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'Enormous potential' for nicotine vaccines, new report claims

The major markets for prescription anti-smoking therapies remain underdeveloped with 'enormous potential for growth', according to a new report, It also suggests that new products which are more effective than current therapies at preventing relapses should generate 'substantial revenue' for manufacturers.

The major markets for prescription anti-smoking therapies remain underdeveloped with "enormous potential for growth," according to a new report, It also suggests that new products which are more effective than current therapies at preventing relapses should generate "substantial revenue" for manufacturers.

Datamonitor's Pipeline Insight: Substance Dependence report (Jan 25) on the nicotine dependence market notes that even though the vast majority of anti-smoking products are made available over-the-counter (OTC), a new wave of prescription-only nicotine vaccines and combination products, several of which are currently in late-stage development, could help the 3.88m of the 4m people in the UK who attempt, yet fail, to kick the habit each year. 

Sales for OTC nicotine replacement therapies across seven major markets - UK, France, Germany, Italy, Japan, Spain and the US - exceeded $2bn in 2006, comprising the myriad gum, patch and lozenge products etc. In the same year, the market for prescription products, which comprises just two marketed therapies (Pfizer's Chantix and GlaxoSmithKline's Zyban), generated USD213m.

However, due to the low success rate of quitters - in the UK as few as 3 per cent succeed in any year, using mainly OTC products - nicotine dependence is a chronically relapsing condition, costing the NHS dearly in treating related, yet preventable, illnesses including cardiovascular disease, lung cancer, stroke and emphysema. 

If effective new products are successfully launched onto the market, Datamonitor forecasts the prescription sector (in the seven key markets) to grow at a compound annual rate of 16 per cent, soaring to USD4.6bn over the next eight years.

UK market challenges
Yet, the rise in Chantix (marketed as Champix in Europe) prescriptions seen in the US was deemed to result from a direct-to-consumer (DTC) marketing campaign. Referring to potential emulation in the UK of the product's uptake in America, CNS analyst and author of Datamonitor's report Charlotte Mackey said that in the absence of DTC advertising in the UK and Europe, "physician education by Pfizer's sales representatives will be of great importance" if the drug is to realise its commercial potential.

She added: "However, I expect Chantix will benefit from a large word-of-mouth effect among smokers, prompting those with sufficient motivation to quit to seek help from their GP."

Furthermore, she considers that achieving reimbursement in the UK market is "unlikely to be difficult" as healthcare cost advisers and payers should be keen to recommend and approve products which reduce the significant bill in treating chronic smoking-related disease.

She told PMLive: "In view of the size of the patient potential of nicotine dependence, the opportunity for a drug offering an improvement on current treatments is huge." 

Chantix warning - latest
Since the publication of Datamonitor's report, Pfizer has updated Chantix' label, warning healthcare professionals to check users for serious neuropsychiatric symptoms, including behaviour change, agitation, depressed mood, suicidal ideation and suicidal behaviour. 

Mackey admitted on Monday January 28 that the revised labelling "would deter a small proportion of patients from taking the drug," yet maintained that market prospects for prescription anti-smoking products - especially new therapies - remained strong.

Vaccines & combination packages
Nicotine vaccines, which prevent nicotine from entering the brain, are the largest drug class in late-stage development for nicotine dependence - indicating a future shift away from the traditional and currently dominant OTC nicotine replacement therapies. 

Two eagerly-awaited products include Nabi Biopharmaceuticals' NicVAX (potential launch in 2010) and Novartis' NIC-002 (potential launch in 2012). Being first in market and with a novel mechanism of action, Nabi is expected to garner significant interest from medics, generating in excess of USD700m in sales of NicVAX across the seven major markets by 2016, Datamonitor has forecast. However, Novartis' marketing prowess is expected to see the firm ultimately leapfrog NIC-002 into top spot, achieving sales of USD1.3bn by 2016. 

The main benefits of the new vaccine products include their convenient dosing regimen (although they are administered via injection) and long-term irreversibility, thereby side-stepping issues of non-compliance and reducing the risk of relapse.

Despite promising trial results, however, the two vaccines do not stop patients from craving nicotine. Hence, they could be most effective when administered with an 'anti-craving' supplement. Indeed, Mackey suggested that 'packages' of products offered by pharma might be most successful with European health systems.

"Offering a package [such as nicotine vaccine + anti-craving medication + patient support services] represents an opportunity yet to be exploited by companies wishing to supplement the efficacy of their vaccines and increase their market share."

Longevity - revenue
The overall prevalence of nicotine dependence is falling, and has been since the mid-1960s. However, Mackey does not concede that this will spell a short-lived marketing opportunity for new anti-smoking therapies.

"I do not believe that smoking bans will put a lifespan on nicotine vaccines in the immediate future, simply because of the enormous patient potential. In fact, smoking bans may work in favour of pharmaceutical companies by increasing the negative perception of smoking, thereby urging more people to seek treatment. Very few people currently seek help when quitting from their GP, so I believe companies still have many treatment naïve patients to target over the coming years."

Datamonitor estimates that nicotine dependence affects nearly 116m individuals across the seven major markets.

28th January 2008

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