Year: 2007-08

Company: Amylin Pharmaceuticals

Liaison(s): David Litzinger

Amylin Pharmaceuticals Inc. is committed to the discovery, development and commercialization of novel medicines for the treatment of metabolic diseases. With two first-in-class products on the market, SYMLIN® (pramlintide acetate) and BYETTA® (exenatide), Amylin is continually striving to meet the therapeutic needs of patients. The goal of the project was to apply novel drug delivery technologies to Amylin’s active pharmaceutical ingredients, yielding a new generation of products that reduce the frequency of patient-driven dosing while enhancing patient compliance. Using a comprehensive, multidisciplinary approach, several implantable drug delivery systems were evaluated for potential inclusion as treatment options within the diabetes and obesity therapeutics market. Historically, implantable drug delivery devices have been developed for a variety of therapeutic areas including pain management, viral infection, delivery of hormones and cancer treatment. The drug delivery systems investigated for Amylin were generally small devices designed to be subcutaneously implanted in patients. The devices provide controlled and sustained delivery of drug for extended periods of time. To assess the market for implantable devices, the team evaluated the compatibility and feasibility of each type of implant with Amylin’s compounds and also investigated the implants from a financial and market acceptance point of view. The implications of launching a drug delivery product of this nature for the diabetes and obesity markets were evaluated based on several factors including patient, physician and payer acceptance, along with the reimbursement landscape and product utility. Other delivery technologies that prolong drug action were examined to explore changing the treatments for diabetics and obese patients. Summaries of the team’s findings, including analysis of regulatory issues and development of a commercialization strategy, were organized into traditional marketing frameworks. Ultimately, a final recommendation detailing the most effective drug delivery systems was given.