Brief summaries of recent product and company developments in the device industry, including a rift in the orthopedics industry following the DOJ settlement, new OTC aesthetics devices, and MannKind's prospects for partnering its inhaled insulin.

Cell Pathways began as the pet project of a man suffering a rare inherited disease causing colon polyps. He'd heard an anti-inflammatory from Merck might help, and when it did, he asked the prescribing physician to research it further. Hopes that Merck would take up the work were dismissed, so the founders decided to develop a metabolite of the original drug on their own. They got some money from angel investors and set to. The small firm came to believe its compound triggered cell death by a novel mechanism-and decided utter secrecy was necessary to protect the discovery. That choice meant Cell Pathways built no scientific credibility and found no partners. A new CEO has attracted some investors, taken the firm public and expanded its focus to cancer treatment. He too sought partners at first, before deciding the company had more to gain by keeping all rights to the product. Cell Pathways' credibility problem--compounded by a Phase III failure early in 1999--could be greatly healed if, as management now hopes, a revised data package convinces FDA to approve Aptosyn after all. The company insists it is not a one-trick pony, and says Aptosyn is in fact the first in a new class of compounds with the power to treat and even prevent some cancers. But before it can argue for a platform, it must prove the product works.

The CRO faces some long-term challenges. The most important of these may be that of adapting to a changing pharmaceutical landscape, in which the shrinking of the customer base caused by consolidation increases the importance of establishing solid relationships with the large pharma companies remaining. Covance has taken several significant steps to prepare itself for the future, including streamlining its organizational structure and adding to its technology platform. Indeed, Covance's management believes that creating a broad portfolio of service offerings will help it to build long-lasting relationships with its drug company clients. There is, however, a tension between Covance's desire for breadth in its offerings and establishing the specialization that can assure quality. In fact, many believe that a major barrier to building strategic CRO/Pharma partnerships is a perception that CROs can't be depended upon to produce high caliber work.One approach to addressing those concerns is through risk-sharing arrangements that offer CROs larger margins for a job well-done and penalizes them for poor performance. If the only way for CROs to ensure long-term stability is through long-term risk-sharing alliances with drug companies, Covance and its competitors will need to decide whether they can best win these deals with a one-stop shopping mall or with a high end boutique.

Consolidation in the pharmaceutical industry probably means that small biotechs like CVT will find drug companies either uninterested in co-promoting niche products or looking for too large a piece of the profits. Through its innovative deal with Quintiles' CSO, Innovex, CVT obtains considerable sales and marketing muscle, some up-front cash that it can invest in R&D, and gets to keep most of the profits from ranolazine. Innovex, on the other hand, stands to garner royalty payments that will substantially exceed its fee for service margins.There are likely to be more Innovex/CVT-type deals in the near future, as biotechs look for a share in the profits of the drugs that they help to sell. But biotechs like CVT have other options when it comes to co-promotion partners, including Big Biotech, medium-sized drug companies, and ex-US firms looking to increase their US presences.