MUMBAI - New Jersey-headquartered Merck & Co's Indian affiliate MSD India is fanning out 150 trained medical representatives in 17 cities to promote a basket of three vaccines - a moderately aggressive measure as compared to a few other similar-sized companies having presence in the segment.

MSD's latest addition to its portfolio of Gardasil and Pneumovax 23 vaccines is RotaTeq - an oral pentavalent vaccine to prevent rotavirus gastroenteritis, which can cause fatal diarrhea in infants.

Before Merck, GlaxoSmithKline PLC was the only company marketing a rotavirus vaccine in India branded as Rotarix. Compared to a growing vaccines market of nearly 800 crore Indian rupees or $177 million, industry estimates suggest that the rotavirus vaccines segment is minuscule with a turnover of just 28 crore Indian rupees translating to $6.2 million annually, but the future market potential could be much larger given the widespread prevalence of the disease and the lack of access to medicines.

India's annual birth cohort of about 25 million annually is seen as a large business opportunity by big pharmaceutical companies (Also see "As Pfizer-Wyeth Combine Eye Vaccines Business, Novartis, GSK, Sanofi-Aventis And Indian Companies Brace For The Challenge" - Scrip, 1 February, 2009.).

Taking Rotavirus To The Roots?

Significantly, Hilleman Labs - Merck's joint venture with the UK-based Wellcome Trust - has identified rotavirus for future research and seeks to develop a heat-stable vaccine that can reach out to the rural poor in countries like India (Also see "Merck JV Ties Up With MEND To Focus On First Heat-stable Rotavirus Vaccine For Developing Markets" - Scrip, 24 January, 2011.).

Spearheading MSD's Indian business as its managing director, K.G. Ananthakrishnan - an ex-Pfizer Inc. executive - sought to play down competitive issues revolving around RotaTeq while explaining that India accounts for almost one-fourth of all the rotavirus infection deaths in the world.

That number stands at 100,000 deaths every year and is a tall order when it comes to preventive care, said Ananthakrishnan, emphasizing that the impetus is the disease rather than any other brands in the market.

In an interview with PharmAsia News, senior Merck executives discussed ways by which the company is looking to improve its delivery systems to bring life-saving medicines to needy patients. Merck said it plans to cover as many as 4,500 doctors in its first phase of introducing RotaTeq.

Merck intends to implement its time-tested model of an integrated disease management approach for its RotaTeq vaccine launch - the way some of its famous brands like Januvia (sitagliptin) and Gardasil were rolled out in India and have become benchmarks for launch strategies in emerging markets ('Merck Powering Up In Emerging Markets Through Alliance And Pricing Strategies,' PharmAsia News, Dec. 7, 2010).

Ananthakrishnan hinted that the company has initiated alliances with a few renowned medical bodies to propagate its message of preventive care. He also indicated that vaccines will be one of the key growth areas for Merck and much action could be expected in that segment.

Access, Price Key Factors

On the pricing front, MSD executives touted its much publicized India-relevant or responsible pricing strategy for RotaTeq. Made available at around $20 per dose or $60 for the three-shot course, MSD has a much lower shelf price compared to the price it charges in the developed markets.

But that may not be enough to give MSD a distinct edge as GSK's Rotarix with a two-dose regimen is priced much lower at $48 or 2,200 Indian rupees. "Rotarix is doing well for GSK," a spokesperson for the company said, indicating that it has been the only supplier of the vaccines till now.

Asked if the impact of Merck's RotaTeq launch could be felt in smaller cities and towns where the diarrhea prevalence rate is expected to be much higher than in the bigger cities, Rohit Agrawal, president-elect, Indian Association of Pediatricians, explained that once the word spreads through continuous interactions with prescribers, the message will be easily delivered to the interiors.

Also missing is a wholesome preventive vaccination approach from the Indian government, experts say. Agrawal blamed the Indian government for not including rotavirus in its immunization programs. But another pediatrician requesting anonymity said that in terms of priority for inclusion in the National Immunization Program, rotavirus may be placed much lower than a few other problem areas like HiB, typhoid and pneumococcal infections.

After encountering regulatory headwinds in the U.S. last year pertaining to presence of DNA from porcine circovirus type 1 in Rotateq and Rotarix, GlaxoSmithKline and Merck changed the labeling for their vaccines to state that they contain porcine circovirus.

The revised labeling for GSK's Rotarix and Merck's RotaTeq was approved by U.S. FDA Sept. 1; the new language mentions the presence of PCV but does not highlight it as something to be concerned about (Also see "GSK, Merck Revise Rotavirus Vaccine Labeling To Note Presence Of Pig Virus" - Pink Sheet, 9 September, 2010.).

MSD India officials outlined the company's future launches of about five to six products, which may accelerate its goal to figure among the top five pharmaceutical companies operating in India by 2015 (Also see "Merck Vows To Be In Top Five In India By 2015; Push Will Come From 13 New Launches In The Next Two Years" - Scrip, 23 February, 2009.).

The company has recently brought to India several leading drugs, including HIV medication Isentress (raltegravir), asthma drug Singulair (montelukast) and anti-allergy agent Nasonex (mometasone furoate).

- Vikas Dandekar (v.dandekar@elsevier.com)

Merck Aims For Deep Dive Into India's Vaccines Market With RotaTeq Launch; May Bring In Many More

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