Pharmaceutical Executive-05-01-2007

The top 50 pharmaceutical companies, ranked by prescription pharmaceutical drug sales, plus rankings of top products, R&D spend, and more.

As the industry focuses its attention on the upcoming renewal of the Prescription Drug User Fee Act (PDUFA), there is a tendency to overlook two other significant pharmaceutical programs coming up for renewal and a related piece of legislation that has been introduced:

Perhaps the biggest mistake a first-time leader can make is waiting until the job actually begins before going to work.

Direct-to-consumer advertising officially becomes a "tweenager" this August-and, oh my, how it has grown. DTC was officially born in 1997 when FDA gave the green light to companies to advertise their drugs to consumers. In the first year, pharmaceutical marketers bounded onto the scene and spent more than $1 billion. Years passed. Debates ensued. Patients learned more about drugs. And, yes, spending grew. The latest available figures for 2006 show that the industry spent $4.8 billion on DTC advertising, a 13 percent increase over 2005 and the second year of double-digit growth.

The lights were hot, the cameras were flashing, and the B-list celebrities were out in full force for the New York premiere of InnerState, an hour-long documentary following the lives of three individuals who are using biologic drugs to combat different diseases.

When it comes to corporate reputations, it's clear the pharmaceutical industry doesn't quite get it. (Just pick up any newspaper.) But here's the latest newsflash when it comes to managing a bad rap: You get what you pay for.

When it comes to direct-mail marketing, tiny envelopes and wordy letters just don't cut it. But for a fraction of the cost of a sales call, you can create an eye-catching mailer that will land on physicians' desks rather than in the circular file.

Innovation in science is no quick trick, and neither is collaboration. Back in March 2004, FDA sounded a now-famous alarm: Despite the drug industry's 250 percent jump in spending on R&D, drug-development productivity had plunged by 50 percent over the previous decade. The report, which became known as the Critical Path Initiative (CPI), last year yielded an industry-wide call to arms regarding 76 action items (aka, the "Opportunities List") in six key areas: biomarker development, the streamlining of trials, the harnessing of informatics, improving drug manufacturing, public health initiatives against infections and bioterrorism, and special programs for adolescents, children, and other at-risk populations.

In march, us rep. rahm "Mr. Television" Emanuel (D-IL) reintroduced legislation aimed at what he calls "driving down the price of prescription drugs." But the only thing such legislation would accomplish would be the "driving down" of pharmaceutical innovation.

Pharma industry alliances are increasingly critical to success. They are gaining on R&D in terms of importance, especially since many companies are falling short in their internal pipelines and need to look outside for promising compounds. Today, nearly two-thirds of the top 20 pharma and biotech companies have established alliance-management functions. These usually cover deals in the discovery, development, and marketing space.

The reauthorization of the Prescription Drug User Fee Act (PDUFA) comes but once every five years. Set to expire September 30-and with congressional Democrats riding high and consumer confidence in drug safety at record lows-the deal by which pharma pays FDA to review its products is in for a long hot summer of debate.

If I had a dollar for every time I heard the word crisis used to describe the healthcare system of one country or another, I would be rich. And with the '08 elections revving up, we can expect to hear a crisis chorus from many presidential and congressional candidates wise to the fact that healthcare often ranks as voters' No. 1 issue.

The push is on to establish an approval pathway for generic versions of biotech therapies. The Hatch-Waxman Act of 1984 established a process whereby generic-drug manufacturers could obtain approval for a product based on the innovator company's data. But Hatch-Waxman doesn't apply to biologics regulated by the Public Health Service Act, and generics makers-as well as some Big Pharma companies and small biotech firms-want Congress to give the Food and Drug Administration authority to set up a similar process for these products as well.

Back in 2003, Roche resolved a long-standing lawsuit with Igen International by acquiring the company. As part of the deal, Roche acquired a perpetual license to use the Igen technology that gave rise to the lawsuit-electrochemiluminescence (ECL)-in certain applications. Igen's ECL patents, meanwhile, were assigned to a new publicly held spin-off company focusing on biosecurity testing, clinical point-of-care products, and vaccines. In March, Roche announced that it was acquiring the spin-off, Maryland-based BioVeris, for $21.50 per share, or a total of about $600 million.

Once you get past the Disney allusion, it's easy to see the appeal of the idea that everyone in the world is linked by a short chain of social acquaintances. This "small-world phenomenon" was first advanced four decades ago by social psychologist Stanley Milgram, whose groundbreaking work includes the theory that there are only six links, or acquaintances, between any two randomly selected Americans. Popularized as "six degrees of separation," this notion has been transformed by the digital revolution into a buzzing, booming hyperreality beyond anything even the radical Milgram could have imagined.

It's not always obvious just who is reponsible for the various steps of pharmacovigilance.

It's the start of a new quarter, and you've just been named the new product manager for Brand X.

Over the past 20 years, drug companies went from having carte blanche to set drug prices to operating in an ever more tightly controlled environment. Instead of doctors calling the shots, government and private payers are becoming increasingly vocal about which drugs they will and will not cover. Frustrated patients, in turn, are getting anxious about their out-of-pocket costs and access to the medicines they need.

Today's highest science, most fierce competition-and make no mistake, biggest gains-are coming from the oncology arena. In fact, there are more than 380 cancer compounds in development, according to a recent report by IMS Health, with almost 100 of them in Phase III trials.