GlaxoSmithKline reloads its pipeline with new PhIII drugs following approvals, setbacks

GlaxoSmithKline confidently claimed a leading role for new drug development in the Big Pharma world on Wednesday, citing a rising return on its multibillion-dollar R&D budget while looking to swell its late-stage pipeline in 2014 and 2015 with about 10 new therapies.

Altogether GlaxoSmithKline ($GSK) scored 5 new drug approvals last year, about one in 5 of all new approvals at the FDA in 2013. Another drug, albiglutide for diabetes, is the next therapy on the most-likely-to-be-approved list. And the pharma giant says that its return on investment in R&D has surged to 13%, just below the 14% mark laid out by CEO Andrew Witty after he called for a new approach to drug research a few years ago.

In its annual review of the numbers the company said it was "delighted with the sustained improvement in both quality of our compounds and more especially the research areas currently being prospected. Our work in areas such as immuno-inflammation, antibody platforms, epigenetics and heart failure is particularly encouraging."

GSK spent about $6.4 billion on R&D last year (at today's exchange rate), right in line with the year earlier and easily enough to qualify for the top 10. While drugs like Tivicay and Breo and Anoro were approved last year, the company also experienced a series of setbacks for its heart drug darapladib, the cancer vaccine MAGE-A3 and a late-stage program for Duchenne muscular dystrophy.

Now it's time to reload the Phase III pipeline. Among its next late-stage programs expected in 2014 and 2015 you'll find two new respiratory programs for COPD and asthma; afuresertib, an AKT inhibitor for multiple myeloma; losmapimod for acute coronary syndrome; '275 gene therapy (Wiskott-Aldrich Syndrome); '944 topoisomerase inhibitor (an antibacterial); retosiban for preterm labor; tafenoquine (malaria) and PRAME ASCI (NSCLC).

GlaxoSmithKline reorganized R&D around a new research unit dubbed the DPU. The big idea here--as voiced by R&D chief Moncef Slaoui--was that carefully focused groups of investigators would keep their eyes on the prize of a new drug approval. They may not have earned a reputation for advancing new drugs that offer a dramatic improvement for patients, but they have been successful in winning over regulators.   

- here's the press release (PDF)