: When did you first hear the phrase metabolic syndrome? When did it start to become part of your business and its plans?

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