Bharat Bio’s lysostaphin to treat staphylococcal infections wins US, EU patents

India’s biotech firm Bharat Biotech International (BBIL) has won patent rights for lysostaphine, an antibacterial enzyme against staphylococcal infections from leading markets including US, Europe, China and Australia.

Lysostaphin is a potent antibacterial therapeutic targeted specifically against Staphylococcus aureus (S.aureus).

Lysostaphin is a glycylglycine endopeptidase that rapidly cleaves the peptidoglycan backbone of S.aureus, leading to the collapse of staph cell in all its metabolic states.

Staphylococcus aureus is one of toughest bacterium to deal with using the currently available antibiotic drugs.

Staphylococcus causes a broad spectrum of diseases, including superficial lesions, such as wound infections; systemic and life-threatening conditions, such as endocarditis, osteomyelitis, pneumonia, brain abscesses, meningitis, and bacteremia; and toxinoses, such as food poisoning, scalded skin syndrome, and toxic shock syndrome.

Staphylococcus strains are also resistant to most of the antibiotic drugs.

Lysostaphin being bactericidal in action is indifferent to antibiotic resistance and could be drug of choice for treating life threatening S.aureus bacteremia caused drug resistant S.aureus.

A pre-IND (Investigational New Drug) – application submitted to get approval for clinical trials on new compounds with US FDA – Application meeting of the pre-clinical data has already been held with US FDA, according to Dr Krishna Ella, chairman and managing director, Bharat Biotech.

Patent rights for Lysostaphin is a significant milestone could pave way to develop products for regulated markets, in addition to India, Dr Ella hoped.

Apart from lysostaphin, Bharat Bio has  malaria vaccine candidates, PVrII, rotavirus vaccine candidates, ORV116E and anti infectives products currently in different stages of clinical trials.

Headquartered in Hyderabad, India Bharat Biotech International Limited (BBIL/Bharat Biotech),  is specialising in product-oriented research, development and manufacturing of vaccines and biotherapeutics. Bharat Biotech, established in the year 1996 by Dr. Krishna M. Ella &  Suchitra K. Ella as the  founder directors, is engaged in developing next-generation vaccines and bio-therapeutics through innovative and collaborative research.

Bharat Bio’s state-of-the-art manufacturing plant at Genome Valley, Hyderabad is the largest of its kind in Asia-Pacific. The Genome Valley is the first bio-pharma facility in the country to be audited and approved by Korean Food & Drugs Administration (KFDA). Built with an investment of over INR 1000 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 Biotech International Limited, a Hyderabad-based manufacturer of vaccines and biotherapeutics, on Monday launched COMVAC5, a single-shot pentavalent combination vaccine which contains the first indigenously developed and manufactured haemophilus influenza type-b (Hib) vaccine in India and the only Hepatitis B vaccine in the world to be manufactured without the use of cesium chloride.

In February, Bharat Bio launched COMVAC5, a single-shot pentavalent combination vaccine which contains the first indigenously developed and manufactured haemophilus influenza type-b (Hib) vaccine in India and the only Hepatitis B vaccine in the world to be manufactured without the use of cesium chloride.

COMVAC5, which contains diphtheria, pertussis, tetanus and Hepatitis B, and Hib, offers complete protection against Hib antigen bacterium. Hib can cause meningitis and severe pneumonia, leading to about 3 million cases of serious illness and 400,000 deaths each year in children under 5 years of age.

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.

Last year Bharat Bio announced the completion of he Indian Rotavirus Vaccine Development Project (RVDP) Phase I/II clinical trial of a live, natural reassortant, oral rotavirus vaccine 116E (ORV 116E), conducted in New Delhi, India.

RVDP is a collaborative effort with support and guidance from the Department of Biotechnology,
Government of India; PATH; US Centers for Disease Control and Prevention (CDC);Stanford University; US National Institutes of Health, National Institute of Allergy and Infectious Diseases (NIAID); Society for Applied Studies; National Institute of
Immunology, New Delhi; Indo-US Vaccine Action Program; All India Institute of Medical Sciences and Bharat Biotech International Limited.