DefinedHealth

Jeffrey M Bockman, PhD.

Other than those intrepid and risky biotechs, the pharmaceutical industry has not yet made any big play in gene and cell therapies. Big Pharma’s migration into spaces occupied currently by Specialty Pharma may, however, lead them to more complex therapeutics that are oftenindividualized and will require some type of specialized processing and service component. While the recent spate of deals and M&A activity in vaccines (including GSK’s acquisition of ID Biomedical and Novartis’ takeover of Chiron) is evidence of real near and mid term growth potential for this well-vetted category, it is possible that such moves will lower Pharma’s threshold for therapeutics that are more complex than biologicals and bring them closer to developing and commercializing complex therapeutics.

An alliance such as Roche’s with StressGen around a therapeutic vaccine for HPV-induced cervical intraepithelial neoplasia suggests one way Pharma might back into new, innovative approaches to treating diseases: moving from preventive to therapeutic vaccines might be less of a conceptual challenge than going from prophylactic vaccines to gene therapy. Many other players are now eyeing complex therapies (including therapeutic vaccines other than those for cancer, such as smoking cessation), and of particular interest are non-traditional players.> Recent moves include those such as BioVeris’ acquisition of rights to a broad portfolio of Baxter’s vaccine candidates, Crucell’s acquisition of Berna, Teva’s investment in Gamida’s cord blood-based StemEx for bone marrow transplantation and Cambrex’s deal with Ortec for marketing and distribution of Orcel, a cell therapy for wound care (Cambrex is already the exclusive manufacturer of the product). Meanwhile, complex and specialized therapeutics are progressing through the clinic. Including novel therapeutic tumor vaccines, at least 70 products are in Phase II or III in the US, of which roughly half are for cancer, with many of the remainder for indications such as cardiovascular disease or wound healing.

This Insight Briefing will be an update on progress in this field since we last explored it a year ago. We will also high-light new players entering this space and why, the latest developments in clinical trials, re-consideration of commercial challenges, and discuss what it might take to compete and succeed with a complex therapeutic