Seeking to Capitalize on New Device Technology Drug Companies are Reformulating IV Drugs for Subcutaneous Injection

(Amherst, NH) – As the pace of competition increases within the pharmaceutical and biotech industries, the concept of life cycle management is becoming a key component of drug product management. Much of the recent emphasis in this area has centered on efforts to extend patent rights protection. While reformulation has been and is an important approach, efforts to prolong IP benefits have only recently involved IV-to-SC drug re-engineering. This migration path is now becoming a significant pathway in the life cycle of many parenteral drugs. A number of technology approaches are currently being employed to accomplish this migration. By pursuing IV-to-SC strategies, drug owners are finding they can achieve a number of competitive advantages.

A number of therapeutic drug segments and individual drug classes with large user populations are still being delivered in legacy fashion. Infusion and intravenous drug delivery is a prime example. Such situations can provide exciting opportunities for infusion device market participants and their drug development partners. The companies behind a number of infusible and injectable drugs are well-aware that drugs delivered intravenously have been so far bypassed by the evolution that has taken place in the subcutaneous space. We expect drug developers to be willing participants in discussions about possible collaborative projects with device suppliers that have validated technology, and business models that have not outstripped their resources.

IV-to-SC drug repositioning refers to the strategy of positioning therapies requiring infusion by a qualified clinician as subcutaneous injectables in prefilled devices that are safe and efficacious when self-administered by the patient. A number of factors favoring patient self-care are driving interest in IV-to-SC repositioning among drug developers. These factors include managed care initiatives that cost savings of self care relative to outpatient infusion centers. Patient preference is a growing factor, as patients opt for the convenience and economy of home care in lieu of repeated visits to medical facilities to receive IV drugs.

The next generation in the evolution of infusion devices is the wearable subcutaneous infusion device. These small form factor subcutaneous infusion (SFFSI) devices are reaching a tipping point that is forcing the industry at-large to take notice and re-assess their product strategies accordingly. While there are currently two dozen products launched and in development, the presence of large pharmaceutical companies in this space and the strategic agreements in place with key SFFSI device developers indicates that the approach has found important advocates.

Capabilities such as compact device designs, flexible cannula insertion, variable dosing and drug cartridge replacement have positioned these devices squarely within the home healthcare space. Ease-of-use features such as intuitive infusion activation, strategic button placement, digital displays and tactile feedback cues further enhance the feeling of assurance and wellbeing among users.

These developments are detailed in a new and comprehensive report researched and written by Greystone Research Associates. The report – Intravenous-to-Subcutaneous Drug Repositioning - analyzes IV drugs that have been or are being developed for subcutaneous delivery. The report groups drugs by indication, supplier and drug class, and includes product analysis, opportunity assessments and participant profiles.

More information is available at http://www.greystoneassociates.org

Source: Greystone Research Associates

About Greystone

Greystone Research Associates is a medical technology consulting firm focused on the areas of medical market strategy, product commercialization, venture development, and market research. We assist medical and healthcare market participants in achieving their business objectives through the creation of detailed development strategies, product commercialization programs, and comprehensive market and technology research and analysis. Our market research publications are designed, researched and written to provide timely and insightful information and data on focused market segments, with the aim of providing market participants with the essential knowledge to refine and execute their marketing plans and financial targets

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Greystone Research Associates
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www.greystoneassociates.org

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