‘Oxford of the East’ meets pharma of the West

Merck and Serum Institute collaborate on pneumococcal conjugate vaccine

Lloyd Dunlap
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WHITEHOUSE STATION, N.J.—Merck & Co. Inc. and the SerumInstitute of India Ltd. have agreed to work together to develop andcommercialize a pneumococcal conjugate vaccine (PCV) for use in the emergingand developing world countries.
The two organizations estimate that one out of every twochildren immunized in the world is inoculated by a vaccine manufactured bySerum Institute. In addition, Merck has developed more than one-third of theworld's vaccines for children, adolescents and adults.
Together, Merck and Serum will form a product advisorycommittee to oversee the activities required to develop and seek approval forPCV and pursue World Health Organization (WHO) prequalification. Under theterms of the agreement, Merck, through an affiliate, will receive specificrights to market PCV in certain designated territories, and Serum will receivespecific rights in other territories. Both companies will contribute to thedevelopment and manufacture of PCV. Specific financial details of thisagreement are confidential.
The Serum Institute, based in Pune, India—sometimes referredto as the "Oxford of the East"—is the largest manufacturer of DTP and MMR groupof vaccines and supplies its products to United Nations Agencies and also tomore than 140 countries. The recent launch of MenAfriVac, which was developedspecifically for Sub-Saharan Africa, has been "acknowledged by one and allrelated to the vaccine community," the institute states.
"Serum is committed to improving access to and affordabilityof vaccines for children throughout the world," says Cyrus Poonawalla, chairmanof the institute. "In working closely with Merck in the development of thiscollaboration, it became clear that we share parallel public health goals andthat our passion for getting vaccines to everyone who needs them is made evenstronger by working together."
Health ministers from WHO and Brazil/India/Russia/China(BRIC) have applauded India's role in making quality, safe and effective drugsmore accessible and affordable globally. At the BRIC meeting held in Beijing inJuly, they were unanimous in their praise for the pool of talented scientistsavailable in India, its strength in basic and pure sciences and its capacityfor innovation. The forum's participants said they were certain that India'scontribution to the global public health agenda is only set to grow due to itscitizens and leadership.

In her address, WHO Director General Dr. Margaret Chan singled out India'seffort when she stated that when African countries wanted a meningococcalvaccine at a cost of not more than 50 cents, it was the Serum Institute thatcame forward and did the job.
"All the major manufacturers of the world were approached byWHO but could not meet the cost criteria, which was critical for the Africancountries. The supply of this vaccine by India has saved hundreds and thousandsof lives in low- and middle-income African households," she stated.

Pneumococcal disease is a bacterial infection that causes pneumonia,meningitis, sepsis and other life-threatening ailments. Current estimates showthat at least 1 million children die of pneumococcal disease every year, mostlyyoung children in developing countries.
"Working side-by-side with Serum gives us the best chance ofdeveloping and bringing a product to the market that will help to protect morebabies and children," says Julie L. Gerberding, president of Merck Vaccines."Expanding vaccine access to emerging and developing markets is a top priorityand we feel strongly that this collaboration will be a giant step towardimpacting the devastation of pneumococcal disease."
In late 2009, Merck announced the creation of the HillemanLaboratories, a joint venture with the Wellcome Trust. At that time, Merck saidthe decision to base the new facility in India was largely based on the factthat, "India is a country which recognizes the need for low-cost healthcaresolutions to address the unmet medical needs of developing world populations.India has developed extensive and growing research, development, academic andregulatory capabilities that make it an ideal location. Furthermore, basing theventure in India will also facilitate engagement and partnership with a broadrange of developing country experts in vaccine research, policy andmanufacturing."

Lloyd Dunlap

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