Refueling for a longer race

Managers are trying hard to extend the life of their existing products to maintain the revenue streams for their companies, thereby making life cycle management an important issue in the pharma industry, Nandini Patwardhan discovers

Brands have life, and like humans, they die too. While they are alive, they pass through various stages, including introduction, growth, maturity and decline. It is up to managers to steer their products successfully by deploying appropriate strategies to maximise returns in each of the phases. In the pharma context, life cycle management gains importance because this is a knowledge-intensive industry.

“Managers have to decide the timing of the entry and pricing of medicine depending on what stage of life cycle the product is in, vis-à-vis, competition,” explains Partha Ghosh, US-based independent consultant.

"My brand manager says that the brand life cycle is matured and this is a declining brand and I don't agree" -S P Maitra, Senior Marketing Director, JB Chemicals and Pharmaceuticals

According to Venkat Jayanti, Manager, Market Research, Pharmaceutical Products Division, of US-based Abbott Laboratories, “An important reason for managing a product's life cycle is leveraging the market potential for any product and also retaining the leadership and the market share, if they have a dominant position in the market.”

Yet another reason is to be able to generate a revenue stream for in-house product development, R&D and investment into other sources that would spark the revenues. SP Maitra, Senior Marketing Director, JB Chemicals and Pharmaceuticals, quotes an example of Amlodipine, a calcium channel blocker. While calcium channel blockers were witnessing a negative growth, a company came up with a reverse molecule called S-Amlodipine, and it acted as a brand energiser. As a doctor devises various methods to save a patient, a company too can adopt various strategies to save the product from an untimely death.

The options

Pharma companies can implement many strategies. According to Ghosh, strategies can depend on the pipeline of products for any company. “Sometimes when a company has an active pipeline, life cycle should focus on exit to suit the entry of the next product and in the process keep the prices high.”

“On the other hand, if the pipeline is not active, one must extend the life cycle as much as possible and manage the pricing in such way that the next generation products will find it difficult to compete,” he adds.

"You have a choice of entering a new molecule in the same category or doing something to the existing molecule to make it more useful" - Ajey Kumar, CEO, Ethypharm

Ajey Kumar, CEO, Ethypharm, which is a global, NDDS company, believes that there are many ways of managing the life of a pharma product even if it has reached a mature phase or declining phase. “You have a choice of entering a new molecule in the same category or doing something to the existing molecule to make it more useful.” This could be through marketing, wherein, a company can move it on to a new positioning or can also use a delivery system on the molecule to improve patient compliance, patient comfort and also reduce the cost of therapy. However, strategies that a company deploys should be properly researched and backed with clinical studies to ensure that patient safety is not compromised in any manner. Some of the strategies that can be implemented by pharma cos are as under:

In-licensing: When drugs go off-patent, companies need to keep generating new products to replenish the product portfolio. Since companies cannot generate a molecule at the drop of a hat, they prefer to in-license products. “That's what is happening in the US right now,” says Jayanti. “Most of the big pharmaceutical companies are in-licensing because in-house development takes several years. These companies acquire and in-license products that can help them strengthen their portfolio.”

Indication expansion: Indication expansion is a vital strategy that can be implemented to extend a product's life. For this, explains Maitra, companies need to evaluate their strengths. For instance, if a company has expertise and experience in the gastro segment, the brand manager's job for the company will be to find a therapy gap, identify a molecule and decide if it can be launched. In such a scenario, the company can launch an anti-spasmodic, which is also used by gynaecologists. Thus, even though the focus is gastro, the company still gets access to a larger patient pool through indication expansion.

Reformulation: There are two aspects to reformulation. A company can change the molecule supported by various stability, safety, and clinical studies and a completely changed dossier. The company can change some exipients, to offer more benefits. Jayanti explains the strategy with the example of Procardia, which was launched in 1970s and subsequently went off-patent. Pfizer re-launched this drug with a different delivery system in collaboration with California-based Alpha Oros. Together, they developed the same Procardia into an extended release formulation called Procardia XL and launched it. They received an original patent on this because it was a totally new formulation.

According to Maitra, Omeprazole sodium, which used to be marketed in capsule form, was launched as Omeprazole Magnesium tablet after patent expiry. This is a classic example of using reformulation and Novel Drug Delivery Systems (NDDS) as a strategy to enhance the life of a product.

NDDS: Take the case of paracetamol, a 20-30-year-old molecule. Ethypharm came up with a patented drug delivery technology known as 'Flashtab (a registered trademark of Ethypharm SA France)' for this old molecule. “Through taste masking, the taste has been improved and now it tastes almost like candy. It also dissolves in the mouth and hence patients don't need to swallow it. Thus, an old molecule was transformed through NDDS,” explains Kumar. This move has also resulted in an expansion of the target audience to include paediatrics and geriatrics. “Since there is no need to swallow the tablet and there is no messy syrup in the picture, it can be administered to anyone, from kids to adults, to elderly patients,” says Kumar.

Other examples of NDDS include, transdermal patches, sustained release medicines, oral inhalations and so forth. The objective of the NDDS strategy is to increase patient comfort and compliance, as well as, lower the cost of therapy. NDDS also helps in lowering the cost of manufacturing for the partner company. There are many molecules that have lower bio-availability. So there is a need to micronise them to increase availability in the human body. “For instance, fenofidrate is a molecule with poor bio-availability. Earlier the prevalent dose was 200 mg. Now very highly micronised versions servethe purpose at doses as low as 130 mg,” explains Kumar. “This may bring down the cost of manufacturing and more importantly improve patient safety,” he adds.

Combination products: Maitra opines that combination drugs are doing well in our country. There are as many as five drug combinations available today. Combination of drugs is one way of energising a pharma brand. For instance, one company has launched a five drug combo for coronary arterial disease patients, consisting of three anti-hypertensives, one statin and one aspirin. In this strategy, companies need to confirm compatibility of the drugs with one another.

Brand Extensions: Brand extensions or brand energisers, as they are often called, are a great way of boosting the mother brand. Every time a company comes up with new additions, a noise level is created, which in turn benefits the mother brand if it is experiencing a little decline. Maitra explains the strategy with an in-house example of 'Metrogyl', “My brand manager said that the brand life cycle is matured and this is a declining brand and I didn't agree,” says Maitra. A survey conducted by the company convinced them of the tremendous scope presented by the rural markets. Having realised the lack of awareness about the product in the interiors of the country, JB Chemicals & Pharmaceuticals introduced a few brand energisers, Metrogyl P ointment and solutions, which gave the necessary boost to the mother brand.

Patents and Life Cycles: Patents go a long way in protecting the brand for any pharma company. Hence, companies are aggressively looking at various strategies to get a patent extension. This is where NDDS comes into the picture. Companies can change the technology of the product and get a patent extension, thereby increasing the life of the brand and generate income.

"Most of the best selling products are old products, but they are still not mature" - Dr J B Smarta, Founder and Managing Director Interlink Marketing Consultancy

As soon as a new molecule is introduced, the innovator companies may collaborate with NDDS players to come up with a new technology, so that they can go in for an extension, once the molecule is supposed to go off-patent. “At times, we devise a new delivery mechanism and go to the innovator company with it. Thus we end up working with the originator many times,” says Ajey Kumar of Ethypharm.

In addition to these strategies, companies can also decide to switch markets from prescription to OTC, or look at expanding the user base for the product or co-marketing agreements with various other companies.

Plan of action?

Whatever the strategy they adopt, companies need to do a careful analysis of their brands before they execute it. Dr JB Smarta, founder and Managing Director of Interlink Marketing Consultancy, says, “By deploying one of these strategies, we can surely delay the decline of a company's product. But the point to consider is, are we getting profits through it?”

Another point to be considered is the stage of the product. A product may be 50 years old, but it does not necessarily mean that it is in the declining stage. “Managers consider that a product, because it is aged or launched in the 70s, is an aged product. Most bestselling products are old products, but they are still not mature. They are still growing,” comments Smarta. For instance, brands like Dexorange, Betnesol are some old but bestselling products. Companies need to undertake a systematic and a scientific analysis of their products and brands. They need to answer questions like, “What kind of obsolescence are we trying to create-technological? How much do we depend on this brand? What kind of profits will the strategy reap? Or will any kind of strategy implementation help at all?”

Pharma companies are here to stay, and for that they need to keep their brands in the market. Companies also need to undertake a detailed product portfolio analysis and decide which brands do they need to keep and which ones to get rid of. From the ones that will stay, managers need to understand every product and how it is growing and the growth potential of the segments that they are in. Answers to these questions will help managers to zero in on a strategy to extend the life of a brand.

editorial@expresspharmaonline.com