GlaxoSmithKline targets filing 20 new drugs for approval by 2020

GlaxoSmithKline said Tuesday at an investor presentation that it hopes to file up to 20 new drugs with regulators before 2020, including seven medicines that are currently in late-stage development and could be launched before the end of the decade. CEO Andrew Witty commented "today, we have profiled around 40 innovative potential new medicines and vaccines which will support future growth in our pharmaceuticals and vaccines businesses." He added "for the first time, we have also outlined the scale of new earlier stages of development, notably in areas such as oncology and immuno-inflammation."

GlaxoSmithKline noted that it can potentially initiate Phase II studies for approximately 30 new chemical entities and product line extensions by 2017 and start Phase III development of up to 20 new chemical entities and product line extensions. The company, which is focused on the core areas of HIV and other infections, respiratory medicine, oncology, immuno-inflammation, vaccines and rare diseases, added that it additionally plans to begin late-stage studies of up to 20 assets between 2021 and 2025.

"The level of innovation in this portfolio is substantial," Witty stated, adding "we believe this is critical in today's operating environment as payers look to balance pressures of pricing and demand." GlaxoSmithKline noted that about 80 percent of the 40 experimental drugs and vaccines have a novel mechanism of action that could make them first-in-class therapies. Witty indicated that partnerships will be crucial in allowing GlaxoSmithKline to keep moving its most promising new drugs through development without increasing spending. "We have made that choice to prioritise our R&D capacity behind the assets we are talking about today," Witty said, adding "so as the new molecules move forward through Phase II, Phase III, the resource is there to start to back them."

The late-stage drugs highlighted by GlaxoSmithKline included Nucala (mepolizumab) for severe eosinophilic asthma, the experimental shingles vaccine Shingrix, the investigational rheumatoid arthritis therapy sirukumab, daprodustat for the treatment of anaemia, cabotegravir for HIV, a candidate combination vaccine for the prevention of bacterial meningitis and a new inhaled triple therapy for treatment of chronic obstructive pulmonary disease. The FDA is expected to issue a final decision concerning whether to approval Nucala by November 4 after an advisory panel backed clearance of the therapy for adults in June, while the European Medicines Agency's Committee for Medicinal Products for Human Use recommended authorising the drug in September. Meanwhile, GlaxoSmithKline indicated that global regulatory filings are anticipated for Shingrix in the second half of next year.

The drugmaker also said that it plans to advance cabotegravir, a long-acting integrase strand inhibitor, to late-stage development next year. In a Phase II study separately announced on Tuesday, cabotegravir in combination with Johnson & Johnson's Edurant (rilpivirine) exhibited similar efficacy in maintaining viral suppression as cabotegravir in combination with two nucleoside reverse transcriptase inhibitors. Meanwhile, a new collaboration will undertake a study investigating the potential of GlaxoSmithKline's NS5B polymerase inhibitor 2878175 and with Regulus Therapeutics' miR-122 antagonist RG-101 to offer a single treatment cure for hepatitis C.

GlaxoSmithKline reiterated a prior forecast that core earnings would grow at a mid-to-high single digit rate on a constant currency basis between 2016 and 2020. The drugmaker noted that the estimate includes a projection of at least 6 billion pounds ($9.2 billion) in annual revenue for new pharmaceutical and vaccine products by 2020. Only Nucala and Shingrix were included in the earlier forecast, and Witty said this figure now looked conservative.

Separately, on Tuesday, GlaxoSmithKline unveiled an agreement with Merck & Co. to initiate an early-phase study of its investigational immunotherapy GSK3174998 as monotherapy and in combination with Merck's Keytruda (pembrolizumab) for the treatment of locally advanced, recurrent or metastatic solid tumours that progressed after standard treatment.

For further analysis, see ViewPoints: More promises, but it's time for GlaxoSmithKline to deliver.

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