Blunting the bite

Written by Soma Das | Updated: Apr 29 2012, 07:28am hrs
Synriam, the sonorous brand, stands for the first original drug for malaria developed in India by a company of Indian origin, Ranbaxy Labs Ltd. Good news on new drugs usually infuses a new high in pharma companies, excites investors, takes share prices to record heights and sends analysts into projection frenzies to calculate potential revenues. By that yardstick, the response to Synriam has been muted. On the day of the launch, Ranbaxys shares closed down 1.80% since the previous closing at the BSE. That is because, Synriam (targeted at uncomplicated Plasmodium malaria)a combination of arterolane maleate and piperaquine phosphatetheat this juncture doesnt come with great economic promise and has been positioned as a product with a social intent. However, Ranbaxys achievement in developing a new drug is no mean feat, considering many pharma companies globally see this day only once in their lifetime and many more never see it at all despite relentless pursuit in drug discovery.

Economics of the drug

Ranbaxys eureka moment for its first new drug took eight years and an investment of over R150 crore, of which the government chipped in about R5 crore. On an average, the discovery of a commercial new drug takes over 10 years and an investment of over $1 billion (at least in US, which has churned out the maximum number of new drugs). Does this in itself qualify Ranbaxys drug to be seen as a great drug discovered extremely efficiently Not really, considering the greatness of any newly discovered drug cannot be detached from the therapeutic advantages it brings over existing drugs in the same category. Much of the success of the drug can be assessed during post-marketing surveillance and uptake in the retail market. For now, priced at R130 for three doses to be taken one per day for three days, Synriam can best be termed as a value innovation with incremental benefits. At length on some parameters, it is comparable to innovations that India has produced in other sectorsTatas Nano and GE Indias portable ultrasound machines. Ranbaxy claims it will be the cheapest therapy available in the category. It would have helped if the company defined the category better. The main competition, Novartis, doesnt sell its anti-malaria drug Coartem (artemether lumefantrine, against which Ranbaxy has pitched Synriam) in the open market in India and only gets into bulk procurement deals with the government. Price points of branded and unbranded generics vary widely.

Seeking answers on returns on investment for this product could be misplaced, considering the company has packaged it as a corporate social responsibility venture. And this is not very surprising as anyone remotely connected to the business of medicine knows that malaria is not where money is. It is a neglected disease that mostly afflicts poor people in poor countries. When asked the number of years it might take Ranbaxy to recover costs incurred on the R&D, Arun Sawhney, managing director and CEO, Ranbaxy, smiles and shrugs I dont know.

The company is surely working out ways to recover costsfirstly it is exploring ways to partner with the government so that the drug can become part of the national programme. For that, the price has to be slashed further. But soaring volumes should compensate. Secondly, it is conducting late-stage clinical trials in Africa, almost as an afterthought. The first set of trials happened in India, Thailand and Bangladesh, where the company initially planned to market the drug. Now it is preparing to finish trials in Africa by the next quarter, fulfill other regulatory requirements that might take about six more months and then export to African countries, says Sudershan Arora, president, R&D, Ranbaxy. Thirdly, trials for Synriam are on for Plasmodium vivax malaria and a paediatric formulation to expand target coverage.

However, analysts reckon that for it to become anything economically significant, it would first need a World Health Organisation prequalification for being more acceptable to international malarial programmes.

Therapeutic superiority

Ranbaxy also claims that Synriam is independent of dietary restrictions of fatty food and milk, unlike existing drugs. More significantly, existing drugs derive their raw material, artemesinin, from a plant, which exposes this critical drug to price fluctuations and supply constraints depending on availability of the plant. Synriam is based on a synthetic source, so Arora claims that production of the drug can be scaled up on a short notice, depending on the intensity of outbreak of disease. Maintaining a consistent supply would not be a problem, promises Arora.

But a section of scientific community is sceptical. Piperaquine phosphatethe, part of the composition, is a completely new drug. We would have preferred much larger trials, a scientist specialising in malarial drugs says. He hopes that any adverse effects of the drug would be strictly monitored. Ranbaxy, of course, maintains that the safety and efficacy of the drug has been thoroughly studied.

Also, the lower dosage regimen compared to other drugs that mandate more tablets could be effective in countering a difficult menacenon-compliance. If this drug succeeds in improving compliance, especially in remote areas, it could be tackling a very important problem of malariadrug resistance. Ranbaxy claims a cure rate of 95%.

New beginning for Ranbaxy

This drug may not prove to be a gross earner for Ranbaxy like its top, over R150-crore brand Revital, but might actually end up revitalising the company, which has been under a long spell of emotional turmoil. It has been tiding over one crisis after the other, especially owing to regulatory troubles in the US and frequent change of leadership in the past four years. A palpable high energy was visible amongst company officials in a high-profile ceremony that marked the launch of Synriam. This rejuvenation could also have had to do with other brighter spots that the company has recently seenbecoming the first pharma company from India to cross $2 billion in annual revenue in 2011, launching the generic version of Lipitor in US on time and making it a success story despite the odds stacked up by Pfizer to retain its market share, and beginning the sorting out process with US Food and Drug Administration.

Chief Arun Sawhney opened up to the media for the first time since his coronation in the company as MD in August 2010. When FE asked him if Synriam would be the first and the last drug to a come out of the stable of independent Ranbaxy, considering the company transferred its new drug discovery research unit to Daiichi Sankyo India Pvt Ltd in 2010, he said, This is a perception we would like to clear. R&D is in the DNA of the company and we would continue to innovate. At the time of transfer, Ranbaxy retained the rights to independently develop this drug, largely because it didnt fit well into Daiichis existing R&D portfolio.

Symbolic milestone for India

Synriam, which would technically remain the first new drug for malaria to be developed out of India, would attain a special place in the history of the Indian pharmaceutical industry. It would stand as a reminder that given patience, right environment, motivation, incentive and investment, Indian scientists have the prowess to innovate and can do beyond just reverse engineer drugs innovated by big pharmas. Meanwhile, the search for the first commercially successful new drug from India is still on.

Malaria in india

Malaria claims half a million lives every year globally. About 25 million cases and 38,000 deaths due to malaria were reported in 2010, especially in south-east Asia, according to estimates by the World Health Organisation. India contributes 77% malaria cases of the 2.5 million cases of malaria reported annually from south-east Asia.

About 95% population in the country resides in malaria endemic areas and 80% of malaria reported in the country is confined to tribal, hilly, difficult and inaccessible areas.

Following questions being raised on Indias abysmally low official malaria death count (around 1,000 persons per year), the Centre set up an expert panel to review the figure. Preliminary estimates indicate that every year around 40,000 adult Indians die of malaria.

The urban areas especially pose a challenge in malaria control owing to increased population and haphazard and unplanned growth. Consequently, urban slums are on the rise, where insanitary living conditions promote breeding of mosquitoes, which are vectors for diseases like malaria, filaria and dengue fever.

Under the National Malaria Drug Policy (2010), it has been recommended that the first line of treatment of all Plasmodium falciparum cases in the entire country will be Artemisinin-based Combination Therapy (ACT).

Scary numbers

Total number of malaria cases

2010

15,99,986

2011 (Provisional)

12,78,760

2012 (P)

92,467 up to Feb

Source: National Vector Borne Disease Control Programme