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.
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Angiotech positions itself as the first specialty pharmaceutical company dedicated to the drug/device interface. Best known as Boston-Scientific's pharmaceutical partner on the Taxus drug-eluting stent, Angiotech has created a large body of intellectual property around drug-device combinations. Focusing on the essential biological mechanisms involved in device failures, the company develops existing drugs for new applications in combination products for surgical markets, and it also owns a broad-based portfolio of drug eluting biomaterials. Now, as it looks to life after drug-eluting stents, Angiotech has plans to offer drug plus device combinations in peripheral vascular disease, orthopedics, ob/gyn surgery, and anti-infective coatings. It will thus face the challenge of managing, as a small to mid-sized company, a great variety of projects with limited resources. To lessen reliance on partners, going forward, it aims to capture an increasing proportion of revenues from product sales, taking some products from preclinical stage to market itself. But as a mid-sized company, it might have to choose between sacrificing a percentage of product sales to partners that provide development or distribution expertise that it doesn't have, or narrowly focusing on markets that it can address itself, but limiting its opportunities in a niche specialty.
Profitable but pipeline-poor Enzon tried to build a road back to R&D. But its value-oriented investors wouldn't support the spending ambitions, particularly as their royalty income declined. Enzon tried to merge with NPS, a pipeline-rich unprofitable company, hoping to transform its conservative shareholder base for one looking for biopharma-type home runs--but there too ran smack into the immovable force of investor inertia.
The successful commercialization of drug-eluting stents (DES) has done much to pave the way for the biocoating industy. DES not only helped establish a new regulatory body to facilitate device-drug reviews, the FDA Office of Combination Products, they also proved that biocoated devices could take market share from uncoated products, command premium pricing and premium reimbursement.