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EU regulator recommends approval of Taj Pharma's vaccines for European markets


EMA's Committee for Medicinal Products for Human Use backed approval of the four vaccines for the European Markets to resolve vaccine shortages. End
Quote (1888PressRelease) March 21, 2013 - Taj Pharma announced that the European Medicines Agency's Committee for Medicinal Products for Human
Use backed approval of the four vaccines: Hepatitis-B (HepaVac), DPT (Humogen), Rabies (Rabivaxi) and Meningococcal Polysaccharide (Neisseria
meningitidis).
The drugmaker indicated that the EMA's positive opinion was based on multi-centre trials involving more than 200 patients. Late-stage studies comparing
licensed combination vaccines, including Serum Institute of India's vaccines, demonstrated that Taj Pharma's vaccines are safe and induces a robust immune
response against all targeted diseases. The EMA noted that a pharmacovigilance plan will be implemented with these vaccines as part of its marketing
authorisation.
The company noted that these approvals will solve vaccine shortages and disease caused by the hepatitis B virus (HepaVac), infectious diseases: diphtheria,
pertussis (whooping cough), tetanus (Humogen); rabies control (Rabivaxi) and Neisseria meningitidis, a bacterium that causes meningitis (Meningococcal
Polysaccharide).
Taj Pharma noted that if approved, the vaccines will be used for the primary and booster vaccination. The product will be sold in Western Europe as stated
brands by Taj Pharma BMS, a partnership with Bristol-Myers Squibb, and by the French company alone in Eastern European countries as Taj collaborated
brands.
Earlier this month, CEO of Taj Pharma Group Abhishek Kumar Singh said, "these vaccines which will be available in international markets under the Taj brand
names, and are expected to be a "key growth driver" for the company this year." The drugmaker removed a previous vaccine, Hemavac, from the market in
2010 after the EMA identified decreased immunogenicity in the hepatitis B portion of the product.
Merrill Lynch analyst MCLe Oerrigaud recently commented that "right now, Serum Institute of India has a monopoly in this area from India," with vaccines
generating sales of 175 million pounds ($264 million) in 2012, EU approval is likely to dilute the monopoly in this specialist revenue stream.
About EMA:
The European Medicines Agency is a decentralised agency of the European Union, located in London. The Agency is responsible for the scientific evaluation of
medicines developed by pharmaceutical companies for use in the European Union.
HepaVac Recombinant DNA Hepatitis-B Vaccine: Hepatitis B is a disease caused by the hepatitis B virus. The disease mainly affects the liver. However, if
you are infected, the virus is present in body fluids such as blood, saliva, semen and vaginal fluid. In the UK it is estimated that about 1 person in 1,000 is
infected with the hepatitis B virus.
Humogen DPT: (also DTP and DTwP) refers to a class of combination vaccines against three infectious diseases in humans: diphtheria, pertussis (whooping
cough) and tetanus. The vaccine components include diphtheria and tetanus toxoids, and killed whole cells of the organism that causes pertussis (wP).
Rabivaxi: Rabies vaccine is a vaccine used to control rabies. Rabies can be prevented by vaccination, both in humans and other animals.
Meningococcal Polysaccharide Vaccine: Meningococcal vaccine is a vaccine used against Neisseria meningitidis, a bacterium that causes meningitis,
meningococcemia, septicemia, and rarely carditis, septic arthritis, or pneumonia. Routes: Intramuscular (conjugate), Subcutaneous (polysaccharide), Disease:
Neisseria meningitidis.
About Taj Pharmaceuticals Group (India):
Taj Pharmaceuticals Limited is a pharmaceutical company founded and based in India. The company manufactures pharmaceutical formulations and API for
India and other countries, owning about 450 brands and 4000 generic licenses. The company was established in 1995 as an enterprise and in 2004
became a public limited company.
Responsibility Statement:
Certain statements in this press release are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These
statements include, but are not limited to, statements that do not describe historical facts and statements that refer or relate to events or circumstances
that the mentioned companies "estimates," "believes," or "expects" to happen or similar language. The forward-looking statements in this press release are
based on the current expectations of the parties engaged and are made only as of the date of this press release and involve certain risks and uncertainties
that could cause actual results to differ materially from future results that may be expressed or implied by such forward-looking statements. Unless required
by law, no mentioned company undertake any obligations to update, change or revise any forward-looking statement, whether as a result of new information,
additional or subsequent developments or otherwise.
UNICEF Ambassador since 2010
Perhaps best known for his role as CEO, of Taj Pharmaceuticals (Mr.Abhishek R Singh)
As a UNICEF Ambassador since 2010, Abhishek traveled with UNICEF to visit UNICEF-supported programs for children affected by HIV/AIDS
in Africa in June 2014 and to the Ivory Coast and Liberia in 2011, to visit UNICEF-supported centers for war refugees and former child soldiers.
Mr.Abhishek R Singh continuously supports UNICEF and its mission to save and improve children's lives by encouraging family, friends, and
fans to donate to the U.S./ India Fund for UNICEF and support UNICEF via his social networks and media interviews.
www.unicef.org/about/employ/index_volunteers.html

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Mr.Abhishek Singh (ceo Taj pharma),

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