Monday, November 20, 2006

Nimesulide revisited

Perception building has been an important component of the marketing warfare involving nimesulide, maintain CJK Simon and Sunil S Chiplunkar

You may recollect that ranitidine was at one time the topmost antiulcerant in the market. So intensive was the promotion, ranitidine achieved success even though ranitidine has side effects of impotence and gynaecomastia (development of breasts and female characteristics in males) in a small percentage of patients. Moreover, ranitidine was premium priced when launched. Further, ranitidine was able to out beat the formidable competitor famotidine which is purported to be a superior H2 receptor blocker and most economical. This is why the marketing gurus Al Ries and Jack Trout called marketing as a war of perceptions. The power of promotion was able to build a favourable perception of ranitidine.

Another example is piroxicam, which was a dud when launched by many companies. However, when a leading pharma company entered with piroxicam, they made it a top grosser NSAID brand in India. So forceful was their promotion, they built a very favourable perception for piroxicam. In this NSAID theatre, a new drama unfolded recently starring nimesulide. Perception building was an important component of the marketing warfare involving nimesulide.

Nimesulide market
As per ORG MAT Nov 2002, the nimesulide oral solids market is worth Rs 170.623 crores with a growth of 18.6 per cent. The leading Indian oral solid brand is worth Rs 53.30 crores as per ORG MAT Nov. 2002. The nimesulide oral liquid market is about Rs 26.50 crores with 2.82 per cent change. So the total retail market for nimesulide is about Rs 200 crores with mainly Indian players. Further, ORG does not cover institutional sales.

The opportunity: In this backdrop just imagine replacing the nimesulide market with some other NSAID by creating a negative perception for nimesulide.

A brief history
Nimesulide was first developed and marketed by Helsinn Healthcare, a privately-owned Swiss company based at Lugano. It was first launched in August 1985. Today, Helsinn’s nimesulide is on the market in more than 50 countries. Helsinn collects and manages wide post-marketing surveillance information based on more than 346 million treatment courses. Nimesulide is effectively used for the treatment of a variety of inflammatory and painful conditions including osteoarthritis in European and Asian countries for more than 15 years. Its marketshare is reported to be fifth amongst the NSAIDs in the worldwide market. In India it was introduced in the early 1990s and there are more than 70 brands.

A pharmaco profile
Nimesulide is a potent analgesic, anti-inflammatory and antipyretic. Nimesulide has a multi-factorial mode of action that sets it apart from other NSAIDs. Nimesulide is a preferential COX-2 inhibitor having around five to 20-fold greater potency against COX-2 than COX-1. Hence, nimesulide possesses a much lower risk for gastroduodenal lesions in comparison to classical NSAIDs.
Nimesulide inhibits the production of oxygen-derived free radicals, monochloramines and hypochlorous acid (which are all proinflammatory) from neutrophils and other inflammatory cells. Free radicals amplify the inflammatory process.
Nimesulide inhibits the release of histamine from mast cells and basophils. In the case of asthmatics, this property is very beneficial since there is no aggravation of asthma. Nimesulide inhibits the production of proinflammatory PAF (platelet activating factor) by neutrophils.
Other anti-inflammatory effects include the fact that nimesulide inhibits phosphodiesterase 4, neutrophil esterase, cartilage collagenase and stromylesin (which are all enzymes that catalyse breakdown of tissues).
Thus, in acute and chronic inflammatory conditions in patients, nimesulide is more effective than placebo and has comparable anti-inflammatory activity to well-established NSAIDs.

Long term therapeutic use of nimesulide has not caused serious GI symptoms. Also, nimesulide is safe for use in aspirin sensitive asthmatic patients. Nimesulide is beneficial in relieving the symptoms of rhinitis (common cold - where pain and fever may be there), rhinopharyngitis, and secretory otitis media (middle ear infection) with concomitant antibiotic
In more than 18 years of marketing experience, nimesulide has proved safe and effective in the symptomatic treatment of a wide range of conditions such as osteoarthritis, tendinitis, bursitis, respiratory tract inflammation, post dental surgery etc.
Clinically observed adverse events are typical as those found with other NSAIDs.
A post-marketing surveillance of nimesulide suspension (50 mg/ml) conducted through 600 paediatricians all over India, has also indicated the absence of nimesulide-related hepatotoxicity in children.
The incidence of rare and unpredictable liver reactions with nimesulide is about 0.1 per one lakh treated patients, which is not higher than most of the other NSAIDs like diclofenac. The individual or inherent risk factors (like genetic factors) of the patient can predispose him or her to increased risk for development of nimesulide associated unpredictable hepatic reactions. This is just as with other drugs.
The wide clinical efficacy with unique pharmacodynamic actions and beneficial gastrotolerability and bronchotolerability in comparison with other NSAIDs may outweigh the relative risk of nimesulide-associated liver reaction (common to the
class of NSAIDs) in the long-term use of the drug.

In a cover story, The Hindustan Times (13.2.2003) declared: ‘IMA ends debate: nimesulide is safe.’ The IMA has pointed out that in an exhaustive survey doctors found nimesulide has minimal side effects. The benefits of nimesulide outweigh its adverse effects. Besides, only a handful of countries had banned the drug and most countries like Israel had withdrawn the ban. So this was the drama involving nimesulide - an attractive Rs 200-crore plus retail market.

CJK Simon is manager, Marketing and Sales, while Sunil S Chiplunkar is senior manager, Product and Training, Juggat Pharma, Bangalore

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