The traditional drug-delivery business model of service for hire has fallen from popularity. Big Pharmas are doing few deals of this sort, and investors want bigger returns than fees and royalties can provide. Start-ups with drug delivery technologies are increasingly using their platforms on their own behalf, to create products they can out-license or possibly market themselves. Now content--getting the molecules to be delivered--is an issue.

Disturbing news from a major hormone study, bad regulatory luck, and a botched attempt to reassure German gynecologists have hurt Schering's HRT business. Yet the company hopes to use its risk-lowering franchise strategy to distinguish its HRT products from competitors'.

Alkermes' success in creating a commercial product out of Genentech's growth hormone has taken it across a fundamental credibility gap all new drug delivery companies face. One result: an extraordinarily high valuation that has permitted it to raise plenty of cash. And it's using these assets--credibility, cash and valuation--to invest in programs which can bring it nearer term revenues and higher margins, in terms of new, accelerated, or risk-sharing deals. Indeed, it's even treating its current net-loss position as an asset, spending heavily now--which its profitable competitors can't, given their valuation-sensitive earnings constraints--and even signing complex deals to take its partners' expenses onto its own P&L, reimbursing itself with equity and downstream milestones. Moreover, it's shown itself, as in its acquisition of Advanced Inhalation Research, willing to dramatically expand its portfolio of technologies with work done on the outside. Alkermes also wants to develop products for its own account, though its strategy for commercializing them, while maintaining a strong delivery technology base, is unclear.

As an industry segment, drug delivery was virtually created by two companies--Alza Corp. and Elan Corp. PLC. These companies have since evolved into drug companies, abandoning a significant part of the field to second-generation arrivistes. Such companies that have survived the funding drought for small-cap companies have benefited, Inhale Therapeutics, for example, has a number of partnerships for its pulmonary delivery technology. Alkermes, probably the leading drug-delivery pure play, now has its first approved product. What is somewhat surprising about the industry is how little it has consolidated, particularly when one considers that no single drug delivery technology is applicable to a majority of drug delivery problems.