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.

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