Inhalation

catalent.com Until fairly recently, most large, fully integrated pharma- ceutical and biotechnology companies liked to keep all aspects of product development and manufacturing in- house, under direct control of the company. Today, howev- er, we estimate that the industry spends nearly one dollar out of every five on outsourced services, and Big Pharma has joined smaller companies in turning to contract devel- opment. In some areas of development and manufactur- ing, as much as two thirds of all of a company's expendi- tures on an inhaled product may go towards outsourcing. And with the substantial growth of specialty, emerging, and virtual pharmaceutical and biotechnology companies, partnering for mission criti-cal expertise and services has become the rule rather than an exception. Why are more and more pharmaceutical companies turn- ing to outsourcing partners for inhalation devel-opment and manufacturing? One reason has to do with the diver- sification of the market for inhalation products in recent years. Since its introduction, inhalation therapy has most- ly focused on the topical delivery of drugs to the nasal and pulmonary airways for the treatment of diseases such as asthma, chronic obstructive pulmonary disease (COPD) and seasonal/allergic rhinitis. By 2006, according to re- ports from Frost & Sullivan and Datamonitor, the value of product sales in this market segment exceeded $25 billion, and continued growth is forecasted. Much of that continued growth is taking companies be- yond their well-established expertise in drugs for the treatment of pulmonary diseases. After the 1987 Montreal Protocol, pharmaceutical companies devoted nearly two decades to the long and arduous journey through the transition from the use of CFCs to HFA as a propellant for MDI products. Development work focused mainly on what were essentially line extensions of existing products. Now, with the transition to HFA nearly complete, companies are turning their attention to other treatment areas. Although the development and production of several inhaled insu- lin products has now been dropped, the approval of Pfizer and Nektar's Exubera in 2006 demonstrated the potential for successful development of inhaled products in new areas. Clinical trials are underway for inhalation and nasal products to treat conditions as diverse as obesity, break- through pain in cancer patients, and Alzheimer's disease. Despite the substantial interest in the use of inhalation and nasal delivery platforms for a variety of drugs, few pharmaceutical and biotechnology companies today have the in-house expertise or intellectual property necessary for timely and cost effective development. Whether they involve new chemical entities (NCEs) or existing drugs reformulated for delivery with an inhaler or spray pump, these products generally present much more complicated development challenges than do solid dosage forms, in- jectables, and even the standard inhalables like salmetrol and fluticasone. Depending on the size of the pharmaceu- tical company and its experience with inhaled products, it may turn to a contract research organization (CRO) for help with one aspect of development or complete devel- opment all the way from feasibility studies to commercial- ization (Figure 1). 17 Why companies are looking for product development partners, how the process works, and what to look for in a CRO. Craig Davies-Cutting and Dean McKinney Catalent Pharma Solutions Figure 1

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