Abstract

Upcoming India-Discovered Antibacterials against Superbugs and Drugs for Myeloid Leukemia Therapy

Noel de Souza, Consultant, Independent Pharma Drug Discovery & Development

The author describes drugs discovered and developed under his leadership at different phases of his career, commencing in 1970. Teams of Indian scientists were brought together at the Drug Discovery units and Research Centres which he was instrumental in setting up. These drugs are currently generating international interest and recognition. Three of the drugs are in the therapeutic area of anti-infectives. In recent months, the USFDA has granted two of them, WCK 771 and WCK 2349, Qualified Infectious Disease Product (QIDP) status, the first instance of an Indian pharmaceutical company receiving a QIDP status. One is an injectable and the other a solid oral dosage form, both recently recognized for their activity against acute bacterial skin and skin structure infections, and hospital acquired bacterial pneumonia. The third drug in this series is Nadoxin , a topical dermatological antiinfective, marketed successfully already since a few years domestically and in international developed country markets. Two other drugs are in the therapeutic field of cancer chemotherapy, the leukemias. Alvocidib is a multi cyclin-dependent kinase ( CDK9 ) small molecule inhibitor for the treatment of patients with acute myeloid leukemia (AML). In April 2014 USFDA granted it orphan drug designation. A newer forskolin analog with selective protein phosphatase 2A activity offers an opportunity for use in chronic myeloid leukemia (CML). On a global basis, drug discoveries encounter different fates: very few become blockbusters, most bite the dust, and a few go on through an arduous process spread over several years after discovery to get marketing authorization approval. The lecture, while focussing on this last category of drug discoveries, provides encouragement to Indian researchers to engage more in drug discovery activities rather than to be mere generics followers.