7/3/2017 EU regulator recommends approval of Taj Pharma's vaccines for European markets by The Financial Times Ltd

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

Contact Informa on
March 21, 2013

EMA's Committee for Medicinal Products for Human Use backed approval of the four vaccines for the Jack Andrew
European Markets to resolve vaccine shortages. The Financial Times Ltd
Alexandra Buildings, 28 Queen St,
(1888PressRelease) March 21, 2013 - Taj Pharma
Manchester M2 5LF
announced that the European Medicines
Agency's Commi ee for Medicinal Products for M2 5LF
Human Use backed approval of the four vaccines: Voice: 0161 834 9381
Hepa s-B (HepaVac), DPT (Humogen), Rabies Visit our Site
(Rabivaxi) and Meningococcal Polysaccharide
(Neisseria meningi dis).

The drugmaker indicated that the EMA's posi ve

opinion was based on mul -centre trials
involving more than 200 pa ents. Late-stage
studies comparing licensed combina on
vaccines, including Serum Ins tute 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 marke ng
authorisa on.

The company noted that these approvals will solve vaccine shortages and disease caused by the hepa s
B virus (HepaVac), infec ous diseases: diphtheria, pertussis (whooping cough), tetanus (Humogen);
rabies control (Rabivaxi) and Neisseria meningi dis, a bacterium that causes meningi s (Meningococcal
Polysaccharide).

Taj Pharma noted that if approved, the vaccines will be used for the primary and booster vaccina on.
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 interna onal 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 a er the EMA iden ed decreased immunogenicity in the hepa s B por on of the
product.

Merrill Lynch analyst MCLe Oerrigaud recently commented that "right now, Serum Ins tute of India has a
monopoly in this area from India," with vaccines genera ng 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 scien c evalua on of medicines developed by pharmaceu cal
companies for use in the European Union.

HepaVac Recombinant DNA Hepa s-B Vaccine: Hepa s B is a disease caused by the hepa s B virus.
The disease mainly aects the liver. However, if you are infected, the virus is present in body uids such
as blood, saliva, semen and vaginal uid. In the UK it is es mated that about 1 person in 1,000 is

https://www.1888pressrelease.com/eu-regulator-recommends-approval-of-taj-pharma-s-vaccines-fo-pr-461937.html 1/2
7/3/2017 EU regulator recommends approval of Taj Pharma's vaccines for European markets by The Financial Times Ltd
infected with the hepa s B virus.

Humogen DPT: (also DTP and DTwP) refers to a class of combina on vaccines against three infec ous
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 vaccina on,
both in humans and other animals.

Meningococcal Polysaccharide Vaccine: Meningococcal vaccine is a vaccine used against Neisseria

meningi dis, a bacterium that causes meningi s, meningococcemia, sep cemia, and rarely cardi s,
sep c arthri s, or pneumonia. Routes: Intramuscular (conjugate), Subcutaneous (polysaccharide),
Disease: Neisseria meningi dis.

About Taj Pharmaceu cals Group (India):

Taj Pharmaceu cals Limited is a pharmaceu cal company founded and based in India. The company
manufactures pharmaceu cal formula ons 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 Securi es Li ga on 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 men oned companies "es mates," "believes," or "expects" to happen or similar
language. The forward-looking statements in this press release are based on the current expecta ons of
the par es engaged and are made only as of the date of this press release and involve certain risks and
uncertain es that could cause actual results to dier materially from future results that may be
expressed or implied by such forward-looking statements. Unless required by law, no men oned
company undertake any obliga ons to update, change or revise any forward-looking statement, whether
as a result of new informa on, addi onal or subsequent developments or otherwise.

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