Bharat Biotech Launches COMVAC5® the First Indigenously Developed Single Shot Pentavalent Combination Vaccine

Bharat Biotech International (BBIL) a leading producer of vaccines and biotherapeutics in India with a strong focus on product-oriented research and development announced today the launch of COMVAC5®, a single shot Pentavalent Combination vaccine containing Diphtheria, Pertussis, Tetanus and Hepatitis B, and Haemophilus Influenza type b (Hib).

COMVAC5® is safe, efficacious and an affordable vaccine that offers complete protection against Haemophilus influenza type b (Hib) antigen bacterium causes serious disease, often life-threatening illnesses in young children. Hib can cause meningitis and severe pneumonia, leading to ~3 million cases of serious illness and 400,000 deaths each year in children under 5 years of age.

Making the announcement Dr. Krishna M. Ella, Chairman and Managing Director of Bharat Biotech International, said, the launch of COMVAC5® is a milestone effort from Bharat Biotech to research, develop and bring to market absolutely indigenous vaccine that helps reduce childhood sicknesses and deaths from preventable diseases at affordable cost. With a single injection this vaccine has the ability to protect children against multiple infectious diseases. This Pentavalent vaccine demonstrates our commitment to consistently develop, safe and affordable vaccines for the emerging world.

Combination Pentavalent vaccines have been approved by several countries and included in their respective National Immunization programs for childhood vaccinations. Combination vaccines come highly recommended by WHO and other global regulatory agencies since they combine 5 antigens into a single dose, thus eliminating the need for multiple injections to infants. Reduction of injections to infants has proven to reduce the amount of side effects, and reduce the probability of disease transmission through needle contamination. Combination vaccines have proven to improve compliance with parents and infants since the # of doctor visits can be reduced. Pentavalent vaccines have also proved to be more cost effective to the patient than individual vaccines effectively reducing the cost of manufacturing and cost of administration.

COMVAC5® also provides protection against Hepatitis B virus, which causes, severe disease of the liver causing an estimated 5.7 million cases of acute hepatitis B infection and more than 521 000 deaths from hepatitis B-related disease. In addition to providing protection against Diphtheria, Pertussis, and Tetanus, which cause severe childhood diseases .This has been already included into the national immunization program and given to every single new born in India.

While other Indian manufacturers have imported conjugation and manufacturing technologies from Europe, and USA, the scientific, manufacturing and product development teams at Bharat Biotech have indigenously developed all processes required to manufacture COMVAC5® in-house at Bharat Biotech. Bharat Biotech has made significant investments to the tune of several million dollars over the past 4 years, into its R&D capabilities and its manufacturing facilities to enable the development and manufacture of COMVAC5®.

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About Bharat Biotech International Limited

Bharat Biotech International Limited, Hyderabad, India, is a multidimensional biotechnology company specializing in product-oriented research, development and manufacturing of vaccines and biotherapeutics. Bharat Biotech was established in the year 1996, is engaged in developing next-generation vaccines and biotherapeutics through innovative and collaborative research. Bharat Biotech is one of the first bio-pharma facilities in India to be audited and approved by Korean Food & Drugs Administration (KFDA). Bharat Biotech is also a WHO prequalified manufacturer of vaccines for supply to UNICEF and global procurement agencies.

Bharat Biotech sprawls over a picturesque campus at Genome Valley, Hyderabad, built with an investment of over USD 100 million, the facility’s Manufacturing, Control Procedures and Protocols, conform to the stringent standards laid down by internationally recognized institutions such as USFDA, UKMCA and WHO. Bharat has set new benchmarks in Innovation and Quality that epitomizes the tremendous progress of Indian biotechnology in the global arena. Bharat Biotech is the largest primary manufacturer of Vi Capsular Polysaccharide Typhoid vaccine, TYPBAR™, Bharat Biotech has commercialized India’s first recombinant Epidermal Growth Factor, REGEN-D® to combat diabetic foot ulcers, burns. Bharat Biotech’s INDIRAB™ (anti-rabies vaccine) is a market leader in protection against rabies infections from dog bites. Bharat Biotech is a world leader in Hepatitis B vaccines with the first company the world to manufacture REVAC-B MCF™, a cesium chloride free hepatitis B vaccine and the first company in India to manufacture a Thiomersol free hepatitis B vaccine. Bharat Biotech has supplied ~ 400 million doses of BIOPOLIO®, oral polio vaccine to the Govt of India during 2008-2009. Bharat Biotech has a strong pipeline of vaccines and therapeutics to combat Malaria, Rotavirus, Staph Aureus (MRSA) and Japanese Encephalitis infections.

Important information about forward-looking statements

Certain statements in this press release may be considered “forward-looking”. Such forward-looking statements are based on current expectations, and, accordingly, entail and are influenced by various risks and uncertainties. The Company therefore cannot provide any assurance that such forward-looking statements will materialize and does not assume an obligation to update or revise any forward-looking statement, whether as a result of new information, future events or any other reason. Additional information concerning risks and uncertainties affecting the business and other factors that could cause actual results to differ materially from any forward-looking statement is contained in the prospectus.