'Power peddling' drug lifecycles

In the highly competitive world of pharmaceuticals, the ultimate trump card is a drug with superb lifecycle potential. So, what is the cocktail for lifecycle success?

Answer: mix a strong patent position with potential for new indications, unrivalled safety and efficacy claims, multiplicity of dosage forms, and a dollop of good luck. A large pocket is also a big help – a pocket that can throw money at the all-important promotional spend.

Norvasc maintains no.1 spot

Pfizer's handling of its antihypertensive Norvasc (amlodipine), first launched in 1990, is an excellent example. Calcium antagonists are seeing their market share in the treatment of hypertension slip - from 25.1% in 1999 to 19.3% in 2000 according to IMS HEALTH's World Review . Pfizer's Norvasc, however, is the number one drug in hypertension, with a 34% market share in 2000 and 13% sales growth in US dollar terms. In comparison, Bayer's calcium antagonist Adalat (nifedipine), first launched in 1975, was number two, with a market share of 12% but static growth.

In an interview with IMS HEALTH Pharmaceutical Company Profiles in May 2001, Dr David Ebsworth, President and General Manager of Bayer's Pharma Business Group, admitted, "Pfizer has been very successful with Norvasc because they have spent a lot of money and created a high noise level – Bayer has not had that luxury."

Adalat lost its patent in 1985. Bayer has therefore done a remarkable job in milking its lifecycle. Ebsworth told IMS HEALTH that a number of factors contributed to Adalat's success:

• ability to recognise emerging indications (initially a treatment for angina, it became apparent that Adalat was even more effective in hypertension)
• dosage flexibility – it has become a once-daily product, having started off being taken three times a day
• geographic expansion – it is established in over 100 countries.

GSK says promotional spending key...

Dr Jean-Pierre Garnier, CEO of GlaxoSmithKline, highlights the power of promotional spending. Referring to GSK's corticosteroid Flovent/Flixotide (fluticasone), launched in its first European market in 1993, Garnier told Pharmaceutical Company Profiles that weighty promotional spending could capitulate changes in prescribing habits.

US doctors, contrary to their European counterparts, have been slow in adopting the use of corticosteroids in the treatment of asthma. Specifically, they have been loath to embrace the theory that breaking the cycle of inflammation improves patient outcome. GSK, by advertising directly to patients, got them more interested in their treatment.

"We think this has accelerated the many discussions between the patients and the physicians and I think precipitated the adoption of corticosteroids in asthma in medical practice in America. Clearly, the opinion leaders and the medical literature have presented strong cases that in asthma you need to treat the inflammation. But probably, awareness of patients, through the Internet and TV, has contributed to the more rapid acceptance," commented Garnier.

Flixotide/Flovent – Worldwide rankings and market share

...while AstraZeneca goes for efficacy

Demonstrating improved efficacy is a powerful lifecycle driver. Dr Hamish Cameron, Vice President and Head of Cardiovascular Therapy Area at AstraZeneca, told IMS HEALTH that the angiotensin II antagonist Atacand (candestartan cilexetil), another antihypertensive, is "a flagship product for AstraZeneca". The company is underpinning the lifecycle of Atacand, and challenging market leader Cozaar (losartan), from Merck & Co. In 2000, this had a market share of 39.9% (dollar growth of 19%) versus Atacand’s 8.7% share (but 65% dollar growth rate).

The CLAIM study is investigating the efficacy of Atacand and losartan in reducing blood pressure in hypertensive patients. According to Cameron, "CLAIM will give Atacand a boost as best in class. Moreover, via a series of other studies AstraZeneca is assessing the whole lifecycle of Atacand." For example:

• use in elderly hypertensives
• patients with congestive heart failure intolerant to ACE inhibitors
• and diabetic retinopathy (the latter highlighted as an area of unmet medical need).

"Atacand has one of the best lifecycle programmes in its class that should deliver a cascade of indications over the next few years," stated Cameron.

The lifecycle can be milked further by cleverly co-ordinating and marketing the benefits of one drug within a particular therapy area with another. AstraZeneca is doing this with Atacand and its ACE inhibitor Zestril (lisinopril). "Zestril forms part of a lifecycle continuum with Atacand – Atacand is recommended in the treatment of mild-to-moderate hypertension and Zestril in severe. AstraZeneca has been able to sustain Zestril growth while launching and growing Atacand, which flies against the predictions of many analysts," concluded Cameron.

Patent expiries and sales figures for some key
lifecycle drugs

Aventis starts at the beginning

Product lifecycle is not just concerned with post-launch phenomena: it begins at the discovery phase of research. Richard Markham, CEO of Aventis, told IMS HEALTH's Pharmaceutical Company Profiles that in choosing early R&D projects, the effect of the product on total healthcare cost is becoming an increasingly important selection criteria:

"The most efficient quality control is to ensure that the process is right from the beginning and that the product does not have any flaws. The second choice is to catch the flaws at the end of the production line. We need to be investing in products whose benefit to society is obvious. Companies will no longer be able to overwhelm the market with large sales forces and make third, fourth or fifth entries interesting – such a strategy will not be sustainable in the long run."

The power of the industry to increasingly exploit drug lifecycles is evidenced by the fact that in every single year between 1994 and 2000, despite the concomitant decline in the number of new products, the growth rate for the top 50 drugs exceeded that of the total pharma market. Research suggests that products peak much later than realised – 14 years is the current average for successful drugs. As stated above, Zestril is already off patent, but this has not prevented AstraZeneca from extracting every last drop of usefulness and profit from it.