Aurobindo Pharma Limited is working on developing several viral vaccines including one for COVID-19 even as the candidate was approved for funding by the Department of BioTechnology, the company said in its latest annual report.
"During the year (FY20), we have further strengthened our presence in the vaccines segment through the acquisition of R&D assets from Profectus Biosciences through Auro Vaccines. Using those R&D assets, the team is working on developing several viral vaccines, including a vaccine for COVID-19," it said.
In November 2019, Aurobindo Pharma said its subsidiary Auro Vaccines LLC entered into a pact to acquire certain business assets from Profectus BioSciences Inc USA for an upfront cash consideration of USD 11.29 million (around ₹80 crore) with potential earn-outs on achieving certain milestones.
"Our vaccine candidate underwent an evaluation by BIRAC (Biotechnology Industry Research Assistance Council, Department of BioTechnology). BIRAC has evaluated our platform extensively and we have been informed that our vaccine has been shortlisted by BIRAC for funding initial development up," the city-based drug maker said in the annual report.
The company is developing Pneumococcal Conjugate Vaccine (PCV).
The global market size of the product is USD 6.2 billion.
The company has successfully completed the Phase-I and Phase II studies.
Phase-III clinical study is expected to be initiated by December 2020.
The final product would be launched by the end of FY22, Aurobindo said.
"The acquisition (of Profectus BioSciences) will also lead to the enhancement of our R&D capabilities and expertise in developing new vaccines from basic discovery to FDA approved products. As part of our commitment to patient needs, we have started working on developing a vaccine for COVID- 19," the report said.
Aurobindo is setting up manufacturing facilities for orals in China, injectables and other routes of administration like patches, topicals, inhalers, among others in India and in the USA.Also, its biosimilars (Unit XVII) and vaccines facilities (Unit XVIII) are ready for commercialisation.
The COVID-19 pandemic impacted select business segments like generic injectables due to a decline in in- patient volumes and out-patient footfalls in the hospitals during the last fiscal.
However, the muted growth was offset by volume improvement in other businesses.
Founded in 1986 by Mr. P.V. Ramprasad Reddy, Mr. K. Nityananda Reddy and a small group of highly committed professionals, Aurobindo Pharma was born of a vision. The company commenced operations in 1988-89 with a single unit manufacturing Semi-Synthetic Penicillin (SSP) at Pondicherry.
Aurobindo Pharma became a public company in 1992 and listed its shares on the Indian stock exchanges in 1995. In addition to being the market leader in Semi-Synthetic Penicillin’s, Aurobindo Pharma has a presence in key therapeutic segments such as neurosciences (CNS), cardiovascular (CVS), anti-retroviral, anti-diabetics, gastroenterology and Anti-biotics
Through cost effective manufacturing capabilities and a few loyal customers, the company also entered the high margin specialty generic formulations segment. Today Aurobindo Pharma has evolved into a knowledge driven company manufacturing active pharmaceutical ingredients and formulation products. It is R&D focused and has a multi-product portfolio with manufacturing facilities in several countries.
The formulation business is systematically organized with a divisional structure, and has a focused team for key international markets. Leveraging its large manufacturing infrastructure for APIs and formulations, wide and diversified basket of products and confidence of its customers, Aurobindo achieved revenue of USD 2.6 billion in FY2017-18. Aurobindo’s 11 units for APIs / intermediates and 15 units (10 in India, 3 in USA, 1 in Brazil and 1 in Portugal) for formulations are designed to meet the requirements of both advanced as well as emerging market opportunities.
A well-integrated pharma company, Aurobindo Pharma features among the top 2 Pharmaceutical companies in India in terms of consolidated revenues. Aurobindo exports to over 150 countries across the globe with around 90% of revenues derived from international operations. Our customers include premium multi-national companies. With multiple facilities approved by leading regulatory agencies such as USFDA, EU GMP, UK MHRA, South Africa-MCC, Health Canada, WHO and Brazil ANVISA, Aurobindo makes use of in-house R&D for rapid filing of patents, Drug Master Files (DMFs), Abbreviated New Drug Applications (ANDAs) and formulation dossiers across the world. Aurobindo Pharma is among the largest filers of DMFs and ANDAs in India.