NexGenerix™: Useful not Fancy -The Generics Pipeline Database

ABSTRACT  The drug substance/product generic manufacturers need to anticipate and monitor the developments in the market, legal and regulatory landscape of the global pharmaceutical industry. The complexity of any generic drug launch has been increasingly mitigated by use of specialist databases such as Newport, GenericsWeb or Future Generic Drugs (FGD). These databases offer the Cadillac ride for the price insensitive market segment, typically large pharmaceutical companies. Marketchemica found that small & medium size enterprises (SMEs) do not have access to reliable information at an accessible price point. MarketChemica worked with Becker & Associates to carve out from their top of the line FGD database a subset database sold under the brand name NexGenerix™. NexGenerix™ is specifically designed to meet the day-to-day needs of the typical decision maker in the generic industry in a cost efficient manner. INTRODUCTION Chemical and pharmaceutical manufacturers need to manage proactively their generic product pipeline. They must develop and maintain in-house knowledge of the complex and continuously evolving pharmaceutical landscape in order to decide on the products and the timeline for a successful generic launch. Gaining an early understanding of the future opportunities requires constant monitoring of the IP, regulatory and market related aspects. This monitoring is by necessity broad in scope and focused on a few critical aspects. The outcome is a list of strong candidates for the company’s product generic pipeline. Making final decisions on the portfolio of products that will actually be developed and launched is narrow in scope but has to explore exhaustively the vast information surrounding these products. These two levels of activities will require access to very different levels of information. There are several high quality databases offering access to comprehensive information on intellectual property, market authorization, sales and market trends etc. In our view, the designers of these databases strive to respond to the complexity of the generic development decision by compiling data relevant to every conceivable need of any conceivable pharmaceutical company. This “one size fits-all” approach is not driven by the real life needs of the generic industry professionals but rather simply made possible by the advent of huge computing power. Licensing-in eclectic subsets of data from various market leaders and availability of information is unfortunately reflected in he cost structure of the premium databases. This cost structure pushes the price beyond the reach of most SMEs. This is why from a buyer’s perspective it is important to think of investing in databases that are providing just enough information for the day-to-day decision making process. It is often more cost effective to collect the relevant information for your specific needs on a case by case basis rather than paying upfront for this “one-size fits all” information. DISCUSSION In an effort to glean the extent to which the information contained in various databases is useful in the day-to-day activity of a generic SME MarketChemica undertook a product study of several popular databases[1]. The study is based on information publically available on the company websites, company presentations and hands-on experience with these databases. The market leader database, Newport Premium divides its product features in three main categories: 1) product intelligence, 2) company intelligence and 3) intellectual property intelligence. MarketChemica analyzed the products attributes along these three competitive directions for ease of comparison. Surprisingly, we found that much of the information included in these offerings is in fact not necessarily useful for the generic pipeline decision. Based on this observation, Becker & Associates launched a new product, NexGenerix™. The product was specifically designed to respond to the critical needs of the SME generic community[2]. Product Intelligence  Table 1 shows the claims made under the product intelligence category [3]. NexGenerix Table 1: Claims by the market leader under “Product Intelligence” category While having access to information on thousands of active pharmaceutical ingredients is certainly impressive, the reality is that there are only roughly 3500 launched API in the world with a further 800 to 1000 mixtures of APIs bringing the total drugs of commercial interest to 4500
[1] FUTURE GENERIC DRUGS (FGD), GENERICSWEB and NEWPORT were considered for the purpose of this article
[2] For the sake of full disclosure MarketChemica advised Becker & Associates on the marketing of the NexGenerix™ brand. [3] and