RESEARCH AND DEVELOPMENT
Winning Research & Development
We’ve long believed that world-class R&D infrastructure and capabilities were the key drivers of value creation and sustainable growth. Consequently, our strong emphasis, deep focus, and industry-leading financial commitment towards R&D, has enabled us to set up one of the most comprehensive R&D facilities in the world with end-to-end discovery research and New Chemical Entity (NCE) development competencies. Our state-of-the-art, multidisciplinary R&D facilities are located across India, USA, UK and UAE.
Over the years, our strategic decision to focus on New Drug Discovery, Recombinant Biopharmaceuticals, Novel Drug Delivery and Generics, has been highly successful, satisfying and encouraging. With a product pipeline that focuses on less competitive and difficult to replicate products, we have built a strong Intellectual Property (IP) base filing patents and developing products for Abbreviated New Drug Applications (ANDAs) for the US and European markets. Till date, we have filed 3,037 patents cumulatively, and have been granted 628 patents.
Winning the War on AMR
The globally rising concern over AMR (Antimicrobial Resistance) and the promising developments of our Drug Discovery Programme have placed us on the cusp of an extremely exciting phase in the quest for discovering new antibiotics.
Our over 2-decade long focus and efforts in developing novel antibiotics has resulted in 5 of our new drugs under development being accorded Qualified Infectious Disease Product (QIDP) status by US FDA, all of which have entered Phase III clinical stage. Being developed as novel antibiotics, all 5 drugs are expected to significantly help the global war against Antimicrobial Resistance (AMR) in the near future. The progress made has been shared, presented and published at various industry fora.
STATUS OF NCEs
- WCK 5222 (Combination of Zidebactam and Cefepime that meets the urgent threat of Carbopenem-resistant Enterobacteriaceae and serious threats like Multidrug-resistant Acinetobacter, Extended spectrum β-lactamase producing Enterobacteriaceae (ESBLs), Drug-resistant Salmonella typhi and Multidrug-resistant Pseudomonas aeruginosa) – During the year, in a major development in Phase 3 Clinical trial, your Company finalized the Phase 3 study protocol in consultation with US FDA. Study to commence in 2nd half of fiscal 2018-19.
- WCK 4282 (Combination of high dose cefepime and tazobactam that meets the urgent threat of certain Carbapenemresistant Enterobacteriaceae and serious threats like Extended spectrum β-lactamase producing Enterobacteriaceae (ESBLs), Drug-resistant Salmonella typhi) - Phase 3 study protocol finalized in consultation with US FDA during the year. Study is expected to commence in mid 2018-19. EMEA feedback on Phase 3 protocol also received during the year and EMEA accepted WCK 4282 as carbapenem sparing drug and single Phase 3 study size of 1,100 patients would be acceptable.
- WCK 4873 (Respiratory antibiotic active against MDR Pneumococci which are regarded as serious threat as Pneumococci cause life threatening pneumonia often requiring hospitalization. WCK 4873 is also effective against clindamycin resistant streptococci which are regarded as concerning threat) – In a major development during the year, Phase 2 study has been completed in USA and Europe.
- WCK 771 (This is a broad spectrum anti drug – MRSA are regarded as serious threat as they could cause life threatening infections such as pneumonia and blood stream infection. WCK 771 is also active against MDR pneumococci, a serious threat category pathogen as well as Vancomycin resistant Staphylococcus aureus (VRSA) which is regarded as concerning threat category pathogen) – Phase 3 complicated skin and skin structure infections study progressing well in India. 325 patients already recruited with a target of 500 patients.
- WCK 2349, an oral drug corresponding to WCK 771 and has similar pathogen coverage as described above.
