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Elan: The Virtues of the Middle

Executive Summary

Big Pharma's growth problems are horrendous; biotech's a crapshoot. Much to everyone's surprise, mid-sized drug companies may have the most options. Having done four modest acquisitions since 1986, Elan has transformed itself and, in the process, shown how middle tier companies can take advantage of licensing and acquisition opportunities big companies can't touch.

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Angiotech: Specialty Pharma in the Device World

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.

Clinical Trial Diversity Would Benefit From Regulatory, Financial Incentives, Experts Say

Access to expedited regulatory pathways, marketing exclusivity and tax credits in exchange for enrolling and retaining diverse clinical trial populations could provide a ‘carrot’ to the ‘stick’ in US FDA guidance and legislative proposals; attorneys Sarah Thompson Schick and Winston Kirton also call for a re-examination of concerns about remuneration for trial participants.

Could US FDA Move Gene Therapy Regulation To Device Center In Years To Come?

CBER Director Peter Marks said more sophisticated manufacturing expected in the next decade could lead to questions about whether gene therapies should be regulated by his center or CDRH.

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