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Lifecycle decisions are crucial to the success of new products, but often we fail to see the risks involved in the wider context. By reviewing what makes the ‘best’ product in early phases, companies can improve their later strategies.

Mike Rea at IDEA Pharma

There are three strategic opportunities inherent in the phrase ‘product lifecycle decisions’ that separate innovator companies from traditionalists. Firstly,‘product’ is a concept built around a molecule that that should focus on a combination of features, including indication, regimen, formulation, patient type, data acquired and so on. Pharma tends to discuss ‘molecules’ when it should talk about ‘product’. Secondly,‘lifecycle’ is a concept that, for many, means end-of-life patent management. However, as the life of a product begins in the lab, so should lifecycle options. Finally, ‘decisions’ are made possible when there is more than one option from which to choose.

Product

The product is dependent upon the variables inherent in path-to-market design, such as patient group, indication, endpoints, dose, regimen, formulation and so on. Therefore, it is helpful to maintain a view of the product as the outcome of a set of decisions that create a drug’s intrinsic properties and, in turn, the basis for the label and the resulting claims.

The challenge of traditional development has usually been summed up by the view that a molecule does what a molecule does and you cannot change it. While this is wholly true, it is not the whole truth – delivered differently, at a higher or lower dose, to different kinds of patient (whether younger, older or fitter), with different kinds of disease and degrees of severity (is an ‘obesity’ agent actually for type 2 diabetes, for example, or CV event reduction, or obesity per se) – a molecule can look like several different products. Consider Cymbalta for example, which could have launched as an (average) anti-depressant instead of one which had a pain

label, or Crestor, which owns ‘atherosclerosis reduction’ as a result of a differentiated clinical plan.

The label is a summary of these product characteristics, and it is a well-understood paradigm that will evolve over time as new data are gathered and new indications are explored. However, seeing this as an active process rather than a passive, semi-directed accumulation of data – following the path of lowest technical resistance – leads to a product that is intrinsically differentiated. Setting a direction for a product can establish a framework against which development decisions can be made.

Intrinsic differentiation describes a product that does not rely on promotion to differentiate itself within the market. Extrinsic differentiation describes the creation of a perception of the product as differentiated, and either (ideally) builds on intrinsic differentiation or tries to work in its stead.

A key part of the intrinsic product is the value proposition – the demonstration of why the product is worth the price being asked. As the price of the product is a variable, it is critical that a product demonstrate a value that is higher than the price being asked. Increasingly, payers are demanding that this value has been demonstrated in the clinic versus

a standard of care to show that the work of establishing comparative effectiveness has been undertaken rigorously and actively, and that the reimbursement of the product will be limited to those patients and situations where this value has been demonstrated. As an example, an agent that might work as an obesity agent will have several approaches that it could pursue to be better, each of which will have a different value proposition to prescribers and payers. Simply demonstrating the degree of average weight loss is a path 

already pursued (unsuccessfully, in the most part) by most entrants in this market. Each of the propositions around this wheel would have different consequences in terms of value to a payer or prescriber, but each could be evaluated differently in Phase 3.

Lifecycle

Traditionally, lifecycle management was bolted onto end-of- patent-life, but it is increasingly becoming something that is considered in earlier phases of development. This difference is simply a case of the directed evolution of the product versus a more accidental pathway.

This separates it from the previous views of the role of the lifecycle as a way to blunt entry of generics, to one that enables the sequencing of launches. This view can then stop companies having to aim at a mass-market ‘blockbuster’ type launch to one that is appropriate for a product that knows where it wants to go. Gleevec, for example, is a blockbuster precisely because it launched into a high value space that was a perfect fit for the drug, not despite such a highly targeted launch; later they began to develop further indications.

The answer to the question ‘how soon is too soon to begin thinking about where else the product could go?’ is usually self-evident. The industry is increasingly moving from a

paradigm that was driven by the need to stock portfolios with de-risked options. Instead they are beginning to take a more ‘domino-like’ approach, where success in one indication can lead to another, rather than the older ‘multiple shots on goal’ approach that inevitably carried commercial risk. Although

it is possible to launch a product that has only been studied against placebo, this presents a commercial challenge. As a platform from which to launch successive propositions, this low risk position is increasingly recognised as a mistake.

Companies are more frequently electing to launch into a high value space with good indication of commercial success, such as a niche proposition with a high value in a limited population, and then following this with a series of equally well considered moves. As in chess, a bad opening series of moves will affect the whole game, not just the first moves. The commercial risk inherent in trying to launch a relatively undifferentiated product may mean that successive additions to the label seem simply like trying to close the stable door after the horse has bolted. Examples such as Elidel, Faslodex and Xenical – which launched as undifferentiated propositions versus the sometimes generic standard of care, but then tried to add in more compelling data or propositions once on market – show that it is rare that success follows failure to establish a foothold in the market. Compare this to a product like Cymbalta, which immediately established a high value proposition at launch....

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