The report, published by research group Cutting Edge Information, analyses line extensions and new market entry strategies as mechanisms to preserve a brand's place in the market and defend against the ever-present threat of generics. The key factor in firms' decisions to relaunch a drug, perhaps unsurprisingly, was identified as the new product's potential return on investment. If a company is unlikely to make any money from a line extension relaunch or new market entry product, there is little sense in devoting tens of even hundreds of millions of dollars towards the project. However, bumping up revenues was not the only reason behind launching follow-on products to existing brands according to the 30 pharmaceutical firms Cutting Edge approached during its research. Defending an established brand against generics also plays a major role in the development of relaunched drugs: "New formulations, when launched at the proper time and in the right sequence, can effectively stymie the market share erosion typically caused by generic competition," the authors claim. According to data provided by the pharma companies surveyed in the report, the average new formulation strategy can protect a brand franchise's market share for almost 27 months. However, timing is key, with the potential success or failure of a newly introduced product or formulation relying on savvy planning and knowledge of the marketplace. "If a product team waits to long to pursue a relaunch, the drug's patent expiration date may be approaching too rapidly to implement any meaningful tactics," say the report's authors. "However, brand teams with at least eight months on their sides can attempt to pursue a new dosing regimen strategy, for example. Other relaunch strategies require nearly two years of implementation, but new dosing regimens can create effective competitive advantages over both branded and generic products." As a result of the research, the report authors were able to put together a series of rules that pharma firms should keep to hand when contemplating a product relaunch, the report's 'Five Principles for Success'. The first rule reinforces the emphasis on timing, key in gaining the competitive advantage. With the greater success of a product resulting in greater competition from generics on expiration of the innovative drug's patent, early planning is essential no matter what particular strategy a product team decides to employ. According to the report, many companies put lifecycle management on the back burner, with 57 per cent of the companies surveyed leaving off relaunch planning until after the launch of the original product, and 32 per cent not even contemplating relaunch strategies until a product's fourth year on the market. Cost is also a major factor when considering relaunch options. Cutting Edge identified three main factors that affect to what extent a relaunch drain a company's coffers: therapeutic area, time to complete additional clinical testing, and the type of relaunch strategies employed. Cost can vary wildly depending on relaunch strategy, ranging from under $10m to ten times that figure. Schemes that involve complex scientific or technological elements are obviously towards the higher end of the scale, but the closer a product remains to initial market, the lower the cost. For example, a new indication relaunch within the same therapeutic area will require lower costs to target the same physicians. Relaunches for new indications involve new target populations which translates into more in-depth clinical trials and consequently higher costs - an average of $93.7m, going by the firms Cutting Edge surveyed. Multi-faceted approaches to product relaunches often yield the most successful results, combining multiple strategies that are well-timed and coordinated. Although in a ideal world only one relaunch (if any) would be required to protect a product's market share, in reality each relaunch forms part of a coordinated progression of relaunches designed to maximise a brand franchise's revenue stream, says the report. Integrated relaunch plans often sit more strategically with overall lifecycle management schemes, according to the report, so companies are often tempted to combine tactics and launch new formulations that also incorporate new dosing alternatives, for example. "Integrated relaunch strategies incorporate early planning and strong market research to keep track of changes in the competitive landscape," warns the report. "Furthermore, product teams must also coordinate the proper promotional mix to support their relaunch efforts." Profitability and return on investment are justifiably the driving factors behind pharma firms' decision to relaunch a product. Although some relaunches may only yield a $5m or $10m increase in sales, the profit margins on those relatively small revenue increases could cost as little as $1m to achieve. "Sometimes merely maintaining a product's or band franchise's revenue stream is enough to make the relaunch investment worthwhile, especially for a drug facing generic competition," says the report. Finally, the last pillar of Cutting Edge's guidelines for a successful relaunch strategy insists that any relaunch programmes must be part of a larger, considered lifecycle management plan to preserve market share and defend against generics. Generic competition and the potential threat it poses to pharma revenues have become a growing concern for many industry players, particularly with numerous blockbuster drugs due to come off patent in the relatively near future. In fact, according to the Cutting Edge report, generics have grown from a $21bn industry in 1998 to over twice that value today, with 53 per cent of all US prescriptions being filled with a generic product. According to the executives interviewed for the study, patent expiration is indeed a key driver for developing line extensions and relaunching a drug. Depending on the number of generic products waiting in the wings for a drug to come off patent, a branded product can easily lose 50-80 per cent of it annual revenue within a year of patent expiry according to the report. However, intelligent planning and sufficient investment can make all the difference; for example, the report cites the case of Bristol-Myers Squibb's blockbuster diabetes drug Glucophage (metformin) which came off patent in 2001. The company launched multiple formulations in an attempt to stave off the competition and defend its revenues in a successful strategy that added over $500m to the company's revenue stream. Product relaunches should form the cornerstone of lifecycle management schemes, according to the report authors, especially when confronted with the current risk associated with generic competition. "Pharmaceutical relaunches, although not always runaway successes, have the potential to thwart generic competition to the point where generics find the market wholly unsuitable to pursue." An integrated approach combining relaunch strategies with wider lifecycle management efforts can yield significant results in maintaining or increasing revenue streams and market share. The evidence presented in the report however, does seem to emphasise one particular recommendation with respect to the relaunch planning process - it's never to early to start.