The drug-delivery market came close to shattering the $10 billion ceiling last year, driven by looming patent expirations, consumer demand for easier-to-use products, and new biologics that can't be administered in pill form.

Not surprisingly, pharma has taken note of the trend, with more and more companies adjusting business strategies to take advantage of these new technologies, according to Greystone Associates. The tech consulting firm reports that the number of alliances between drug makers and drug deliverers has escalated over the past year, and often these partnerships involved administering an old drug in a new way--as a tool to extend patent life or even restart the clock on a generic drug.

The therapeutic areas benefiting from the technology span the spectrum, including cancer, ophthalmology, attention deficit and hyperactivity disorder, and virology (most notably flu vaccines.) Last week, for instance, Teikoku and Dermatrends signed a deal to codevelop a transdermal patch for schizophrenia and bipolar disorder. Two high-profile acquisitions last year also met drug-delivery needs: Teva tapped Antares to be its sole provider of mini-needle and needle-free injection technology, while Barr Laboratories cited Pliva's ointment and injection technologies as key drivers in its decision to buy the firm.

The largest portion of the $9.8 billion market--$7.3 billion--belongs to implantable, sustained-release, and targeted injectable products, according to a study from Kalorama Information, and this segment is expected to rake in $9 billion by 2010. A smaller piece belongs to needle-free technologies, which are more convenient for patients and safer for healthcare workers. That segment should reach in $3 billion by 2010, the report found.

But not all patient-friendlier drug delivery has been rosy. Pfizer had tagged its inhaled insulin product, Exubera, as another blockbuster in its arsenal, but so far uptake has been slow because of reimbursement and safety issues. The company has tried to remedy these problems through aggressive contracting with payers and a 24-7 call center staffed by healthcare professionals. "Sales to date have been minimal, reflecting a phased rollout of this product in connection with our education and training programs for healthcare specialists" is how Pfizer put it in its annual report.

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Pharma is forging more partnerships with technology companies to extend patent life.

Drug Delivery Ka-Ching!

A throng of plus-size Americans chanting "Free Acomplia now!" and "How many more have to diet?" descended on FDA's Rockville, MD-based headquarters this week, blocking doors and smashing windows to protest the agency's third delay of approval for the much-hyped anti-obesity drug.

We're joshing, of course--demand for Sanofi-Aventis's fat fighter, which is already marketed in 12 countries with full-year sales of over $40 million, hasn't yet reached quite that pitch. But with its next up-at-bat postponed until late July, the ever-growing costs and complications facing the French drug giant may help explain why other companies are leery about entering a market with such lucrative potential.

The Paris-based firm's silence has only deepened the mystery over the reasons for the FDA delay. In a sparsely worded statement, executives noted they had submitted more documents to FDA but named only their Serenade study--which shows that the drug doesn't only cause weight loss but improves cholesterol, blood pressure, and blood sugar. Still, reports of adverse psychiatric adverse events like depression and anxiety have dogged Acomplia (rimonabant), a cannabinoid type 1 receptor blocker that targets brain centers.

Public health officials and payers have long been warning our fast-food nation that "an epidemic of obesity" will add up to spiraling healthcare costs for related conditions--a predicament that may well make reimbursement for weight-loss drugs look like a thrifty alternative. Nevertheless, only two drugs have been approved to treat it: Abbott's Meridia (sibutramine), an appetite suppressant, and Roche's Xenical (orlistat), a drug that blocks fat absorption and is now sold over-the-counter by GlaxoSmithKline as Alli.

"With the health consequences of no therapy, we are shocked at the limited number of companies with late-stage therapies," concluded a report from Susquehanna Financial Group on specialty pharmas. "The surgery options lead to impressive weight-loss results--however, it should be viewed as a treatment of last resort."

But Allan Haberman, principal of consulting firm Haberman Associates, noted that there are ongoing difficulties with developing anti-obesity drugs. While the prescription for weight loss is simple--eat less, exercise more--replicating the results biologically is far from it.

Multiple factors go into appetite and eating, from the psychological to various signaling processes that occur between the brain, liver, muscles, endocrine system, pancreas, and so on. And since obesity has a social construction as well as a physiological one, collecting data from animal studies is difficult. "The standard models in mice are very extreme," Haberman said. "They're like nothing in humans." He added that the answer may come in the form of a pill that hits multiple targets, and even that might still need to be combined with behavior modification.

Yet the regulatory and scientific hurdles haven't entirely blunted the hunger for a silver bullet. Heavy-hitters AstraZeneca, Merck, and GlaxoSmithKline are among the companies vying for a slice of the, er, pie.

Third regulatory delay highlights difficulty of developing weight loss products.

FDA and Acomplia: Stuck on Each Other?

Despite its uncertain legal future, Wyeth's franchise of hormone-replacement therapies (HRT) has achieved blockbuster status. The company's overall pharmaceutical revenue grew nine percent, and officials cited Premarin and its cousin Prempro as key growth drivers.

A Philadelphia jury last month came out against the drug maker, siding with a woman who claimed HRT had caused her to develop breast cancer. The $3 million verdict is Wyeth's second loss in the four cases that have been decided, and the company insisted that it would appeal.

Yet so far the backlash has not put a damper on sales. With HRT still widely prescribed--albeit in lower doses--for severe symptoms of menopause, the Premarin family earned $1.05 billion in 2006 revenue, a 16 percent increase over the previous year. The company has also launched a new marketing campaign for the products, including the Web site, www.knowmenopause.com.

There are currently 5,200 pending HRT cases involving 8,400 women who suffered predominantly from breast cancer, but also from ovarian cancer, stroke, and heart disease. The company is taking a legal strategy similar to Merck's Vioxx team in pledging to fight each suit individually rather than under class-action status.

"We intend to defend the litigation case by case for as long as it takes," chairman and CEO Robert Essner told investors last week. "We are not interested in settling--we do believe we have strong cases." As if to reinforce the point, Essner added that the company has not set aside legal reserves to cover unfavorable verdicts.

Attorneys believe that because each plaintiff has a unique medical history, it's often to a drug company's advantage to address each suit on its own. In addition, judges have dismissed two HRT cases on the basis that labeling questions--whether Wyeth had adequately warned patients--were matters for FDA to decide, and that the company had done what was required of it.

The next trial is scheduled for mid-April. The number of cases has leveled off since the fourth anniversary of the release of the Women's Health Initiative data, which first raised the red flag about cardiovascular and other risks related to HRT. Yet there are clouds on the horizon. In December, researchers reported that breast-cancer rates have dropped 7.2 percent in the two years since women began abandoning HRT.

HRT franchise grows despite lawsuits, new safety fears.

Pharmaceutical Executive-03-07-2007

Drug Delivery Ka-Ching!

FDA and Acomplia: Stuck on Each Other?

Wyeth's Hormones Still Raging