The Big Squeeze - Pharmaceutical Executive


The Big Squeeze
The simple answer to pharma's pipeline crisis? Get more value out of the products you already have

Pharmaceutical Executive

Enlarge the playing field. One of the most familiar, and favored, tactics in product lifecycle management is expanding the uses of the product. Bayer's Adalat is just one example of a group of drugs that were introduced as treatments for angina and went on to achieve greater commercial success as antihypertensives. Indication expansion is also tried and tested in the psychotropic field, where diagnostic distinctions can be blurred and a drug initially promoted as an antidepressant may later find a niche in, for example, bipolar disorders. In gastrointestinal disease, it is now commonplace for drugs such as proton pump inhibitors to have a wide range of licensed indications, from full-blown peptic ulcer to dyspepsia.

Prolong the effect. Some drugs taken orally are absorbed from the stomach, but most reach the bloodstream from the small intestine. Thereafter, unless they have inherently long half-lives, their useful life in the bloodstream is around four hours. The inconvenience of having to take tablets so frequently was the spur for the growth of the industry's drug-delivery sector. Special drug-delivery formulations were mainly intended, at first, to achieve 12-hourly or even once-daily dosing.

The best-known example of an early sustained-release formulation is Voltaren Retard (diclofenac) from Ciba (now Novartis). The original Voltaren was a first-generation nonsteroidal anti-inflammatory drug (NSAID). Introduced from the early 1970s onward, NSAIDs revolutionized the management of arthritis and rheumatism. But the first-generation drugs were all short-acting and had to be taken three times a day. Already, second-generation candidates with inherently longer action were in the pipeline. But Ciba beat them to the market by launching a sustained-release form of its already highly successful Voltaren. The result was that Voltaren became, and remained, the most successful NSAID of them all.

The technology that is available to drug-delivery formulation scientists is far more advanced than simply making long-acting oral dosage forms. Transdermal patches and various inhalers have been familiar for many years, and there is ongoing research into newer, patient-friendly methods of administration, such as an inhalation form of insulin. Dosage-form innovation continues to be an important means of refreshing an established product and perhaps of expanding its usefulness.

Protect innovation. The importance of protecting pharmaceutical intellectual property is well recognized. Like other aspects of product lifecycle management, this should be considered at an early stage in a product's development. The increase in regulatory stringency in the 1970s and 1980s eroded the period of patent cover left to a product by the time it obtained marketing approval, but the Hatch-Waxman Act in the United States and the Supplementary Protection Certificates (SPC) measures in the EU meant that companies could effectively recoup the time a product lost due to regulatory delays. This greatly reduces the risk of losing exclusivity by filing early. However, there have been developments affecting the later stage of patent cover, and companies should be aware of them when contemplating the defense of a product against impending generic competition.

Go public. Branding is of far greater importance for OTC products than it is in the prescription marketplace, and failure to recognize this is probably a major reason why Rx-to-OTC switches have so often failed. A switch must be planned, according to some authorities, while the product is still in pre-licensing clinical trials, and certainly at least seven or eight years before the switch is made. This time is necessary to lay the groundwork for introducing the product as a consumer brand.

GSK's success in switching Zovirax (aciclovir) from prescription to OTC in the UK is a good example of the value of early planning. It was launched as self-medication for the treatment of cold sores in 1993, three years before patent expiry. Sales switched from the prescription product to the OTC version, which continued to maintain sales and to retain an OTC market share of more than 90 percent in subsequent years. Zovirax still sells at around $15 million per year at retail prices.


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